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Completed

NCT Number: NCT02351479

Hula, a Physical Activity Intervention for Female-Cancer Survivors

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.

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Key information

Conditions

Physical Activity Adnexal Diseases Behavior Breast Cancer Breast Diseases Breast Neoplasms Cervical Cancer Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Motor Activity Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hula

Behavioral

Primary outcomes

  1. 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)

    Time frame: 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 outcomes

  1. Biomarkers - Sex Hormones (Circulating levels of sex hormones measured in serum samples)

    Time frame: Baseline, 6 months and 12 months after the start of the intervention program

    Circulating levels of sex hormones measured in serum samples.

  2. Biomarkers - Cytokines (Circulating levels of cytokines measured in serum samples.)

    Time frame: Baseline, 6 months and 12 months after the start of the intervention program

    Circulating levels of cytokines measured in serum samples.

  3. Biomarkers - Inflammatory Markers (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

    Circulating levels of leptin, CRP, IGF-1, and IGFBP3 measured in serum samples collectively.

  4. DNA Methylation Patterns (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

    DNA methylation patterns as detected with the Illumina Assay containing methylation sites in RefSeq genes and CpG islands collectively.

  5. 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.)

    Time frame: 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.

  6. Self-Report Outcomes - Physical Activity (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

    Minutes per week of exercise assessed using The Women's Health Initiative Physical Activity Questionnaire

  7. 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

  8. Self-Report Outcomes - Fatigue (assessed using The Brief Fatigue Inventory (BFI)

    Time frame: 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).

  9. Self-Report Outcomes - Depression (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

    The presence of depression as indicated using The Centers for Epidemiological Studies Depression Scale (CES-ED).

  10. Self-Report Outcomes - Affective States (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

    Affect of participants assessed using The Profile of Mood States short form (POMS-SF) questionnaire.

  11. Self-Report Outcomes - Social Constraints (assessed using The 10-item Social Constraints Scale.)

    Time frame: 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.

  12. Self-Report Outcomes - Cognitive Functioning (assessed using the 42-item FACTcog

    Time frame: Baseline, 6 months and 12 months after the start of the intervention program

    2 subscales assess cognitive deficiency and cognitive capability

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 30, 2015
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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