NCT Number: NCT00352638
Educational Intervention With or Without Telephone Counseling in Increasing Colorectal Cancer Screening Compliance in Brothers and Sisters of Patients With Colorectal Cancer
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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Notify MeKey information
Conditions
Age range
40 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Helen F. Graham Cancer Center at Christiana Care, Newark, Delaware, United States
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Educational Intervention
Otherstudy of socioeconomic and demographic variables
OtherPrimary outcomes
-
Colorectal cancer screening compliance
Secondary outcomes
-
Impact on movement in stage of adoption
-
Increased knowledge and attitudes
-
Cost
Sponsors and collaborators
Lead sponsor
Fox Chase Cancer Center
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients
Important dates
- Study start
- 2005
- Primary completion
- 2012
- Study completion
- 2013
- First posted
- Jul 14, 2006
- Registry last updated
- May 16, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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