Community health advisors trained using traditional/classroom methods and provided with technical assistance/support as needed

Community health advisors trained using technology/online methods and provided minimal technical assistance/support

Community Health Advisor education

Cheryl L Holt, PhD

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.

Implementation of Evidence-Based Cancer Early Detection in Black Churches

University of Maryland, College Park

Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Vasoconstrictor Agents

Respiratory System Agents

All Drugs and Chemicals

Epinephrine

Racepinephrine

Epinephryl borate

Intervention arm participants will be scheduled to receive the CHA intervention within 4 to 6 weeks after enrollment, a FIT kit, a mailed targeted CRC brochure, and a follow-up telephone survey at 3- and 12-months post-intervention

Control group participants will receive a FIT kit, a mailed targeted CRC brochure, and complete a follow-up telephone survey at 3- and 12-months after the mailing.

Intervention arm participants will receive one 45-minute face-to-face meeting followed by two CHA phone calls in one-week intervals over a period of three weeks beginning within one month following baseline survey completion. These CRC educational activities delivered by the CHAs will include the use of NCI CRC resources and materials, including an S2S PowerPoint presentation, and CRC educational brochures. The intervention will follow a conversation guide/standard script for intervention fidelity. CHAs will take notes following each interaction to document the call length, deviations from the script, and tone of the call. Participants will receive an additional text message reminder once a week for an additional three weeks - with instructions for participants to text "yes" to confirm they received the message - for a total of six weeks of intervention delivery. The personalized text messages will have positive tones and include short messages about the benefits of CRC screening.

Community Health Advisor

Control arm participants will receive a FIT kit, a mailed targeted colorectal cancer brochure, and complete a follow-up telephone survey at 3- and 12-months after the mailing.

Usual care

Karam Soliman, PhD

This study will test the effectiveness of an outreach strategy to increase colorectal cancer (CRC) screening in African Americans. The investigators will recruit 250 African Americans ages 45-64 years who are not up-to-date with CRC screening or have never been screened, with the goal to evaluate screening knowledge, behavior, and intervention effects on CRC screening outcomes. Participants will be randomly assigned to the TUNE-UP intervention or a control group. The TUNE-UP intervention arm will utilize a community health advisor (CHA) to encourage return of stool blood testing kits through cell phone outreach. The control group will receive educational materials about CRC screening plus a resource list but no CHA counseling support or cellphone / text contact. The primary study outcome is receipt of CRC screening (colonoscopy or FIT) following the intervention. The secondary outcomes will include CRC screening knowledge, self-efficacy (confidence to receive CRC screening), intention to screen, and follow-up in the case of an abnormal test result. The research objective is to test the CHA intervention effectiveness for promoting stool blood testing as a preferred screening test in an under-screened African American population.

Participants will be randomly assigned to the TUNE-UP intervention or a control group that will receive educational materials about CRC screening plus a resource list but no Community Health Advisor (CHA) counseling support or cellphone / text contact like in the TUNE-UP CHA intervention group.

Participant will complete surveys and receive mailings and not know if they are in control arm or intervention arm.

Test Up Now Education Program

Data sharing will be overseen by the Principal Investigator. To facilitate sharing of data, study outcome publications from this CRC screening intervention study will provide email contact information for interested persons to obtain details on accessing de-identified data. The data sharing option will be available for at least 3 years following completion of the project, consistent with NIH policy on maintenance of study data.

The investigator requesting the data will be required to submit a data request detailing the research question to be investigated, the specific variables necessary for the intended analyses, a list of individuals who will have access to the data, and proof of adequate training in the protection of human subjects for all individuals with access to data.

The colorectal cancer screening measure asks about completion of colonoscopy and blood stool tests. These tests are described prior to questions about completion of each test. The first question asks when was the most recent stool blood test (\> 1 year but \< 2 years ago; \> 2 years but not more than 5 years ago; or \> 5 years). The second question asks when was the most recent colonoscopy (a year ago or less; \> 1 year but \< 5 years ago; \> 5 years but not more than 10 years ago; or \> 10 years). Colorectal cancer screening receipt will be determined based on self-report and chart review to determine screening rates for each screening modality. Those answering a "a year ago or less" for the most recent stool blood test and "less than 10 years ago" for most recent colonoscopy are considered up to date.

Participants are asked four True/False questions about colon cancer: if their chance of getting colon cancer is higher if they have a family history, if it can be cured if caught early, if colon cancer is associated with pain or other symptoms, and if a warning sign of colon cancer is having a rash. They are also asked six additional True/False questions later in the survey to test knowledge about colorectal cancer screening. The range of the scale is 0-10. Each answer is scored as correct or incorrect. A score of 7 to 10 is considered "high". A score of 4 to 6 is considered "average". A score of 0 to 3 is considered "low."

A validated 4-item measure of colorectal cancer screening self-efficacy (alpha = 0.82) asks participants to respond using a Likert scale about colorectal cancer screening test difficulty, finding time, ease of completing the test, and scheduling the test. Total scale scores range from 1 to 4. A score of 3 to 4 is considered "low self-efficacy" and a score of 1 to 2 is considered "high self-efficacy."

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Implementation of Evidence-Based Cancer Early Detection in Black Churches	NCT02076958	Information Dis... Evidence-Based ...	Community Healt...	40 Years - 75 Years	University of Maryland, College Park
Test Up Now Education Program	NCT04304001	Colorectal Canc...	Community Healt... Usual care	45 Years - 64 Years	Florida A&M University
Implementation of Evidence-Based Cancer Early Detection in Black Churches	NCT02076958	Information Dis... Evidence-Based ...	Community Healt...	40 Years - 75 Years	University of Maryland, College Park
Test Up Now Education Program	NCT04304001	Colorectal Canc...	Community Healt... Usual care	45 Years - 64 Years	Florida A&M University
Test Up Now Education Program	NCT04304001	Colorectal Canc...	Community Healt... Usual care	45 Years - 64 Years	Florida A&M University

Spots Global Cancer Trial Database for community health advisor