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:
Fox Chase Cancer Center
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
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized |
| Official Title: | Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients |
Resource links provided by NLM:
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) |
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 | |
| Hunterdon Regional Cancer Center at Hunterdon Medical Center | |
| Flemington, New Jersey, United States, 08822 | |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | |
| Marlton, New Jersey, United States, 08053 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | |
| Vineland, New Jersey, United States, 08360 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| United States, Pennsylvania | |
| PinnacleHealth Regional Cancer Center at Polyclinic Hospital | |
| Harrisburg, Pennsylvania, United States, 17105-8700 | |
| St. Mary Regional Cancer Center | |
| Langhorne, Pennsylvania, United States, 19047 | |
| Fox Chase Cancer Center CCOP Research Base | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Fox Chase Cancer Center - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Presbyterian Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Pottstown Memorial Regional Cancer Center | |
| Pottstown, Pennsylvania, United States, 19464 | |
| 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 | |
| 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
Investigators
| Principal Investigator: | Sharon Manne, PhD | Fox Chase Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00352638 History of Changes |
| Obsolete Identifiers: | NCT00491205 |
| Other Study ID Numbers: | CDR0000485294, FCCC-FCRB-04-004-P, FCCC-00-841 |
| Study First Received: | July 13, 2006 |
| Last Updated: | July 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
colon cancer rectal cancer |
Additional relevant 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 |
ClinicalTrials.gov processed this record on May 22, 2013