Implementation Intention Guide for Colorectal Cancer Screening

Not yet recruiting at 4 trial locations

Overseen By Timothy McAuliffe, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12-18 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special planning tool, the Implementation Intention Guide, can help more people complete their colorectal cancer screening using fecal immunochemical tests (FIT). The guide assists participants in planning and overcoming obstacles in the screening process. Researchers aim to determine if this guide increases the number of completed tests and reduces issues like sample rejections and delays. Individuals aged 45-75 who are patients at specific clinics in New Hampshire or Vermont, or eligible through a specific VA program, may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance screening processes for many.

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 prior data suggests that the implementation intention guide is safe for colorectal cancer screening?

Research has shown that an implementation intention guide can safely help people complete screening tests like the fecal immunochemical test (FIT) for colorectal cancer. Studies on these guides have not identified any negative effects on participants. The guide serves as an additional document to encourage completion of screenings.

The FIT is a common and widely accepted test for detecting colorectal cancer. The implementation intention guide acts as an extra tool to ensure the test is completed, without altering the test itself. This study focuses on finding a better way to help people complete an existing test, not on testing a new medical treatment.

In summary, no known safety concerns exist with using this guide. It is simply a support tool to improve habits and follow through with health screenings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how a simple addition—a one-page implementation intention guide—might improve colorectal cancer screening rates. Unlike the standard FIT screening, which relies solely on the test itself and standard instructions, this guide helps participants plan exactly when, where, and how they will complete the test. This approach harnesses the power of intention-based planning to potentially increase follow-through, making it easier for people to complete their screenings and catch cancer early.

What evidence suggests that the implementation intention guide is effective for increasing FIT completion rates?

Research shows that simple planning tools can help more people complete colorectal cancer screening tests, such as the fecal immunochemical test (FIT). Studies have found that clear plans about when and how to perform a task increase the likelihood of completion. This approach is particularly effective in encouraging participation in health screenings, which can detect diseases early. In this trial, participants in the Intervention Arm will receive an Implementation Intention Guide along with the FIT standard of care. Using these planning tools has been linked to higher completion and return rates of FIT tests. Including a planning guide may facilitate the completion of FIT screenings, potentially aiding in the early detection of colorectal cancer. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who are due for colorectal cancer screening using the fecal immunochemical test (FIT). Participants should be willing to follow a guide designed to help them complete their FIT. There's no specific mention of exclusion criteria, so it appears open to all adults recommended for CRC screening.

Inclusion Criteria

I am between 45 and 75 years old.

Cared for by primary care at General Internal Medicine Clinic, Dartmouth-Hitchcock Medical Center (Lebanon, NH), Dartmouth Hitchcock Clinics Heater Road Primary Care (Lebanon, NH), Dartmouth Hitchcock Clinics Lyme Primary Care (Lyme, NH), or White River Junction Veterans Affairs Medical Center (White River Junction, VT) OR eligible for FIT through VA Mailed FIT Program

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the fecal immunochemical test (FIT) and, if in the intervention arm, an implementation intention guide to encourage completion

12-18 months

Follow-up

Participants are monitored for FIT completion rates and lab sample rejection rates

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Implementation Intention Guide

Trial Overview The study is testing whether an 'implementation intention guide' helps people complete their FIT screening for colorectal cancer more effectively. It will measure if this guide increases the number of completed tests, lowers sample rejection rates, and speeds up the process from collection to lab analysis.

How Is the Trial Designed?

Group I: Intervention Arm (FIT Standard of Care with Implementation Intention Guide) Experimental Treatment 1 Intervention

The Intervention Arm will receive the fecal immunochemical test (FIT) standard of care and the implementation intention guide one-page document. Participants in this arm will be evaluated by their ordering provider about their eligibility and appropriateness for FIT for colorectal cancer screening. If appropriate, these participants will receive the FIT, instructions, and any other documentations always provided to participants receiving FIT in clinical practice. They will also receive the implementation intention guide being evaluated in this study. Any follow-up materials or communications with their provider will also follow FIT standard of care.

Group II: Control Arm (FIT Standard of Care) Active Control 1 Intervention

The Control Arm will receive the fecal immunochemical test (FIT) standard of care. Participants in this arm will be evaluated by their ordering provider about their eligibility and appropriateness for FIT for colorectal cancer screening. If appropriate, these participants will receive the FIT, instructions, and any other documentations always provided to participants receiving FIT in clinical practice. Any follow-up materials or communications with their provider will also follow FIT standard of care. They will not receive any additional document/implementation intention guide with their FIT.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

White River Junction Veterans Affairs Medical Center

Collaborator

Trials

32

Recruited

17,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07183046

Implementation Intention Planning Guide for FIT Colon ... In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4311575/

Implementation Intentions and Colorectal Screening The integrated Precaution Adoption Process Model and Implementation Intentions concept applied to colorectal cancer (CRC) screening in this study. Table 2.

3. bmjopenquality.bmj.com bmjopenquality.bmj.com/content/14/1/e003004

Evaluating the implementation of a multicomponent ... Screening has proven effective at reducing the incidence and mortality of colorectal cancer (CRC). The faecal immunochemical test (FIT) is ...

4. cghjournal.org cghjournal.org/article/S1542-3565(25)00835-3/fulltext

Behavioral Interventions Improve Mailed Colorectal Cancer ... Mailed fecal immunochemical testing (FIT) can boost colorectal cancer screening (CRC) rates, but response rates remain limited. We evaluated if ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827026

Centralized Colorectal Cancer Screening Outreach in ... The findings of this study suggest that centralized mailed fecal immunochemical testing outreach can substantially improve CRC screening in diverse patient ...

6. ajpmonline.org ajpmonline.org/article/S0749-3797(14)00457-7/abstract

Implementation Intentions and Colorectal Screening The study aimed to test a theoretically based "implementation intentions" intervention for improving CRC screening among unscreened adults in ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2773065424000075

Implementing an Organized Colorectal Cancer Screening ... Robust data management is needed to identify, track, and analyze program outcomes. •. Detailing implementation of cancer screening programs might increase ...