View Clinical Trial (Medical Research Study)
Tailored Navigation in CRC Screening
| City: |
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Philadelphia |
| State: |
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Pennsylvania |
| Zip Code: |
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19107 |
| Conditions: |
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Colorectal Cancer |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00617071 |
| Primary Contact: |
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Study Chair
Ronald Myers, PhD
Jefferson Medical College of Thomas Jefferson University
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| Backup Contact: |
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N/A |
| Location Contact: |
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Philadelphia, Pennsylvania 19107
United States
Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer
Phone: 215-955-6084
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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