Information DisseminationProject HEALNCT02076958
Implementation of Evidence-Based Cancer Early Detection in Black Churches
A study testing Community Health Advisor education in people with Information Dissemination and Evidence-Based Public Health, run by University of Maryland, College Park at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Information Dissemination, Evidence-Based Public Health
- What is being tested?
- Community Health Advisor education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 2018
- 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 40 to 75 years
- 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
- over 21 years of age
- regularly attend church services
Show all 11Show fewer
- 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.
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 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.
- Being tested
- Community Health Advisor education
- Keywords
- Implementation, Cancer, Early detection, Faith-based, Community health advisor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Advisor educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Traditional/classroom | Active comparator | Community health advisors trained using traditional/classroom methods and provided with technical assistance/support as needed Receives: Behavioral: Community Health Advisor education |
| Technology | Experimental | Community health advisors trained using technology/online methods and provided minimal technical assistance/support Receives: Behavioral: Community Health Advisor education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to program delivery protocol - Implementation of the 3-workshop series.
Measured: Up to 10 months
Secondary outcomes (19)
Number of training events (workshops)
Measured: Up to 10 months
Number of CHA trainees
Measured: Baseline
Completion of CHA training
Measured: Baseline
Self-report of modifications or problems with program delivery
Measured: Up to 12 months
Number of booster CHA training sessions over two-year period
Measured: 12-month; 24-month
Change in number of survey completion from baseline to 12-month to 24-month
Measured: Baseline; 12-month; 24-month
Number of educational sessions participants attended
Measured: Up to 10 months
Change in knowledge of cancer early detection from workshop 1 to workshop 3
Measured: Up to 10 months
Change in perceived benefits of screening
Measured: Up to 10 months
Change in perceived barriers to screening
Measured: Up to 10 months
Change in self-efficacy for screening
Measured: Up to 10 months
Change in self-report of screening from baseline to 12-month to 24-month
Measured: Baseline; 12-month; 24-month
Ratings of program
Measured: Up to 10 months
Percent of eligible congregation that enrolled in the project
Measured: Baseline
Number of participants that attended educational sessions
Measured: Up to 10 months
Enrollment of churches
Number agreed/total approached
Measured: Baseline
Number of additional training cycles completed over two year period
Measured: 12-months; 24-months
Amount of supplemental funding church receives for additional health education over two years
Measured: 12-month; 24-month
Number of continued health education activities including cancer education over two year period
Measured: 12-month; 24-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startMar 2011
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Information DisseminationStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheryl L Holt, PhD, Principal investigator, University of Maryland School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076958
- Sponsor's protocol ID
- R01CA147313
- Acronym
- Project HEAL
- Status last verified
- May 2022
- First submitted
- 27 Feb 2014
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24885069Santos 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.
PubMed 25320894Huq MR, He X, Woodard N, Chen C, Knott CL. The role of community health advisors' cancer history in implementation and efficacy of a cancer control intervention. Health Educ Res. 2023 Jul 25;38(4):350-361. doi: 10.1093/her/cyad011.
PubMed 36892605Holt 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.
PubMed 30041105Holt 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.
PubMed 29955889Scheirer 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.
PubMed 28351405Santos 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.
PubMed 28292299
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Evidence-Based Cancer Early Detection in Black Churches
- ClinicalTrials.gov ID
- NCT02076958
- Acronym / sponsor ID
- Project HEAL / R01CA147313
- Keywords
- Implementation, Cancer, Early detection, Faith-based, Community health advisor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 4 Mar 2014 (estimated)
- 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 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional/classroom | Active comparator | Behavioral: Community Health Advisor educationCommunity health advisors trained using traditional/classroom methods and provided with technical assistance/support as needed |
| Technology | Experimental | Behavioral: Community Health Advisor educationCommunity health advisors trained using technology/online methods and provided minimal technical assistance/support |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 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:
- 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.
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 |
|---|---|---|
| Community Health Advisor education | Behavioural | Technology, Traditional/classroom |
Primary outcome
Adherence to program delivery protocol - Implementation of the 3-workshop series.
Time frame: Up to 10 months
19 secondary outcomes
Number of training events (workshops)
Time frame: Up to 10 months
Number of CHA trainees
Time frame: Baseline
Completion of CHA training
Time frame: Baseline
Self-report of modifications or problems with program delivery
Time frame: Up to 12 months
Number of booster CHA training sessions over two-year period
Time frame: 12-month; 24-month
Change in number of survey completion from baseline to 12-month to 24-month
Time frame: Baseline; 12-month; 24-month
Number of educational sessions participants attended
Time frame: Up to 10 months
Change in knowledge of cancer early detection from workshop 1 to workshop 3
Time frame: Up to 10 months
Change in perceived benefits of screening
Time frame: Up to 10 months
Change in perceived barriers to screening
Time frame: Up to 10 months
Change in self-efficacy for screening
Time frame: Up to 10 months
Change in self-report of screening from baseline to 12-month to 24-month
Time frame: Baseline; 12-month; 24-month
Ratings of program
Time frame: Up to 10 months
Percent of eligible congregation that enrolled in the project
Time frame: Baseline
Number of participants that attended educational sessions
Time frame: Up to 10 months
Enrollment of churches
Time frame: Baseline
Number of additional training cycles completed over two year period
Time frame: 12-months; 24-months
Amount of supplemental funding church receives for additional health education over two years
Time frame: 12-month; 24-month
Number of continued health education activities including cancer education over two year period
Time frame: 12-month; 24-month
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 23 May 2022.
- Background: PubMed 24885069Holt 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.
- Background: PubMed 25320894Santos 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.
- Derived from this study: PubMed 36892605Huq MR, He X, Woodard N, Chen C, Knott CL. The role of community health advisors' cancer history in implementation and efficacy of a cancer control intervention. Health Educ Res. 2023 Jul 25;38(4):350-361. doi: 10.1093/her/cyad011.
- Derived from this study: PubMed 30041105Holt 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.
- Derived from this study: PubMed 29955889Holt 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.
- Derived from this study: PubMed 28351405Scheirer 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.
- Derived from this study: PubMed 28292299Santos 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.
- Community Health Awareness, Messages and Prevention (CHAMP) LabLink 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
University of Maryland School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Advisor education in people with Information Dissemination and Evidence-Based Public Health, 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 11 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 23 May 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?
Adherence to program delivery protocol - Implementation of the 3-workshop series. (time frame: Up to 10 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 NCT02076958, which also lists 7 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 23 May 2022.