mFOCUS (Multilevel FOllow-up of Cancer Screening)

Completed · Not applicable

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT03979495

Run by

Massachusetts General Hospital

People needed

11980

Starts

2020-08-24

Expected to finish

2022-08-10

Last updated by the study team

2024-05-10

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dartmouth Hitchcock — Hanover, New Hampshire, United States

Full record on ClinicalTrials.gov

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