A Mammography FastTrack Program in Increasing the Number of Women Undergoing Breast Cancer Screening

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael J. Barry, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00462891
First received: April 18, 2007
Last updated: May 18, 2013
Last verified: May 2013
  Purpose

RATIONALE: Screening may help doctors find breast cancer cells early and plan better treatment for breast cancer. The Mammography FastTrack program may be effective in increasing the number of patients who undergo mammography.

PURPOSE: This randomized clinical trial is studying the use of a Mammography FastTrack program to increase the number of women who undergo mammography.


Condition Intervention
Breast Cancer
Other: IT System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Breast Cancer Screening and Follow-Up in a PBRN: The Mammography FastTrack Trial

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Proportion of overdue patients completing mammography screening in intervention and control groups [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Proportion of overdue patients completing mammography screening in intervention and control groups over the 1-year study.


Secondary Outcome Measures:
  • Difference in percentage of patients overdue at baseline receiving mammogram during the study period in intervention and control practices at 6 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Comparison of time to mammography completion in intervention vs control groups [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Clinical and nonclinical outcomes recorded by Mammography FastTrack tool [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 6730
Study Start Date: March 2007
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IT System
IT system to send reminder letters to patients overdue for breast cancer screening.
Other: IT System
No Intervention: Usual Care

Detailed Description:

OBJECTIVES:

  • Classify all patients within the Massachusetts General Primary Care-Practice Based Research Network (MGPC-PBRN) according to patient-primary care provider (PCP) linkage status.
  • Develop a breast cancer screening intervention program called Mammography FastTrack that facilitates the ordering of mammograms to be used either by PCPs (for PCP-linked patients) or by practice managers (for practice-linked patients).
  • Compare the impact of the Mammography FastTrack program on mammography screening rates in PCP-linked vs practice-linked patients overdue for breast cancer screening.

OUTLINE: This is a randomized, multicenter study.

Mammography-eligible women are linked to either a provider or a practice within the Massachusetts General Primary Care Practice-Based Research Network (MGPC-PBRN). Practices within the MGPC-PBRN are stratified according to baseline mammography screening rates (high vs low) and practice type (community health center vs hospital-based vs community-based) and are randomized to 1 of 2 arms.

  • Arm I: Physicians and practice managers receive e-mail alerts at months 1 and 3 informing them of the availability of mammography screening data for their panel of primary-care patients. A hyperlink refers the provider to a web-portal for the Mammography FastTrack program that lists all eligible patients who have not undergone mammography. The provider may then click a button to schedule, defer (providing reason for deferral), or provide the date of a recent mammogram.
  • Arm II: Practices continue standard care. At the end of 12 months, electronic report and billing data and a review of electronic health records are used to determine the completion of mammograms.

PROJECTED ACCRUAL: A total of 6,730 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Any outpatient at a participating Massachusetts General Primary Care Practice-Based Research Network (MGPC-PBRN) practice within the past 3 years

    • No patient who the Massachusetts General Hospital system lists as having a primary care provider who is not in one of the MGPC-PBRN networks (linking patients with a provider or practice)
    • No patient who is not linked to specific provider or practice (randomized portion of study)
  • Billing, scheduling, and clinical electronic data sources required
  • No mammogram within the past 2 years (randomized portion of study)
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Age 42 to 69 years (randomized portion of study)
  • Female
  • Menopausal status not specified

PRIOR CONCURRENT THERAPY:

  • No prior bilateral mastectomy (randomized portion of study)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462891

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Study Chair: Michael J. Barry, MD Massachusetts General Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael J. Barry, MD, Project Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00462891     History of Changes
Other Study ID Numbers: 02-114, R21CA121908, MGH-2005-P-002474/1
Study First Received: April 18, 2007
Last Updated: May 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014