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

November 26, 2014 updated by: Dartmouth-Hitchcock Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

2729

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10018
        • Clinical Directors Network, Incorporated

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Patients enrolled in the Prevention Care Manager (PCM) controlled, randomized clinical trial (RCT) must meet the following criteria:

    • Registered to receive care at a participating Community Health Center for at least 6 months

    • Overdue for at least one cancer screening as per the following time periods:

      • No mammography within the past 12 months
      • No Pap test within the past 12 months
      • No home fecal occult blood test within the past 12 months
      • No sigmoidoscopy within the past 5 years
      • No colonoscopy within the past 10 years
    • Must not plan to move out of area or change Community Health Center within 15 months
    • No unresolved, urgent abnormal cancer screening result found in medical record

  • Patients enrolled in the PCM dissemination pilot study through Affinity Health Plan must meet the following criteria:

    • Enrolled with Affinity Health Plan for at least 12 months

    • Overdue for at least one cancer screening as per the following time periods:

      • No mammography within the past 2 years
      • No Pap test within the past 3 years
      • No home fecal occult blood test within the past year for women ≥ 50 years old
      • No sigmoidoscopy within the past 5 years
      • No colonoscopy within the past 10 years
    • Must have received care at 1 of 6 participating Community Health Centers in New York City

PATIENT CHARACTERISTICS:

  • Female
  • Must not be in acute distress or have an acute illness
  • Age 50 to 69 years for controlled study patients
  • Age 40 to 69 years for pilot study patients

PRIOR CONCURRENT THERAPY:

  • No concurrent chemotherapy or radiotherapy
  • No concurrent active cancer treatment
  • No concurrent palliative care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Series of telephone support calls from a trained prevention care manager
Other: educational intervention
Other: study of socioeconomic and demographic variables
No Intervention: Usual Care
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Follow-up patient cancer 3 months after completion of study treatment
Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Allen J. Dietrich, MD, Norris Cotton Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

September 13, 2006

First Submitted That Met QC Criteria

September 13, 2006

First Posted (Estimate)

September 15, 2006

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 26, 2014

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000450797
  • R01CA087776 (U.S. NIH Grant/Contract)
  • DMS-15524

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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