Screening Messages for Colorectal Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michigan State University

Disqualifiers: Non-African American, Age, Insurance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

600 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to improve use of colorectal cancer screening among screening eligible African Americans who are served by Federally Qualified Health Centers in Michigan. The main questions it aims to answer are: * To what extent to individual prefer and select to complete screening with colonoscopy versus stool-based (FIT Kit or sDNA) options? * Can full completion of (i.e. follow-through with) screening with a selected modality be enhanced by delivery of a culturally targeted intervention? Participants will learn about colonoscopy, FIT Kit and sDNA as recommended and widely used screening options. Participants will select a modality to complete their own screening with. Participants will then be randomized to one of three arms (usual care, standard intervention, culturally targeted intervention). Researchers will compare the extent to which intervention arms enhance completion rates across each of the three screening modalities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Implementation Intention Intervention: Culturally-Targeted Message, Implementation Intention Intervention: Standard Message for colorectal cancer screening?

Research shows that tailoring messages to individuals can increase their intention to get screened for colorectal cancer. Studies have found that personalized communication strategies, like culturally-targeted messages, can make people feel the information is more relevant to them, which can lead to higher screening rates. ^{1 2 3 4 5}

How does the treatment in the colorectal cancer screening trial differ from other treatments?

The treatment in this trial is unique because it focuses on culturally-tailored educational outreach and messaging to improve colorectal cancer screening rates, particularly among diverse and underserved populations, rather than using a new drug or medical procedure. ^{1 4 6 7 8}

Eligibility Criteria

This trial is for African Americans aged 45-72 who are patients at Federally Qualified Health Centers in Michigan, have Medicaid or Medicare, and are due for colorectal cancer screening. They must not have had a colonoscopy in the last 10 years or other screenings more recently than recommended.

Inclusion Criteria

I am covered by Medicaid or Medicare insurance.

Enrolled in a FQHC

I am African American and between 45-72 years old.

Exclusion Criteria

All who do not meet inclusion criteria.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Selection

Participants learn about colonoscopy, FIT Kit, and sDNA as screening options and select a modality for their screening.

2 weeks

1 visit (in-person or virtual)

Intervention

Participants receive either usual care, standard implementation intention messages, or culturally-targeted implementation intention messages to enhance screening completion.

6 months

Follow-up

Participants are monitored for completion of the selected screening modality and assessed for attitudes and perceptions related to colorectal cancer screening.

6 months

Treatment Details

Interventions

• Implementation Intention Intervention: Culturally-Targeted Message
• Implementation Intention Intervention: Standard Message

Trial Overview The study tests if colorectal cancer screening rates improve when participants choose their preferred method (colonoscopy, FIT Kit, sDNA) and receive either usual care messages or one of two interventions: a standard message or a culturally-targeted message.

Participant Groups

Group I: Implementation Intention Intervention: Culturally-Targeted Message Experimental Treatment 1 Intervention

Participants selecting a colorectal cancer screening will receive culturally-targeted implementation intention messages in addition to the "usual care" from the FQHC.

Group II: Usual Care Message Active Control 1 Intervention

Participants selecting a colorectal cancer screening will receive "usual care" from the FQHC.

Group III: Implementation Intention Intervention: Standard Message Active Control 1 Intervention

Participants selecting a colorectal cancer screening will receive implementation intention messages in addition to the "usual care" from the FQHC.

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Findings from Research

Mailed outreach strategies, especially those including fecal immunohistochemical tests (FIT) or guaiac-based fecal occult blood tests (gFOBT), significantly increased colorectal cancer screening adherence in low-income populations, with relative risks of 2.20 and 4.34 respectively.

Patient navigation and non-individualized education also effectively improved screening rates, while individualized education and mailed outreach with incentives did not show significant benefits, highlighting the importance of intervention design in promoting screening adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to increase colorectal cancer screening adherence in low-income settings within the United States: A systematic review and meta-analysis. Rubin, L., Okitondo, C., Haines, L., et al.[2023]

A review of 15 community-based randomized controlled trials found that 73% of interventions significantly increased colorectal cancer screening rates, particularly those using patient mailings and telephone outreach.

Tailoring information to patient preferences and considering community-level factors were key strategies that contributed to the success of these interventions in improving screening rates among multi-ethnic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based colorectal cancer screening trials with multi-ethnic groups: a systematic review. Morrow, JB., Dallo, FJ., Julka, M.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

A culturally and linguistically salient pilot intervention to promote colorectal cancer screening among Latinos receiving care in a Federally Qualified Health Center. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Interventions to increase colorectal cancer screening adherence in low-income settings within the United States: A systematic review and meta-analysis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Communicating risk to promote colorectal cancer screening: a multi-method study to test tailored versus targeted message strategies. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Community-based colorectal cancer screening trials with multi-ethnic groups: a systematic review. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Examining the Durability of Colorectal Cancer Screening Awareness and Health Beliefs Among Medically Underserved Patients: Baseline to 12 months Post-Intervention. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Preliminary Evaluation of Educational Outreach to Promote Colorectal Cancer Screening Among South Asians in the San Francisco Bay Area. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Patient-Refined Messaging for a Mailed Colorectal Cancer Screening Program: Findings from the PROMPT Study. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Recruitment Challenges of a Colorectal Cancer Screening Dissemination Study. [2023]