Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients

Cancer Clinical Trial

Official title:

Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582829
• Other study ID #: 03-043
• Status: Completed
• Phase: Phase 0
• First received: December 21, 2007
• Last updated: November 6, 2008
• Start date: June 2003
• Est. completion date: May 2008

Study information

• Verified date: November 2008
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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)

Study Design

N/A

Related Conditions & MeSH terms

• Cancer
• Colorectal
• Colorectal Neoplasms
• Intervention
• Screening

Intervention

Other:
• Generic Print Intervention
Generic Print Intervention: The generic print intervention will consist of the pamphlet, "Colorectal Cancer Screening Saves Lives" published by the Center for Disease Control that will be mailed to the participant.
• Tailored Print Intervention
Tailored Print Intervention: The tailored print intervention will consist of a cover letter detailing the participant's stage of readiness along with a color pamphlet with information personally tailored for the individual participant.
• Tailored print plus tailored phone intervention
Tailored print plus tailored phone intervention: The tailored print plus tailored telephone intervention will consist of a phone counseling session and the tailored print information described above. The tailored print material will serve as a guide during the telephone counseling contact and a reinforcement of the information.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (23)

Lead Sponsor

Collaborator

Memorial Sloan Kettering Cancer Center

Associates of Central New York, Christiana Care Health Services, Fox Chase Cancer Center, Georgia Regents University, HematologyOncology, Hunterdon Cancer Center, Icahn School of Medicine at Mount Sinai, Jersey Hospital, Lombardi Cancer Research Center, Main Line Health, Massachusetts General Hospital, Micromass Communications, Cary, NC, National Cancer Institute (NCI), Northeast Regional Cancer Institute, Pinnacle Health Regional Cancer Center, Harrisburg, PA, Roswell Park Cancer Institute, Rutgers Cancer Institute of New Jersey, South Jersey Regional Cancer Center, Bridgton, New Jersey, St. Mary Regional Cancer Center, Langhorne, PA, Temple University, University of Pennsylvania, Virtua Memorial Hospital and Virtua West

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phone follow-up interview. Participants will be contacted by study assistant and the survey administered.		6 months after baseling	No