## Protocol Section
### Identification Module
**NCT ID:** NCT00994279

**Brief Title:** Yoga or Educational Wellness Class for Women With Stage I, Stage II, or Stage III Breast Cancer Undergoing Chemotherapy

**Official Title:** Yoga or Wellness Education During Breast Cancer Treatment: Establishing Community-Based Partnerships

#### Organization Study ID Info
**ID:** IRB00011383
#### Organization
**Class:** OTHER
**Full Name:** Wake Forest University Health Sciences
#### Secondary ID Infos
**ID:** U10CA081851
**Link:** https://reporter.nih.gov/quickSearch/U10CA081851
**Type:** NIH
**Domain:** NCI
**ID:** REBACCCWFU97309
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2011-10-14

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-10-20

**Type:** ACTUAL

**Last Update Submit Date:** 2021-09-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-10-14

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-03-09

**Type:** ACTUAL

**Results First Submit Date:** 2015-07-15

**Results First Submit QC Date:** 2017-01-18

#### Start Date
**Date:** 2010-01

**Type:** ACTUAL

**Status Verified Date:** 2021-09

#### Study First Post Date
**Date:** 2009-10-14
**Type:** ESTIMATED
**Study First Submit Date:** 2009-10-13
**Study First Submit QC Date:** 2009-10-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Wake Forest University Health Sciences

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** RATIONALE: Yoga and wellness classes may reduce fatigue and improve mood, sleep, and quality of life in women receiving chemotherapy for breast cancer. It is not yet known whether yoga is more effective than wellness education for women with breast cancer who are undergoing chemotherapy.

PURPOSE: This randomized phase II trial is studying a community-based yoga class to see how well it works compared with an educational wellness class for women with stage I, stage II, or stage III breast cancer undergoing chemotherapy.

**Detailed Description:** OBJECTIVES:

Primary

* To estimate the participation rate, accrual, adherence, and retention to a community-based study of yoga vs an active control (wellness education) in women with stage I-III breast cancer undergoing chemotherapy.

Secondary

* To obtain estimates of the variability of women's self-reported fatigue and depressive symptoms, sleep quality, and health-related quality of life from baseline to the end of the intervention at 10 weeks.
* To obtain estimates of the efficacy of a community-based yoga intervention in women with breast cancer.
* To standardize the yoga protocol for use in multiple community settings with breast cancer patients, and ascertain that yoga teachers can adhere to a uniform protocol.

OUTLINE: This is a multicenter study. Patients are stratified according to CCOP site and chemotherapy-treatment status (planning vs started). Patients are randomized to 1 of 2 intervention arms.

Patients must begin their class or group within 3 weeks of starting chemotherapy. All women enter their class or group on a rolling basis so that their class or group coincides with the weeks that they receive chemotherapy treatments.

* Arm I (Yoga intervention): In weeks 1-10, patients attend a community-based weekly 75-minute Integral Yoga class led by an experienced yoga teacher specifically trained in adapting yoga for people with cancer. The yoga class includes postures, deep relaxation, breathing practices, and meditation to create a profound experience of peace and well-being. Women are asked to attend ≥ 8 of 10 classes over a 12-week period to allow for missed classes. Women are also provided with a yoga mat, associated yoga props (bolster, strap), and a 45-minute cancer-specific yoga DVD for home practice. Women are asked to practice yoga outside of the class at least twice per week, and are encouraged to practice more frequently than that.
* Arm II (Active control): Patients meet for a weekly 75-minute wellness education group in weeks 1-10 (women may make-up missed classes during weeks 11 and 12). The group focuses on issues that women with breast cancer face as they undergo treatment; topics include symptom management, financial and insurance issues, emotional issues/coping with cancer, communicating with healthcare providers/navigating the healthcare system, healthful eating/cooking demonstrations, sexual issues/fertility/body image, mobilizing social support/impact of cancer on family and friends, survivorship (advocacy) opportunities, and common concerns/fear of recurrence. Women are provided with reading materials relevant to the topics that will be covered in each group meeting and are asked to spend approximately 45 minutes twice weekly reading these materials and incorporating any relevant principles/ideas into their daily lives. Women may request additional reading materials in further topics of interest from the group facilitators.

Patients complete questionnaires at baseline and at weeks 5, 10, and 14 to assess fatigue (FACIT-Fatigue), depressive symptoms (Center for Epidemiologic Studies-Depression Scale \[CES-D\]), treatment-related symptoms (M.D. Anderson Symptom Inventory \[MDASI\]), sleep disturbance (Medical Outcomes Study Sleep Measure \[MOS-Sleep\]), and health-related quality of life (Functional Assessment of Cancer Therapy-Breast \[FACT-B\]). Patients also track time spent on all home-yoga practice (arm I) or wellness-group homework (arm II). After the intervention (week 10), patients are asked to provide feedback on the program. Yoga/Wellness teachers will completion intervention feedback forms 6 months from the start of the first intervention and at completion of the study.

