NCT00376909

A Telephone-Based Prevention Care Manager in Increasing Screening Rates for Breast Cancer, Cervical Cancer, and Colorectal Cancer in Minority and Low-Income Women

New York Prevention Care Manager Project

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2,729 (estimated)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: Female
• Age: 40 Years – 69 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer
• Cervical Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	educational intervention
OTHER	study of socioeconomic and demographic variables

Timeline

• Start date: 2001-11-01
• Primary completion: 2004-04-01
• First posted: 2006-09-15
• Last updated: 2014-12-02

Locations

2 sites across 1 country: United States