Breast Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Physical Activity
Conditions
Keywords
hula, breast cancer, female, hawaii, physical activity, cervical cancer, ovarian cancer, endometrial cancer
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.
Interventions
BEHAVIORALHula
Sponsors
University of Hawaii
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 6 months after the start of the intervention program | 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
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers - Cytokines (Circulating levels of cytokines measured in serum samples.) | Baseline, 6 months and 12 months after the start of the intervention program | 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.) | Baseline, 6 months and 12 months after the start of the intervention program | 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.) | Baseline, 6 months and 12 months after the start of the intervention program | 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.) | Baseline, 6 months and 12 months after the start of the intervention program | 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) | Baseline, 6 months and 12 months after the start of the intervention program | Minutes per week of exercise assessed using The Women's Health Initiative Physical Activity Questionnaire |
| Biomarkers - Sex Hormones (Circulating levels of sex hormones measured in serum samples) | Baseline, 6 months and 12 months after the start of the intervention program | Circulating levels of sex hormones measured in serum samples. |
| Self-Report Outcomes - Fatigue (assessed using The Brief Fatigue Inventory (BFI) | Baseline, 6 months and 12 months after the start of the intervention program | 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) | Baseline, 6 months and 12 months after the start of the intervention program | 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.) | Baseline, 6 months and 12 months after the start of the intervention program | 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.) | Baseline, 6 months and 12 months after the start of the intervention program | 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 | Baseline, 6 months and 12 months after the start of the intervention program | 2 subscales assess cognitive deficiency and cognitive capability |
| 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 | — |
Countries
United States
Outcome results
None listed