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Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients

Phase 3
40 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients


- 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.


- 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.

Inclusion Criteria


- 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)


- Age 40 and over OR within 10 years of proband's (patient's) age at diagnosis

- English speaking


- 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

Type of Study:


Study Design:

Allocation: Randomized

Outcome Measure:

Colorectal cancer screening compliance

Safety Issue:


Principal Investigator

Sharon Manne, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 2005

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • colon cancer
  • rectal cancer
  • Colorectal Neoplasms



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Hunterdon Regional Cancer Center at Hunterdon Medical CenterFlemington, New Jersey  08822
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
St. Mary Regional Cancer CenterLanghorne, Pennsylvania  19047
Pottstown Memorial Regional Cancer CenterPottstown, Pennsylvania  19464
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Fox Chase Cancer Center CCOP Research BasePhiladelphia, Pennsylvania  19140
PinnacleHealth Regional Cancer Center at Polyclinic HospitalHarrisburg, Pennsylvania  17105
Franklin & Edith Scarpa Regional Cancer Center at South Jersey HealthcareVineland, New Jersey  08360
H. Lee Moffitt Cancer Center CCOP Research BaseTampa, Florida  33612
Helen F. Graham Cancer Center at Christiana CareNewark, Delaware  19713
Presbyterian Medical CenterPhiladelphia, Pennsylvania  19104
Northeast Regional Cancer InstituteScranton, Pennsylvania  18510