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

Phase 2

Completed

• Conditions: Colorectal Cancer; Cervical Cancer; Breast Cancer
• Interventions: Other: educational intervention; Other: study of socioeconomic and demographic variables

• Registration Number: NCT00376909
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2004-04
• Status Verified: 2006-09
• Study First Submitted: 2006-09-13
• Study First Submitted QC: 2006-09-13
• Study First Posted: 2006-09-15
• Last Update Submitted: 2014-11-26
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2729

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	study of socioeconomic and demographic variables	Series of telephone support calls from a trained prevention care manager
Intervention	educational intervention	Series of telephone support calls from a trained prevention care manager

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Clinical Directors Network, Incorporated; 🇺🇸 New York, New York, United States