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<front>
<journal-meta>
<journal-id journal-id-type="nlm-ta">Integr Cancer Ther</journal-id>
<journal-id journal-id-type="iso-abbrev">Integr Cancer Ther</journal-id>
<journal-id journal-id-type="publisher-id">ICT</journal-id>
<journal-id journal-id-type="hwp">spict</journal-id>
<journal-title-group>
<journal-title>Integrative Cancer Therapies</journal-title>
</journal-title-group>
<issn pub-type="ppub">1534-7354</issn>
<issn pub-type="epub">1552-695X</issn>
<publisher>
<publisher-name>SAGE Publications</publisher-name>
<publisher-loc>Sage CA: Los Angeles, CA</publisher-loc>
</publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="pmid">38757745</article-id>
<article-id pub-id-type="pmc">11102686</article-id>
<article-id pub-id-type="doi">10.1177/15347354241252698</article-id>
<article-id pub-id-type="publisher-id">10.1177_15347354241252698</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Study Protocol</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>Exploring Guolin Qigong (Mind-Body Exercise) for Improving Cancer Related
Fatigue in Cancer Survivors: A Mixed Method Randomized Controlled Trial Protocol</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<contrib-id contrib-id-type="orcid" authenticated="false">
https://orcid.org/0000-0001-6296-6052</contrib-id>
<name>
<surname>Low</surname>
<given-names>Sara L. K.</given-names>
</name>
<degrees>MRes</degrees>
<xref rid="aff1-15347354241252698" ref-type="aff">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Ho</surname>
<given-names>Gwo Fuang</given-names>
</name>
<degrees>FRANZCR</degrees>
<xref rid="aff2-15347354241252698" ref-type="aff">2</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Liu</surname>
<given-names>Bingkai</given-names>
</name>
<degrees>PhD</degrees>
<xref rid="aff3-15347354241252698" ref-type="aff">3</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Koh</surname>
<given-names>Eng-Siew</given-names>
</name>
<degrees>FRANZCR</degrees>
<xref rid="aff4-15347354241252698" ref-type="aff">4</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Fei</surname>
<given-names>Yutong</given-names>
</name>
<degrees>PhD</degrees>
<xref rid="aff5-15347354241252698" ref-type="aff">5</xref>
</contrib>
<contrib contrib-type="author">
<contrib-id contrib-id-type="orcid" authenticated="false">
https://orcid.org/0000-0003-1071-443X</contrib-id>
<name>
<surname>Teo</surname>
<given-names>Chiah Shean</given-names>
</name>
<degrees>MD</degrees>
<xref rid="aff6-15347354241252698" ref-type="aff">6</xref>
</contrib>
<contrib contrib-type="author">
<contrib-id contrib-id-type="orcid" authenticated="false">
https://orcid.org/0000-0002-2909-5926</contrib-id>
<name>
<surname>Zhu</surname>
<given-names>Xiaoshu</given-names>
</name>
<degrees>PhD</degrees>
<xref rid="aff1-15347354241252698" ref-type="aff">1</xref>
<xref rid="corresp1-15347354241252698" ref-type="corresp" />
</contrib>
</contrib-group>
<aff id="aff1-15347354241252698"><label>1</label>Western Sydney University, Penrith South,
NSW, Australia</aff>
<aff id="aff2-15347354241252698"><label>2</label>University Malaya Medical Centre, Kuala
Lumpur, Wilayah Persekutuan, Malaysia</aff>
<aff id="aff3-15347354241252698"><label>3</label>Pitié-Salpêtrière Hospital,
Paris, France</aff>
<aff id="aff4-15347354241252698"><label>4</label>University of New South Wales, Liverpool,
NSW, Australia</aff>
<aff id="aff5-15347354241252698"><label>5</label>Beijing University of Chinese Medicine,
Beijing, China</aff>
<aff id="aff6-15347354241252698"><label>6</label>UCSI University, Malaysia</aff>
<author-notes>
<corresp id="corresp1-15347354241252698">Xiaoshu Zhu, Chinese Medicine Centre (an
international collaboration between Western Sydney University and Beijing University of
Chinese Medicine), Western Sydney University, Locked Bag 1797, Penrith, NSW 2751,
Australia. Email: <email>x.zhu@westernsydney.edu.au</email></corresp>
</author-notes>
<pub-date pub-type="epub">
<day>17</day>
<month>5</month>
<year>2024</year>
</pub-date>
<pub-date pub-type="collection">
<year>2024</year>
</pub-date>
<volume>23</volume>
<elocation-id>15347354241252698</elocation-id>
<history>
<date date-type="received">
<day>5</day>
<month>8</month>
<year>2023</year>
</date>
<date date-type="rev-recd">
<day>5</day>
<month>4</month>
<year>2024</year>
</date>
<date date-type="accepted">
<day>18</day>
<month>4</month>
<year>2024</year>
</date>
</history>
<permissions>
<copyright-statement>© The Author(s) 2024</copyright-statement>
<copyright-year>2024</copyright-year>
<copyright-holder content-type="sage">SAGE Publications Inc unless otherwise noted.
Manuscript content on this site is licensed under Creative Commons Licenses</copyright-holder>
<license>
<ali:license_ref xmlns:ali="http://www.niso.org/schemas/ali/1.0/"
specific-use="textmining" content-type="ccbylicense">
https://creativecommons.org/licenses/by/4.0/</ali:license_ref>
<license-p>This article is distributed under the terms of the Creative Commons
Attribution 4.0 License (<ext-link ext-link-type="uri"
xlink:href="https://creativecommons.org/licenses/by/4.0/">
https://creativecommons.org/licenses/by/4.0/</ext-link>) which permits any use,
reproduction and distribution of the work without further permission provided the
original work is attributed as specified on the SAGE and Open Access page (<ext-link
ext-link-type="uri"
xlink:href="https://us.sagepub.com/en-us/nam/open-access-at-sage">
https://us.sagepub.com/en-us/nam/open-access-at-sage</ext-link>).</license-p>
</license>
</permissions>
<abstract>
<sec id="section1-15347354241252698">
<title>Background:</title>
<p>Cancer-related fatigue and its associated symptoms of sleep disorder and depression
are prevalent in cancer survivors especially among breast, lung, and colorectal cancer
survivors. While there is no gold standard for treating cancer-related fatigue
currently, studies of mind-body exercises such as Qigong have reported promise in
reducing symptoms. This study was designed to evaluate the feasibility and effect of
Guolin Qigong on cancer-related fatigue and other symptoms in breast, lung and
colorectal cancer survivors while exploring their perceptions and experiences of
Guolin Qigong intervention.</p>
</sec>
<sec id="section2-15347354241252698">
<title>Methods:</title>
<p>This is an open-label randomized controlled trial with 60 participants divided into 2
study groups in a 1:1 ratio. The intervention group will receive 12 weeks of
Guolin Qigong intervention with a 4-week follow-up while control will receive usual
care under waitlist. The primary outcome will be feasibility measured based on
recruitment and retention rates, class attendance, home practice adherence, nature,
and quantum of missing data as well as safety. The secondary subjective outcomes of
fatigue, sleep quality and depression will be measured at Week-1 (baseline), Week-6
(mid-intervention), Week-12 (post-intervention), and Week-16 (4 weeks
post-intervention) while an objective 24-hour urine cortisol will be measured at
Week-1 (baseline) and Week-12 (post-intervention). We will conduct a semi-structured
interview individually with participants within 3 months after Week-16
(4 weeks post-intervention) to obtain a more comprehensive view of practice
adherence.</p>
</sec>
<sec id="section3-15347354241252698">
<title>Discussion:</title>
<p>This is the first mixed-method study to investigate the feasibility and effect of
Guolin Qigong on breast, lung, and colorectal cancer survivors to provide a
comprehensive understanding of Guolin Qigong’s intervention impact and
participants’ perspectives. The interdisciplinary collaboration between Western
Medicine and Chinese Medicine expertise of this study ensures robust study design,
enhanced participant care, rigorous data analysis, and meaningful interpretation of
results. This innovative research contributes to the field of oncology and may guide
future evidence-based mind-body interventions to improve cancer survivorship.</p>
</sec>
<sec id="section4-15347354241252698">
<title>Trial registration:</title>
<p>This study has been registered with ANZCTR (ACTRN12622000688785p), was approved by
Medical Research Ethic Committee of University Malaya Medical Centre (MREC ID NO:
2022323-11092) and recognized by Western Sydney University Human Research Ethics
Committee (RH15124).</p>
</sec>
</abstract>
<kwd-group>
<kwd>Qigong</kwd>
<kwd>cancer</kwd>
<kwd>cancer survivors</kwd>
<kwd>fatigue</kwd>
<kwd>sleep</kwd>
<kwd>insomnia</kwd>
<kwd>depression</kwd>
<kwd>cortisol</kwd>
<kwd>mind body exercise</kwd>
</kwd-group>
<funding-group specific-use="FundRef">
<award-group id="award1-15347354241252698">
<funding-source id="funding1-15347354241252698">
<institution-wrap>
<institution>Chinese Medicine Centre</institution>
<institution-id />
</institution-wrap>
</funding-source>
<award-id rid="funding1-15347354241252698">Research Fund</award-id>
</award-group>
<award-group id="award2-15347354241252698">
<funding-source id="funding2-15347354241252698">
<institution-wrap>
<institution>Western Sydney University</institution>
<institution-id institution-id-type="FundRef">https://doi.org/10.13039/501100018822</institution-id>
</institution-wrap>
</funding-source>
<award-id rid="funding2-15347354241252698">Research Training Program Fund</award-id>
</award-group>
</funding-group>
<custom-meta-group>
<custom-meta>
<meta-name>cover-date</meta-name>
<meta-value>January-December 2024</meta-value>
</custom-meta>
<custom-meta>
<meta-name>typesetter</meta-name>
<meta-value>ts1</meta-value>
</custom-meta>
</custom-meta-group>
</article-meta>
</front>
<body>
<sec id="section5-15347354241252698">
<title>Background</title>
<p>Cancer-related fatigue (CRF) has been increasingly recognized as an important symptom
during and after treatment of cancer, impacting physical, mental, and emotional functions.<sup>
<xref rid="bibr1-15347354241252698" ref-type="bibr">1</xref>
</sup> CRF is a
prevalent symptom among survivors of the most common types of cancer, including breast,
lung, and colon cancer.<sup><xref rid="bibr2-15347354241252698" ref-type="bibr">2</xref>,<xref
rid="bibr3-15347354241252698" ref-type="bibr">3</xref></sup> It is a distressing
symptom<sup>
<xref rid="bibr3-15347354241252698" ref-type="bibr">3</xref>
</sup> and one of
the main reasons for the interruption of treatment or exacerbation of the disease.<sup>
<xref rid="bibr2-15347354241252698" ref-type="bibr">2</xref>
</sup> Between 74%
and 90% of cancer survivors undergoing chemotherapy or radiotherapy<sup><xref
rid="bibr4-15347354241252698" ref-type="bibr">4</xref>
<xref
rid="bibr5-15347354241252698" ref-type="bibr" />-<xref rid="bibr6-15347354241252698"
ref-type="bibr">6</xref></sup> experienced fatigue with adverse effect on other
co-morbidity, quality of life, independent living, and work productivity.<sup><xref
rid="bibr3-15347354241252698" ref-type="bibr">3</xref>,<xref
rid="bibr7-15347354241252698" ref-type="bibr">7</xref></sup> While fatigue is more
prevalent within 6 months of receiving cancer treatment, cancer survivors including
those who did not receive treatment continue to experience fatigue many years after
treatment.<sup>
<xref rid="bibr5-15347354241252698" ref-type="bibr">5</xref>
</sup></p>
<p>Cancer diagnosis and its treatment also bring with it a host of physiological changes
affecting various functions of the body including cortisol dysregulation associated with
fatigue,<sup><xref rid="bibr8-15347354241252698" ref-type="bibr">8</xref>
<xref
rid="bibr9-15347354241252698" ref-type="bibr" /><xref rid="bibr10-15347354241252698"
ref-type="bibr" /><xref rid="bibr11-15347354241252698" ref-type="bibr" />-<xref
rid="bibr12-15347354241252698" ref-type="bibr">12</xref></sup> sleep disorders,<sup><xref
rid="bibr8-15347354241252698" ref-type="bibr">8</xref>,<xref
rid="bibr13-15347354241252698" ref-type="bibr">13</xref>
<xref
rid="bibr14-15347354241252698" ref-type="bibr" />-<xref rid="bibr15-15347354241252698"
ref-type="bibr">15</xref></sup> depression,<sup><xref rid="bibr12-15347354241252698"
ref-type="bibr">12</xref>,<xref rid="bibr16-15347354241252698" ref-type="bibr">16</xref></sup>
anxiety, stress,<sup><xref rid="bibr17-15347354241252698" ref-type="bibr">17</xref>,<xref
rid="bibr18-15347354241252698" ref-type="bibr">18</xref></sup> functional disability,<sup>
<xref rid="bibr12-15347354241252698" ref-type="bibr">12</xref>
</sup> survival
outcomes, and prognosis<sup><xref rid="bibr13-15347354241252698" ref-type="bibr">13</xref>
,<xref rid="bibr18-15347354241252698" ref-type="bibr">18</xref>
<xref
rid="bibr19-15347354241252698" ref-type="bibr" /><xref rid="bibr20-15347354241252698"
ref-type="bibr" />-<xref rid="bibr21-15347354241252698" ref-type="bibr">21</xref></sup>
in cancer survivors.</p>
<p>The pathogenesis of CRF is still unclear, but might include proinflammatory cytokines,
growth factors, circadian rhythm modulation, adrenal axis interruption, serotonin
imbalance, afferent activation of the vagus nerve, and the production or use of abnormal
adenosine triphosphate.<sup>
<xref rid="bibr22-15347354241252698" ref-type="bibr">22</xref>
</sup> Host
factors not related to cancer and its treatment such as genetic, biological, psychosocial,
and behavioral factor also play an important role in the development of CRF.<sup>
<xref rid="bibr23-15347354241252698" ref-type="bibr">23</xref>
</sup></p>
<p>CRF is also associated with various risk factors such as low performance status,
undergoing chemoradiotherapy, insomnia, pain, neuroticism, depression and being female.<sup>
<xref rid="bibr24-15347354241252698" ref-type="bibr">24</xref>
</sup></p>
<p>It is further suggested that cancer-related fatigue is a composite of interacting
responses to stress related to diagnosis and treatment, with the relationship of sleep
disorders, depression, anemia, and inflammation featuring centrally for those under
treatment as well as into the survivorship phase.<sup>
<xref rid="bibr25-15347354241252698" ref-type="bibr">25</xref>
</sup> CRF and a
number of these factors and symptoms, including sleep disruption and emotional distress
often co-occur as a symptom cluster,<sup><xref rid="bibr26-15347354241252698"
ref-type="bibr">26</xref>
<xref rid="bibr27-15347354241252698" ref-type="bibr" />-<xref
rid="bibr28-15347354241252698" ref-type="bibr">28</xref></sup> with some of these
associations potentially linked to the underlying inflammatory biomarker changes such as
cortisol level<sup>
<xref rid="bibr29-15347354241252698" ref-type="bibr">29</xref>
</sup> most
associated with fatigue.<sup><xref rid="bibr3-15347354241252698" ref-type="bibr">3</xref>,<xref
rid="bibr24-15347354241252698" ref-type="bibr">24</xref>,<xref
rid="bibr30-15347354241252698" ref-type="bibr">30</xref></sup></p>
<p>Exploring symptom clusters is an important gap in symptom research to shed light on the
common biological mechanisms<sup>
<xref rid="bibr31-15347354241252698" ref-type="bibr">31</xref>
</sup> and is
gaining increased attention in the field of oncology in an attempt to improve the quality
of life of patients diagnosed with cancer.<sup>
<xref rid="bibr32-15347354241252698" ref-type="bibr">32</xref>
</sup></p>
<p>Hence, there is a need to pay attention to the co-occurrences of fatigue, sleep disorder
and depression as a symptom cluster in the evaluation and treatment of cancer survivors
experiencing CRF.<sup><xref rid="bibr3-15347354241252698" ref-type="bibr">3</xref>,<xref
rid="bibr26-15347354241252698" ref-type="bibr">26</xref>
<xref
rid="bibr27-15347354241252698" ref-type="bibr" />-<xref rid="bibr28-15347354241252698"
ref-type="bibr">28</xref></sup></p>
<p>In spite of fatigue being the most common symptom reported by patients, they were least
likely to report getting wanted help for it, perhaps due to the complexity of treating
this common condition.<sup>
<xref rid="bibr5-15347354241252698" ref-type="bibr">5</xref>
</sup> Given the
multifactorial nature of CRF which is still poorly understood, there is currently no
“gold standard” treatment for CRF despite some approaches such as exercise,
psychosocial interventions, and mind-body interventions being reported to yield beneficial
effects in improving CRF.<sup>
<xref rid="bibr23-15347354241252698" ref-type="bibr">23</xref>
</sup></p>
<p>Emerging studies have shown that mind-body exercise such as Qigong can reduce fatigue,
improve sleep, depression, anxiety, quality of life and cognitive changes associated with
cancer as well as biomarkers of stress, cortisol level, inflammation and immune function
in cancer survivors during and after treatment.<sup><xref rid="bibr29-15347354241252698"
ref-type="bibr">29</xref>,<xref rid="bibr33-15347354241252698" ref-type="bibr">33</xref>
<xref
rid="bibr34-15347354241252698" ref-type="bibr" /><xref rid="bibr35-15347354241252698"
ref-type="bibr" /><xref rid="bibr36-15347354241252698" ref-type="bibr" /><xref
rid="bibr37-15347354241252698" ref-type="bibr" /><xref rid="bibr38-15347354241252698"
ref-type="bibr" /><xref rid="bibr39-15347354241252698" ref-type="bibr" /><xref
rid="bibr40-15347354241252698" ref-type="bibr" /><xref rid="bibr41-15347354241252698"
ref-type="bibr" /><xref rid="bibr42-15347354241252698" ref-type="bibr" /><xref
rid="bibr43-15347354241252698" ref-type="bibr" />-<xref rid="bibr44-15347354241252698"
ref-type="bibr">44</xref></sup></p>
<p>The term “Qigong” is made up of 2 characters: Qi and Gong translated as the
skill or practice to cultivate Qi. The concept of Qi, an inherent function and energizing
essence of human being, is found in Traditional Chinese Medicine.<sup>
<xref rid="bibr45-15347354241252698" ref-type="bibr">45</xref>
</sup> Qi also
refers to life force, vitality, or intelligence within a bio-electric body<sup><xref
rid="bibr46-15347354241252698" ref-type="bibr">46</xref>,<xref
rid="bibr47-15347354241252698" ref-type="bibr">47</xref></sup> as well as the
universe.<sup>
<xref rid="bibr48-15347354241252698" ref-type="bibr">48</xref>
</sup> There are
a few thousand different forms of Qigong such as Tai Chi, BaDuanJin, Chan Chuang, Zhineng
Qigong, and Guolin Qigong, all of which can be broadly classified into Chinese Medical
Qigong, Daoist Qigong, Buddhist Qigong, Confucian Qigong, and martial arts Qigong. All
forms of Qigong involve the recognition and cultivation of Qi to promote a balanced Qi and
smooth flow of Qi in the body<sup>
<xref rid="bibr49-15347354241252698" ref-type="bibr">49</xref>
</sup> to
enhance physical, psychological, and spiritual health through mind-body integration of
specific movements, breathing techniques, and meditation.<sup>
<xref rid="bibr50-15347354241252698" ref-type="bibr">50</xref>
</sup> Mind-body
integration of Qigong is also believed to promote health through the activation of
neurohormonal pathways and other physiological mechanisms.<sup>
<xref rid="bibr51-15347354241252698" ref-type="bibr">51</xref>
</sup> Qigong
offers several potential advantages when compared to modern medical therapy as it
emphasizes a holistic approach with minimal adverse effects<sup><xref
rid="bibr40-15347354241252698" ref-type="bibr">40</xref>,<xref
rid="bibr52-15347354241252698" ref-type="bibr">52</xref></sup> when practiced
correctly after proper guidance. It is also known to improve neuropsychiatric conditions<sup>
<xref rid="bibr53-15347354241252698" ref-type="bibr">53</xref>
</sup> without
the side effects of pharmaceutical drugs. More importantly, it promotes self-empowerment
as it empowers individuals to take an active role in their health. Lastly, Qigong is more
cost- effective compared to certain medical treatments as once learned, it can be
practiced regularly to promote a healthy lifestyle without the need to incur additional
expenses.</p>
<p>Among the many styles of Qigong is Guolin Qigong (GQ). This form of Qigong has been
specifically adapted for cancer survivors by offering a moderate and adaptable exercise
routine. It is a moderate walking exercise that integrates coordinated arm movements and
trunk rotations, coupled with controlled breathing techniques. What sets it apart is its
gentle nature, designed to be accommodating and adjustable. This adaptability is crucial,
as it allows for modifications in speed, duration, and intensity, ensuring that it caters
to the unique health conditions and needs of individual cancer survivors. The flexible
approach of GQ prioritizes the well-being and comfort of each participant, making it a
safe and beneficial practice for those navigating the complexities of cancer recovery.
Therefore GQ is suitable for cancer survivors—especially advanced cancer patients
who may be unable to engage in other forms of physical activity.<sup>
<xref rid="bibr54-15347354241252698" ref-type="bibr">54</xref>
</sup> A
moderate-intensity walking exercise program was reported to be a feasible and effective
intervention method for managing fatigue,<sup><xref rid="bibr55-15347354241252698"
ref-type="bibr">55</xref>,<xref rid="bibr56-15347354241252698" ref-type="bibr">56</xref></sup>
anxiety, depression,<sup>
<xref rid="bibr57-15347354241252698" ref-type="bibr">57</xref>
</sup> and sleep
in cancer survivors at different stages of cancer.<sup><xref
rid="bibr58-15347354241252698" ref-type="bibr">58</xref>
<xref
rid="bibr59-15347354241252698" ref-type="bibr" />-<xref rid="bibr60-15347354241252698"
ref-type="bibr">60</xref></sup> GQ exercise training also facilitates the inhaling of
oxygen which is important for the homeostasis of oxygen-carbon dioxide in controlling
cancer and ultimately survival, as supported by a 10-year longitudinal cohort study of 122
lung and nasopharyngeal cancer patients which reported that improvements in End Tidal
Breath Holding Time (ETBHT), alveolar O<sub>2</sub> (aO<sub>2</sub>) pressure, and
alveolar CO<sub>2</sub> (aCO<sub>2</sub>) pressure capacity with GQ was associated with
higher survival years, 5 years survival rate and survival probability.<sup>
<xref rid="bibr61-15347354241252698" ref-type="bibr">61</xref>
</sup> In the
above-mentioned cohort study,<sup>
<xref rid="bibr61-15347354241252698" ref-type="bibr">61</xref>
</sup> GQ also
demonstrated improvement in depression among cancer participants. Additionally, in breast
cancer patients undergoing 5 to 6 weeks of radiotherapy, women with elevated
depressive symptoms at the start of treatment showed significant enhancements in fatigue
and QOL.<sup>
<xref rid="bibr50-15347354241252698" ref-type="bibr">50</xref>
</sup></p>
<p>However, the impact of GQ on CRF, often associated with sleep and depression<sup><xref
rid="bibr3-15347354241252698" ref-type="bibr">3</xref>,<xref
rid="bibr26-15347354241252698" ref-type="bibr">26</xref>
<xref
rid="bibr27-15347354241252698" ref-type="bibr" />-<xref rid="bibr28-15347354241252698"
ref-type="bibr">28</xref></sup> and its correlation with cortisol levels has not been
explored.</p>
<p>In addition to that, a qualitative study to evaluate the perception and acceptance of GQ
is needed to explore the feasibility, adherence, and experience related to this complex
intervention. It aims to understand the more subjective domains and identify potential
factors for improving healthcare<sup>
<xref rid="bibr62-15347354241252698" ref-type="bibr">62</xref>
</sup> to
address the multi-faceted needs of this population. Such research, however, has not been
conducted yet.</p>
<p>Therefore, the purpose of this paper is to describe the protocol of a mixed-method study
comprising,</p>
<list list-type="order" id="list1-15347354241252698">
<list-item>
<p>A randomized-controlled trial to evaluate the feasibility of GQ training and its
effect on CRF, sleep, depression, and cortisol levels in breast, lung and colon cancer
survivors and,</p>
</list-item>
<list-item>
<p>Semi-structured interview with study participants from the randomized- controlled
trial to understand their perceptions and experiences of GQ to identify: <list
list-type="simple" id="list2-15347354241252698">
<list-item>
<p>(a) other physiological and psychological benefits gained from the GQ
intervention,</p>
</list-item>
<list-item>
<p>(b) the barriers to GQ participation, adherence, and recommendations for
improvement.</p>
</list-item>
</list></p>
</list-item>
</list>
<p>We hypothesized that</p>
<list list-type="order" id="list3-15347354241252698">
<list-item>
<p>It is feasible for cancer survivor participants to engage in the GQ training and
those who participated in the GQ training will experience positive impacts on CRF,
sleep, depression, and cortisol level. Feasibility of this study is established at
about 80% to 85% retention rate and 75% to 85% class attendance rate based on prior
similar studies.<sup><xref rid="bibr63-15347354241252698" ref-type="bibr">63</xref>
<xref
rid="bibr64-15347354241252698" ref-type="bibr" />-<xref
rid="bibr65-15347354241252698" ref-type="bibr">65</xref></sup></p>
</list-item>
<list-item>
<p>The semi-structured interview will identify a broader spectrum of benefits and
barriers to participation and adherence to GQ training to provide valuable insights
for program enhancement.</p>
</list-item>
</list>
</sec>
<sec sec-type="methods" id="section6-15347354241252698">
<title>Methods</title>
<sec id="section7-15347354241252698">
<title>Study Design</title>
<sec id="section8-15347354241252698">
<title>Intervention/clinical trial</title>
<p>The primary objective of this study is to explore the feasibility of a GQ
intervention in patients with various cancer types who experience CRF. This study
includes the 3 most prevalent cancer types that is, breast, lung and colon cancers.
