Implementation Intention Planning Guide for FIT Colon Cancer Screening

NCT07183046 | Not Yet Recruiting

• 1 other identifier: STUDY02002735
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 5

Brief Summary

Fecal immunochemical tests (FIT) are a primary method of screening for colorectal cancer (CRC). Implementation intention planning involves encouraging completion or eliminating barriers for the participant to make a plan to complete a behavior or activity. This randomized control study seeks to answer whether the addition of an implementation intention guide impacts behaviors when completing FIT screening. The primary objective includes determining if the implementation intention guide increases completion rate of screening FIT. The secondary objectives is whether this intervention decreases the lab sample rejection rate and reduces the duration between sample collection and laboratory receipt/evaluation of screening FIT.

Conditions

Fecal Immunochemical Test; Colorectal Cancer Screening

Outcome Measures

Primary Outcomes (1)

• FIT completion rate

  Percentage of participants who have completed, returned, and have received completed lab results for FIT 90 days following participant reception of FIT.

  Through study completion, approximately 12-18 months

Secondary Outcomes (2)

• Duration between FIT collection date and receipt by the laboratory

  Through study completion, approximately 12-18 months

• Rate of lab sample rejection

  Through study completion, approximately 12-18 months

Study Arms (2)

Control Arm (FIT Standard of Care)

NO 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.

Intervention Arm (FIT Standard of Care with Implementation Intention Guide)

EXPERIMENTAL

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.

Behavioral: Implementation Intention Guide

Interventions

Implementation Intention Guide BEHAVIORAL

The intervention is the addition of implementation intention guide document provided with the FIT. This is a one-page piece of paper that was developed by the investigator team and finalized with input/feedback from patient partners. The implementation intention guide includes instructions about the importance of developing a plan to complete FIT. It also includes fillable fields for participants to enter their plan for when to complete, where to store, when to return, and where to return their FIT. Participants will also be able to follow a QR code on the implementation intention guide document to a link to complete an anonymous, electronic version of the guide and share feedback on the intervention.

Intervention Arm (FIT Standard of Care with Implementation Intention Guide)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45-75
• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• White River Junction Veterans Affairs Medical Center: collaborator

Study Sites (5)

Dartmouth Hitchcock Clinics, Heater Road Primary Care

Lebanon, New Hampshire, 03766, United States

Location

Dartmouth-Hitchcock Medical Center, General Internal Medicine Clinic

Lebanon, New Hampshire, 03766, United States

Location

Dartmouth Hitchcock Clinics, Lyme Primary Care Clinic

Lyme, New Hampshire, 03768, United States

Location

White River Junction Veterans Affairs Medical Center, Primary Care Clinic

White River Junction, Vermont, 05009, United States

Location

White River Junction Veterans Affairs Medical Center, VA Mailed FIT Program

White River Junction, Vermont, 05009, United States

Location

Central Study Contacts

Audrey H Calderwood, MD, MS

CONTACT

603-650-5261; Audrey.H.Calderwood@hitchcock.org

Timothy McAuliffe, BA

CONTACT

timothy.john.mcauliffe@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Comprehensive Gastroenterology Center; Professor of Medicine, Geisel School of Medicine and the Dartmouth Institute; Staff physician, Gastroenterology and Hepatology

Model Details: Participants will be grouped into intervention and control groups based on alternating weeks/months when they obtain their FIT throughout the study. These timelines will be designated before the initiation of the study with appropriate frequency of alternation to reduce variability between non-study conditions between the weeks/months.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: September 19, 2025
• Study Start: October 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)