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

Sponsors and Collaborators:	Fox Chase Cancer Center CCOP Research Base National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00352638

Purpose

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	Intervention	Phase
Colorectal Cancer	Other: counseling intervention Other: educational intervention Other: study of socioeconomic and demographic variables	Phase III

Study Type:	Interventional
Study Design:	Randomized, Active Control
Official Title:	Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Colorectal cancer screening compliance [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	660
Study Start Date:	August 2005
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352638

Locations

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

Sponsors and Collaborators

Fox Chase Cancer Center CCOP Research Base

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Sharon Manne, PhD

Fox Chase Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000485294, FCCC-FCRB-04-004-P, FCCC-00-841
Study First Received:	July 13, 2006
Last Updated:	July 9, 2009
ClinicalTrials.gov Identifier:	NCT00352638 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

colon cancer
rectal cancer

Study placed in the following topic categories:

Rectal Cancer
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Colonic Diseases

Rectal Neoplasm
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 03, 2009