This is a randomized-controlled trial that compares the GQ intervention group to a
usual care waitlist control group receiving standard medical care allocated in a 1:1
ratio to evaluate the feasibility and effects of a 12-week GQ intervention on 60
eligible breast, lung, and colorectal cancer survivors’ fatigue, sleep quality,
depression, and 24-hour urine cortisol change. Refer to <xref
rid="fig1-15347354241252698" ref-type="fig">Figure 1</xref> for an overview of the
study. This study protocol was developed based on the SPIRIT 2013 Statement (Standard
Protocol Items: Recommendations for Interventional Trials) (<ext-link
xlink:href="https://journals.sagepub.com/doi/suppl/10.1177/15347354241252698"
ext-link-type="uri">Supplemental Material 1</ext-link>).<sup>
<xref rid="bibr66-15347354241252698" ref-type="bibr">66</xref>
</sup></p>
<fig position="float" id="fig1-15347354241252698">
<label>Figure 1.</label>
<caption>
<p>Participant flow diagram.</p>
</caption>
<graphic xlink:href="10.1177_15347354241252698-fig1" position="float" />
</fig>
</sec>
<sec id="section9-15347354241252698">
<title>Interview</title>
<p>We will use a qualitative descriptive design, with a semi-structured interview to
collect in-depth information to enhance our understanding of the perceptions and
experiences of GQ participation of cancer survivors based on purposive sampling until
data saturation is reached.</p>
<p>The qualitative interview will be reported within the primary randomized feasibility
trial according to the guidelines recommended in the CONSORT 2010 statement extension.<sup>
<xref rid="bibr67-15347354241252698" ref-type="bibr">67</xref>
</sup></p>
</sec>
</sec>
<sec id="section10-15347354241252698">
<title>Study Setting</title>
<p>The trial is conducted at University Malaya Medical Centre (UMMC) in Kuala Lumpur,
Malaysia. Participants are recruited by referrals from UMMC or online and print
advertisements such as posting recruitment in UMMC, cancer support groups, GQ
Association and GQ practice stations around Klang Valley, and social media platforms
including X Corp (formerly known as Twitter) and Facebook.</p>
</sec>
<sec id="section11-15347354241252698">
<title>Recruitment</title>
<p>Recruitment started in October 2022. Upon first contact, the Researcher will screen
potential breast, lung, or colon cancer survivors and provide information about the
study to those who meet the eligibility criteria and indicate interest to participate.
Thereafter a Physician/Oncologist Screening Form, Participant Information Sheet, and 2
copies of Participant Consent Form will be given, explained, and a separate date agreed
for in-person enrollment.<sup>
<xref rid="bibr67-15347354241252698" ref-type="bibr">67</xref>
</sup></p>
</sec>
<sec id="section12-15347354241252698">
<title>Inclusion Criteria</title>
<list list-type="simple" id="list4-15347354241252698">
<list-item>
<p>(1) Age ≥ 18 years old;</p>
</list-item>
<list-item>
<p>(2) *Cancer survivor diagnosed with breast, lung and colorectal cancer;</p>
</list-item>
<list-item>
<p>(3) Able to read and answer questionnaires in English and/or Bahasa Malaysia
language by oneself;</p>
</list-item>
<list-item>
<p>(4) Suffering from moderate to severe fatigue as assessed by the simple
fatigue scale; with severity score of 3 and above<sup>
<xref rid="bibr68-15347354241252698" ref-type="bibr">68</xref>
</sup>
;</p>
</list-item>
<list-item>
<p>(5) Able to use smart phones and the WeChat or WhatsApp application;</p>
</list-item>
<list-item>
<p>(6) Life expectancy of more than 3 months;</p>
</list-item>
<list-item>
<p>(7) Able to give informed consent;</p>
</list-item>
<list-item>
<p>(8) Available and willing to comply with the study requirements.</p>
</list-item>
</list>
<p>*A cancer survivor is defined as an individual diagnosed with cancer through the
balance of life according to National Cancer Institute.<sup>
<xref rid="bibr69-15347354241252698" ref-type="bibr">69</xref>
</sup></p>
<p>Including cancer survivors throughout the continuum of survivorship in our sample
inclusion criteria allows us to capture a comprehensive spectrum of experiences. From
those newly diagnosed to long-term survivors, each stage brings unique perspectives on
GQ participation and its impact. This approach ensures a thorough exploration of how GQ
intervention intersects with varying phases of the cancer journey, providing a rich
understanding of the diverse narratives and challenges encountered across this
continuum.</p>
</sec>
<sec id="section13-15347354241252698">
<title>Exclusion Criteria</title>
<list list-type="simple" id="list5-15347354241252698">
<list-item>
<p>(1) Cardiopulmonary disease, nerve, muscle, or joint disease, or other
malignant tumors affecting movement;</p>
</list-item>
<list-item>
<p>(2) Mental illness or serious cognitive impairment and defects in language
that significantly impairs communication;</p>
</list-item>
<list-item>
<p>(3) Post-operative heart, cerebral vessel, or other serious complications;</p>
</list-item>
<list-item>
<p>(4) Neurological degenerative disease (e.g. dementia), reduced cognitive;
capacity in any way that would affect ability to understand trial procedures and
give informed consent;</p>
</list-item>
<list-item>
<p>(5) Patients who are not able to walk;</p>
</list-item>
<list-item>
<p>(6) Other medical conditions which would preclude study intervention or make
study participation unsafe such as severe chronic heart failure.</p>
</list-item>
</list>
</sec>
<sec id="section14-15347354241252698">
<title>Randomization and Blinding</title>
<p>After informed consent, participants will be randomly assigned to either the GQ or
usual care waitlist control group at a 1:1 ratio with the random sequence generated by
an online computerized randomization system using minimization method<sup><xref
rid="bibr70-15347354241252698" ref-type="bibr">70</xref>
<xref
rid="bibr71-15347354241252698" ref-type="bibr" />-<xref
rid="bibr72-15347354241252698" ref-type="bibr">72</xref></sup> by an independent
research assistant.</p>
</sec>
<sec id="section15-15347354241252698">
<title>Intervention</title>
<p>After being advised of group allocation, the study participant will be given a few days
to decide on whether to proceed with enrollment. Incorporating a brief period for
participants to reflect and opt-out after randomization supports ethical research
practices, ensures ethical informed consent, reduces pressure, enhances retention, and
respects participant autonomy in clinical trials or studies.</p>
<sec id="section16-15347354241252698">
<title>Guolin Qigong</title>
<p>Participants in the intervention group will attend a 2-hour supervised face-to-face
(F2F) GQ training class for 12 weeks with home-practice on non-class days.
There will be 2 training classes per week for the first 2 weeks and once per
week for the next 10 weeks.</p>
<p>The GQ training involves a modified version of a Chinese medical qigong therapy often
referred to as “walking qigong” developed by Guo Lin.<sup>
<xref rid="bibr38-15347354241252698" ref-type="bibr">38</xref>
</sup>
GQ was developed specifically for cancer and consisted of several breathing and moving
exercises. The GQ training in the current study includes the following 3 main
exercises:</p>
<list list-type="simple" id="list6-15347354241252698">
<list-item>
<p>1. Feng Hu Xi Zhi Ran Xing Gong (Natural Wind Breathing Walking)</p>
</list-item>
</list>
<p>Participants walk in a circle, synchronizing their breathing, arm movements, and
steps focusing on the movement of their body with the goal of calming one’s
mind, relaxing various parts of the body and the mind, and revitalizing the
“life-force,” that is, <italic toggle="yes">qi</italic>.</p>
<list list-type="simple" id="list7-15347354241252698">
<list-item>
<p>2. Dian Bu Gong (Step Tap Method)</p>
</list-item>
</list>
<p>A modified natural Wind Breathing Walking Exercise with additional step tap.</p>
<list list-type="simple" id="list8-15347354241252698">
<list-item>
<p>3. Sheng Jiang Kai He Fa (Ascending, Descending, Opening, and Closing
Method)</p>
</list-item>
</list>
<p>A calming and relaxation method of synchronized arms and legs movements on the spot
which can be practiced within limited space.</p>
<p>Each main exercise has to be practiced separately as individual sets comprising 3
parts:</p>
<list list-type="simple" id="list9-15347354241252698">
<list-item>
<p>a. Preparatory relaxation exercise (gentle breathing and meditation;
4 minutes):</p>
</list-item>
</list>
<p>In relaxed standing posture, synchronize the breath with gentle arm movements in
front of the abdomen (opening and closing of the Dantian). Dantian is a Chinese
medicine concept that refers to the “elixir field” or “energy
center.” It has different locations but often referred to the lower abdomen
between the navel and pubic bone of the human body.<sup><xref
rid="bibr73-15347354241252698" ref-type="bibr">73</xref>,<xref
rid="bibr74-15347354241252698" ref-type="bibr">74</xref></sup></p>
<list list-type="simple" id="list10-15347354241252698">
<list-item>
<p>b. Main exercise</p>
</list-item>
<list-item>
<p>i. Feng Hu Xi Zhi Ran Xing Gong (Natural Wind Breathing Walking) or</p>
</list-item>
<list-item>
<p>ii. Dian Bu Gong (Step Tap Method) or</p>
</list-item>
<list-item>
<p>iii. Sheng Jiang Kai He Fa (Ascending, Descending, Opening, and Closing
Method).</p>
</list-item>
<list-item>
<p>c. Concluding exercise: breathing exercises, opening, and closing of the
Dantian, and self-massage (3-6 minutes).<sup>
<xref rid="bibr50-15347354241252698" ref-type="bibr">50</xref>
</sup></p>
</list-item>
</list>
<p>Please refer to <ext-link
xlink:href="https://journals.sagepub.com/doi/suppl/10.1177/15347354241252698"
ext-link-type="uri">Supplemental Material 2</ext-link> for detailed steps. All
movements will include modifications to enhance safety. Participants will be advised
to rest as and when necessary, according to their health status.</p>
<p>The F2F GQ class will be taught by qualified GQ instructors who are both long-term
cancer survivors with more than 20 years of GQ training experience to ensure
the full potential of the GQ intervention. The Researcher, who is a registered Chinese
Medicine practitioner in Malaysia and Australia with more than 20 years’
experience in Qigong, will be in attendance during the F2F GQ class to ensure the safe
and seamless facilitation of the training session.</p>
<p>Home practice is recommended for non-class days according to individual health status
and available time.<sup>
<xref rid="bibr54-15347354241252698" ref-type="bibr">54</xref>
</sup>
Participants will be provided with class notes and video links (<ext-link
xlink:href="https://journals.sagepub.com/doi/suppl/10.1177/15347354241252698"
ext-link-type="uri">Supplemental Material 3</ext-link>) to promote and support home
practice. Home practice after the intervention period is encouraged for incorporation
into daily life to foster a healthy lifestyle.</p>
</sec>
</sec>
<sec id="section17-15347354241252698">
<title>Usual Care Waitlist Control</title>
<p>Participants in the usual care waitlist control group will be advised to continue with
their usual care routines and exercises and will be asked not to attend any other Qigong
exercises. They will be offered to attend the same GQ training class after Week-16 of
the GQ training of their cohort.</p>
<p>However, to maintain integrity of the study, instructors will not be informed about the
allocation of participants. Consequently, when instructors commence training of
subsequent cohorts, they will be unaware of which participants belong to the
intervention group (commencing from Week 1), and which are part of the control group
(joining the GQ group in Week 1), given the GQ training will be offered continuously.
