An interventional study of Hula in Physical Activity, Breast Cancer and Cervical Cancer, sponsored by University of Hawaii. Completed at 1 site in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-04-18.
Sponsored by University of Hawaii · Not applicable, Interventional, and Supportive care
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 73 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →University of Hawaii is the lead sponsor of 95 studies on the registry; 20 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Time frame: 6 months after the start of the intervention program
Biomarkers - Sex Hormones (Circulating levels of sex hormones measured in serum samples)
Circulating levels of sex hormones measured in serum samples.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.)
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline, 6 months and 12 months after the start of the intervention program
Plan to share: No
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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University of Hawaii