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The In4M Study: Integrating 4 Methods to Assess Physical Function in Cancer Patients
NCT05214144 · View on ClinicalTrials.gov ↗
Study Summary
This is a prospective observational cohort study. Breast cancer and lymphoma patients planned to receive cytotoxic therapy will be recruited at Yale and Mayo Clinic. The Study Period is 9 months, during which enrolled patients will use their personal smartphone, computer, or other web-connected device to connect with the Hugo platform which will deliver PRO questionnaires, and sync to the wearable device in the study (Fitbit). The PerfO (6MWT) will be conducted twice in clinic during the study period. Structured information from the electronic health record (EHR) and patient portals will be collected and where needed, the EHR will be directly reviewed to record AEs, hospitalizations/emergency department visits and dose delay/reductions. Required in-person face to face visit is only at baseline for consent, enrollment and receipt of wearable device; patients can be followed remotely afterward (i.e. do not need to be treated at Mayo or Yale)
Conditions Studied
Interventions
- DEVICE Fitbit
- OTHER PRO Instruments assessment questionnaire
- OTHER Baseline Survey Clinician- reported (ClinRO) ECOG
- OTHER Hugo Health ("Hugo")
- OTHER 6 Minute Walk Test (6MWT)
Study Locations (2)
Connecticut
- Yale Cancer Center — New Haven
Minnesota
- Mayo Clinic — Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2022-01-27 |
| Est. Completion | 2024-10-24 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05214144
The ClinicalTrials.gov registry entry for NCT05214144 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 208 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,283 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions — of which Fitbit is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05214144 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Connecticut, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05214144 about?
NCT05214144 is a clinical study titled "The In4M Study: Integrating 4 Methods to Assess Physical Function in Cancer Patients". This is a prospective observational cohort study. Breast cancer and lymphoma patients planned to receive cytotoxic therapy will be recruited at Yale and Mayo Clinic. The Study Period is 9 months, during which enrolled patients will use their personal smartphone, computer, or other web-connected devi...
What is the current status of trial NCT05214144?
This trial is currently completed. The enrollment target is 208 participants. The study started on 2022-01-27. Estimated completion is 2024-10-24.
What conditions does trial NCT05214144 study?
This clinical trial studies the following conditions: Lymphoma, Quality of Life, Cancer, Breast, Physical Function, Patient Education. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05214144?
The interventions under investigation include: Fitbit (DEVICE), PRO Instruments assessment questionnaire (OTHER), Baseline Survey Clinician- reported (ClinRO) ECOG (OTHER), Hugo Health ("Hugo") (OTHER), 6 Minute Walk Test (6MWT) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05214144?
This trial is sponsored by Yale University, which has 1,283 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05214144 being conducted?
This trial has 2 study locations across Connecticut, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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