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Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients

Primary Purpose

Colorectal, Cancer, Screening

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Generic Print Intervention
Tailored Print Intervention
Tailored print plus tailored phone intervention
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Colorectal focused on measuring Colorectal, Cancer, Screening, Intervention, Family

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Arm Label

1

2

3

Arm Description

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: 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: 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.

Outcomes

Primary Outcome Measures

Phone follow-up interview. Participants will be contacted by study assistant and the survey administered.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2007
Last Updated
November 6, 2008
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), Fox Chase Cancer Center, Icahn School of Medicine at Mount Sinai, Lombardi Comprehensive Cancer 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, Augusta University
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1. Study Identification

Unique Protocol Identification Number
NCT00582829
Brief Title
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

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), Fox Chase Cancer Center, Icahn School of Medicine at Mount Sinai, Lombardi Comprehensive Cancer 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, Augusta University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal, Cancer, Screening, Intervention
Keywords
Colorectal, Cancer, Screening, Intervention, Family

7. Study Design

Enrollment
213 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Description
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.
Arm Title
2
Arm Description
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.
Arm Title
3
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Generic Print Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tailored Print Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tailored print plus tailored phone intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Phone follow-up interview. Participants will be contacted by study assistant and the survey administered.
Time Frame
6 months after baseling

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnold Markowitz, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients

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