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Men's Prostate Awareness Church Training (M-PACT)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Men's Workshops
Co-Educational Workshops
Sponsored by
University of Maryland, College Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer focused on measuring 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

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Maryland School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Co-Educational Workshops

Men's Workshops

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 28, 2014
Last Updated
May 16, 2022
Sponsor
University of Maryland, College Park
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1. Study Identification

Unique Protocol Identification Number
NCT02131779
Brief Title
Men's Prostate Awareness Church Training
Acronym
M-PACT
Official Title
Prostate Cancer Education in African American Churches
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 4, 2018 (Actual)
Study Completion Date
January 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, College Park

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
536 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Co-Educational Workshops
Arm Type
Experimental
Arm Description
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.
Arm Title
Men's Workshops
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Men's Workshops
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Co-Educational Workshops
Intervention Description
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.
Primary Outcome Measure Information:
Title
Informed Decision making for Prostate Cancer Screening
Description
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.
Time Frame
Baseline to 12 month follow-up
Secondary Outcome Measure Information:
Title
Theory-based measures, prostate cancer knowledge, and prostate cancer screening
Description
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
Time Frame
Change from baseline to 12 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl L Holt, PhD
Organizational Affiliation
University of Maryland School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland School of Public Health
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23718958
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.
Results Reference
background
PubMed Identifier
26324051
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.
Results Reference
derived
PubMed Identifier
26089253
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.
Results Reference
derived
PubMed Identifier
25330866
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.
Results Reference
derived
Links:
URL
https://sph.umd.edu/research-impact/laboratories-projects-and-programs/community-health-awareness-messages-and-prevention-champ-lab
Description
Community Health Awareness, Messages & Prevention --University of Maryland, Research lab where the project is based
URL
http://www.cancer.org
Description
American Cancer Society

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