Breast Cancer Clinical Trial
Official title:
New York Prevention Care Manager Project
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.
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.
- Part 1: Some patients undergo a series of structured interviews about the obstacles to
early cancer detection. Participating sites are assessed for study eligibility.
- Part 2: Pilot testing, training, and competency testing of the Prevention Care Managers
(PCM) are conducted.
- Part 3: Patients are randomized to 1 of 2 intervention arms.
- Arm I: Patients are offered health education and follow-up services by telephone
with a PCM.
- Arm II: Patients receive usual care.
PROJECTED ACCRUAL: A total of 2,729 (1,413 for PCM randomized controlled study and 1,316 for
pilot study) patients will be accrued for this study.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
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