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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of a digital tool, called eNav, in assisting people with colorectal cancer screening. The tool includes a website and text messages that provide information, motivation, and reminders to complete the screening. Participants will either use eNav or receive usual care without the tool. Ideal candidates are treated at the Institute for Family Health, speak English or Spanish, and are due for a colorectal cancer screening.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance cancer screening processes.

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 prior data suggests that the eNav tool is safe for improving colorectal cancer screening?

Research has shown that the eNav tool helps patients understand and complete colorectal cancer screenings. It provides easy access to information, motivational messages, and reminders. Without involving physical or chemical treatments, it avoids the side effects associated with medications.

The eNav tool serves as a digital guide, not a drug or medical procedure, and is expected to be very safe. It delivers information and support through a website and text messages. This type of tool generally poses no risk to users. It's similar to using a health app or receiving reminder texts, which most people find easy to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the eNav Toolkit for colorectal cancer screening because it introduces a new way to engage with patients digitally. Unlike traditional methods that rely on in-person consultations and mailed reminders, eNav uses an online platform to provide patients with easy access to information and resources about colorectal cancer screening. This digital approach aims to increase participation in screenings by making it more convenient and accessible, potentially leading to earlier detection and better outcomes.

What evidence suggests that the eNav tool is effective for improving colorectal cancer screening?

Research has shown that digital tools like eNav, which participants in this trial may receive, can increase colorectal cancer screening rates. Studies have found that guiding patients, especially through text messages, improves both the frequency and quality of completed screenings. eNav assists patients at community health centers by providing website information, motivational support, and text message reminders. By making resources and reminders easily accessible, eNav aims to help patients complete their screenings. This method has successfully increased screening rates in similar settings. ^{1 2 3 4 6}

Who Is on the Research Team?

Sarah Miller

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06184594

Evaluating the Efficacy of the eNav Toolkit to Improve ...

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 ...

2.

reporter.nih.gov

reporter.nih.gov/project-details/11051184

Project Details - NIH RePORTER

Patient navigation has proven effective for improving CRC screening completion rates and screening quality. The effects of patient navigation are robust across ...

3.

formative.jmir.org

formative.jmir.org/2024/1/e53224/PDF

The Development of a Digital Patient Navigation Tool to ...

Recent studies support the efficacy of digital patient navigation, especially SMS text message navigation, to improve CRC screening uptake [20- ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39321451/

The Development of a Digital Patient Navigation Tool to ...

This study conducts user testing of a digital patient navigation tool, called eNav, designed to support FQHC patients in preparing for, requesting, and ...

5.

labs.icahn.mssm.edu

labs.icahn.mssm.edu/sarahmillerlab/enav-developing-and-testing-a-digital-toolkit-to-improve-colorectal-cancer-screening-rates-in-federally-qualified-health-centers/

eNav Study - - Research Portal

We are conducting a multi-site study that aims to improve colorectal cancer screening uptake among patients treated at federally qualified health centers (FQHC) ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/11464930/

The Development of a Digital Patient Navigation Tool to ...

On the primary landing pages, the eNav website offers information about CRC including (1) CRC and its risk factors, (2) polyps, (3) signs and ...