Educational Intervention With or Without Telephone Counseling in Increasing Colorectal Cancer Screening Compliance in Brothers and Sisters of Patients With Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00352638|
Recruitment Status : Completed
First Posted : July 14, 2006
Last Update Posted : May 16, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Other: counseling intervention Other: educational intervention Other: study of socioeconomic and demographic variables||Phase 3|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||660 participants|
|Official Title:||Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||November 2013|
- Colorectal cancer screening compliance
- Impact on movement in stage of adoption
- Increased knowledge and attitudes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352638
|Principal Investigator:||Sharon Manne, PhD||Fox Chase Cancer Center|