Personalized Screening Plans to Increase Colorectal Cancer Screening in Healthy Participants
|ClinicalTrials.gov Identifier: NCT00617071|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : February 15, 2008
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Other: medical chart review Other: survey administration Procedure: fecal occult blood test Procedure: screening colonoscopy||Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Primary Purpose:||Health Services Research|
|Official Title:||Tailored Navigation in CRC Screening|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||December 2010|
- Screening utilization over the 6-month observation period
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617071
|United States, Pennsylvania|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107-5541|
|Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer 215-955-6084|
|Study Chair:||Ronald Myers, PhD||Jefferson Medical College of Thomas Jefferson University|