### Conditions Module

**Conditions:**

- Breast Cancer

- Depression

- Fatigue

- Sleep Disorders

**Keywords:**

- fatigue

- depression

- sleep disorders

- stage IA breast cancer

- stage IB breast cancer

- stage II breast cancer

- stage IIIA breast cancer

- stage IIIB breast cancer

- stage IIIC breast cancer

- recurrent breast cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Yoga Intervention

**Intervention Names:**

- Behavioral: Yoga

**Label:** Arm 1: Yoga Intervention

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Educational Wellness Group

**Intervention Names:**

- Behavioral: Education

**Label:** Arm 2: Educational Wellness Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm 1: Yoga Intervention

**Description:** Yoga sessions

**Name:** Yoga

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Arm 2: Educational Wellness Group

**Description:** Educational Wellness Group

**Name:** Education

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Proportion of participants completing the 10 week study

**Measure:** Retention

**Time Frame:** 10 weeks

#### Secondary Outcomes

**Description:** FACIT-Fatigue patient reported outcome. This questionnaire consists of 13 questions answered on a 0 to 4 scale with a min of 0 and a max of 52. Higher scores indicate less fatigue.

**Measure:** Fatigue at 10 Weeks

**Time Frame:** 10 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Women will be eligible if they are:

* Scheduled to begin chemotherapy treatment within 3 weeks of study registration, or able to start Yoga/Wellness sessions prior to second chemotherapy treatment.
* ≥18 years of age.
* Physically able to attend yoga classes (simply meaning that they can physically make it to the intervention session and are able to sit on a chair or lie on the floor) (ECOG Performance Status rating 0-2; Zubrod et al., 1960).
* Diagnosed with breast cancer Stages I-III.
* Chemotherapy is anticipated to continue during the 10 weeks of the study intervention.
* 2-8 weeks post-completion of breast surgery (unless receiving neoadjuvant chemotherapy).
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Have practiced yoga on a regular basis (at least once a week) within the past 4 weeks to recruit women who are not already regularly practicing yoga. Given that the benefits of yoga are likely more immediate than long-term, however, we will enroll women who have previously had a yoga practice.
* Are being treated with surgery and/or radiation therapy and/or hormonal treatment only and/or Herceptin therapy only (no chemotherapy).
* Anticipate undergoing surgery related to their breast cancer or receipt of radiation therapy during the study period.
* Have regularly engaged in moderate (activity that makes you breathe somewhat harder than normal; may include carrying light loads, bicycling at a regular pace, fast walking, tennis, easy swimming, or popular or folk dancing) or vigorous (activity that causes heavy breathing, sweating, rapid fatigue; it can only be sustained for very short periods of time, like running or swimming strongly) physical activity at least 3-5 days per week (on average) within the past 4 weeks.

Pregnant women will not be excluded from this study because the study intervention(s) pose no risk of potential for teratogenic or abortifacient effects. In fact, gentle yoga practice is quite safe for pregnant women and poses can be slightly modified, if needed. The anticipated number of pregnant women eligible to enroll is minimal.

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Wake Forest University Comprehensive Cancer Center

**State:** North Carolina

**Zip:** 27157-1096

#### Overall Officials

**Official 1:**

**Affiliation:** Wake Forest University Health Sciences

**Name:** Edward G. Shaw, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000001523

- Term: Mental Disorders

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depression

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M8364

- Name: Fatigue

- Relevance: HIGH

- As Found: Fatigue

- ID: M22242

- Name: Parasomnias

- Relevance: HIGH

- As Found: Sleep Disorders

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: HIGH

- As Found: Sleep Disorders

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000012893

- Term: Sleep Wake Disorders

- ID: D000020447

- Term: Parasomnias

- ID: D000005221

- Term: Fatigue

- ID: D000003863

- Term: Depression

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Sample includes all patients with follow-up toxicity assessments. This number is different from the sample size in other analyses because some participants provided follow-up toxicity assessments before they went off study. Patients were asked about adverse events at each assessment visit.

