Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients
NCT ID: NCT00582829
Last Updated: 2008-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
213 participants
OBSERVATIONAL
2003-06-30
2008-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
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.
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.
2
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 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.
3
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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)
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Fox Chase Cancer Center
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
Lombardi Comprehensive Cancer Center
OTHER
Micromass Communications, Cary, NC
UNKNOWN
University of Pennsylvania
OTHER
Christiana Care Health Services
OTHER
Pinnacle Health Regional Cancer Center, Harrisburg, PA
UNKNOWN
Temple University
OTHER
St. Mary Regional Cancer Center, Langhorne, PA
UNKNOWN
South Jersey Regional Cancer Center, Bridgton, New Jersey
UNKNOWN
Hunterdon Cancer Center
UNKNOWN
Northeast Regional Cancer Institute
OTHER
Virtua Memorial Hospital and Virtua West
UNKNOWN
Jersey Hospital
UNKNOWN
Rutgers Cancer Institute of New Jersey
OTHER
Massachusetts General Hospital
OTHER
Main Line Health
OTHER
Roswell Park Cancer Institute
OTHER
HematologyOncology
UNKNOWN
Associates of Central New York
UNKNOWN
Augusta University
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Memorial Sloan Kettering Cancer Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arnold Markowitz, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
03-043
Identifier Type: -
Identifier Source: org_study_id