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Tailored Navigation in CRC Screening


Phase 3
50 Years
74 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Tailored Navigation in CRC Screening


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Single Blind, Primary Purpose: Health Services Research

Outcome Measure:

Screening utilization over the 6-month observation period

Safety Issue:

No

Principal Investigator

Ronald Myers, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Jefferson Medical College of Thomas Jefferson University

Authority:

Unspecified

Study ID:

CDR0000584278

NCT ID:

NCT00617071

Start Date:

January 2007

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • colon cancer
  • rectal cancer
  • Colorectal Neoplasms

Name

Location

Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107