Back to resultsHula, a Physical Activity Intervention for Female-Cancer Survivors
Primary Purpose
Physical Activity, Breast Cancer, Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hula
Sponsored by
About this trial
This is an interventional supportive care trial for Physical Activity focused on measuring hula, breast cancer, female, hawaii, physical activity, cervical cancer, ovarian cancer, endometrial cancer
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
Sites / Locations
- University of Hawaii Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Hula
Arm 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Biomarkers - Sex Hormones (Circulating levels of sex hormones measured in serum samples)
Circulating levels of sex hormones measured in serum samples.
Biomarkers - Cytokines (Circulating levels of cytokines measured in serum samples.)
Circulating levels of cytokines measured in serum samples.
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.
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.
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.
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
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.)
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).
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).
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.
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.
Self-Report Outcomes - Cognitive Functioning (assessed using the 42-item FACTcog
2 subscales assess cognitive deficiency and cognitive capability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02351479
Brief Title
Hula, a Physical Activity Intervention for Female-Cancer Survivors
Official Title
Hula, a Physical Activity Intervention for Female-Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hawaii
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Breast Cancer, Cervical Cancer, Ovarian Cancer, Endometrial Cancer
Keywords
hula, breast cancer, female, hawaii, physical activity, cervical cancer, ovarian cancer, endometrial cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hula
Arm Type
Other
Arm 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 Type
Behavioral
Intervention Name(s)
Hula
Primary Outcome Measure Information:
Title
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)
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
Time Frame
6 months after the start of the intervention program
Secondary Outcome Measure Information:
Title
Biomarkers - Sex Hormones (Circulating levels of sex hormones measured in serum samples)
Description
Circulating levels of sex hormones measured in serum samples.
Time Frame
Baseline, 6 months and 12 months after the start of the intervention program
Title
Biomarkers - Cytokines (Circulating levels of cytokines measured in serum samples.)
Description
Circulating levels of cytokines measured in serum samples.
Time Frame
Baseline, 6 months and 12 months after the start of the intervention program
Title
Biomarkers - Inflammatory Markers (Circulating levels of leptin, CRP, IGF-1, and IGFBP3 measured in serum samples collectively.)
Description
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
Title
DNA Methylation Patterns (DNA methylation patterns as detected with the Illumina Assay containing methylation sites in RefSeq genes and CpG islands collectively.)
Description
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
Title
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.)
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.
Time Frame
Baseline, 6 months and 12 months after the start of the intervention program
Title
Self-Report Outcomes - Physical Activity (Minutes per week of exercise assessed using The Women's Health Initiative Physical Activity Questionnaire)
Description
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
Title
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
Title
Self-Report Outcomes - Fatigue (assessed using The Brief Fatigue Inventory (BFI)
Description
The severity and impact of fatigue on daily functioning assessed using The Brief Fatigue Inventory (BFI).
Time Frame
Baseline, 6 months and 12 months after the start of the intervention program
Title
Self-Report Outcomes - Depression (indicated using The Centers for Epidemiological Studies Depression Scale (CES-ED)
Description
The presence of depression as 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
Title
Self-Report Outcomes - Affective States (assessed using The Profile of Mood States short form (POMS-SF) questionnaire.)
Description
Affect of participants 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
Title
Self-Report Outcomes - Social Constraints (assessed using The 10-item Social Constraints Scale.)
Description
How people adjust and cope with a cancer diagnosis assessed using The 10-item Social Constraints Scale.
Time Frame
Baseline, 6 months and 12 months after the start of the intervention program
Title
Self-Report Outcomes - Cognitive Functioning (assessed using the 42-item FACTcog
Description
2 subscales assess cognitive deficiency and cognitive capability
Time Frame
Baseline, 6 months and 12 months after the start of the intervention program
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Bantum, MA, PhD
Organizational Affiliation
University of Hawaii Cancer Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hawaii Cancer Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hula, a Physical Activity Intervention for Female-Cancer Survivors
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