This ensures the instructors are effectively blinded to the allocation to maintain
impartiality in the delivery of the training and minimizes any potential biases that may
arise from instructor knowledge of group allocation.</p>
</sec>
<sec id="section18-15347354241252698">
<title>Study Assessments</title>
<p>The variables under consideration will encompass basic demographic data, primary
outcomes, and secondary outcomes. Basic characteristics will be collected at baseline
(Week-1).</p>
<p>Primary feasibility outcomes on adherence, attendance, and any adverse events will be
recorded throughout the intervention period from Week-1 to Week-12 in the practice diary
by the participants. Secondary patient-reported outcomes on fatigue, depression, and
sleep will be measured at baseline (Week-1), mid-intervention (Week-6),
post-intervention (Week-12), and 4 weeks after completion of intervention
(Week-16). Urine samples (for urine cortisol test) to assess 24-hour urinary cortisol
will be collected a day prior to enrollment date and post-intervention (Week-12).
Primary feasibility outcomes and secondary patient-reported outcomes will be assessed by
an independent research assistant to minimize bias. A summary of the planned data
collection is shown in <xref rid="fig2-15347354241252698" ref-type="fig">Figure 2</xref>
.</p>
<fig position="float" id="fig2-15347354241252698">
<label>Figure 2.</label>
<caption>
<p>Schedule of enrollment, intervention and data collection</p>
<p>Abbreviations: BFI, Brief Fatigue Inventory, CES-D, Centre for Epidemiologic
Studies Depression; PSQI, Pittsburgh Sleep Quality Index.</p>
</caption>
<graphic xlink:href="10.1177_15347354241252698-fig2" position="float" />
</fig>
<sec id="section19-15347354241252698">
<title>Basic demographic data</title>
<p>Participants’ basic characteristics (sex, marital status, age) and cancer
history will be collected using a self-designed questionnaire.</p>
</sec>
<sec id="section20-15347354241252698">
<title>Feasibility outcomes</title>
<p>Feasibility will be assessed based on recruitment rate, retention rate, class
attendance, home practice adherence, the nature and extent of missing data, and
safety. Safety will be monitored and assessed based on total number of Adverse Event
and the presence of any Serious Adverse Event.<sup>
<xref rid="bibr75-15347354241252698" ref-type="bibr">75</xref>
</sup></p>
</sec>
<sec id="section21-15347354241252698">
<title>Patient-reported outcomes and cortisol biomarker</title>
<list list-type="simple" id="list11-15347354241252698">
<list-item>
<p>i. Patient-reported outcomes</p>
</list-item>
</list>
<p>Participants will complete several patient-reported outcome measures to evaluate
fatigue—Brief Fatigue Inventory (BFI),<sup>
<xref rid="bibr68-15347354241252698" ref-type="bibr">68</xref>
</sup>
sleep quality—Pittsburgh Sleep Quality Index (PSQI)<sup>
<xref rid="bibr76-15347354241252698" ref-type="bibr">76</xref>
</sup>
and depression—Centre for Epidemiologic Studies Depression (CES-D)<sup><xref
rid="bibr77-15347354241252698" ref-type="bibr">77</xref>,<xref
rid="bibr78-15347354241252698" ref-type="bibr">78</xref></sup> at Week-1, Week-6,
Week-12, and Week-16.</p>
<list list-type="simple" id="list12-15347354241252698">
<list-item>
<p>a. Fatigue—The Brief Fatigue Inventory (BFI)</p>
</list-item>
</list>
<p>The BFI was developed for the rapid assessment of fatigue severity in cancer patients
for use in both clinical screening and clinical trials. It is easy to administer, and
patients can complete them easily as it has only 9 items with simple wordings that are
easy to understand and translate.<sup>
<xref rid="bibr68-15347354241252698" ref-type="bibr">68</xref>
</sup>
Items 1 to 3 rate participants’ worst, usual, and current fatigue during the
past 24 hours using a visual analog scale (VAS) ranging from 0 (no fatigue) to
10 (very severely fatigued). A composite fatigue severity score was obtained by
averaging the 3 severity scores. The remaining 6 items rate the level at which
patients` fatigue interferes with certain functions such as daily activity, work,
walking ability, normal work, relations with others, and enjoyment in life. Each item
is rated on a scale of 0 (does not interfere) to 10 (completely interferes). A
composite fatigue interference score will be obtained by averaging the scores of the 6
interference items. Severity scores of 1 to 3 suggest mild fatigue, 4 to 6 moderate,
and 7 to 10 represent severe fatigue. The internal consistency Cronbach’s
α at .96 supports the reliability of BFI which is correlated with measures of
performance status (patients who are more ill reported higher levels of fatigue).<sup>
<xref rid="bibr68-15347354241252698" ref-type="bibr">68</xref>
</sup></p>
<list list-type="simple" id="list13-15347354241252698">
<list-item>
<p>b. Sleep—Pittsburgh Sleep Quality Index (PSQI)</p>
</list-item>
</list>
<p>The PSQI, proposed by Buysse et al<sup>
<xref rid="bibr76-15347354241252698" ref-type="bibr">76</xref>
</sup>
in 1989, is currently the most commonly used scale for assessing sleep quality. The
PSQI is a 19-item scale measuring 7 aspects of the sleep quality and disturbances,
that is, subjective sleep quality, sleep latency, duration, efficiency, disturbances,
use of sleep medication, and daytime sleep dysfunction, each weighted equally on a 0
to 3 scale. The total score ranges between 0 and 21, with increasing scores indicating
worse sleep quality.<sup>
<xref rid="bibr76-15347354241252698" ref-type="bibr">76</xref>
</sup>
It has a sensitivity of 89.6% and a specificity of 86.5% to detect insomnia cases and
is a useful first-line, easy-to-handle, and time-efficient questionnaire to evaluate
sleep quality.<sup>
<xref rid="bibr79-15347354241252698" ref-type="bibr">79</xref>
</sup>
The PSQI was reported to be a stable measure of sleep quality with high test-retest
reliability and construct validity.<sup><xref rid="bibr79-15347354241252698"
ref-type="bibr">79</xref>,<xref rid="bibr80-15347354241252698" ref-type="bibr">80</xref></sup></p>
<list list-type="simple" id="list14-15347354241252698">
<list-item>
<p>c. Depression—Centre for Epidemiologic Studies Depression (CES-D)</p>
</list-item>
</list>
<p>The CES-D is a short self-reported 20-item scale<sup>
<xref rid="bibr81-15347354241252698" ref-type="bibr">81</xref>
</sup>
to be administered to measure depression symptoms at baseline, mid-intervention,
post-intervention, and follow-up. The CES-D shows very high internal consistency and
adequate test-retest repeatability.<sup>
<xref rid="bibr81-15347354241252698" ref-type="bibr">81</xref>
</sup>
The score is the sum of all items, and the maximum score is 60.
