Health PromotionNCT06964633
The Ku Ola Project: Enhancing Health Promotion Among Native Hawaiian Men.
A study testing Kūkākūkā Discussion Sessions in people with Health Promotion and Health, run by University of Hawaii at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health Promotion, Health
- What is being tested?
- Kūkākūkā Discussion Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yoko Takahashi, MD contact
United States1 site
University of Hawai'i Cancer Center
Honolulu, Hawaii, 96813
Kevin Cassel, DrPH, MPH, 808-564-5916, Kevin@cc.hawaii.edu
About this study
Official title: 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.
- Conditions
- Health Promotion, Health
- Being tested
- Kūkākūkā Discussion Sessions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kūkākūkā Discussion SessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Educational & Behavioral Intervention | Experimental | 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. Receives: Behavioral: Kūkākūkā Discussion Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surveys
Participants complete pretest and post-test surveys gathering demographic data and module-specific health information and knowledge to evaluate program effectiveness.
Measured: Pretest immediately before each module and post-test immediately after completion (within the same day).
Commitment Contract
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.
Measured: From immediately after the post-test survey to the six-month follow-up call.
Evaluation:
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.
Measured: Immediately following each session.
Screening
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.
Measured: Within six months of the commitment contract.
Discussion
One-sentence description: Thematic analysis of anonymized audio-recorded group discussions and facilitator notes from each module, capturing key insights and participant engagement.
Measured: At the end of each module session (each session is 2 hours long)
Tracking Groups and Facilitators
Aggregate counts of men reached, number of modules delivered, and number of facilitators trained, tracked continuously in the Kū Ola database.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 May 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Health PromotionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Cassel, DrPH, MPH, Principal investigator, University of Hawaii Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964633
- Sponsor's protocol ID
- CASSEL-2024-2
- Other IDs
- U0610X
- Status last verified
- Mar 2026
- First submitted
- 27 Apr 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19856087Jain 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.
PubMed 37017832Hughes CK. Factors associated with health-seeking behaviors of Native Hawaiian men. Pac Health Dialog. 2004 Sep;11(2):176-82.
PubMed 16281697Harmon 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.
PubMed 24667037Cassel 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.
PubMed 32008466Braun 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.
PubMed 25063936
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ku Ola Project
- ClinicalTrials.gov ID
- NCT06964633
- Acronym / sponsor ID
- CASSEL-2024-2
- Conditions
- Health Promotion, Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 9 May 2025 (actual)
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational & Behavioral Intervention | Experimental | Behavioral: Kūkākūkā Discussion SessionsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Kūkākūkā Discussion SessionsParticipants 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. | Behavioural | Educational & Behavioral Intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Results publication: PubMed 19856087Moy 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.
- Results publication: PubMed 37017832Jain 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.
- Results publication: PubMed 16281697Hughes CK. Factors associated with health-seeking behaviors of Native Hawaiian men. Pac Health Dialog. 2004 Sep;11(2):176-82.
- Results publication: PubMed 24667037Harmon 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.
- Results publication: PubMed 32008466Cassel 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.
- Results publication: PubMed 25063936Braun 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.
- Assessment and Priorities for Health \& Well-Being in Native Hawaiians \& other Pacific Peoples.Link provided by the sponsor.
- 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.
Yoko Takahashi, MD contact
Kevin Cassel, DrPH, MPH 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 Kūkākūkā Discussion Sessions in people with Health Promotion and Health, 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?
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: opening soon, as of the sponsor's last update on 31 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Cassel, DrPH, MPH (808-564-5916, Kevin@cc.hawaii.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surveys (time frame: Pretest immediately before each module and post-test immediately after completion (within the same day).). The study lists 6 primary outcomes in all. 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 NCT06964633, which also lists 6 linked publications.
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 31 Mar 2026.