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CompletedNCT02351479Updated Apr 18, 2019

Hula, a Physical Activity Intervention for Female-Cancer Survivors

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

Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Not applicable
Ages
21 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Physical Activity
  • Breast Cancer
  • Cervical Cancer
  • Ovarian Cancer
  • Endometrial Cancer

Keywords

  • hula
  • breast cancer
  • female
  • hawaii
  • physical activity
  • cervical cancer
  • ovarian cancer
  • endometrial cancer
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In context

Ovarian Neoplasms

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts 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

Exclusion Criteria:

  • Currently undergoing chemotherapy or radiation therapy
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
73 participants (actual)

Study arms

  • Other
    Hula

    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

Interventions

  • BehavioralHula
06

What researchers measure

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)

    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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  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.)

    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

  6. 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

  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)

    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

  9. 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

  10. 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

  11. 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

  12. 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

07

Study locations

1 site
  • University of Hawaii Cancer Center
    Honolulu, Hawaii 96813, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02351479
Lead sponsor
University of Hawaii
Responsible party
Sponsor
First posted
Jan 30, 2015
Start date
Sep 2013
Primary completion
Dec 2017
Completion
Dec 2017
Last update
Apr 18, 2019

Study contacts

Erin Bantum, MA, PhD
principal investigator · University of Hawaii Cancer Research Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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