Scores ≥ 16 on the CES-D is considered as having
“depressed symptoms.” The cut off score of 12 has been validated with
DSM-III criteria for clinical depression.<sup><xref rid="bibr81-15347354241252698"
ref-type="bibr">81</xref>,<xref rid="bibr82-15347354241252698" ref-type="bibr">82</xref></sup></p>
<list list-type="simple" id="list15-15347354241252698">
<list-item>
<p>ii. Cortisol biomarker: 24-hour urine cortisol</p>
</list-item>
</list>
<p>Urine sample will be collected at baseline (Week-1) and post-intervention (Week- 12).<sup>
<xref rid="bibr83-15347354241252698" ref-type="bibr">83</xref>
</sup>
Participants are briefed on the urine collection procedure during assessment and
advised to obtain the 2.5 L urine collection container from any nearby BP
Laboratories before baseline (Week-1) and post-intervention (Week-12). We use 24-hour
urinary cortisol as a non-invasive, integrated measure of cortisol stress hormone
activity that could be collected in participants’ home environments.
Participants are instructed to collect all urine for 24 hours from 8:00am a day
prior to baseline (Week-1) and post-intervention (Week-12) to 8:00am the next mornings
and to send the urine sample collected to the nearest BP Laboratories the next morning
itself. If the 2.5L collection container is completely full, subjects are advised to
use a clean mineral water bottle to collect any specimen in excess of the 2.5 L
collection. If subjects are unable to collect all urine for any reason, their samples
will be deemed inadequate and no urinary cortisol data will be recorded for these
subjects.</p>
<p>The 24-hour urine cortisol test provides a more accurate estimate of overall cortisol
secretion<sup>
<xref rid="bibr84-15347354241252698" ref-type="bibr">84</xref>
</sup>
to assess urinary-free cortisol (UFC) over a 24-hour period and provides an index of
(unbound serum cortisol) the total amount of cortisol released by the adrenals. The
24-hour collection time reflects the amount of cortisol that is released over a
complete circadian cycle, which is a physiologically meaningful unit of time. An
integrated mean of cortisol levels over a 24-hour period is thought to provide a
moderately stable measure of adrenocortical output.<sup>
<xref rid="bibr85-15347354241252698" ref-type="bibr">85</xref>
</sup>
Urinary cortisol output will be analyzed by chemiluminescent microparticle immunoassay
(CMIA) at BP Laboratories, headquartered in Shah Alam, Selangor Darul Ehsan, Malaysia.</p>
</sec>
<sec id="section22-15347354241252698">
<title>Qualitative interview</title>
<p>Semi-structured interviews will be conducted to inform interpretation of quantitative
results and participants’ acceptance, experience, and subjective perception of
the study as well as to find out areas for further improvement<sup>
<xref rid="bibr86-15347354241252698" ref-type="bibr">86</xref>
</sup>
after Week-16.</p>
<p>A prepared interview guide (<ext-link
xlink:href="https://journals.sagepub.com/doi/suppl/10.1177/15347354241252698"
ext-link-type="uri">Supplemental Material 4</ext-link>) is designed to delve into
participants’ experiences and will be used in the interview to cover 3 primary
themes: the experiences of practicing GQ, changes in the physical and emotional state,
and suitability of GQ for cancer survivors. Examples of questions to be asked are
“How do you feel about the 12 weeks of Guolin Qigong study?,”
“Have you had other benefits from this Guolin Qigong study?,” and
“Would you recommend Guolin Qigong to other cancer survivors? Why? Why
not?.”</p>
<p>Each interview will take approximately 45 minutes and will be audio-recorded
and transcribed verbatim by the Researcher.</p>
</sec>
</sec>
</sec>
<sec id="section23-15347354241252698">
<title>Protocol Amendments</title>
<p>The Researcher is responsible for submitting materials to the human ethics committee.</p>
<sec id="section24-15347354241252698">
<title>Trial Monitoring</title>
<p>The Researcher will report progress of the trial to the panel of supervisors on a
quarterly basis. Annual reports will be submitted to the human ethics committee to
monitor the trial progress and outcomes. Participants in the GQ group will be advised to
record any perceived adverse events in the practice diary and this will be recorded in
participants’ Adverse Event Form by the Researcher. The severity, expectedness
and causal relationship with GQ intervention will be assessed for every adverse event
according to guidelines for safety reporting.<sup><xref rid="bibr75-15347354241252698"
ref-type="bibr">75</xref>,<xref rid="bibr87-15347354241252698" ref-type="bibr">87</xref></sup></p>
<p>The schedule of the enrollment, intervention, and data collection is shown in <xref
rid="fig2-15347354241252698" ref-type="fig">Figure 2</xref>.</p>
</sec>
<sec id="section25-15347354241252698">
<title>Sample Size</title>
<p>Using a small effect size (0.2)<sup>
<xref rid="bibr65-15347354241252698" ref-type="bibr">65</xref>
</sup>
rather than a medium effect size (0.5)<sup>
<xref rid="bibr64-15347354241252698" ref-type="bibr">64</xref>
</sup> to
achieve a more conservative estimation, the sample size is 25 cases in each group with
90% power and two-sided 5% significance trial design.<sup>
<xref rid="bibr88-15347354241252698" ref-type="bibr">88</xref>
</sup>
Allowing for a drop-out of about 20% based on previous studies,<sup><xref
rid="bibr89-15347354241252698" ref-type="bibr">89</xref>
<xref
rid="bibr90-15347354241252698" ref-type="bibr" /><xref
rid="bibr91-15347354241252698" ref-type="bibr" />-<xref
rid="bibr92-15347354241252698" ref-type="bibr">92</xref></sup> a total sample of 60
(30 in each group) would be required.</p>
</sec>
<sec id="section26-15347354241252698">
<title>Data Collection</title>
<p>De-identified information will be collected and managed by assigning an identification
code to each participant. Demographic information, medical history, any occurrence of
adverse events, practice adherence and intervention outcomes during the study will be
collected and recorded on paper or electronic file.</p>
<p>Demographic information and medical history will first be collected by the Researcher.
De-identified Practice Diary, Brief Fatigue Index, Pittsburgh Sleep Quality Index, and
Centre for Epidemiologic Studies Depression will be collected at Week-1, Week-6,
Week-12, and Week-16, while the 24-hour urine cortisol results will be collected by the
research assistant at Week-1 and Week-12. Interviews will be conducted by the Researcher
after Week-16, audio-recorded, de-identified, and transcribed verbatim.</p>
<p>During the study, all data will be recorded in participant source document files in
paper format (sociodemographic data, feasibility and clinical data), administered by
independent research assistants and will be transferred to an electronic format for
storage and analysis. The 2 independent research assistants will verify and check the
data collected by each other. After all data are confirmed and checked the research
assistants will extract the data into an Excel sheet for analysis.</p>
<p>After participants have been randomized, dropout and premature termination or
withdrawal from the 2 groups at any point will be recorded along with relevant reasons.
