NCT02131779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
536

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2018

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

5.9 years

First QC Date

April 28, 2014

Last Update Submit

May 16, 2022

Conditions

Prostate Cancer

Keywords

prostate cancer disparitiesAfrican AmericanSpiritually based interventionMen's HealthInformed Decision MakingCommunity Based Participatory ResearchHealth CommunicationHealth Information TechnologyCommunity Health Advisors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Theory-based measures, prostate cancer knowledge, and prostate cancer screening

    Change from baseline to 12 month follow-up

Study Arms (2)

Co-Educational Workshops

EXPERIMENTAL

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

Men's Workshops

ACTIVE COMPARATOR

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

Interventions

Men's WorkshopsBEHAVIORAL

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.

Men's Workshops
Co-Educational WorkshopsBEHAVIORAL

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.

Co-Educational Workshops

Eligibility Criteria

Age40 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male Study Participants
  • African American Men church attending men
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland School of Public Health

College Park, Maryland, 20742, United States

Location

Related Publications (4)

  • 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.

    PMID: 23718958BACKGROUND

  • 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.

    PMID: 26324051DERIVED

  • 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.

    PMID: 26089253DERIVED

  • 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.

    PMID: 25330866DERIVED

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Cheryl L Holt, PhD

    University of Maryland School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 6, 2014

Study Start

February 1, 2012

Primary Completion

January 4, 2018

Study Completion

January 4, 2018

Last Updated

May 23, 2022

Record last verified: 2022-05

Locations

US(1)