Implementation Intention Planning Guide for FIT Colon Cancer Screening
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorDartmouth-Hitchcock Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
none
Trial design
Design model
Parallel
Treatments tested in this trial
Implementation Intention Guide
BehavioralThe 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.
Treatment groups
1,600 Participants
are divided into 2 treatment groupsGroup A: Control Arm (FIT Standard of Care)No intervention 0 interventions
Group B: Intervention Arm (FIT Standard of Care with Implementation Intention Guide)Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Through study completion, approximately 12-18 monthsSecondary outcomes
1
Duration between FIT collection date and receipt by the laboratory
Number of days from the participant FIT collection date (as reported by the participant on the FIT collection bottle) to the date the lab received the participant's FIT.
Time frame
Through study completion, approximately 12-18 months2
Rate of lab sample rejection
Percentage of FIT samples rejected from the lab to not be appropriate for further evaluation (e.g., incorrect sampling/storage, expired test)
Time frame
Through study completion, approximately 12-18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dartmouth-Hitchcock Medical Center
Lead sponsor
White River Junction Veterans Affairs Medical Center
Collaborator
Source ClinicalTrials.gov
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