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

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ClinicalTrials.gov Identifier: NCT02131779
Recruitment Status : Unknown
Verified May 2014 by University of Maryland.
Recruitment status was:  Enrolling by invitation
First Posted : May 6, 2014
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):
University of Maryland

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Men's Workshops Behavioral: Co-Educational Workshops Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Prostate Cancer Education in African American Churches
Study Start Date : July 2010
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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United States, Maryland
University of Maryland School of Public Health
College Park, Maryland, United States, 20742
Sponsors and Collaborators
University of Maryland
Investigators
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Principal Investigator: Cheryl L Holt, PhD University of Maryland School of Public Health

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Maryland
ClinicalTrials.gov Identifier: NCT02131779     History of Changes
Other Study ID Numbers: 12-0095
American Cancer Society ( Other Grant/Funding Number: 119421-RSGT-10-113-01-CPPB )
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014

Keywords provided by University of Maryland:
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

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases