Hula, a Physical Activity Intervention for Female-Cancer Survivors

Study Overview
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Brief Summary
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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.

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

Conditions
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Physical Activity, Breast Cancer, Cervical Cancer, Ovarian Cancer, Endometrial Cancer

Intervention / Treatment
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* Behavioral: Hula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hula<br>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. | Behavioral: Hula<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Compliance as measured by the proportion of total sessions attended and a questionnaire regarding satisfaction with the program at the end of the intervention | 6 months after the start of the intervention program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers - Sex Hormones (Circulating levels of sex hormones measured in serum samples) | Circulating levels of sex hormones measured in serum samples. | Baseline, 6 months and 12 months after the start of the intervention program | 
| Biomarkers - Cytokines (Circulating levels of cytokines measured in serum samples.) | Circulating levels of cytokines measured in serum samples. | Baseline, 6 months and 12 months after the start of the intervention program | 
| Biomarkers - Inflammatory Markers (Circulating levels of leptin, CRP, IGF-1, and IGFBP3 measured in serum samples collectively.) | Circulating levels of leptin, CRP, IGF-1, and IGFBP3 measured in serum samples collectively. | Baseline, 6 months and 12 months after the start of the intervention program | 
| DNA Methylation Patterns (DNA methylation patterns as detected with the Illumina Assay containing methylation sites in RefSeq genes and CpG islands collectively.) | DNA methylation patterns as detected with the Illumina Assay containing methylation sites in RefSeq genes and CpG islands collectively. | Baseline, 6 months and 12 months after the start of the intervention program | 
| 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.) | 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. | Baseline, 6 months and 12 months after the start of the intervention program | 
| Self-Report Outcomes - Physical Activity (Minutes per week of exercise assessed using The Women's Health Initiative Physical Activity Questionnaire) | Minutes per week of exercise assessed using The Women's Health Initiative Physical Activity Questionnaire | Baseline, 6 months and 12 months after the start of the intervention program | 
| 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.) |  | Baseline, 6 months and 12 months after the start of the intervention program | 
| Self-Report Outcomes - Fatigue (assessed using The Brief Fatigue Inventory (BFI) | The severity and impact of fatigue on daily functioning assessed using The Brief Fatigue Inventory (BFI). | Baseline, 6 months and 12 months after the start of the intervention program | 
| Self-Report Outcomes - Depression (indicated using The Centers for Epidemiological Studies Depression Scale (CES-ED) | The presence of depression as indicated using The Centers for Epidemiological Studies Depression Scale (CES-ED). | Baseline, 6 months and 12 months after the start of the intervention program | 
| Self-Report Outcomes - Affective States (assessed using The Profile of Mood States short form (POMS-SF) questionnaire.) | Affect of participants assessed using The Profile of Mood States short form (POMS-SF) questionnaire. | Baseline, 6 months and 12 months after the start of the intervention program | 
| Self-Report Outcomes - Social Constraints (assessed using The 10-item Social Constraints Scale.) | How people adjust and cope with a cancer diagnosis assessed using The 10-item Social Constraints Scale. | Baseline, 6 months and 12 months after the start of the intervention program | 
| Self-Report Outcomes - Cognitive Functioning (assessed using the 42-item FACTcog | 2 subscales assess cognitive deficiency and cognitive capability | Baseline, 6 months and 12 months after the start of the intervention program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hula, breast cancer, female, hawaii, physical activity, cervical cancer, ovarian cancer, endometrial cancer