Implementation Intention Planning Guide for FIT Colon Cancer Screening

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT07183046
Status
Not Yet Recruiting

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Conditions

  • Colorectal Cancer Screening
  • Fecal Immunochemical Test

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Jul 2025
Primary completion
Mar 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
1,600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • No Intervention: Control Arm (FIT Standard of Care)
    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.
  • Experimental: Intervention Arm (FIT Standard of Care with Implementation Intention Guide)
    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.

Primary Outcome Measure

FIT completion rate [ Time Frame: Through study completion, approximately 12-18 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Dartmouth Hitchcock Clinics, Heater Road Primary CareLebanonNew Hampshire03766
Audrey H Calderwood, MD, MS
[email protected]
Dartmouth-Hitchcock Medical Center, General Internal Medicine ClinicLebanonNew Hampshire03766
Audrey H Calderwood, MD, MS
[email protected]
Dartmouth Hitchcock Clinics, Lyme Primary Care ClinicLymeNew Hampshire03768
Audrey H Calderwood, MD, MS
[email protected]
White River Junction Veterans Affairs Medical Center, Primary Care ClinicWhite River JunctionVermont05009
Douglas Robertson, MD, MPH
[email protected]
White River Junction Veterans Affairs Medical Center, VA Mailed FIT ProgramWhite River JunctionVermont05009
Douglas Robertson, MD, MPH
[email protected]

Find similar trials in Lebanon, NH

By research site
Dartmouth Hitchcock Clinics, Heater Road Primary Care· Lebanon, NHDartmouth-Hitchcock Medical Center, General Internal Medicine Clinic· Lebanon, NHDartmouth Hitchcock Clinics, Lyme Primary Care Clinic· Lyme, NHWhite River Junction Veterans Affairs Medical Center, Primary Care Clinic· White River Junction, VTWhite River Junction Veterans Affairs Medical Center, VA Mailed FIT Program· White River Junction, VT

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