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

Colorectal Cancer Clinical Trial

Official title:

Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352638
• Other study ID #: FCCC-FCRB-04-004-P
• Secondary ID: CDR0000485294FCC
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2006
• Last updated: May 15, 2014
• Start date: August 2005
• Est. completion date: November 2013

Study information

• Verified date: May 2014
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00491205

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: November 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• counseling intervention

• educational intervention

• study of socioeconomic and demographic variables

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Hunterdon Regional Cancer Center at Hunterdon Medical Center	Flemington	New Jersey
United States	PinnacleHealth Regional Cancer Center at Polyclinic Hospital	Harrisburg	Pennsylvania
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	St. Mary Regional Cancer Center	Langhorne	Pennsylvania
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	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Helen F. Graham Cancer Center at Christiana Care	Newark	Delaware
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center CCOP Research Base	Philadelphia	Pennsylvania
United States	Presbyterian Medical Center	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	H. Lee Moffitt Cancer Center CCOP Research Base	Tampa	Florida
United States	Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare	Vineland	New Jersey
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colorectal cancer screening compliance			No
Secondary	Impact on movement in stage of adoption			No
Secondary	Increased knowledge and attitudes			No
Secondary	Cost			No