mFOCUS (Multilevel FOllow-up of Cancer Screening)

Mass General Brigham

Status: Completed

Conditions: Cancer

Treatments: Other: mFOCUS

Study type: Interventional

Funder types: Other

Identifiers

NCT03979495

2019P000341

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11,980 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11,980 participants in 4 patient groups

Standard of care

No Intervention group

Description:

standard of care

IT platform

Active Comparator group

Description:

Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results

Treatment:

Other: mFOCUS

IT platform with reminders

Active Comparator group

Description:

Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results.

Treatment:

Other: mFOCUS

IT platform and patient navigation

Active Comparator group

Description:

the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care.

Treatment:

Other: mFOCUS