N/A
Completed N=11,980
mFOCUS (Multilevel FOllow-up of Cancer Screening)
Source: ClinicalTrials.gov NCT03979495 ↗Enrolled (actual)
11,980
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Completion of Follow-up Test — 672; 796; 831; 1062 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Completion of Follow-up Test |
672; 796; 831; 1062 | — |
| SECONDARY Number of Participants Who Complete the Required Diagnostic Evaluation |
423; 464; 514; 653; 249; 332 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03979495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.