Personalized Screening Plans to Increase Colorectal Cancer Screening in Healthy Participants



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:50 - 74
Updated:4/2/2016
Start Date:January 2007

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Tailored Navigation in CRC Screening

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.

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.

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
We found this trial at
1
site
111 S 11th St,
Philadelphia, Pennsylvania 19107
(877) 503-8350
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia The Kimmel Cancer Center at Jefferson...
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mi
from
Philadelphia, PA
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