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OpenTrials
Completed

NCT Number: NCT03979495

mFOCUS (Multilevel FOllow-up of Cancer Screening)

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.

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Key information

Conditions

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mFOCUS

Other

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.

Primary outcomes

  1. Completion of Follow-up Test

    Time frame: 120 days

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

Secondary outcomes

  1. Number of Participants Who Complete the Required Diagnostic Evaluation

    Time frame: up to 240 days

    How many participants completed the required diagnostic evaluation (EHR), 0-60, 61-120, 121-180, 181-240 day intervals were evaluated.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Brigham and Women's Hospital
  • Dartmouth-Hitchcock Medical Center

Registry information

Acronym: mFOCUS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2019
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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