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

May 15, 2014 updated by: Fox Chase Cancer Center

Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

660

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • Helen F. Graham Cancer Center at Christiana Care
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center CCOP Research Base
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Hunterdon Regional Cancer Center at Hunterdon Medical Center
      • Marlton, New Jersey, United States, 08053
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
      • New Brunswick, New Jersey, United States, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • Vineland, New Jersey, United States, 08360
        • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17105-8700
        • PinnacleHealth Regional Cancer Center at Polyclinic Hospital
      • Langhorne, Pennsylvania, United States, 19047
        • St. Mary Regional Cancer Center
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104
        • Presbyterian Medical Center
      • Philadelphia, Pennsylvania, United States, 19140
        • Fox Chase Cancer Center CCOP Research Base
      • Pottstown, Pennsylvania, United States, 19464
        • Pottstown Memorial Regional Cancer Center
      • Reading, Pennsylvania, United States, 19612-6052
        • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
      • Scranton, Pennsylvania, United States, 18510
        • Northeast Regional Cancer Institute
    • Texas
      • Houston, Texas, United States, 77030-4009
        • M.D. Anderson Cancer Center at University of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Colorectal cancer screening compliance

Secondary Outcome Measures

Outcome Measure
Cost
Impact on movement in stage of adoption
Increased knowledge and attitudes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fox Chase Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

July 13, 2006

First Submitted That Met QC Criteria

July 13, 2006

First Posted (Estimate)

July 14, 2006

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 15, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCCC-FCRB-04-004-P
  • CDR0000485294 (Registry Identifier: PDQ (Physician Data Query))
  • FCCC-00-841

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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