Hula, a Physical Activity Intervention for Female-Cancer Survivors

April 16, 2019 updated by: University of Hawaii
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after the start of the intervention program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 months and 12 months after the start of the intervention program
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.
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.)
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.
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.)
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.
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.)
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.
Baseline, 6 months and 12 months after the start of the intervention program
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
Baseline, 6 months and 12 months after the start of the intervention program
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
Baseline, 6 months and 12 months after the start of the intervention program
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).
Baseline, 6 months and 12 months after the start of the intervention program
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).
Baseline, 6 months and 12 months after the start of the intervention program
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.
Baseline, 6 months and 12 months after the start of the intervention program
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.
Baseline, 6 months and 12 months after the start of the intervention program
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
Baseline, 6 months and 12 months after the start of the intervention program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hawaii

Investigators

  • Principal Investigator: Erin Bantum, MA, PhD, University of Hawaii Cancer Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

January 29, 2015

First Posted (Estimate)

January 30, 2015

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bantum-2013-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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