NCT06964633

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress1%
May 2026May 2028

First Submitted

Initial submission to the registry

April 27, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

April 27, 2025

Last Update Submit

March 29, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Surveys

    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

    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:

    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

    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

    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

    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).

Study Arms (1)

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.

Behavioral: Kūkākūkā Discussion Sessions

Interventions

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.

Educational & Behavioral Intervention

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must self-identify as male, with recruitment efforts emphasizing Native Hawaiian men.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hawai'i Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Related Publications (6)

  • 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.

Related Links

Study Officials

  • Kevin Cassel, DrPH, MPH

    University of Hawaii Cancer Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Cassel, DrPH, MPH

CONTACT

Yoko Takahashi, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 27, 2025

First Posted

May 9, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2028

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations