CancermFOCUSNCT03979495
mFOCUS (Multilevel FOllow-up of Cancer Screening)
A study testing mFOCUS in people with Cancer, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- mFOCUS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,980 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Aug 2020to 10 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dartmouth Hitchcock
Hanover, New Hampshire, 03755
About this study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- mFOCUS
- Keywords
- Abnormal Screening Results
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOCUSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | standard of care |
| IT platform | Active comparator | Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results Receives: Other: mFOCUS |
| IT platform with reminders | Active comparator | Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results. Receives: Other: mFOCUS |
| IT platform and patient navigation | Active comparator | the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care. Receives: Other: mFOCUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Follow-up Test
Completion of follow-up test within 120 days of eligibility for mFOCUS (EHR)
Measured: 120 days
Secondary outcomes (1)
Number of Participants Who Complete the Required Diagnostic Evaluation
How many participants completed the required diagnostic evaluation (EHR), 0-60, 61-120, 121-180, 181-240 day intervals were evaluated.
Measured: up to 240 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start24 Aug 2020
- Primary completion12 Apr 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All individuals in this study will receive the current standard of care at Massachusetts General Hospital, Brigham and Women's Hospital, and Dartmouth Hitchcock for the follow-up of abnormal cancer screening tests (Arms 1-4). In addition to this standard of care, we will test 3 additional arms of increasing intensity of intervention: Arm 2-access to an IT platform to facilitate updates to HM modifiers and problem lists for visit-based reminders; Arm 3- the IT platform in addition to automated reminders to patients between visits and the care team; Arm 4-the IT platform, automated reminders, and administrative outreach and navigation to help with scheduling and to address social barriers to care.
- Masking
- None (open label)
- Enrolment
- 11,980 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer S Haas, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979495
- Sponsor's protocol ID
- 2019P000341
- Acronym
- mFOCUS
- Status last verified
- Dec 2023
- First submitted
- 30 May 2019
- Last updated
- 10 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atlas SJ, Gallagher KL, McGovern SE, Wint AJ, Smith RE, Aman DG, Zhao W, Burdick TE, Orav EJ, Zhou L, Wright A, Tosteson ANA, Haas JS. Patient Perceptions on the Follow-Up of Abnormal Cancer Screening Test Results. J Gen Intern Med. 2025 May;40(6):1280-1287. doi: 10.1007/s11606-024-09128-4. Epub 2024 Oct 18.
PubMed 39424768Atlas SJ, Tosteson ANA, Wright A, Orav EJ, Burdick TE, Zhao W, Hort SJ, Wint AJ, Smith RE, Chang FY, Aman DG, Thillaiyapillai M, Diamond CJ, Zhou L, Haas JS. A Multilevel Primary Care Intervention to Improve Follow-Up of Overdue Abnormal Cancer Screening Test Results: A Cluster Randomized Clinical Trial. JAMA. 2023 Oct 10;330(14):1348-1358. doi: 10.1001/jama.2023.18755.
PubMed 37815566Haas JS, Atlas SJ, Wright A, Orav EJ, Aman DG, Breslau ES, Burdick TE, Carpenter E, Chang F, Dang T, Diamond CJ, Feldman S, Harris KA, Hort SJ, Housman ML, Mecker A, Lehman CD, Percac-Lima S, Smith R, Wint AJ, Yang J, Zhou L, Tosteson ANA. Multilevel Follow-up of Cancer Screening (mFOCUS): Protocol for a multilevel intervention to improve the follow-up of abnormal cancer screening test results. Contemp Clin Trials. 2021 Oct;109:106533. doi: 10.1016/j.cct.2021.106533. Epub 2021 Aug 8.
PubMed 34375748
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mFOCUS (Multilevel FOllow-up of Cancer Screening)
- ClinicalTrials.gov ID
- NCT03979495
- Acronym / sponsor ID
- mFOCUS / 2019P000341
- Conditions
- Cancer
- Keywords
- Abnormal Screening Results
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,980 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Dartmouth-Hitchcock Medical Center
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Posted 10 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- All individuals in this study will receive the current standard of care at Massachusetts General Hospital, Brigham and Women's Hospital, and Dartmouth Hitchcock for the follow-up of abnormal cancer screening tests (Arms 1-4). In addition to this standard of care, we will test 3 additional arms of increasing intensity of intervention: Arm 2-access to an IT platform to facilitate updates to HM modifiers and problem lists for visit-based reminders; Arm 3- the IT platform in addition to automated reminders to patients between visits and the care team; Arm 4-the IT platform, automated reminders, and administrative outreach and navigation to help with scheduling and to address social barriers to care.
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –standard of care |
| IT platform | Active comparator | Other: mFOCUSAccess to an IT platform for visit-based reminders about overdue abnormal cancer screening test results |
| IT platform with reminders | Active comparator | Other: mFOCUSAccess to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results. |
| IT platform and patient navigation | Active comparator | Other: mFOCUSthe IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| mFOCUSTo 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. | Other | IT platform, IT platform and patient navigation, IT platform with reminders |
Primary outcome
Completion of Follow-up Test
Time frame: 120 days
Completion of follow-up test within 120 days of eligibility for mFOCUS (EHR)
1 secondary outcome
Number of Participants Who Complete the Required Diagnostic Evaluation
Time frame: up to 240 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39424768Atlas SJ, Gallagher KL, McGovern SE, Wint AJ, Smith RE, Aman DG, Zhao W, Burdick TE, Orav EJ, Zhou L, Wright A, Tosteson ANA, Haas JS. Patient Perceptions on the Follow-Up of Abnormal Cancer Screening Test Results. J Gen Intern Med. 2025 May;40(6):1280-1287. doi: 10.1007/s11606-024-09128-4. Epub 2024 Oct 18.
- Derived from this study: PubMed 37815566Atlas SJ, Tosteson ANA, Wright A, Orav EJ, Burdick TE, Zhao W, Hort SJ, Wint AJ, Smith RE, Chang FY, Aman DG, Thillaiyapillai M, Diamond CJ, Zhou L, Haas JS. A Multilevel Primary Care Intervention to Improve Follow-Up of Overdue Abnormal Cancer Screening Test Results: A Cluster Randomized Clinical Trial. JAMA. 2023 Oct 10;330(14):1348-1358. doi: 10.1001/jama.2023.18755.
- Derived from this study: PubMed 34375748Haas JS, Atlas SJ, Wright A, Orav EJ, Aman DG, Breslau ES, Burdick TE, Carpenter E, Chang F, Dang T, Diamond CJ, Feldman S, Harris KA, Hort SJ, Housman ML, Mecker A, Lehman CD, Percac-Lima S, Smith R, Wint AJ, Yang J, Zhou L, Tosteson ANA. Multilevel Follow-up of Cancer Screening (mFOCUS): Protocol for a multilevel intervention to improve the follow-up of abnormal cancer screening test results. Contemp Clin Trials. 2021 Oct;109:106533. doi: 10.1016/j.cct.2021.106533. Epub 2021 Aug 8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mFOCUS in people with Cancer, run by Massachusetts General Hospital at 2 sites 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?
The sponsor lists 5 inclusion and 3 exclusion criteria. 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 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 10 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Completion of Follow-up Test (time frame: 120 days). 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 NCT03979495, which also lists 3 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 10 May 2024.