- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06964633
- Original Trial
The Ku Ola Project: Enhancing Health Promotion Among Native Hawaiian Men.
March 29, 2026 updated by: University of Hawaii
The Ku Ola Project
The Ku Ola Project: The goal of this study is to determine if community-based discussion groups and small educational sessions enhance health awareness and behaviors among Native Hawaiian men.
The study will examine if these interventions improve participants' health knowledge, attitudes, and self-efficacy while fostering local networks to support ongoing health promotion.
Participants will engage in group discussions and educational sessions designed to build capacity and encourage healthy lifestyle choices.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
600
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 Contact
- Name: Kevin Cassel, DrPH, MPH
- Phone Number: 808-564-5916
- Email: Kevin@cc.hawaii.edu
Study Contact Backup
- Name: Yoko Takahashi, MD
- Email: ytakahashi@cc.hawaii.edu
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96813
- University of Hawai'i Cancer Center
-
Contact:
- Kevin Cassel, DrPH, MPH
- Phone Number: 808-564-5916
- Email: Kevin@cc.hawaii.edu
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
- Inclusion Criteria Self-identified as male At least 18 years of age Hawaii residency Able to read and understand English
- Exclusion Criteria Under 18 years of age Not proficient in English Any medical condition or situation that, in the investigator's judgment, would make continued participation not in the participant's best interest
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: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Educational & Behavioral Intervention
Participants take part in Kū Ola kūkākūkā (discussion group) modules-each a 2-hour session integrating a health topic (e.g., colorectal, lung, oro/nasopharyngeal cancer) with Hawaiian cultural content-complete pre- and post-test surveys, draft a commitment contract, and, where applicable, undergo cancer screening and receive follow-up support.
|
Participants attend a single 2-hour, flip-chart-guided module that integrates a focused health topic (e.g., colorectal cancer screening) with Hawaiian cultural teachings-beginning with an 'ōlelo no'eau (proverb) and guided by trained facilitators-to foster peer discussion, deliver key health information, and assess knowledge via pre- and post-test surveys.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surveys
Time Frame: Pretest immediately before each module and post-test immediately after completion (within the same day).
|
Participants complete pretest and post-test surveys gathering demographic data and module-specific health information and knowledge to evaluate program effectiveness.
|
Pretest immediately before each module and post-test immediately after completion (within the same day).
|
|
Commitment Contract
Time Frame: From immediately after the post-test survey to the six-month follow-up call.
|
After completing the post-test survey, participants draft a commitment contract proposing a specific health behavior change and leave their contact information so Kū Ola staff can follow up six months later to offer support and collect outcome data.
|
From immediately after the post-test survey to the six-month follow-up call.
|
|
Evaluation:
Time Frame: Immediately following each session.
|
After each session, participants complete short-answer and multiple-choice evaluation questions assessing how well the session fostered health-related communication and their perceived learning.
|
Immediately following each session.
|
|
Screening
Time Frame: Within six months of the commitment contract.
|
The proportion of eligible participants who complete their committed cancer screening test (e.g., FIT or PSA) as recorded by the PI and communicated to primary care physicians.
|
Within six months of the commitment contract.
|
|
Discussion
Time Frame: At the end of each module session (each session is 2 hours long)
|
One-sentence description: Thematic analysis of anonymized audio-recorded group discussions and facilitator notes from each module, capturing key insights and participant engagement.
|
At the end of each module session (each session is 2 hours long)
|
|
Tracking Groups and Facilitators
Time Frame: From the date the first participant completes their initial module session through six months after the last participant completes their post-test survey (estimated up to 12 months).
|
Aggregate counts of men reached, number of modules delivered, and number of facilitators trained, tracked continuously in the Kū Ola database.
|
From the date the first participant completes their initial module session through six months after the last participant completes their post-test survey (estimated up to 12 months).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kevin Cassel, DrPH, MPH, University of Hawaii Cancer Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Moy KL, Sallis JF, David KJ. Health indicators of Native Hawaiian and Pacific Islanders in the United States. J Community Health. 2010 Feb;35(1):81-92. doi: 10.1007/s10900-009-9194-0.
- Jain B, Bajaj SS, Patel TA, Vapiwala N, Lam MB, Mahal BA, Muralidhar V, Amen TB, Nguyen PL, Sanford NN, Dee EC. Colon Cancer Disparities in Stage at Presentation and Time to Surgery for Asian Americans, Native Hawaiians, and Pacific Islanders: A Study with Disaggregated Ethnic Groups. Ann Surg Oncol. 2023 Sep;30(9):5495-5505. doi: 10.1245/s10434-023-13339-0. Epub 2023 Apr 5.
- Hughes CK. Factors associated with health-seeking behaviors of Native Hawaiian men. Pac Health Dialog. 2004 Sep;11(2):176-82.
- Harmon BE, Little MA, Woekel ED, Ettienne R, Long CR, Wilkens LR, Le Marchand L, Henderson BE, Kolonel LN, Maskarinec G. Ethnic differences and predictors of colonoscopy, prostate-specific antigen, and mammography screening participation in the multiethnic cohort. Cancer Epidemiol. 2014 Apr;38(2):162-7. doi: 10.1016/j.canep.2014.02.007. Epub 2014 Mar 22.
- Cassel KD, Hughes C, Higuchi P, Lee P, Fagan P, Lono J, Ho R, Wong N, Brady SK, Ahuna W. No Ke Ola Pono o Na Kane: A Culturally Grounded Approach to Promote Health Improvement in Native Hawaiian Men. Am J Mens Health. 2020 Jan-Feb;14(1):1557988319893886. doi: 10.1177/1557988319893886.
- Braun KL, Kim BJ, Ka'opua LS, Mokuau N, Browne CV. Native Hawaiian and Pacific Islander Elders: What Gerontologists Should Know. Gerontologist. 2015 Dec;55(6):912-9. doi: 10.1093/geront/gnu072. Epub 2014 Jul 25.
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 (Estimated)
May 1, 2026
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2028
Study Registration Dates
First Submitted
April 27, 2025
First Submitted That Met QC Criteria
May 6, 2025
First Posted (Actual)
May 9, 2025
Study Record Updates
Last Update Posted (Actual)
March 31, 2026
Last Update Submitted That Met QC Criteria
March 29, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- CASSEL-2024-2
- U0610X (Other Grant/Funding Number: UNIVERSITY HAWAII FOUNDATION)
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
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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