## Protocol Section
### Identification Module
**NCT ID:** NCT02351479

**Brief Title:** Hula, a Physical Activity Intervention for Female-Cancer Survivors

**Official Title:** Hula, a Physical Activity Intervention for Female-Cancer Survivors

#### Organization Study ID Info
**ID:** Bantum-2013-2
#### Organization
**Class:** OTHER
**Full Name:** University of Hawaii
### Status Module
#### Completion Date
**Date:** 2017-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-04-18

**Type:** ACTUAL

**Last Update Submit Date:** 2019-04-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-12

**Type:** ACTUAL

#### Start Date
**Date:** 2013-09

**Status Verified Date:** 2019-04

#### Study First Post Date
**Date:** 2015-01-30
**Type:** ESTIMATED
**Study First Submit Date:** 2015-01-20
**Study First Submit QC Date:** 2015-01-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Hawaii

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** A six-month interventional program to determine the biological and psychosocial effects of hula as a form of physical activity for female breast, cervical, endometrial or ovarian cancer survivors living on Oahu.

### Conditions Module

**Conditions:**

- Physical Activity

- Breast Cancer

- Cervical Cancer

- Ovarian Cancer

- Endometrial Cancer

**Keywords:**

- hula

- breast cancer

- female

- hawaii

- physical activity

- cervical cancer

- ovarian cancer

- endometrial cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 73

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Hula is an ancient, Native Hawaiian dance form of cultural expression and physical activity. Participants will attend one-hour hula classes twice a week for six months.

**Intervention Names:**

- Behavioral: Hula

**Label:** Hula

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Hula

**Name:** Hula

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Compliance as measured by the proportion of total sessions attended and a questionnaire regarding satisfaction with the program at the end of the intervention

**Measure:** Hula Program Feasibility (Compliance as measured by the proportion of total sessions attended and a questionnaire regarding satisfaction with the program at the end of the intervention)

**Time Frame:** 6 months after the start of the intervention program

#### Secondary Outcomes

**Description:** Circulating levels of sex hormones measured in serum samples.

**Measure:** Biomarkers - Sex Hormones (Circulating levels of sex hormones measured in serum samples)

**Time Frame:** Baseline, 6 months and 12 months after the start of the intervention program

**Description:** Circulating levels of cytokines measured in serum samples.

**Measure:** Biomarkers - Cytokines (Circulating levels of cytokines measured in serum samples.)

**Time Frame:** Baseline, 6 months and 12 months after the start of the intervention program

**Description:** Circulating levels of leptin, CRP, IGF-1, and IGFBP3 measured in serum samples collectively.

**Measure:** Biomarkers - Inflammatory Markers (Circulating levels of leptin, CRP, IGF-1, and IGFBP3 measured in serum samples collectively.)

**Time Frame:** Baseline, 6 months and 12 months after the start of the intervention program

**Description:** DNA methylation patterns as detected with the Illumina Assay containing methylation sites in RefSeq genes and CpG islands collectively.

**Measure:** DNA Methylation Patterns (DNA methylation patterns as detected with the Illumina Assay containing methylation sites in RefSeq genes and CpG islands collectively.)

**Time Frame:** Baseline, 6 months and 12 months after the start of the intervention program

**Description:** Collectively looking at demographic items as measured on the baseline questionnaire, including ethnicity, education, family, history of cancer, stage of cancer, treatment type, and comorbidities.

**Measure:** Self-Report Outcomes - Demographics (Collectively looking at demographic items as measured on the baseline questionnaire, including ethnicity, education, family, history of cancer, stage of cancer, treatment type, and comorbidities.)

**Time Frame:** Baseline, 6 months and 12 months after the start of the intervention program

**Description:** Minutes per week of exercise assessed using The Women's Health Initiative Physical Activity Questionnaire

**Measure:** Self-Report Outcomes - Physical Activity (Minutes per week of exercise assessed using The Women's Health Initiative Physical Activity Questionnaire)

**Time Frame:** Baseline, 6 months and 12 months after the start of the intervention program

**Measure:** Self-Report Outcomes - Health-Related Quality of Life (Quality of life of participants assessed using The European Organization for Research and Treatment of Cancer QLQ-C30.)

**Time Frame:** Baseline, 6 months and 12 months after the start of the intervention program

**Description:** The severity and impact of fatigue on daily functioning assessed using The Brief Fatigue Inventory (BFI).

**Measure:** Self-Report Outcomes - Fatigue (assessed using The Brief Fatigue Inventory (BFI)

**Time Frame:** Baseline, 6 months and 12 months after the start of the intervention program

**Description:** The presence of depression as indicated using The Centers for Epidemiological Studies Depression Scale (CES-ED).

**Measure:** Self-Report Outcomes - Depression (indicated using The Centers for Epidemiological Studies Depression Scale (CES-ED)

**Time Frame:** Baseline, 6 months and 12 months after the start of the intervention program

**Description:** Affect of participants assessed using The Profile of Mood States short form (POMS-SF) questionnaire.

**Measure:** Self-Report Outcomes - Affective States (assessed using The Profile of Mood States short form (POMS-SF) questionnaire.)

**Time Frame:** Baseline, 6 months and 12 months after the start of the intervention program

**Description:** How people adjust and cope with a cancer diagnosis assessed using The 10-item Social Constraints Scale.

**Measure:** Self-Report Outcomes - Social Constraints (assessed using The 10-item Social Constraints Scale.)

**Time Frame:** Baseline, 6 months and 12 months after the start of the intervention program

**Description:** 2 subscales assess cognitive deficiency and cognitive capability

**Measure:** Self-Report Outcomes - Cognitive Functioning (assessed using the 42-item FACTcog

**Time Frame:** Baseline, 6 months and 12 months after the start of the intervention program

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Lives on Oahu
* Diagnosed with primary breast,cervical, endometrial or ovarian cancer (stage I-III)
* Completed initial regional and systemic treatment for breast cancer 2 months ago
* Physically capable of doing the hula-based physical activity
* Receives approval by attending physician to participate in trial

Exclusion Criteria:

* Currently undergoing chemotherapy or radiation therapy

**Minimum Age:** 21 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Honolulu

**Country:** United States

**Facility:** University of Hawaii Cancer Center

**State:** Hawaii

**Zip:** 96813

#### Overall Officials

**Official 1:**

**Affiliation:** University of Hawaii Cancer Research Center

**Name:** Erin Bantum, MA, PhD

**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: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000010049

- Term: Ovarian Diseases

- ID: D000000291

- Term: Adnexal Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000091662

- Term: Genital Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000006058

- Term: Gonadal Disorders

- ID: D000014594

- Term: Uterine Neoplasms

- ID: D000002577

- Term: Uterine Cervical Diseases

- ID: D000014591

- Term: Uterine Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5830

- Name: Uterine Cervical Neoplasms

- Relevance: HIGH

- As Found: Cervical Cancer

- ID: M12974

- Name: Ovarian Neoplasms

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: M1704

- Name: Carcinoma, Ovarian Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M19235

- Name: Endometrial Neoplasms

- Relevance: HIGH

- As Found: Endometrial Cancer

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12972

- Name: Ovarian Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3643

- Name: Adnexal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9163

- Name: Gonadal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17342

- Name: Uterine Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5825

- Name: Uterine Cervical Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4352

- Name: Ovarian Cancer

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: T4354

- Name: Ovarian Epithelial Cancer

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010051

- Term: Ovarian Neoplasms

- ID: D000002583

- Term: Uterine Cervical Neoplasms

- ID: D000016889

- Term: Endometrial Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
