Clinical trial NCT00582829: Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients
Official title: Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal
Cancer
Screening
Intervention
Keywords: Colorectal
Cancer
Screening
Intervention
Family
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Fox Chase Cancer Center
name: Icahn School of Medicine at Mount Sinai
name: Lombardi Comprehensive Cancer Center
name: Micromass Communications, Cary, NC
name: University of Pennsylvania
name: Christiana Care Health Services
name: Pinnacle Health Regional Cancer Center, Harrisburg, PA
name: Temple University
name: St. Mary Regional Cancer Center, Langhorne, PA
name: South Jersey Regional Cancer Center, Bridgton, New Jersey
name: Hunterdon Cancer Center
name: Northeast Regional Cancer Institute
name: Virtua Memorial Hospital and Virtua West
name: Jersey Hospital
name: Rutgers Cancer Institute of New Jersey
name: Massachusetts General Hospital
name: Main Line Health
name: Roswell Park Cancer Institute
name: HematologyOncology
name: Associates of Central New York
name: Augusta University
First posted: 2007-12-28
Enrollment: 213
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: This proposed study will use previous study results to guide the development and evaluation of interventions to improve CRC screening acceptance. The proposed study will evaluate the impact of three interventions to promote CRC screening among siblings in this increased-risk group, who are not currently compliant with CRC screening guidelines: 1) a generic print intervention; 2) a tailored print intervention, and; 3) a tailored print plus tailored telephone counseling intervention.

Detailed description: First-degree relatives of individuals with CRC are at increased-risk of developing colorectal cancer (CRC). For these increased-risk individuals current guidelines recommend initiating CRC screening a decade earlier than for those at average-risk for CRC; thus, starting at age 40, or 10 years younger than the age at which the affected relative was diagnosed with CRC. In our prior study of 504 at-risk siblings of patients with a history of CRC, diagnosed at age less than 56, we found that approximately 44% of these siblings were not compliant with CRC screening guidelines. Guided by the Transtheoretical, Health Belief and Dual Process models, our prior study identified key attitudinal and non-attitudinal predictors of screening behaviors and intentions.

This proposed study will use these results to guide the development and evaluation of interventions to improve CRC screening acceptance. The proposed study will evaluate the impact of three interventions to promote CRC screening among siblings in this increased-risk group, who are not currently compliant with CRC screening guidelines: 1) a generic print intervention; 2) a tailored print intervention, and; 3) a tailored print plus tailored telephone counseling intervention.

Siblings in the generic print condition will receive a pamphlet about colorectal cancer screening published by the Center for Disease Control. Siblings in the tailored print and telephone counseling conditions will receive messages tailored specifically to their responses on targeted attitudinal and non-attitudinal measures. Five hundred twenty four siblings meeting eligibility criteria will be randomly assigned to one of the three conditions after a baseline interview assessing CRC screening behaviors and attitudes, and it is anticipated that 427 siblings will complete the study. For siblings in the tailored conditions, baseline information will be utilized to design the tailored messages. After receiving the intervention information, participants will be interviewed again six months later regarding CRC screening behaviors and attitudes to assess the impact of the intervention.

Eligibility criteria: Inclusion Criteria:

* How old is the participant? (≥ 18 years)
* Is the participant either:
* currently age 40 or above (YES) OR
* within 10 years of the age at which the patient/proband was initially diagnosed with CRC (whichever is the younger age) (YES)
* Is the participant a full or half biological sibling of the patient/proband? (YES)

Exclusion Criteria:

* Is the participant currently not compliant with standard CRC screening guidelines? (NO)
* Is the participant English speaking? (YES)
* Does the participant have a primary language other than English? (NO)
* Does the participant have a history of Inflammatory Bowel Disease? (NO)
* Does the participant have a history of colorectal cancer of colorectal polyp? (NO)
* Does the participant have a history of hereditary colorectal cancer syndrome? (Familial Adenomatous Polyposis or Hereditary Nonpolyposis Colorectal Cancer) (NO)

Primary outcomes:
measure: Phone follow-up interview. Participants will be contacted by study assistant and the survey administered.
timeFrame: 6 months after baseling
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Arnold Markowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: