Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00352638
Recruitment Status : Completed
First Posted : July 14, 2006
Last Update Posted : May 16, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: counseling intervention Other: educational intervention Other: study of socioeconomic and demographic variables Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Official Title: Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients
Study Start Date : August 2005
Actual Primary Completion Date : February 2012
Actual Study Completion Date : November 2013



Primary Outcome Measures :
  1. Colorectal cancer screening compliance

Secondary Outcome Measures :
  1. Impact on movement in stage of adoption
  2. Increased knowledge and attitudes
  3. Cost


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352638


Locations
Show Show 18 study locations
Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Sharon Manne, PhD Fox Chase Cancer Center

Layout table for additonal information
Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00352638    
Obsolete Identifiers: NCT00491205
Other Study ID Numbers: FCCC-FCRB-04-004-P
CDR0000485294 ( Registry Identifier: PDQ (Physician Data Query) )
FCCC-00-841
First Posted: July 14, 2006    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014
Keywords provided by Fox Chase Cancer Center:
colon cancer
rectal cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases