Colorectal Cancer
Conditions
Keywords
colon cancer, rectal cancer
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.
Interventions
OTHERcounseling intervention
OTHEReducational intervention
OTHERstudy of socioeconomic and demographic variables
Sponsors
National Cancer Institute (NCI)
Fox Chase Cancer Center
Study design
Allocation
RANDOMIZED
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colorectal cancer screening compliance | — |
Secondary
| Measure | Time frame |
|---|---|
| Impact on movement in stage of adoption | — |
| Increased knowledge and attitudes | — |
| Cost | — |
Countries
United States
Outcome results
None listed