Breast CancerNCT00462891
A Mammography FastTrack Program in Increasing the Number of Women Undergoing Breast Cancer Screening
A study testing IT System in people with Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- IT System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,730 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Breast Cancer Screening and Follow-Up in a PBRN: The Mammography FastTrack Trial
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- IT System
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IT SystemOther
| Study group | Role | What they receive |
|---|---|---|
| IT System | Experimental | IT system to send reminder letters to patients overdue for breast cancer screening. Receives: Other: IT System |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 year
Comparison of time to mammography completion in intervention vs control groups
Measured: 1 year
Clinical and nonclinical outcomes recorded by Mammography FastTrack tool
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Michael J. Barry, MD, Massachusetts General Hospital
- Investigators
- Michael J. Barry, MD, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462891
- Sponsor's protocol ID
- 02-114
- Other IDs
- R21CA121908, MGH-2005-P-002474/1
- Status last verified
- May 2013
- First submitted
- 18 Apr 2007
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20872083Atlas 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.
PubMed 23286611
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Screening and Follow-Up in a PBRN: The Mammography FastTrack Trial
- ClinicalTrials.gov ID
- NCT00462891
- Acronym / sponsor ID
- 02-114
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,730 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2007
- Primary completion
- Mar 2008 (actual)
- First posted
- 19 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IT System | Experimental | Other: IT SystemIT system to send reminder letters to patients overdue for breast cancer screening. |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IT System | Other | IT System |
Primary outcome
Proportion of overdue patients completing mammography screening in intervention and control groups
Time frame: 1 year
Proportion of overdue patients completing mammography screening in intervention and control groups over the 1-year study.
3 secondary outcomes
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
Comparison of time to mammography completion in intervention vs control groups
Time frame: 1 year
Clinical and nonclinical outcomes recorded by Mammography FastTrack tool
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
- Results publication: PubMed 20872083Atlas 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.
- Derived from this study: PubMed 23286611Atlas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J. Barry, MD study chair
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IT System in people with Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of overdue patients completing mammography screening in intervention and control groups (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00462891, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2013.