Breast CancerNCT03178383
Integration of Cancer Health Activities Into African American Churches
A study testing Project HEAL and Project HEAL 2.0 in people with Breast Cancer and Prostate Cancer, run by University of Maryland, College Park at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Colorectal Cancer
- What is being tested?
- Project HEAL and Project HEAL 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- Workshop Participants: Men and women who have had breast, prostate, or colorectal cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Public Health
College Park, Maryland, 20742
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Prostate Cancer, Colorectal Cancer
- Being tested
- Project HEAL, Project HEAL 2.0
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project HEALBehavioural
Standard group churches will not be asked to, or provided special encouragement to technical assistance with, institutionalizing health promotion activities in their churches.
Project HEAL 2.0Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Integrated Approach | Experimental | 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). Receives: Behavioral: Project HEAL 2.0 |
| Standard Comparison | Active comparator | Standard group churches will not be asked to, or provided special encouragement to technical assistance with, institutionalizing health promotion activities in their churches. Receives: Behavioral: Project HEAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integration of health-relation practices assessed via church survey
Intervention impact on institutionalization at 12 and 24 months
Measured: Change from baseline to 12 and 24 months
Secondary outcomes (5)
Reach: Number of participants from priority population engaged in intervention as assessed by enrollment logs
Participants from priority population engaged in intervention
Measured: Up to 4 months
Efficacy: Increased knowledge of cancer as assessment by participant surveys
Cancer-related knowledge
Measured: Up to 12 months
Efficacy: Increased self-report of cancer screening as assessment by participant surveys
Self-reported cancer screening
Measured: Up to 12 months
Adoption
Cooperation rate of churches
Measured: At recruitment/enrollment
Implementation: Extent to which intervention is implemented as intended as assessed by a fidelity checklist completed by staff
Adherence to intervention protocol
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start1 Jul 2016
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Community Ministry of Prince George's County, Access to Wholistic and Productive Living Institute
- Responsible party
- Sponsor
- Investigators
- Cheryl L Holt, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178383
- Sponsor's protocol ID
- RSG-16-022-01-CPPB
- Status last verified
- Oct 2022
- First submitted
- 18 May 2017
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Knott CL, Chen C, Bowie JV, Mullins CD, Slade JL, Woodard N, Robinson-Shaneman BR, Okwara L, Huq MR, Williams R, He X. Cluster-randomized trial comparing organizationally tailored versus standard approach for integrating an evidence-based cancer control intervention into African American churches. Transl Behav Med. 2022 May 26;12(5):673-682. doi: 10.1093/tbm/ibab088.
PubMed 34255087Knott CL, Bowie J, Mullins CD, Santos SLZ, Slade J, Rosenberg E, Woodard N, Williams R, Williams RM. An Approach to Adapting a Community-Based Cancer Control Intervention to Organizational Context. Health Promot Pract. 2020 Mar;21(2):168-171. doi: 10.1177/1524839919898209. Epub 2020 Jan 20.
PubMed 31959002
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Cancer Health Activities Into African American Churches
- ClinicalTrials.gov ID
- NCT03178383
- Acronym / sponsor ID
- RSG-16-022-01-CPPB
- Conditions
- Breast Cancer, Prostate Cancer, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Community Ministry of Prince George's County, Access to Wholistic and Productive Living Institute
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Approach | Experimental | Behavioral: Project HEAL 2.0In 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). |
| Standard Comparison | Active comparator | Behavioral: Project HEALStandard group churches will not be asked to, or provided special encouragement to technical assistance with, institutionalizing health promotion activities in their churches. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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+
Key exclusion criteria (1 listed)
- Workshop Participants: Men and women who have had breast, prostate, or colorectal cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project HEALStandard group churches will not be asked to, or provided special encouragement to technical assistance with, institutionalizing health promotion activities in their churches. | Behavioural | Standard Comparison |
| Project HEAL 2.0In 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). | Behavioural | Integrated Approach |
Primary outcome
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
5 secondary outcomes
Reach: Number of participants from priority population engaged in intervention as assessed by enrollment logs
Time frame: Up to 4 months
Efficacy: Increased knowledge of cancer as assessment by participant surveys
Time frame: Up to 12 months
Efficacy: Increased self-report of cancer screening as assessment by participant surveys
Time frame: Up to 12 months
Adoption
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 34255087Knott CL, Chen C, Bowie JV, Mullins CD, Slade JL, Woodard N, Robinson-Shaneman BR, Okwara L, Huq MR, Williams R, He X. Cluster-randomized trial comparing organizationally tailored versus standard approach for integrating an evidence-based cancer control intervention into African American churches. Transl Behav Med. 2022 May 26;12(5):673-682. doi: 10.1093/tbm/ibab088.
- Derived from this study: PubMed 31959002Knott CL, Bowie J, Mullins CD, Santos SLZ, Slade J, Rosenberg E, Woodard N, Williams R, Williams RM. An Approach to Adapting a Community-Based Cancer Control Intervention to Organizational Context. Health Promot Pract. 2020 Mar;21(2):168-171. doi: 10.1177/1524839919898209. Epub 2020 Jan 20.
- CHAMP Lab WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl L Holt, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project HEAL and Project HEAL 2.0 in people with Breast Cancer and Prostate Cancer, run by University of Maryland, College Park at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integration of health-relation practices assessed via church survey (time frame: Change from baseline to 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03178383, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.