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.

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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.

View Eligibility Criteria

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

Study is for people with:

Colon Cancer

Phase:

Phase 3

Estimated Enrollment:

660

Study ID:

NCT00352638

Recruitment Status:

Completed

Sponsor:

Fox Chase Cancer Center

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There are 18 Locations for this study

See Locations Near You

Helen F. Graham Cancer Center at Christiana Care
Newark Delaware, 19713, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington District of Columbia, 20007, United States
H. Lee Moffitt Cancer Center CCOP Research Base
Tampa Florida, 33612, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington New Jersey, 08822, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton New Jersey, 08053, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick New Jersey, 08903, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland New Jersey, 08360, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
Harrisburg Pennsylvania, 17105, United States
St. Mary Regional Cancer Center
Langhorne Pennsylvania, 19047, United States
Presbyterian Medical Center
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia Pennsylvania, 19111, United States
Fox Chase Cancer Center CCOP Research Base
Philadelphia Pennsylvania, 19140, United States
Pottstown Memorial Regional Cancer Center
Pottstown Pennsylvania, 19464, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading Pennsylvania, 19612, United States
Northeast Regional Cancer Institute
Scranton Pennsylvania, 18510, United States
M.D. Anderson Cancer Center at University of Texas
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 3

Estimated Enrollment:

660

Study ID:

NCT00352638

Recruitment Status:

Completed

Sponsor:


Fox Chase Cancer Center

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