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

Breast Cancer Clinical Trial

Official title: New York Prevention Care Manager Project

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cervical Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Uterine Cervical Neoplasms

• NCT number: NCT00376909
• Study type: Interventional
• Source: Dartmouth-Hitchcock Medical Center
• Status: Completed
• Phase: Phase 2
• Start date: November 2001