Men's Prostate Awareness Church Training

Prostate Cancer Clinical Trial

— M-PACT  

Official title:

Prostate Cancer Education in African American Churches

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131779
• Other study ID #: 12-0095
• Secondary ID: American Cancer
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: January 4, 2018

Study information

• Verified date: May 2022
• Source: University of Maryland, College Park
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the Prostate Cancer Education in African American Churches project is to develop and evaluate a spiritually-based educational intervention for Informed Decision Making (IDM) for prostate cancer screening to be delivered to African American men in church settings.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: January 4, 2018
• Est. primary completion date: January 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 69 Years

Eligibility

Inclusion Criteria:

Male Study Participants

• 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:

• Workshop participants with a history of prostate cancer, do not meet the age criteria

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Maryland School of Public Health	College Park	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, College Park

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Informed Decision making for Prostate Cancer Screening	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.	Baseline to 12 month follow-up
Secondary	Theory-based measures, prostate cancer knowledge, and prostate cancer screening	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	Change from baseline to 12 month follow-up

External Links

•   American Cancer Society
•   Community Health Awareness, Messages & Prevention --University of Maryland, Research lab where the project is based