Clinical trial NCT00352638: Educational Intervention With or Without Telephone Counseling in Increasing Colorectal Cancer Screening Compliance in Brothers and Sisters of Patients With Colorectal Cancer
Official title: Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: colon cancer
rectal cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-07-14
Enrollment: 660
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED

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.

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 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

Primary outcomes:
measure: Colorectal cancer screening compliance
Secondary outcomes:
measure: Impact on movement in stage of adoption
measure: Increased knowledge and attitudes
measure: Cost
Other outcomes:
Locations:
city: Newark
country: United States
facility: Helen F. Graham Cancer Center at Christiana Care
state: Delaware
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
state: District of Columbia
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center CCOP Research Base
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Flemington
country: United States
facility: Hunterdon Regional Cancer Center at Hunterdon Medical Center
state: New Jersey
city: Marlton
country: United States
facility: Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
city: Vineland
country: United States
facility: Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Harrisburg
country: United States
facility: PinnacleHealth Regional Cancer Center at Polyclinic Hospital
state: Pennsylvania
city: Langhorne
country: United States
facility: St. Mary Regional Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center CCOP Research Base
state: Pennsylvania
city: Pottstown
country: United States
facility: Pottstown Memorial Regional Cancer Center
state: Pennsylvania
city: Reading
country: United States
facility: McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
state: Pennsylvania
city: Scranton
country: United States
facility: Northeast Regional Cancer Institute
state: Pennsylvania
city: Houston
country: United States
facility: M.D. Anderson Cancer Center at University of Texas
state: Texas
Study officials:
affiliation: Fox Chase Cancer Center
name: Sharon Manne, PhD
role: PRINCIPAL_INVESTIGATOR
References: