NCT02351479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

4.3 years

First QC Date

January 20, 2015

Last Update Submit

April 16, 2019

Conditions

Physical ActivityBreast CancerCervical CancerOvarian CancerEndometrial Cancer

Keywords

hulabreast cancerfemalehawaiiphysical activitycervical cancerovarian cancerendometrial cancer

Outcome Measures

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

    6 months after the start of the intervention program

Secondary Outcomes (12)

  • 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

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

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

  • 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

  • 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

  • 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

  • +7 more secondary outcomes

Study Arms (1)

Hula

OTHER

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

HulaBEHAVIORAL
Hula

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Currently undergoing chemotherapy or radiation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Related Publications (1)

  • Bantum EO, Yamada PM, Makolo T, Yu H, Pagano I, Subia N, Walsh C, Loo LWM. Hula as a physical activity and social support intervention for sustained activity in female breast and gynecologic cancer survivors. Front Psychol. 2023 Oct 24;14:1190532. doi: 10.3389/fpsyg.2023.1190532. eCollection 2023.

    PMID: 37941759DERIVED

MeSH Terms

Conditions

Motor ActivityBreast NeoplasmsUterine Cervical NeoplasmsOvarian NeoplasmsEndometrial Neoplasms

Condition Hierarchy (Ancestors)

BehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Erin Bantum, MA, PhD

    University of Hawaii Cancer Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 30, 2015

Study Start

September 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)