Educational Intervention With or Without Telephone Counseling in Increasing Colorectal Cancer Screening Compliance in Brothers and Sisters of Patients With Colorectal Cancer
NCT ID: NCT00352638
Last Updated: 2014-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
660 participants
INTERVENTIONAL
2005-08-31
2013-11-30
Brief Summary
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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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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
Interventions
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counseling intervention
educational intervention
study of socioeconomic and demographic variables
Eligibility Criteria
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Inclusion Criteria
* 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
40 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Fox Chase Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sharon Manne, PhD
Role: PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center
Locations
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Helen F. Graham Cancer Center at Christiana Care
Newark, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center CCOP Research Base
Tampa, Florida, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
Harrisburg, Pennsylvania, United States
St. Mary Regional Cancer Center
Langhorne, Pennsylvania, United States
Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center CCOP Research Base
Philadelphia, Pennsylvania, United States
Pottstown Memorial Regional Cancer Center
Pottstown, 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
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Countries
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Other Identifiers
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CDR0000485294
Identifier Type: REGISTRY
Identifier Source: secondary_id
FCCC-00-841
Identifier Type: -
Identifier Source: secondary_id
FCCC-FCRB-04-004-P
Identifier Type: -
Identifier Source: org_study_id
NCT00491205
Identifier Type: -
Identifier Source: nct_alias
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