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

Temple University Health System (TUHS)

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Other: counseling intervention; Other: educational intervention; Other: study of socioeconomic and demographic variables

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00352638

FCCC-00-841

CDR0000485294 (Registry Identifier)

FCCC-FCRB-04-004-P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 660 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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