Personalized Screening Plans to Increase Colorectal Cancer Screening in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer

Keywords

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colon cancer rectal cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Interventions

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medical chart review

Intervention Type OTHER

survey administration

Intervention Type OTHER

fecal occult blood test

Intervention Type PROCEDURE

screening colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Ronald Myers, PhD

Role: STUDY_CHAIR

Jefferson Medical College of Thomas Jefferson University

Locations

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Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer

Role: primary

Other Identifiers

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TJUH-2006-44

Identifier Type: -

Identifier Source: secondary_id

CDR0000584278