mFOCUS (Multilevel FOllow-up of Cancer Screening)

Cancer Clinical Trial

— mFOCUS  

Official title:

mFOCUS (Multilevel FOllow-up of Cancer Screening)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979495
• Other study ID #: 2019P000341
• Status: Completed
• Phase: N/A
• Start date: August 24, 2020
• Est. completion date: August 10, 2022

Study information

• Verified date: November 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11980
• Est. completion date: August 10, 2022
• Est. primary completion date: April 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• mFOCUS
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.

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock	Hanover	New Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital, Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of follow-up test	Completion of follow-up test within 120 days of eligibility for mFOCUS (EHR)	120 days
Secondary	Amount of time to complete the required diagnostic evaluation	How many days are need for the completion of required diagnostic evaluation (EHR)	120 days
Secondary	Amount of time to complete the required diagnostic evaluation	How many days are need for the completion of required diagnostic evaluation (EHR)	240 days