NCT03979495

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11,980

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

May 30, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 24, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2022

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

May 10, 2024

Completed
Last Updated

May 10, 2024

Status Verified

December 1, 2023

Enrollment Period

1.6 years

First QC Date

May 30, 2019

Results QC Date

February 7, 2023

Last Update Submit

December 4, 2023

Conditions

Cancer

Keywords

Abnormal Screening Results

Outcome Measures

Primary Outcomes (1)

  • Completion of Follow-up Test

    Completion of follow-up test within 120 days of eligibility for mFOCUS (EHR)

    120 days

Secondary Outcomes (1)

  • Number of Participants Who Complete the Required Diagnostic Evaluation

    up to 240 days

Study Arms (4)

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

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.

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.

Other: mFOCUS

Interventions

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.

IT platformIT platform and patient navigationIT platform with reminders

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dartmouth Hitchcock

Hanover, New Hampshire, 03755, United States

Location

Related Publications (3)

  • 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.

    PMID: 39424768DERIVED

  • Atlas 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.

    PMID: 37815566DERIVED

  • Haas 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.

    PMID: 34375748DERIVED

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

Title
Dr. Jennifer Haas
Organization
Massachusetts General Hospital
jhaas@mgh.harvard.edu
617-724-1832

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The intervention is not masked to the providers or the participants. Randomization status is masked to the participants but not the providers. Masking is not feasible because randomization will take place at the level of the practice and practices will need to be informed about intervention components that will be made available to patients in their practice and the health care team
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Peter L. Gross MD Chair in Primary Care, Director of Research and Research Education

Study Record Dates

First Submitted

May 30, 2019

First Posted

June 7, 2019

Study Start

August 24, 2020

Primary Completion

April 12, 2022

Study Completion

August 10, 2022

Last Updated

May 10, 2024

Results First Posted

May 10, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)