Clinical trial NCT02076958: Implementation of Evidence-Based Cancer Early Detection in Black Churches
Official title: Implementation of Evidence-Based Cancer Early Detection in Black Churches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Information Dissemination
Evidence-Based Public Health
Keywords: Implementation
Cancer
Early detection
Faith-based
Community health advisor
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 457
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of the proposed project is to identify an optimal implementation strategy using a set of evidence-based interventions that aim to increase early detection of breast, prostate, and colorectal cancer among African Americans as a model. These three interventions will be packaged and interwoven into a single branded project, Project HEAL (Health through Early Awareness and Learning) which will be delivered through trained Community Health Advisors (CHA) in African-American church settings. The implementation and sustainability will be evaluated using the RE-AIM Framework. Fourteen African American churches in Prince George's County, MD will be randomized to a traditional classroom training approach or an online training approach, in which the CHA training approach and level of technical assistance is varied (in-person classroom training of CHAs + monitoring/evaluation + technical assistance and training vs. online training of CHAs + monitoring and evaluation only, respectively). By varying the training methodology and level of technical assistance, we will be able to determine what level of technical assistance leads to successful implementation and sustainability. We will also identify church organizational capacity characteristics that lead to successful implementation and sustainability. The specific aims of this research are to: (1) Package the three interventions into a single branded project (Project HEAL), develop a local cancer screening resource guide, and pilot test the materials and training. (2) Implement Project HEAL in 14 churches in Prince George's County, Maryland. We will evaluate the implementation outcomes involving treatment fidelity and identify church organizational capacity characteristics that led to successful implementation. We will compare the two implementation strategies (traditional vs. online) to determine the optimal level of technical assistance necessary for successful implementation. (3) Evaluate the sustainability of Project HEAL over a two-year period of time. We will identify church organizational capacity characteristics that led to sustainability, and compare the two implementation strategies (traditional vs. online) to determine the optimal level of technical assistance for successful sustainability.


Eligibility criteria: Inclusion Criteria

* Advisory Panel members: adults ages 21+
* Pastors, representing each of the 14 churches enrolled in the project: active pastor of churches enrolled in the study.
* Community Health Advisors:

  * self-identified African American
  * over 21 years of age
  * regularly attend church services
  * able to complete Project HEAL training
  * have regular access to the Internet and feel comfortable completing online training activities
  * able to recruit 30 participants for the 3-part workshop series
  * able to lead the 3-part workshop series
* Workshop participants: Self-identified African American men and women ages 40-75 for women who are able to complete self-administered paper-and-pencil surveys.

Exclusion Criteria:

* Workshop participants: Men and women who have had breast, prostate, or colorectal cancer

Primary outcomes:
measure: Adherence to program delivery protocol - Implementation of the 3-workshop series.
timeFrame: Up to 10 months
Secondary outcomes:
measure: Number of training events (workshops)
timeFrame: Up to 10 months
measure: Number of CHA trainees
timeFrame: Baseline
measure: Completion of CHA training
timeFrame: Baseline
measure: Self-report of modifications or problems with program delivery
timeFrame: Up to 12 months
measure: Number of booster CHA training sessions over two-year period
timeFrame: 12-month; 24-month
measure: Change in number of survey completion from baseline to 12-month to 24-month
timeFrame: Baseline; 12-month; 24-month
measure: Number of educational sessions participants attended
timeFrame: Up to 10 months
measure: Change in knowledge of cancer early detection from workshop 1 to workshop 3
timeFrame: Up to 10 months
measure: Change in perceived benefits of screening
timeFrame: Up to 10 months
measure: Change in perceived barriers to screening
timeFrame: Up to 10 months
measure: Change in self-efficacy for screening
timeFrame: Up to 10 months
measure: Change in self-report of screening from baseline to 12-month to 24-month
timeFrame: Baseline; 12-month; 24-month
measure: Ratings of program
timeFrame: Up to 10 months
measure: Percent of eligible congregation that enrolled in the project
timeFrame: Baseline
measure: Number of participants that attended educational sessions
timeFrame: Up to 10 months
measure: Enrollment of churches
timeFrame: Baseline
measure: Number of additional training cycles completed over two year period
timeFrame: 12-months; 24-months
measure: Amount of supplemental funding church receives for additional health education over two years
timeFrame: 12-month; 24-month
measure: Number of continued health education activities including cancer education over two year period
timeFrame: 12-month; 24-month
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: Holt CL, Tagai EK, Scheirer MA, Santos SL, Bowie J, Haider M, Slade JL, Wang MQ, Whitehead T. Translating evidence-based interventions for implementation: Experiences from Project HEAL in African American churches. Implement Sci. 2014 May 31;9:66. doi: 10.1186/1748-5908-9-66.
citation: Santos SL, Tagai EK, Wang MQ, Scheirer MA, Slade JL, Holt CL. Feasibility of a web-based training system for peer community health advisors in cancer early detection among african americans. Am J Public Health. 2014 Dec;104(12):2282-9. doi: 10.2105/AJPH.2014.302237. Epub 2014 Oct 16.
citation: Holt CL, Shelton RC, Allen JD, Bowie J, Jandorf L, Zara Santos SL, Slade J. Development of tailored feedback reports on organizational capacity for health promotion in African American churches. Eval Program Plann. 2018 Oct;70:99-106. doi: 10.1016/j.evalprogplan.2018.07.002. Epub 2018 Jul 21.
citation: Holt CL, Tagai EK, Santos SLZ, Scheirer MA, Bowie J, Haider M, Slade J. Web-based versus in-person methods for training lay community health advisors to implement health promotion workshops: participant outcomes from a cluster-randomized trial. Transl Behav Med. 2019 Jul 16;9(4):573-582. doi: 10.1093/tbm/iby065.
citation: Scheirer MA, Santos SL, Tagai EK, Bowie J, Slade J, Carter R, Holt CL. Dimensions of sustainability for a health communication intervention in African American churches: a multi-methods study. Implement Sci. 2017 Mar 28;12(1):43. doi: 10.1186/s13012-017-0576-x.
citation: Santos SL, Tagai EK, Scheirer MA, Bowie J, Haider M, Slade J, Wang MQ, Holt CL. Adoption, reach, and implementation of a cancer education intervention in African American churches. Implement Sci. 2017 Mar 14;12(1):36. doi: 10.1186/s13012-017-0566-z.