Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Fox Chase Cancer Center
- Enrollment
- 660
- Locations
- 18
- Primary Endpoint
- Colorectal cancer screening compliance
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Colorectal cancer screening compliance
Secondary Outcomes
- Impact on movement in stage of adoption
- Increased knowledge and attitudes
- Cost