mFOCUS (Multilevel FOllow-up of Cancer Screening) (mFOCUS)
December 4, 2023 updated by: Jennifer S Haas, MD, Massachusetts General Hospital
To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal cancer screening test.
Study Overview
Detailed Description
Standard care consists of well-characterized existing decision support and systems for follow-up in these three participating primary care networks and their affiliated integrated delivery systems (Brigham and Women's Hospital, Massachusetts General Hospital, and Dartmouth Hitchcock Health, the largest health care provider in New Hampshire).
The primary outcome will be whether an individual receives follow-up, defined based on the type of screening abnormality and organ type (breast, cervical, lung or colorectal cancer), within 120 days of becoming eligible for mFOCUS.
Secondary comparisons will assess multi- and cross-level (individual, team, system) outcomes.
The study design will allow us to examine the marginal effectiveness of system, team and individual-level enhancements, and exploratory analyses will address subgroups defined by race/ ethnicity, socioeconomic status and cancer type.
Study Type
Interventional
Enrollment (Actual)
11980
Phase
- Not Applicable
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
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
New Hampshire
-
Hanover, New Hampshire, United States, 03755
- Dartmouth Hitchcock
-
-
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
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
individuals who have an abnormal screen that is due for follow-up including:
- Breast: women 40-80 years with an incident (i.e., newly detected) abnormal screening mammogram or digital breast tomosynthesis (DBT) exam.
- Cervical: women 21-65 years with an incident abnormal screening Pap.
- Colorectal: adults 40-80 years with an abnormal screen, including incident FOBT (Fecal Occult Blood Test) / FIT (Fecal Immunochemical Test), or prevalent colonoscopy. Because of the long periods of time required for follow-up of colonoscopies, we will look back over a 5-year period and will therefore find prevalent abnormalities that become due for follow-up.
- Lung: adults 55-80 years, current and former smokers, with an incident abnormal LDCT (Low Dose Computed Topography) result.
Exclusion Criteria:
We will exclude patients who:
- are not English or Spanish-speaking
- have had prior cancer of the organ for each screening test (i.e., women with prior breast cancer will not be tracked for breast cancer screening abnormalities) as these individuals may have non-standard follow-up care recommendations.
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard of care
standard of care
|
|
|
Active Comparator: IT platform
Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results
|
To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
|
|
Active Comparator: IT platform with reminders
Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results.
|
To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
|
|
Active Comparator: IT platform and patient navigation
the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care.
|
To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completion of Follow-up Test
Time Frame: 120 days
|
Completion of follow-up test within 120 days of eligibility for mFOCUS (EHR)
|
120 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Complete the Required Diagnostic Evaluation
Time Frame: up to 240 days
|
How many participants completed the required diagnostic evaluation (EHR), 0-60, 61-120, 121-180, 181-240 day intervals were evaluated.
|
up to 240 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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 (Actual)
August 24, 2020
Primary Completion (Actual)
April 12, 2022
Study Completion (Actual)
August 10, 2022
Study Registration Dates
First Submitted
May 30, 2019
First Submitted That Met QC Criteria
June 5, 2019
First Posted (Actual)
June 7, 2019
Study Record Updates
Last Update Posted (Actual)
May 10, 2024
Last Update Submitted That Met QC Criteria
December 4, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019P000341
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.