Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
536 participants
INTERVENTIONAL
2012-02-29
2018-01-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cleveland African American Prostate Cancer Project
NCT05469269
Internet-Based Education for Prostate Cancer Screening
NCT00623090
Educational Intervention in Increasing Knowledge About Prostate Cancer in High-Risk Neighborhoods
NCT03197896
Prostate Cancer Screening: Fostering Informed Decisions
NCT00196807
Facilitating Participation in a Prostate Cancer Risk Assessment Program
NCT02126319
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A randomized controlled trial is utilized, in which churches will be randomized to: 1) male-only educational groups; and 2) co-educational groups where women supportive "health partners" are invited to attend with the men in dyads, and then break out into men's and women's discussion groups. These two approaches are compared through use of cluster randomized design to determine whether the addition of the women health partner increases the intervention efficacy in the study outcome of informed decision making for prostate cancer screening.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Co-Educational Workshops
Community health advisors will be trained using traditional/classroom methods and provided with technical assistance/support to implement the 4 part health series with men and women dyads. Technical assistance and support will be given as needed to community health advisors. Workshop sessions will include didactic lecture, group discussions, video and group exercises.
Co-Educational Workshops
One male and one female Community Health Advisor will be trained using traditional/classroom methods and provided with technical assistance/support to implement the 4 part workshop series. Two break out sessions will occur in the Health Partner condition with separate discussion sessions for men and female health partners.
Men's Workshops
Community health advisors will be trained using traditional/classroom methods and provided with technical assistance/support as needed to deliver 4 part educational sessions to men only groups to relay information about making an informed decision about prostate cancer screening. Workshop sessions will include didactic lecture, group discussions, video and group exercises.
Men's Workshops
Two male Community Health Advisors will be trained using traditional/classroom methods and provided with technical assistance/support to implement the 4 part workshop series.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Men's Workshops
Two male Community Health Advisors will be trained using traditional/classroom methods and provided with technical assistance/support to implement the 4 part workshop series.
Co-Educational Workshops
One male and one female Community Health Advisor will be trained using traditional/classroom methods and provided with technical assistance/support to implement the 4 part workshop series. Two break out sessions will occur in the Health Partner condition with separate discussion sessions for men and female health partners.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* African American Men church attending men
* 40-69 years of age Advisory Panel
* Knowledgeable about the community where the intervention is implemented, adults ages 21+, review materials and provide input for intervention development and program implementation Pastors
* Willing to conduct the intervention at church
* Support the program
* Designate two individuals to serve as community health advisors
* Identify a ministry in the church which will champion the project Community Health Advisors
* attend a 6 hour training and 1 hour certification
* assist in recruitment of study participants
* recruit up to 24 men
* recruit up to 24 females to attend sessions with men in 10 Health Partner Churches
* prepare and conduct the 4 part workshop series
* serve as liaisons between the project and study team Workshop Participants
* self-identified, African American men (40-69), Health Partners --over 18 years of age, able to complete self-administered paper-and-pencil surveys
Exclusion Criteria
40 Years
69 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Maryland, College Park
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cheryl L Holt, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland School of Public Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Maryland School of Public Health
College Park, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Saunders DR, Holt CL, Whitehead TL, Atkinson NL, Le D, Wang MQ, Slade JL, Muwwakkil B, Williams R, Schulz E, Naslund M. Development of the men's prostate awareness church training: church-based workshops for African American men. Fam Community Health. 2013 Jul-Sep;36(3):224-35. doi: 10.1097/FCH.0b013e318292eb40.
Le D, Holt CL, Saunders DR, Wang MQ, Coriolan A, Savoy AD, Slade JL, Muwwakkil B, Atkinson NL. Feasibility and acceptability of SMS text messaging in a prostate cancer educational intervention for African American men. Health Informatics J. 2016 Dec;22(4):932-947. doi: 10.1177/1460458215598636. Epub 2015 Aug 30.
Saunders DR, Holt CL, Le D, Slade JL, Muwwakkil B, Savoy A, Williams R, Whitehead TL, Wang MQ, Naslund MJ. Recruitment and Participation of African American Men in Church-Based Health Promotion Workshops. J Community Health. 2015 Dec;40(6):1300-10. doi: 10.1007/s10900-015-0054-9.
Holt CL, Le D, Saunders DR, Wang MQ, Slade JL, Muwwakkil B, Williams R, Atkinson NL, Whitehead TL, Naslund M. Informed Decision-Making and Satisfaction with a Church-Based Men's Health Workshop Series for African-American Men: Men-Only vs. Mixed-Gender Format. J Cancer Educ. 2015 Sep;30(3):530-4. doi: 10.1007/s13187-014-0731-x.
Related Links
Access external resources that provide additional context or updates about the study.
Community Health Awareness, Messages \& Prevention --University of Maryland, Research lab where the project is based
American Cancer Society
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
American Cancer Society
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
12-0095
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.