New York Prevention Care Manager Project
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Enrollment
- 2729
- Locations
- 2
- Primary Endpoint
- Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy
- Status
- Completed
- Last Updated
- 11 years ago
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. * 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.
Investigators
Eligibility Criteria
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