NCT00462891

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,730

participants targeted

Target at P75+ for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Last Updated

May 21, 2013

Status Verified

May 1, 2013

Enrollment Period

1 year

First QC Date

April 18, 2007

Last Update Submit

May 18, 2013

Conditions

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

  • Proportion of overdue patients completing mammography screening in intervention and control groups

    Proportion of overdue patients completing mammography screening in intervention and control groups over the 1-year study.

    1 year

Secondary Outcomes (3)

  • Difference in percentage of patients overdue at baseline receiving mammogram during the study period in intervention and control practices at 6 months

    1 year

  • Comparison of time to mammography completion in intervention vs control groups

    1 year

  • Clinical and nonclinical outcomes recorded by Mammography FastTrack tool

    1 year

Study Arms (2)

IT System

EXPERIMENTAL

IT system to send reminder letters to patients overdue for breast cancer screening.

Other: IT System

Usual Care

NO INTERVENTION

Interventions

IT System

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Atlas SJ, Grant RW, Lester WT, Ashburner JM, Chang Y, Barry MJ, Chueh HC. A cluster-randomized trial of a primary care informatics-based system for breast cancer screening. J Gen Intern Med. 2011 Feb;26(2):154-61. doi: 10.1007/s11606-010-1500-0. Epub 2010 Sep 15.

  • Atlas SJ, Ashburner JM, Chang Y, Lester WT, Barry MJ, Grant RW. Population-based breast cancer screening in a primary care network. Am J Manag Care. 2012 Dec;18(12):821-9.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michael J. Barry, MD

    Massachusetts General Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Investigator

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 19, 2007

Study Start

March 1, 2007

Primary Completion

March 1, 2008

Last Updated

May 21, 2013

Record last verified: 2013-05

Locations