Clinical trial NCT02351479: Hula, a Physical Activity Intervention for Female-Cancer Survivors
Official title: Hula, a Physical Activity Intervention for Female-Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Hawaii
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 73
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
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)
timeFrame: 6 months after the start of the intervention program
Secondary outcomes:
measure: Biomarkers - Sex Hormones (Circulating levels of sex hormones measured in serum samples)
timeFrame: Baseline, 6 months and 12 months after the start of the intervention program
measure: Biomarkers - Cytokines (Circulating levels of cytokines measured in serum samples.)
timeFrame: Baseline, 6 months and 12 months after the start of the intervention program
measure: Biomarkers - Inflammatory Markers (Circulating levels of leptin, CRP, IGF-1, and IGFBP3 measured in serum samples collectively.)
timeFrame: Baseline, 6 months and 12 months after the start of the intervention program
measure: DNA Methylation Patterns (DNA methylation patterns as detected with the Illumina Assay containing methylation sites in RefSeq genes and CpG islands collectively.)
timeFrame: Baseline, 6 months and 12 months after the start of the intervention program
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.)
timeFrame: Baseline, 6 months and 12 months after the start of the intervention program
measure: Self-Report Outcomes - Physical Activity (Minutes per week of exercise assessed using The Women's Health Initiative Physical Activity Questionnaire)
timeFrame: 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.)
timeFrame: Baseline, 6 months and 12 months after the start of the intervention program
measure: Self-Report Outcomes - Fatigue (assessed using The Brief Fatigue Inventory (BFI)
timeFrame: Baseline, 6 months and 12 months after the start of the intervention program
measure: Self-Report Outcomes - Depression (indicated using The Centers for Epidemiological Studies Depression Scale (CES-ED)
timeFrame: Baseline, 6 months and 12 months after the start of the intervention program
measure: Self-Report Outcomes - Affective States (assessed using The Profile of Mood States short form (POMS-SF) questionnaire.)
timeFrame: Baseline, 6 months and 12 months after the start of the intervention program
measure: Self-Report Outcomes - Social Constraints (assessed using The 10-item Social Constraints Scale.)
timeFrame: Baseline, 6 months and 12 months after the start of the intervention program
measure: Self-Report Outcomes - Cognitive Functioning (assessed using the 42-item FACTcog
timeFrame: Baseline, 6 months and 12 months after the start of the intervention program
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
Study officials:
affiliation: University of Hawaii Cancer Research Center
name: Erin Bantum, MA, PhD
role: PRINCIPAL_INVESTIGATOR
References: