Men's Prostate Awareness Church Training (M-PACT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02131779|
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Behavioral: Men's Workshops Behavioral: Co-Educational Workshops||Not Applicable|
The specific aims of the project are to 1) develop, and 2) test the efficacy of a spiritually-based cancer communication intervention to increase IDM for prostate cancer screening among African American men in church settings, and including women as supportive "health partners".
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||536 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prostate Cancer Education in African American Churches|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||January 4, 2018|
|Actual Study Completion Date :||January 4, 2018|
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
Behavioral: 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.
- Informed Decision making for Prostate Cancer Screening [ Time Frame: Baseline to 12 month follow-up ]IDM for prostate cancer screening for African American men participating in a church-based group educational workshops will be measured at baseline and 12 months. Survey assessments items for informed decision making include: stage of decision making, preference for decision making, and self-efficacy for decision making.
- Theory-based measures, prostate cancer knowledge, and prostate cancer screening [ Time Frame: Change from baseline to 12 month follow-up ]Health Belief Model-based scales including perceived benefits of screening; perceived barriers to screening; self-efficacy for screening; and knowledge including prostate cancer knowledge; knowledge about the prostate cancer screening controversy; and prostate cancer screening through self-report receipt of prostate specific antigen test and digital rectal examination
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131779
|United States, Maryland|
|University of Maryland School of Public Health|
|College Park, Maryland, United States, 20742|
|Principal Investigator:||Cheryl L Holt, PhD||University of Maryland School of Public Health|