Physical ActivityNCT02351479
Hula, a Physical Activity Intervention for Female-Cancer Survivors
A study testing Hula in people with Physical Activity and Breast Cancer, run by University of Hawaii at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Physical Activity, Breast Cancer, Cervical Cancer
- What is being tested?
- Hula
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently undergoing chemotherapy or radiation therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
About this study
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.
- Being tested
- Hula
- Keywords
- hula, breast cancer, female, hawaii, physical activity, cervical cancer, ovarian cancer, endometrial cancer
- Medical subject headings
- Motor Activity, Breast Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HulaBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Hula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after the start of the intervention program
Secondary outcomes (12)
Biomarkers - Sex Hormones (Circulating levels of sex hormones measured in serum samples)
Circulating levels of sex hormones measured in serum samples.
Measured: Baseline, 6 months and 12 months after the start of the intervention program
Biomarkers - Cytokines (Circulating levels of cytokines measured in serum samples.)
Circulating levels of cytokines measured in serum samples.
Measured: 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.)
Circulating levels of leptin, CRP, IGF-1, and IGFBP3 measured in serum samples collectively.
Measured: 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.)
DNA methylation patterns as detected with the Illumina Assay containing methylation sites in RefSeq genes and CpG islands collectively.
Measured: 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.)
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.
Measured: 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)
Minutes per week of exercise assessed using The Women's Health Initiative Physical Activity Questionnaire
Measured: 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.)
Measured: Baseline, 6 months and 12 months after the start of the intervention program
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).
Measured: 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)
The presence of depression as indicated using The Centers for Epidemiological Studies Depression Scale (CES-ED).
Measured: 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.)
Affect of participants assessed using The Profile of Mood States short form (POMS-SF) questionnaire.
Measured: 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.)
How people adjust and cope with a cancer diagnosis assessed using The 10-item Social Constraints Scale.
Measured: Baseline, 6 months and 12 months after the start of the intervention program
Self-Report Outcomes - Cognitive Functioning (assessed using the 42-item FACTcog
2 subscales assess cognitive deficiency and cognitive capability
Measured: Baseline, 6 months and 12 months after the start of the intervention program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startSep 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Bantum, MA, PhD, Principal investigator, University of Hawaii Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351479
- Sponsor's protocol ID
- Bantum-2013-2
- Status last verified
- Apr 2019
- First submitted
- 20 Jan 2015
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37941759
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hula, a Physical Activity Intervention for Female-Cancer Survivors
- ClinicalTrials.gov ID
- NCT02351479
- Acronym / sponsor ID
- Bantum-2013-2
- Keywords
- hula, breast cancer, female, hawaii, physical activity, cervical cancer, ovarian cancer, endometrial cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hula | Other | Behavioral: HulaHula 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Currently undergoing chemotherapy or radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hula | Behavioural | Hula |
Primary outcome
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
12 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 37941759Bantum 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Bantum, MA, PhD principal investigator
University of Hawaii Cancer Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hula in people with Physical Activity and Breast Cancer, run by University of Hawaii at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02351479, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.