Educational Intervention With or Without Telephone Counseling in Increasing Colorectal Cancer Screening Compliance in Brothers and Sisters of Patients With Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|United States, Delaware|
|Helen F. Graham Cancer Center at Christiana Care|
|Newark, Delaware, United States, 19713|
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|United States, Florida|
|H. Lee Moffitt Cancer Center CCOP Research Base|
|Tampa, Florida, United States, 33612|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|United States, New Jersey|
|Hunterdon Regional Cancer Center at Hunterdon Medical Center|
|Flemington, New Jersey, United States, 08822|
|Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton|
|Marlton, New Jersey, United States, 08053|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08903|
|Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare|
|Vineland, New Jersey, United States, 08360|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Pennsylvania|
|PinnacleHealth Regional Cancer Center at Polyclinic Hospital|
|Harrisburg, Pennsylvania, United States, 17105-8700|
|St. Mary Regional Cancer Center|
|Langhorne, Pennsylvania, United States, 19047|
|Presbyterian Medical Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Fox Chase Cancer Center - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Fox Chase Cancer Center CCOP Research Base|
|Philadelphia, Pennsylvania, United States, 19140|
|Pottstown Memorial Regional Cancer Center|
|Pottstown, Pennsylvania, United States, 19464|
|McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center|
|Reading, Pennsylvania, United States, 19612-6052|
|Northeast Regional Cancer Institute|
|Scranton, Pennsylvania, United States, 18510|
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Principal Investigator:||Sharon Manne, PhD||Fox Chase Cancer Center|