#### Event Groups

**Group ID:** EG000

**Title:** Arm 1: Yoga Intervention

**Description:** Yoga Intervention

Yoga: Yoga sessions

**ID:** EG000

**Other Num Affected:** 11

**Other Num at Risk:** 21

**Serious Number Affected:** 1

**Serious Number At Risk:** 21

**Title:** Arm 1: Yoga Intervention

**Group ID:** EG001

**Title:** Arm 2: Educational Wellness Group

**Description:** Educational Wellness Group

Education: Educational Wellness Group

**ID:** EG001

**Other Num Affected:** 8

**Other Num at Risk:** 17

**Serious Number Affected:** 1

**Serious Number At Risk:** 17

**Title:** Arm 2: Educational Wellness Group

**Frequency Threshold:** 5

#### Other Events

**Term:** Back Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Infections and Infestations

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (4.0)

**Term:** Mucositis oral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Musculoskeletal/Soft tissue = Cartilage Tears

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Neck Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Pain in Extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Palmar-plantar erythrodysesthesia syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Peripheral nerve infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (4.0)

**Term:** Peripheral sensory neuropathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Rash acneiform

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Sore Throat

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** CTCAE (4.0)

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (4.0)

#### Serious Events

**Term:** Febrile Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE (4.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 21

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 17

**Num Events:** 1

**Term:** Heart Failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (4.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 21

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 17

**Time Frame:** 14 weeks

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 22

**Group ID:** BG001

**Value:** 18

**Group ID:** BG002

**Value:** 40

**Units:** Participants

### Group

**ID:** BG000

**Title:** Arm 1: Yoga Intervention

**Description:** Yoga Intervention

Yoga: Yoga sessions

### Group

**ID:** BG001

**Title:** Arm 2: Educational Wellness Group

**Description:** Educational Wellness Group

Education: Educational Wellness Group

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 19

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 37

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 29

**Upper Limit:** 83

**Value:** 50

#### Measurement

**Group ID:** BG001

**Lower Limit:** 29

**Upper Limit:** 64

**Value:** 45

#### Measurement

**Group ID:** BG002

**Lower Limit:** 29

**Upper Limit:** 83

**Value:** 47

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 40

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 40

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 5

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 20

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 35

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 40

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 6
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
**Population Description:** All randomized participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Limitations and Caveats
**Description:** There were no limitations.
### Point of Contact
**Email:** dcase@wakehealth.edu
**Organization:** Wake Forest NCI NCORP Research Base
**Phone:** (336) 716-1048
**Title:** Dr. Doug Case
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Null hypothesis is that the two arms will not differ in retention at 14 weeks.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** .53
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Chi-squared
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Null hypothesis is that the two groups would not differ in fatigue at 10 weeks.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** .98
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 60
- **Spread:** 
- **Upper Limit:** 95
- **Value:** 82
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 65
- **Spread:** 
- **Upper Limit:** 99
- **Value:** 89
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.6
- **Upper Limit:** 
- **Value:** 30.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.9
- **Upper Limit:** 
- **Value:** 30.1
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Proportion of participants completing the 10 week study
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** All randomized participants
**Reporting Status:** POSTED
**Time Frame:** 10 weeks
**Title:** Retention
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Yoga Intervention

Yoga: Yoga sessions
**ID:** OG000
**Title:** Arm 1: Yoga Intervention
##### Group
**Description:** Educational Wellness Group

Education: Educational Wellness Group
**ID:** OG001
**Title:** Arm 2: Educational Wellness Group
#### Outcome Measure 2
**Description:** FACIT-Fatigue patient reported outcome. This questionnaire consists of 13 questions answered on a 0 to 4 scale with a min of 0 and a max of 52. Higher scores indicate less fatigue.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants with 10 week outcome data. Note that one participant in the Wellness group was missing this outcome even though they completed the study.
**Reporting Status:** POSTED
**Time Frame:** 10 weeks
**Title:** Fatigue at 10 Weeks
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Yoga Intervention

Yoga: Yoga sessions
**ID:** OG000
**Title:** Arm 1: Yoga Intervention
##### Group
**Description:** Educational Wellness Group

Education: Educational Wellness Group
**ID:** OG001
**Title:** Arm 2: Educational Wellness Group
### Participant Flow Module
#### Group
**Description:** Yoga Intervention

Yoga: Yoga sessions
**ID:** FG000
**Title:** Arm 1: Yoga Intervention
#### Group
**Description:** Educational Wellness Group

Education: Educational Wellness Group
**ID:** FG001
**Title:** Arm 2: Educational Wellness Group
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Toxicity
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Multiple reasons
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 22
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 18
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 18
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 13
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 5
**Recruitment Details:** Participants were recruited from three NCI CCOP sites between 1/2010 and 8/2011
**Has Results:** True