New York Prevention Care Manager Project
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 2,729
- Locations
- 3
- Primary Endpoint
- Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy
Study Overview
Brief Summary
RATIONALE: Studying the barriers that prevent minority and low-income women from undergoing cancer screening, and offering encouragement to them over the telephone, may help improve cancer screening rates.
PURPOSE: This randomized phase II trial is studying how well a telephone-based Prevention Care Manager increases screening rates for breast cancer, cervical cancer, and colorectal cancer in minority and low-income women.
Detailed Description
OBJECTIVES:
- Determine whether telephone support for patients, provided through a Prevention Care Manager (PCM), can increase breast, cervical, and colorectal cancer screening rates among minority and low-income women.
- Measure the amount of PCM time required to improve early cancer detection provided to age-eligible ethnically diverse women seen in community health centers in the New York City area.
- Learn barriers faced by this population in obtaining indicated services (mammograms, Pap tests, fecal occult blood testing, and sigmoidoscopy).
- Assess at baseline and follow-up the office environment and work processes in each participating center (in PCM randomized controlled study only).
- Develop and implement the PCM intervention to help patients overcome barriers.
- Evaluate the impact and costs of the PCM in a randomized controlled efficacy trial.
OUTLINE: This is a randomized, controlled, single-blind, multicenter study. Patients are randomized according to participating center.
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Part 1: Some patients undergo a series of structured interviews about the obstacles to early cancer detection. Participating sites are assessed for study eligibility.
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Part 2: Pilot testing, training, and competency testing of the Prevention Care Managers (PCM) are conducted.
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Part 3: Patients are randomized to 1 of 2 intervention arms.
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Arm I: Patients are offered health education and follow-up services by telephone with a PCM.
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Arm II: Patients receive usual care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 69 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy
Follow-up patient cancer 3 months after completion of study treatment
Secondary Outcomes
No secondary outcomes reported