Hula, a Physical Activity Intervention for Female-Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Hula, a Physical Activity Intervention for Female-Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351479
• Other study ID #: Bantum-2013-2
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 2017

Study information

• Verified date: April 2019
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Ovarian Epithelial
• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Physical Activity
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Hula

Locations

Country	Name	City	State
United States	University of Hawaii Cancer Center	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
University of Hawaii

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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