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Personalized Screening Plans to Increase Colorectal Cancer Screening in Healthy Participants

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
medical chart review
survey administration
fecal occult blood test
screening colonoscopy
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer focused on measuring colon cancer, rectal cancer

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

DISEASE CHARACTERISTICS:

  • Meets the following criteria:

    • No personal history of colorectal neoplasia (cancer or polyps) or inflammatory bowel disease
    • No family history of colorectal cancer (CRC) diagnosed before the age of 60
    • Visited one of the six community-based primary care practices that are part of the Christiana Care Health System (CCHS) in Delaware within the past 2 years
    • Not up-to-date with CRC screening, according to the United States Preventive Services Task Force guidelines

PATIENT CHARACTERISTICS:

  • Must have a complete address and telephone number
  • Able to communicate in English
  • No psychosis or severe dementia

PRIOR CONCURRENT THERAPY:

  • No prior participation in the developmental study CA10241

Sites / Locations

  • Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaRecruiting

Outcomes

Primary Outcome Measures

Screening utilization over the 6-month observation period

Secondary Outcome Measures

Screening preference
Perceived salience and coherence and self-efficacy related to colorectal cancer (CRC) screening
Number and length of contacts with each participant and the type of communication during those contacts
Identification of predictors of CRC screening use and screening preference

Full Information

First Posted
February 14, 2008
Last Updated
December 17, 2013
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00617071
Brief Title
Personalized Screening Plans to Increase Colorectal Cancer Screening in Healthy Participants
Official Title
Tailored Navigation in CRC Screening
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Developing a personalized screening plan may be more effective than usual care in increasing the number of healthy participants who regularly undergo screening for colorectal cancer. PURPOSE: This randomized phase III trial is studying personalized screening plans to see how well they work compared with usual care in increasing colorectal cancer screening in healthy participants.
Detailed Description
OBJECTIVES: To compare the impact of tailored intervention vs standard intervention vs usual care on patient utilization of colorectal cancer (CRC) screening. To compare the impact of these interventions on CRC screening preference. To compare the impact of these interventions on patient perceptions about CRC screening. OUTLINE: This is a multicenter study. Participants are stratified by practice and study wave and blocking. Participants are randomized to 1 of 3 arms. Arm I (usual care): Participants receive usual care in accordance with their normal patterns of interaction with study practices. Arm II (standard intervention [SI]): A generic screening invitation letter, a colorectal cancer (CRC) screening informational booklet, stool blood testing (SBT) cards, and instructions for arranging a colonoscopy screening appointment are mailed to participants on day 15. On day 45, a reminder letter is mailed to participants who have not completed SBT or undergone a screening colonoscopy. Arm III (tailored navigation intervention [TNI]): A test-specific screening invitation letter, a CRC screening informational booklet, and additional test-specific materials (i.e., instructions for arranging a colonoscopy screening appointment or SBT cards) are mailed to participants on day 15. On day 30, a patient navigator contacts participants by telephone who have not completed SBT or undergone a screening colonoscopy. The patient navigator re-assesses screening test-specific decision stage; addresses CRC screening barriers; develops a personalized CRC screening plan to move the participant towards screening use (i.e., explains the steps in completing the SBT or scheduling a colonoscopy appointment); and facilitates screening plan implementation. On day 45, a reminder letter is mailed to participants who were contacted by the navigator. Participants in all arms complete a survey at baseline and then at 6 months. Medical records for each participant are reviewed at 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colon cancer, rectal cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Masking
Single
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
medical chart review
Intervention Type
Other
Intervention Name(s)
survey administration
Intervention Type
Procedure
Intervention Name(s)
fecal occult blood test
Intervention Type
Procedure
Intervention Name(s)
screening colonoscopy
Primary Outcome Measure Information:
Title
Screening utilization over the 6-month observation period
Secondary Outcome Measure Information:
Title
Screening preference
Title
Perceived salience and coherence and self-efficacy related to colorectal cancer (CRC) screening
Title
Number and length of contacts with each participant and the type of communication during those contacts
Title
Identification of predictors of CRC screening use and screening preference

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
DISEASE CHARACTERISTICS: Meets the following criteria: No personal history of colorectal neoplasia (cancer or polyps) or inflammatory bowel disease No family history of colorectal cancer (CRC) diagnosed before the age of 60 Visited one of the six community-based primary care practices that are part of the Christiana Care Health System (CCHS) in Delaware within the past 2 years Not up-to-date with CRC screening, according to the United States Preventive Services Task Force guidelines PATIENT CHARACTERISTICS: Must have a complete address and telephone number Able to communicate in English No psychosis or severe dementia PRIOR CONCURRENT THERAPY: No prior participation in the developmental study CA10241
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Myers, PhD
Organizational Affiliation
Jefferson Medical College of Thomas Jefferson University
Official's Role
Study Chair
Facility Information:
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer
Phone
215-955-6084

12. IPD Sharing Statement

Learn more about this trial

Personalized Screening Plans to Increase Colorectal Cancer Screening in Healthy Participants

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