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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00352638
First received: July 13, 2006
Last updated: July 9, 2009
Last verified: May 2007

July 13, 2006
July 9, 2009
August 2005
March 2009   (final data collection date for primary outcome measure)
Colorectal cancer screening compliance [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00352638 on ClinicalTrials.gov Archive Site
  • Impact on movement in stage of adoption [ Designated as safety issue: No ]
  • Increased knowledge and attitudes [ Designated as safety issue: No ]
  • Cost [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Educational Intervention With or Without Telephone Counseling in Increasing Colorectal Cancer Screening Compliance in Brothers and Sisters of Patients With Colorectal Cancer
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.

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.

Interventional
Phase 3
Allocation: Randomized
Colorectal Cancer
  • Other: counseling intervention
  • Other: educational intervention
  • Other: study of socioeconomic and demographic variables
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
660
Not Provided
March 2009   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00352638
CDR0000485294, FCCC-FCRB-04-004-P, FCCC-00-841
Not Provided
Not Provided
Fox Chase Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Sharon Manne, PhD Fox Chase Cancer Center
National Cancer Institute (NCI)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP