Clinical trial NCT02131779: Men's Prostate Awareness Church Training
Official title: Prostate Cancer Education in African American Churches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer disparities
African American
Spiritually based intervention
Men's Health
Informed Decision Making
Community Based Participatory Research
Health Communication
Health Information Technology
Community Health Advisors
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 536
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Informed Decision making for Prostate Cancer Screening
timeFrame: Baseline to 12 month follow-up
Secondary outcomes:
measure: Theory-based measures, prostate cancer knowledge, and prostate cancer screening
timeFrame: Change from baseline to 12 month follow-up
Other outcomes:
Locations:
city: College Park
country: United States
facility: University of Maryland School of Public Health
state: Maryland
Study officials:
affiliation: University of Maryland School of Public Health
name: Cheryl L Holt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.