Personalized Screening Plans to Increase Colorectal Cancer Screening in Healthy Participants

Phase 3

• Conditions: Colorectal Cancer

• Registration Number: NCT00617071
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-14
• Study First Posted: 2008-02-15
• Status Verified: 2009-07
• Primary Completion: 2010-12
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Screening utilization over the 6-month observation period

Secondary Outcome Measures

Name	Time	Method
Screening preference
Perceived salience and coherence and self-efficacy related to colorectal cancer (CRC) screening
Number and length of contacts with each participant and the type of communication during those contacts
Identification of predictors of CRC screening use and screening preference

Trial Locations

Locations (1)

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States