eNav Toolkit for Colorectal Cancer Screening

Overseen By Cristina Villagra, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Unable to provide consent

Compensation: Varies

Number of Visits: 2

400 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to evaluate the efficacy of a digital navigation tool, called the eNav to improve colorectal cancer screening uptake among patients treated at federally qualified health centers (FQHC)s. The digital navigation tool includes a website and text messaging support. The website includes information, motivational support, decisional support and cues to action (e.g., ability to request a CRC screening test). The eNav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test).

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of the eNav treatment for colorectal cancer screening?

The research suggests that systematic reminders and tailored interventions, like those potentially included in the eNav treatment, can increase colorectal cancer screening rates, which is crucial for reducing cancer mortality. ^{1 2 3 4 5}

How does the eNav Toolkit for Colorectal Cancer Screening differ from other treatments?

The eNav Toolkit for Colorectal Cancer Screening is unique because it likely involves novel approaches to improve individual risk assessment and utilizes emerging technologies like virtual colonoscopy and fecal DNA testing, which are less invasive and more suitable for public use compared to traditional methods. ^{1 6 7 8 9}

Research Team

Sarah Miller

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for patients at federally qualified health centers who need colorectal cancer screening. There are no specific inclusion or exclusion criteria provided, so it's likely open to a broad range of individuals who require screening.

Inclusion Criteria

I can sign the consent form within a month of seeing my primary care doctor.

I am due for a colorectal cancer screening according to my medical records.

I am between 45 and 75 years old, eligible for colorectal cancer screening.

Exclusion Criteria

I am unable to understand and give consent for treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-4 weeks

1 visit (in-person)

Intervention

Participants in the intervention group receive access to the eNav digital toolkit, including a website and text-messaging support.

6 months

Follow-up

Participants complete a follow-up questionnaire assessing health belief model constructs 3-6 weeks after their primary care appointment.

3-6 weeks

1 visit (virtual)

Outcome Assessment

The impact of the eNav Toolkit on CRC screening completion is evaluated by checking medical records at 6 months.

6 months

Treatment Details

Interventions

• eNav

Trial Overview The study is testing the eNav Toolkit—a digital tool with a website and text messaging support designed to increase colorectal cancer screening rates among patients. It provides information, motivation, decision aid, and reminders.

Participant Groups

Group I: eNav intervention Experimental Treatment 1 Intervention

Subjects assigned to this arm will receive a link to the eNav website.

Group II: Usual Care Group Placebo Group 1 Intervention

Subjects assigned to this arm will not receive the link to the website and will receive standard clinical care.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

The Institute for Family Health

Collaborator

Trials

6

Recruited

3,100+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Mailed reminders to patients significantly increased colorectal cancer screening rates from 38.1% to 44.0%, especially among older age groups, indicating that targeted communication can effectively promote screening.

While electronic reminders for physicians did not show a significant overall increase in screening rates, they appeared to be beneficial for patients with frequent primary care visits, suggesting that tailored approaches may enhance screening efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and physician reminders to promote colorectal cancer screening: a randomized controlled trial. Sequist, TD., Zaslavsky, AM., Marshall, R., et al.[2022]

A controlled trial involving 443 participants tested a combined intervention of a patient decision aid and practice-level support to increase colorectal cancer (CRC) screening rates, showing a modest increase in screening from 32.2% in usual care to 39% in the intervention group.

The intervention was particularly more effective for participants with higher incomes, suggesting that socioeconomic factors may influence the success of CRC screening interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a patient and practice-level colorectal cancer screening intervention in health plan members: the CHOICE trial. Pignone, M., Winquist, A., Schild, LA., et al.[2021]

Colorectal cancer screening significantly reduces mortality in individuals aged 50 and older, yet screening rates remain low despite the availability of various recommended tests like colonoscopy and fecal occult blood tests.

Barriers to screening exist for both patients and physicians, highlighting the need for strategies to improve compliance and increase participation in colorectal cancer screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal cancer screening: clinical applications. Walsh, JM., Terdiman, JP.[2019]

Screening for colorectal cancer (CRC) is crucial for prevention, but current methods are underutilized due to discomfort and lack of awareness; new technologies like CT colonography and stool DNA testing offer less invasive and more accurate alternatives.

Before these new screening methods can be widely adopted, issues such as accuracy, preparation, availability, acceptability, and cost-effectiveness need to be resolved, with the potential for a revolutionary miniaturized endoscopic device to significantly improve CRC screening outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging technologies in colorectal cancer screening. Moshkowitz, M., Arber, N.[2005]

References

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

Patient and physician reminders to promote colorectal cancer screening: a randomized controlled trial. [2022]

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

Effectiveness of a patient and practice-level colorectal cancer screening intervention in health plan members: the CHOICE trial. [2021]

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

Colorectal cancer screening: clinical applications. [2019]

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

Text Messaging and Opt-out Mailed Outreach in Colorectal Cancer Screening: a Randomized Clinical Trial. [2022]

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

A Randomized Trial to Compare a Tailored Web-Based Intervention and Tailored Phone Counseling to Usual Care for Increasing Colorectal Cancer Screening. [2021]

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

Colon cancer screening strategies. [2019]

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

Emerging technologies in colorectal cancer screening. [2005]

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

Optimal Strategies for Colorectal Cancer Screening. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Screening for Colorectal Cancer Leading into a New Decade: The "Roaring '20s" for Epigenetic Biomarkers? [2022]