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NCT05214144 · ClinicalTrials.gov registry record
The In4M Study: Integrating 4 Methods to Assess Physical Function in Cancer Patients
A clinical trial of Lymphoma and Quality of Life, sponsored by Yale University.
- Completed
- Registry status
- 208
- Enrollment target
- 2
- Study locations
NCT05214144: Completed study of Lymphoma and Quality of Life, sponsored by Yale University.
NCT05214144 is a study of Lymphoma and Quality of Life that has completed, run by Yale University. The registered enrollment target is 208 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (57% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05214144, a study of Lymphoma and Quality of Life, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- 208 participants
- Enrollment target
- 2
- Study locations
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)
Primary Outcome
ClinRo score at baseline using the Eastern Cooperative Oncology Group (ECOG) performance scale. Possible scores range from 0 to 5. The lower the score the better the performance.
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 |
What the finished NCT05214144 record still lists
NCT05214144 is an observational study that tracks outcomes without assigning an intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (57% lower).
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.
NCT05214144 reports a single indexed study location in Connecticut, Minnesota.
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.
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).
Who is sponsoring clinical trial NCT05214144?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05214144's enrollment target sits among peer trials
208 46th of 299 higher than 254 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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