Participants can choose to withdraw and will not be affected at any time while declining
to participate or withdrawing from the trial. In some cases, participants will
discontinue the intervention, such as illness, progression of their disease, or
inability to engage despite adjustment of the program. Participants who withdraw from
the intervention during the trial will not be replaced.</p>
<p>Interviews will be conducted after Week-16 in person or online via Zoom by the
Researcher at an appointed time. Interview sessions will be audio recorded and
transcribed verbatim using NVivo or the recording feature available in Zoom, ensuring
accurate documentation, and stored in electronic files for analysis.</p>
</sec>
<sec id="section27-15347354241252698">
<title>Data Management</title>
<p>De-identified electronic data will be stored on a password-protected computer. Files
will be accessible for review only to the research team. Specific requests will be
needed from the supervisory panel for any access by any other person. All completed
forms and study information will be de-identified and stored in a locked filing cabinet
together with consent forms at UMMC.</p>
<p>The information collected will be securely locked and only accessible to the research
personnel. The data will be de-identified for analysis and once date is coded, all
identifiable information will be destroyed. All data collected in the study will be
destroyed 7 years after publication.</p>
</sec>
</sec>
<sec id="section28-15347354241252698">
<title>Data Analysis</title>
<sec id="section29-15347354241252698">
<title>Quantitative Data</title>
<p>Data analysis will be conducted by an independent statistician. Data analysis will be
by intention to treat using last observation carried forward (LOCF).<sup>
<xref rid="bibr93-15347354241252698" ref-type="bibr">93</xref>
</sup> The
normality of the study data will be checked by examining the mean, median, skewness, and
kurtosis including graphical representation of the box plot, normal Q-Q Plot or
histogram. Continuous data will be summarized using descriptive statistics including the
number of observations used in the calculation (<italic toggle="yes">n</italic>), mean,
standard deviation (SD), minimum, median and maximum. Categorical data will be
summarized as counts and percentages of each category. Between group comparison will be
conducted using the t test, chi-square test, or Fisher exact test, as
appropriate. We will report the results for two-sided 5% tests for the primary trial
outcome. We will use generalized linear mixed model (GLMM). The outcomes of the model
will be BFI, PSQI, CES-D scores, and 24-hour urine cortisol test results. Models will
include the treatment group as a fixed effect, with time as a random effect to account
for the repeated measurements. Analyses will be conducted to identify the baseline
characteristics of the participants who may benefit most from the intervention. Model
assumptions will be checked and appropriate adjustments to the analysis will be made
where necessary. STATA<sup>®</sup> software version 17.1 (2021; Stata Corporation,
College Station, TX, USA) will be used for all analyses. Cohen’s D will be
calculated as the absolute differences between the mean change in the variable divided
by pooled variance of the change.</p>
</sec>
<sec id="section30-15347354241252698">
<title>Qualitative Data</title>
<p>The researcher will conduct an interview consisting of 6 pre-determined open-ended
questions (Refer <ext-link
xlink:href="https://journals.sagepub.com/doi/suppl/10.1177/15347354241252698"
ext-link-type="uri">Supplemental Material 4</ext-link>) that were identified from
literature review and based on research questions outlined in the study. Probing
questions will only be asked where clarification or expansion of expressed ideas is
required. Interviews will be conducted until data saturation is reached. Interview
transcripts will be analyzed using the inductive qualitative content analysis approach
to provide a comprehensive descriptive summary of the interviewee’s experience
and perception of GQ in everyday terms.<sup>
<xref rid="bibr94-15347354241252698" ref-type="bibr">94</xref>
</sup> All
audio recordings of the interview will be transcribed verbatim with NVivo or Zoom.
First, to obtain an overall impression, the transcribed materials will be read several
times thoroughly. Then, sentences or phrases will be condensed and divided into
ideas/meaning units. The ideas/meaning units are further condensed, abstracted, and
conceived into the categories. All categories will be put together and compared, based
on differences and similarities and group together to create themes. This iterative
approach to analysis will be conducted until no new ideas/codes emerge and saturation is
achieved. A second reviewer will review each phase of the process. A summary of each
theme and supporting quotes from participants will be generated and shared with the
study team to review independently. Data analysis will be repeated in this manner until
a final consensus is reached on final themes to ensure validity.<sup><xref
rid="bibr95-15347354241252698" ref-type="bibr">95</xref>,<xref
rid="bibr96-15347354241252698" ref-type="bibr">96</xref></sup> The Consolidated
Criteria for Reporting Qualitative Research (COREQ)<sup>
<xref rid="bibr62-15347354241252698" ref-type="bibr">62</xref>
</sup> will
be used for reporting the findings.</p>
</sec>
<sec id="section31-15347354241252698">
<title>Trial Registration and Ethical Issues</title>
<p>This study has been registered with ANZCTR (ACTRN12622000688785p), was approved by
Medical Research Ethic Committee of University Malaya Medical Centre (MREC ID NO:
2022323-11092) and recognized by Western Sydney University Human Research Ethics
Committee (RH15124).</p>
</sec>
<sec id="section32-15347354241252698">
<title>Dissemination</title>
<p>The results of this study will be reported in a PhD thesis by the first author and
submitted for publication following the rules of CONSORT in a peer-reviewed journal or
presentation using de-identified or non-identifiable information. Sensitive information
including participants’ details will not be disclosed and will be treated
strictly under the privacy and confidentiality act of Malaysia and Australia.</p>
</sec>
</sec>
<sec sec-type="discussion" id="section33-15347354241252698">
<title>Discussion</title>
<p>CRF is endemic in cancer survivors with disabling effects on quality of life,
co-morbidities, independent living, and work productivity. It includes physiological
changes associated with cancer diagnosis and treatment such as cortisol dysregulation,
sleep disorders, depression, and functional disability, which further contribute to the
burden of CRF. Despite the high incidence of CRF and its symptom clusters involving sleep
quality and depression, there is no effective pharmacological intervention to prevent or
alleviate these symptoms,<sup>
<xref rid="bibr68-15347354241252698" ref-type="bibr">68</xref>
</sup>
highlighting the need to study CRF and its related symptom clusters to understand the
common biological mechanisms to improve quality of life of cancer survivors. Numerous
studies have reported certain psychological and physiological benefits of Qigong for
cancer survivors, promising potential in the realm of cancer medicine. While its
definitive impact requires further extensive research, some studies suggest benefits such
as enhanced physical functioning, stress reduction, improved mental health, immune
enhancement, and improved quality of life, and that it may complement conventional
medicine as adjunct therapy by providing a holistic approach to cancer care.<sup><xref
rid="bibr29-15347354241252698" ref-type="bibr">29</xref>,<xref
rid="bibr33-15347354241252698" ref-type="bibr">33</xref>
<xref
rid="bibr34-15347354241252698" ref-type="bibr" /><xref rid="bibr35-15347354241252698"
ref-type="bibr" /><xref rid="bibr36-15347354241252698" ref-type="bibr" /><xref
rid="bibr37-15347354241252698" ref-type="bibr" /><xref rid="bibr38-15347354241252698"
ref-type="bibr" /><xref rid="bibr39-15347354241252698" ref-type="bibr" /><xref
rid="bibr40-15347354241252698" ref-type="bibr" /><xref rid="bibr41-15347354241252698"
ref-type="bibr" /><xref rid="bibr42-15347354241252698" ref-type="bibr" /><xref
rid="bibr43-15347354241252698" ref-type="bibr" />-<xref rid="bibr44-15347354241252698"
ref-type="bibr">44</xref></sup> As research progresses, understanding its potential
role in cancer medicine could open doors to more comprehensive and patient-centric
approaches to healthcare. In this regard, GQ emerges as a unique mind-body exercise that
combines moderate and adaptive walking exercise with a pronounced focus on a specialized
breathing technique.<sup>
<xref rid="bibr97-15347354241252698" ref-type="bibr">97</xref>
</sup> While
walking has been reported to improve cancer-related symptoms,<sup><xref
rid="bibr57-15347354241252698" ref-type="bibr">57</xref>
<xref
rid="bibr58-15347354241252698" ref-type="bibr" /><xref rid="bibr59-15347354241252698"
ref-type="bibr" />-<xref rid="bibr60-15347354241252698" ref-type="bibr">60</xref></sup>
the incorporation of breathing technique of GQ serves to foster oxygen-carbon dioxide
homeostasis—an essential factor in cancer control and ultimately survival.<sup><xref
rid="bibr60-15347354241252698" ref-type="bibr">60</xref>,<xref
rid="bibr61-15347354241252698" ref-type="bibr">61</xref></sup> As such GQ stands as a
promising avenue for addressing the cluster of symptoms associated with CRF, encompassing
sleep disorder, depression, and alterations in cortisol. However, despite this promising
potential, the comprehensive exploration of GQ’s benefits remains a yet untapped
opportunity.</p>
<p>Therefore, our hypothesis posits that the current study of GQ is a feasible intervention
that holds potential to ameliorate CRF, enhance sleep quality, alleviate depression, and
regulate cortisol levels among breast, lung, and colon cancer survivors, while
concurrently unveiling a comprehensive spectrum of benefits and barriers related to
participation and adherence to GQ training, offering invaluable insights for optimizing
and enriching the program.</p>
<p>This is the first mixed-method study comprising a randomized-controlled trial and semi
structured interview to evaluate the feasibility and benefits of GQ on CRF symptom cluster
among cancer survivors. The quantitative data from the randomized-controlled trial
complements the qualitative insights to be obtained through interviews, allowing for a
comprehensive exploration of the subjective domains of feasibility, adherence, barriers
and participants’ perceptions, experiences of GQ to help improve healthcare and
identify factors for enhancing GQ intervention effectiveness.</p>
<p>Moreover, the composition of this multidisciplinary study team comprising experts from
Western Medicine and Chinese Medicine integrating their expertise from different
perspectives will lead to robust study design, enhanced participant care, rigorous data
analysis and comprehensive interpretation of results.</p>
</sec>
<sec id="section34-15347354241252698">
<title>Limitations</title>
<p>The nature of the intervention precludes blinding of both participants and researcher.
While the researcher remains unblinded as this trial is open-label, the instructors will
not be aware of intervention allocation to minimize bias. Although including cancer
survivors across all stages enables a diverse assessment of feasibility, it potentially
limits the generalizability of the results though sub-group analysis will be conducted.
