Colon Cancer Clinical Trial
Educational Intervention With or Without Telephone Counseling in Increasing Colorectal Cancer Screening Compliance in Brothers and Sisters of Patients With Colorectal Cancer
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.
Full 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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Sibling of a patient diagnosed with adenocarcinoma of the colon or rectum
Patient (proband) must meet the following criteria:
Diagnosed in 1999 or later
Currently living
Seen in Community Clinical Oncology Program member hospital
60 and under at diagnosis
No history of hereditary cancer syndrome (e.g., familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer) (patient and sibling)
No history of colorectal cancer or colorectal polyps (sibling)
No history of inflammatory bowel disease (patient and sibling)
PATIENT CHARACTERISTICS:
Age 40 and over OR within 10 years of proband's (patient's) age at diagnosis
English speaking
PRIOR CONCURRENT THERAPY:
No prior colorectal cancer screening
May have undergone prior screening provided they have not followed, or do not plan to follow, physician's recommendation for screening
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There are 18 Locations for this study
Newark Delaware, 19713, United States
Washington District of Columbia, 20007, United States
Tampa Florida, 33612, United States
Boston Massachusetts, 02114, United States
Flemington New Jersey, 08822, United States
Marlton New Jersey, 08053, United States
New Brunswick New Jersey, 08903, United States
Vineland New Jersey, 08360, United States
New York New York, 10021, United States
Harrisburg Pennsylvania, 17105, United States
Langhorne Pennsylvania, 19047, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19140, United States
Pottstown Pennsylvania, 19464, United States
Reading Pennsylvania, 19612, United States
Scranton Pennsylvania, 18510, United States
Houston Texas, 77030, United States
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