NCT00352638

Educational Intervention With or Without Telephone Counseling in Increasing Colorectal Cancer Screening Compliance in Brothers and Sisters of Patients With Colorectal Cancer

Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 660 (estimated)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

RATIONALE: Printed educational materials and counseling by telephone may improve colorectal cancer screening compliance in brothers and sisters of patients with colorectal cancer. PURPOSE: This randomized phase III trial is studying standard or personalized printed educational materials with or without telephone counseling to compare how well they work in increasing colorectal cancer screening compliance in brothers and sisters of patients with colorectal cancer.

Detailed description

OBJECTIVES: * Compare the impact of 3 interventions (generic educational print intervention, tailored educational print intervention, or tailored educational print intervention plus telephone counseling) on colorectal cancer screening behaviors and intentions among siblings at increased familial risk for colorectal cancer. Secondary * Determine whether demographic factors, medical access, physician recommendation at baseline, and proband (patient) characteristics (e.g., stage of disease) moderate the impact of the interventions on colorectal screening. * Evaluate whether knowledge, attitude, and physician recommendation variables mediate the association between the interventions and colorectal screening, and determine whether these variables are impacted by the interventions. * Analyze the cost of each intervention. OUTLINE: This is a randomized, controlled, cohort, multicenter study. Participants are stratified according to study site. Participants are randomized to 1 of 3 intervention arms. * Arm I: Participants receive generic educational print intervention approximately 1 week after completing the baseline survey. * Arm II: Participants receive tailored educational print intervention within 10 days after completing the baseline survey and a tailored newsletter 1 month after completing the baseline survey. * Arm III: Participants receive tailored educational print intervention approximately 14-18 days after completing the baseline survey. Participants undergo a telephone counseling session within 2 weeks after receiving the tailored print intervention and receive a tailored newsletter 1 month after completing the baseline survey. After study completion, participants are followed at 6 months and/or 1 year. PROJECTED ACCRUAL: A total of 660 participants will be accrued for this study.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	counseling intervention
OTHER	educational intervention
OTHER	study of socioeconomic and demographic variables

Timeline

• Start date: 2005-08-01
• Primary completion: 2012-02-01
• Completion: 2013-11-01
• First posted: 2006-07-14
• Last updated: 2014-05-16

Locations

18 sites across 1 country: United States