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Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients
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.
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.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Helen F. Graham Cancer Center at Christiana Care
Newark, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center CCOP Research Base
Tampa, Florida, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
Harrisburg, Pennsylvania, United States
Start Date
August 1, 2005
Primary Completion Date
February 1, 2012
Completion Date
November 1, 2013
Last Updated
May 16, 2014
660
ESTIMATED participants
counseling intervention
OTHER
educational intervention
OTHER
study of socioeconomic and demographic variables
OTHER
Lead Sponsor
Fox Chase Cancer Center
Collaborators
NCT06696768
NCT04704661
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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