NCT00582829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

November 7, 2008

Status Verified

November 1, 2008

Enrollment Period

4.9 years

First QC Date

December 21, 2007

Last Update Submit

November 6, 2008

Conditions

ColorectalCancerScreeningIntervention

Keywords

ColorectalCancerScreeningInterventionFamily

Outcome Measures

Primary Outcomes (1)

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

    6 months after baseling

Study Arms (3)

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

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

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

Interventions

Generic Print InterventionOTHER

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.

1
Tailored Print InterventionOTHER

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.

2
Tailored print plus tailored phone interventionOTHER

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.

3

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Arnold Markowitz, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 28, 2007

Study Start

June 1, 2003

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

November 7, 2008

Record last verified: 2008-11

Locations

US(1)