Integration of Cancer Health Activities Into African American Churches

October 31, 2022 updated by: University of Maryland, College Park
The proposed project will compare two ways to apply a known-effective cancer educational strategy through African American churches: 1) a standard method vs. 2) a new method in which the churches integrate the strategy into their organizational structure and practice at multiple levels. It will be determined whether this "integrated approach" results in more effective and sustained cancer education and screening activities at both the church and individual levels over time. This project will make important contributions to research in evidence-based medicine and sustainability. In a climate of limited resources, identifying sustainable and effective ways to increase cancer awareness and screening in African American men and women is more important than ever.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This population-based application responds to the American Cancer Society Research Scholar Grant, Priority Program in Cancer Control. Recent years have seen a growing research interest in learning how to get known-effective health education strategies to reach more people who could benefit from them. An important part of this growing movement is a focus on sustained impact, or continued program benefit after the funding period is over. It is believed that the best way to achieve this sustained impact is through integrating the program into the host community at multiple levels. This innovative strategy has not been systematically tested in community-based settings, where the most vulnerable people can be reached. Since churches have a historical and ever-growing role in health promotion particularly among African Americans, they are an ideal place to reach this group for cancer education. The proposed project will compare two ways to apply a known-effective cancer educational strategy through African American churches: 1) a standard method vs. 2) a new method in which the churches integrate the strategy into their organizational structure and practice at multiple levels. It will be determined whether this "integrated approach" results in more effective and sustained cancer education and screening activities at both the church and individual levels over time. The educational strategy is one that has been used successfully in previous work: Project Health through Early Awareness and Learning (HEAL). Project HEAL is a series of three cancer early detection workshops (breast, prostate, colorectal) delivered through trained and certified lay peer community health advisors in African American churches. 14 churches will be randomly chosen to conduct either the standard Project HEAL program or an integrated Project HEAL strategy where the churches build the program into their organization in multiple ways (e.g., allocating volunteer or paid staff, space, or funds; policy change; ministry development). The project will be conducted in three phases: 1) refining the integrated approach with community and stakeholder feedback; 2) pilot testing the integrated approach in 2 churches; and 3) conducting the study to comparatively evaluate the standard vs. the integrated approaches in 14 churches. A scientifically rigorous evaluation plan will be used to look at outcomes at both the individual and the church level. This project will make important contributions to research in evidence-based medicine and sustainability. In a climate of limited resources, identifying sustainable and effective ways to increase cancer awareness and screening in African American men and women is more important than ever.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
446

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • College Park, Maryland, United States, 20742
        • University of Maryland School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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
  • Adults ages 21+
  • Regularly attend church services
  • Able to complete Project HEAL training
  • Able to recruit 40+ participants for a breast, prostate, or colorectal cancer educational workshop
  • Able to lead the breast, prostate, and colorectal cancer workshops
  • Workshop Participants
  • Self-identified African American
  • Adults ages 21+
  • Have no history of breast, prostate, or colorectal cancer

Exclusion Criteria:

  • Workshop Participants: Men and women who have had breast, prostate, or colorectal cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Integrated Approach
In this approach, rather than developing a separate health ministry, cancer activities could be integrated throughout existing church ministries (e.g. men's, women's, seniors).
Behavioral: Project HEAL 2.0
In this approach, rather than developing a separate health ministry, cancer activities could be integrated throughout existing church ministries (e.g. men's, women's, seniors).
Active Comparator: Standard Comparison
Standard group churches will not be asked to, or provided special encouragement to technical assistance with, institutionalizing health promotion activities in their churches.
Behavioral: Project HEAL
Standard group churches will not be asked to, or provided special encouragement to technical assistance with, institutionalizing health promotion activities in their churches.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Integration of health-relation practices assessed via church survey
Time Frame: Change from baseline to 12 and 24 months
Intervention impact on institutionalization at 12 and 24 months
Change from baseline to 12 and 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reach: Number of participants from priority population engaged in intervention as assessed by enrollment logs
Time Frame: Up to 4 months
Participants from priority population engaged in intervention
Up to 4 months
Efficacy: Increased knowledge of cancer as assessment by participant surveys
Time Frame: Up to 12 months
Cancer-related knowledge
Up to 12 months
Efficacy: Increased self-report of cancer screening as assessment by participant surveys
Time Frame: Up to 12 months
Self-reported cancer screening
Up to 12 months
Adoption
Time Frame: At recruitment/enrollment
Cooperation rate of churches
At recruitment/enrollment
Implementation: Extent to which intervention is implemented as intended as assessed by a fidelity checklist completed by staff
Time Frame: Up to 4 months
Adherence to intervention protocol
Up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Maryland, College Park

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Cancer Society, Inc.
Community Ministry of Prince George's County
Access to Wholistic and Productive Living Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cheryl L Holt, PhD, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RSG-16-022-01-CPPB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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