Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients

This study has been completed.
Sponsor:
Collaborators:
Fox Chase Cancer Center
Mount Sinai School of Medicine
Lombardi Cancer Research Center
Micromass Communications, Cary, NC
University of Pennsylvania
Christiana Care Health Services
Pinnacle Health Regional Cancer Center, Harrisburg, PA
Temple University
St. Mary Regional Cancer Center, Langhorne, PA
South Jersey Regional Cancer Center, Bridgton, New Jersey
Hunterdon Cancer Center
Northeast Regional Cancer Institute
Virtua Memorial Hospital and Virtua West
Jersey Hospital
Rutgers Cancer Institute of New Jersey
Massachusetts General Hospital
Main Line Health
Roswell Park Cancer Institute
HematologyOncology
Associates of Central New York
Georgia Regents University
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582829
First received: December 21, 2007
Last updated: November 6, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Colorectal
Cancer
Screening
Intervention
Other: Generic Print Intervention
Other: Tailored Print Intervention
Other: Tailored print plus tailored phone intervention
Phase 0

Study Type: Observational
Official Title: Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Phone follow-up interview. Participants will be contacted by study assistant and the survey administered. [ Time Frame: 6 months after baseling ] [ Designated as safety issue: No ]

Estimated Enrollment: 213
Study Start Date: June 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.
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.
Other: 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.
Other: 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.

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582829

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Fox Chase Cancer Center
Mount Sinai School of Medicine
Lombardi Cancer Research Center
Micromass Communications, Cary, NC
University of Pennsylvania
Christiana Care Health Services
Pinnacle Health Regional Cancer Center, Harrisburg, PA
Temple University
St. Mary Regional Cancer Center, Langhorne, PA
South Jersey Regional Cancer Center, Bridgton, New Jersey
Hunterdon Cancer Center
Northeast Regional Cancer Institute
Virtua Memorial Hospital and Virtua West
Jersey Hospital
Rutgers Cancer Institute of New Jersey
Massachusetts General Hospital
Main Line Health
Roswell Park Cancer Institute
HematologyOncology
Associates of Central New York
Georgia Regents University
Investigators
Principal Investigator: Arnold Markowitz, MD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Arnold Markowitz, Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582829     History of Changes
Other Study ID Numbers: 03-043
Study First Received: December 21, 2007
Last Updated: November 6, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Colorectal
Cancer
Screening
Intervention
Family

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014