Furthermore, the reliance on self-reported data for secondary outcomes emphasizes the
necessity for incorporating objective measures like actigraphy, polysomnography, and
established scales such as the Hamilton Depression Rating Scale to ensure a comprehensive
evaluation of GQ’s impact on CRF, sleep quality, and depression. Additionally, the
predominant participation of Asian Chinese individuals highlights the need for expanded
research to comprehend GQ’s feasibility and effects among cancer survivors from
various ethnic and racial backgrounds. These limitations underscore the challenges
inherent in the study’s design and demographics, emphasizing the importance of
integrating objective measures and broadening participant diversity for more conclusive
and inclusive findings.</p>
<p>Despite the limitations, exploring GQ as a potential intervention to address existing
gaps in effective treatment for CRF and its related symptom cluster of sleep quality and
depression in cancer survivors demonstrates a forward-thinking approach in the field of
oncology. It expands on the knowledge base and promotes innovative thinking, fostering the
development of novel interventions with potential contribution to the advancement of
oncology care.</p>
</sec>
<sec sec-type="conclusions" id="section35-15347354241252698">
<title>Conclusion</title>
<p>The insights gained from this study may guide future design and implementation of
evidence based mind-body interventions to improve cancer survivorship.</p>
</sec>
<sec sec-type="supplementary-material" id="section36-15347354241252698"
specific-use="figshare">
<title>Supplemental Material</title>
<supplementary-material id="suppl1-15347354241252698" position="float"
content-type="local-data">
<caption>
<title>sj-docx-2-ict-10.1177_15347354241252698 – Supplemental material for
Exploring Guolin Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in
Cancer Survivors: A Mixed Method Randomized Controlled Trial Protocol</title>
</caption>
<media xlink:href="sj-docx-2-ict-10.1177_15347354241252698.docx" />
<p>Supplemental material, sj-docx-2-ict-10.1177_15347354241252698 for Exploring Guolin
Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in Cancer Survivors: A
Mixed Method Randomized Controlled Trial Protocol by Sara L. K. Low, Gwo Fuang Ho,
Bingkai Liu, Eng-Siew Koh, Yutong Fei, Chiah Shean Teo and Xiaoshu Zhu in Integrative
Cancer Therapies</p>
</supplementary-material>
<supplementary-material id="suppl2-15347354241252698" position="float"
content-type="local-data">
<caption>
<title>sj-docx-3-ict-10.1177_15347354241252698 – Supplemental material for
Exploring Guolin Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in
Cancer Survivors: A Mixed Method Randomized Controlled Trial Protocol</title>
</caption>
<media xlink:href="sj-docx-3-ict-10.1177_15347354241252698.docx" />
<p>Supplemental material, sj-docx-3-ict-10.1177_15347354241252698 for Exploring Guolin
Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in Cancer Survivors: A
Mixed Method Randomized Controlled Trial Protocol by Sara L. K. Low, Gwo Fuang Ho,
Bingkai Liu, Eng-Siew Koh, Yutong Fei, Chiah Shean Teo and Xiaoshu Zhu in Integrative
Cancer Therapies</p>
</supplementary-material>
<supplementary-material id="suppl3-15347354241252698" position="float"
content-type="local-data">
<caption>
<title>sj-docx-4-ict-10.1177_15347354241252698 – Supplemental material for
Exploring Guolin Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in
Cancer Survivors: A Mixed Method Randomized Controlled Trial Protocol</title>
</caption>
<media xlink:href="sj-docx-4-ict-10.1177_15347354241252698.docx" />
<p>Supplemental material, sj-docx-4-ict-10.1177_15347354241252698 for Exploring Guolin
Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in Cancer Survivors: A
Mixed Method Randomized Controlled Trial Protocol by Sara L. K. Low, Gwo Fuang Ho,
Bingkai Liu, Eng-Siew Koh, Yutong Fei, Chiah Shean Teo and Xiaoshu Zhu in Integrative
Cancer Therapies</p>
</supplementary-material>
<supplementary-material id="suppl4-15347354241252698" position="float"
content-type="local-data">
<caption>
<title>sj-pdf-1-ict-10.1177_15347354241252698 – Supplemental material for
Exploring Guolin Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in
Cancer Survivors: A Mixed Method Randomized Controlled Trial Protocol</title>
</caption>
<media xlink:href="sj-pdf-1-ict-10.1177_15347354241252698.pdf" />
<p>Supplemental material, sj-pdf-1-ict-10.1177_15347354241252698 for Exploring Guolin
Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in Cancer Survivors: A
Mixed Method Randomized Controlled Trial Protocol by Sara L. K. Low, Gwo Fuang Ho,
Bingkai Liu, Eng-Siew Koh, Yutong Fei, Chiah Shean Teo and Xiaoshu Zhu in Integrative
Cancer Therapies</p>
</supplementary-material>
</sec>
</body>
<back>
<ack>
<p>We thank Cansurvive Centre Malaysia Berhad and Breast Cancer Women Association for their
invaluable support in promoting the study through their membership base. We also wish to
express our gratitude to the two Guolin Qigong instructors, Wong Wei Ming of Shah Alam
Guolin Qigong Paradise, Selangor and Chan Lan Fong of Lake Garden Guolin Qigong, Kuala
Lumpur for their unwavering passion and dedication in teaching participants throughout the
duration of the program. Their commitment to the Guolin Qigong classes over most weekends
exemplifies their exceptional dedication to the research study. We are also immensely
thankful to the courageous and resilient cancer survivors who generously share their
personal experiences of their journey to recovery, providing encouragement and hope to the
study participants.</p>
</ack>
<fn-group>
<fn fn-type="con">
<p><bold>Author Contributions:</bold> Conceptualization and design: Sara LK Low, Xiaoshu
Zhu, Gwo Fuang Ho, BingKai Liu, Eng-Siew Koh, and Yutong Fei. Recruitment: Sara LK Low,
Gwo Fuang Ho, Chiah Shean Teo. Investigating : Sara LK Low. Project Administration: Sara
LK Low. Supervision: Xiaoshu Zhu, Gwo Fuang Ho, BingKai Liu, Eng-Siew Koh, and Yutong
Fei. Writing- original draft: Sara LK Low. Writing-review and editing: Sara LK Low, Gwo
Fuang Ho, BingKai Liu, Eng-Siew Koh, Chiah Shean Teo, Yutong Fei, Xiaoshu Zhu. All
authors read and approved the final manuscript.</p>
</fn>
<fn fn-type="other">
<p><bold>Availability of Data and Materials:</bold> The datasets used and/or analyzed
during the current study are available from the corresponding author on reasonable
request.</p>
</fn>
<fn fn-type="other">
<p><bold>Consent for Publication:</bold> Consent for publication is not required as there
is no details on individuals reported within the manuscript.</p>
</fn>
<fn fn-type="COI-statement">
<p>The author(s) declared no potential conflicts of interest with respect to the research,
authorship, and/or publication of this article.</p>
</fn>
<fn fn-type="financial-disclosure">
<p><bold>Funding:</bold> The author(s) disclosed receipt of the following financial
support for the research, authorship, and/or publication of this article: This paper is
part of a PhD study and it is supported by the School of Health Science, Western Sydney
University and Chinese Medicine Centre (an international collaboration between Western
Sydney University and Beijing University of Chinese Medicine). Professor Xiaoshu Zhu and
Professor Yutong Fei who are the supervisors of the first author of this manuscript are
employed as academic by these institutes respectively.</p>
</fn>
<fn fn-type="other">
<p><bold>Trial Status:</bold> Recruitment of participants started on October 2022. The
trial is currently underway and expected to be completed by end of 2025. The protocol is
version no.3 dated 16 May 2022.</p>
</fn>
<fn fn-type="other">
<p><bold>Ethics Approval and Consent to Participate:</bold> This study has been approved
by Medical Research Ethic Committee of University Malaya Medical Centre (MREC ID NO:
2022323-11092) and recognized by Western Sydney University Human Research Ethics
Committee (RH15124). All methods will be conducted in accordance with the ethical
standards of the declaration of Helsinki. Informed consent will be obtained from all
subjects.</p>
</fn>
<fn fn-type="other">
<p><bold>ORCID iDs:</bold> Sara L. K. Low <inline-graphic
xlink:href="10.1177_15347354241252698-img1.jpg" />
<ext-link
xlink:href="https://orcid.org/0000-0001-6296-6052" ext-link-type="uri">
https://orcid.org/0000-0001-6296-6052</ext-link></p>
<p>Chiah Shean Teo <inline-graphic xlink:href="10.1177_15347354241252698-img1.jpg" />
<ext-link
xlink:href="https://orcid.org/0000-0003-1071-443X" ext-link-type="uri">
https://orcid.org/0000-0003-1071-443X</ext-link></p>
<p>Xiaoshu Zhu <inline-graphic xlink:href="10.1177_15347354241252698-img1.jpg" />
<ext-link
xlink:href="https://orcid.org/0000-0002-2909-5926" ext-link-type="uri">
https://orcid.org/0000-0002-2909-5926</ext-link></p>
</fn>
<fn fn-type="supplementary-material">
<p><bold>Supplemental Material:</bold> Supplemental material for this article is available
online.</p>
</fn>
</fn-group>
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