Colorectal Cancer Clinical Trial
Official title:
Tailored Navigation in CRC Screening
RATIONALE: Developing a personalized screening plan may be more effective than usual care in
increasing the number of healthy participants who regularly undergo screening for colorectal
cancer.
PURPOSE: This randomized phase III trial is studying personalized screening plans to see how
well they work compared with usual care in increasing colorectal cancer screening in healthy
participants.
OBJECTIVES:
- To compare the impact of tailored intervention vs standard intervention vs usual care
on patient utilization of colorectal cancer (CRC) screening.
- To compare the impact of these interventions on CRC screening preference.
- To compare the impact of these interventions on patient perceptions about CRC
screening.
OUTLINE: This is a multicenter study. Participants are stratified by practice and study wave
and blocking. Participants are randomized to 1 of 3 arms.
- Arm I (usual care): Participants receive usual care in accordance with their normal
patterns of interaction with study practices.
- Arm II (standard intervention [SI]): A generic screening invitation letter, a
colorectal cancer (CRC) screening informational booklet, stool blood testing (SBT)
cards, and instructions for arranging a colonoscopy screening appointment are mailed to
participants on day 15. On day 45, a reminder letter is mailed to participants who have
not completed SBT or undergone a screening colonoscopy.
- Arm III (tailored navigation intervention [TNI]): A test-specific screening invitation
letter, a CRC screening informational booklet, and additional test-specific materials
(i.e., instructions for arranging a colonoscopy screening appointment or SBT cards) are
mailed to participants on day 15. On day 30, a patient navigator contacts participants
by telephone who have not completed SBT or undergone a screening colonoscopy. The
patient navigator re-assesses screening test-specific decision stage; addresses CRC
screening barriers; develops a personalized CRC screening plan to move the participant
towards screening use (i.e., explains the steps in completing the SBT or scheduling a
colonoscopy appointment); and facilitates screening plan implementation. On day 45, a
reminder letter is mailed to participants who were contacted by the navigator.
Participants in all arms complete a survey at baseline and then at 6 months. Medical records
for each participant are reviewed at 6 months.
;
Allocation: Randomized, Masking: Single Blind, Primary Purpose: Health Services Research
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