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Educational Intervention With or Without Telephone Counseling in Increasing Colorectal Cancer Screening Compliance in Brothers and Sisters of Patients With Colorectal Cancer

Phase 3
Completed
Conditions
Colorectal Cancer
Registration Number
NCT00352638
Lead Sponsor
Fox Chase Cancer Center
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
660
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Colorectal cancer screening compliance
Secondary Outcome Measures
NameTimeMethod
Impact on movement in stage of adoption
Increased knowledge and attitudes
Cost

Trial Locations

Locations (18)

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

🇺🇸

Washington, District of Columbia, United States

Helen F. Graham Cancer Center at Christiana Care

🇺🇸

Newark, Delaware, United States

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

🇺🇸

Marlton, New Jersey, United States

St. Mary Regional Cancer Center

🇺🇸

Langhorne, Pennsylvania, United States

Presbyterian Medical Center

🇺🇸

Philadelphia, Pennsylvania, United States

Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare

🇺🇸

Vineland, New Jersey, United States

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

🇺🇸

New Brunswick, New Jersey, United States

H. Lee Moffitt Cancer Center CCOP Research Base

🇺🇸

Tampa, Florida, United States

Hunterdon Regional Cancer Center at Hunterdon Medical Center

🇺🇸

Flemington, New Jersey, United States

Memorial Sloan-Kettering Cancer Center

🇺🇸

New York, New York, United States

Pottstown Memorial Regional Cancer Center

🇺🇸

Pottstown, Pennsylvania, United States

Fox Chase Cancer Center - Philadelphia

🇺🇸

Philadelphia, Pennsylvania, United States

M.D. Anderson Cancer Center at University of Texas

🇺🇸

Houston, Texas, United States

Massachusetts General Hospital Cancer Center

🇺🇸

Boston, Massachusetts, United States

Fox Chase Cancer Center CCOP Research Base

🇺🇸

Philadelphia, Pennsylvania, United States

PinnacleHealth Regional Cancer Center at Polyclinic Hospital

🇺🇸

Harrisburg, Pennsylvania, United States

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

🇺🇸

Reading, Pennsylvania, United States

Northeast Regional Cancer Institute

🇺🇸

Scranton, Pennsylvania, United States

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