Clinical trial · Observational
The In4M Study: Integrating 4 Methods to Assess Physical Function in Cancer Patients
NCT05214144CI-TRIAL-00082359completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Patient Education | — | UNRESOLVED | — |
| Patient Empowerment | — | UNRESOLVED | — |
| Physical Function | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6 Minute Walk Test (6MWT) | Other | — | UNRESOLVED |
| Baseline Survey Clinician- reported (ClinRO) ECOG | Other | — | UNRESOLVED |
| Fitbit | Device | — | UNRESOLVED |
| Hugo Health ("Hugo") | Other | — | UNRESOLVED |
| PRO Instruments assessment questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- evaluating sources of physical function (PF)
- description
- evaluate 4 distinct modalities of sources of PF (PRO, ClinRo, PerfO and wearable device data) on Hugo Health platform in breast cancer and lymphoma patients undergoing cytotoxic chemotherapy.
- interventionNames
- Other: PRO Instruments assessment questionnaire
- Other: Baseline Survey Clinician- reported (ClinRO) ECOG
- Device: Fitbit
- Other: Hugo Health ("Hugo")
- Other: 6 Minute Walk Test (6MWT)
Primary outcomes (11)
- measure
- To measure Physical Function using Clinician Reported Outcomes (ClinRo) at baseline.
- timeFrame
- baseline
- description
- 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.
- measure
- Change in Patient Reported Outcomes Questionnaire: PRO-CTCAE
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 and over; 2. English- or Spanish-speaking; 3. Pregnant and non-pregnant patients are eligible for participation in this study 4. Eligible cancer type and planned intravenous cytotoxic chemotherapy regimen (defined as including 1 or more cytotoxic agents) 5. ECOG Performance Score of \< 3 6. Breast cancer patients a) Patients with any stage breast cancer for whom a new intravenous cytotoxic chemotherapy regimen is planned within the next 8 weeks (patients with local/regional/distant recurrences are allowed; patients with concurrent/prior/future immunotherapy/radiotherapy, targeted therapy, and endocrine therapy for breast cancer are allowed) 7. Lymphoma patients a) Lymphoma patients of any histology, stage or line of treatment planned to receive a new intravenous cytotoxic containing chemotherapy regimen (patients planned to receive radiation, maintenance chemotherapy, consolidation stem cell transplant or chimeric antigen receptor T (CAR-T) cell therapy are allowed) 8. If patients are receiving the above standard therapies as part of a clinical trial which may include a novel agent or combination, they are also eligible for the present study if the therapeutic protocol permits enrollment in both studies 9. Willing and able to give consent and participate in study 10. Able to access a mobile device (smartphone or tablet) or computer with web access every day to complete study surveys; able to regularly upload data from the Fitbit to a device in a way that it can be transferred to Hugo 11. Willing and able to perform an in-clinic 6-minute walk test (gait aides are permitted if regularly used by the patient). If a patient is recruited remotely outside of Mayo Clinic Rochester or Yale Smilow Cancer Center New Haven, 6-minute walk test may be omitted. 12. Willing to use the health data sharing platform Potential subjects who do not meet all of the enrollment criteria will not be enrolled. Any deviations from these criteria must be reported in accordance with IRB Policies and Procedures. Exclusion Criteria 1. Prior intravenous cytotoxic chemotherapy within 3 weeks prior to study enrollment 2. Excluded regimens (due to length of hospitalization required for chemotherapy administration): 1. R-CODOX-M/IVAC, 2. DA-R-EPOCH (inpatient) 3. Excluded histology (due to length of hospitalization and inpatient predominant treatment for required chemotherapy): primary central nervous system lymphoma a) Other regimens with an anticipated high duration of inpatient care time, at PI discretion 4. Lack of access to a mobile device (smartphone or tablet) or computer with web access 5. Unable or unwilling to connect Fitbit to device 6. Unable or unwilling to use the health data sharing platform 7. Unable to give consent and be enrolled
References
Publications (2)
- DERIVEDThanarajasingam G, Kluetz P, Bhatnagar V, Brown A, Cathcart-Rake E, Diamond M, Faust L, Fiero MH, Huntington S, Jeffery MM, Jones L, Noble B, Paludo J, Powers B, Ross JS, Ritchie JD, Ruddy K, Schellhorn S, Tarver M, Dueck AC, Gross C. Integrating 4 methods to evaluate physical function in patients with cancer (In4M): protocol for a prospective cohort study. BMJ Open. 2024 Jan 10;14(1):e074030. doi: 10.1136/bmjopen-2023-074030. PMID 38199641
- DERIVEDThanarajasingam G, Kluetz PG, Bhatnagar V, Brown A, Cathcart-Rake E, Diamond M, Faust L, Fiero MH, Huntington SF, Jeffery MM, Jones L, Noble BN, Paludo J, Powers B, Ross JS, Ritchie JD, Ruddy KJ, Schellhorn SE, Tarver ME, Dueck AC, Gross CP. Integrating 4 Measures to Evaluate Physical Function in Patients with Cancer (In4M): Protocol for a prospective study. medRxiv [Preprint]. 2023 Mar 9:2023.03.08.23286924. doi: 10.1101/2023.03.08.23286924. PMID 36945495