Philadelphia, Pennsylvania 19107


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Meets the following criteria: - No personal history of colorectal neoplasia (cancer or polyps) or inflammatory bowel disease - No family history of colorectal cancer (CRC) diagnosed before the age of 60 - Visited one of the six community-based primary care practices that are part of the Christiana Care Health System (CCHS) in Delaware within the past 2 years - Not up-to-date with CRC screening, according to the United States Preventive Services Task Force guidelines PATIENT CHARACTERISTICS: - Must have a complete address and telephone number - Able to communicate in English - No psychosis or severe dementia PRIOR CONCURRENT THERAPY: - No prior participation in the developmental study CA10241


NCT ID:

NCT00617071


Primary Contact:

Study Chair
Ronald Myers, PhD
Jefferson Medical College of Thomas Jefferson University


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19107
United States

Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer
Phone: 215-955-6084

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 22, 2018

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