The In4M Study: Integrating 4 Methods to Assess Physical Function in Cancer Patients

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

• Physical Function
• Cancer, Breast
• Lymphoma
• Patient Empowerment
• Patient Education
• Quality of Life

Interventions

OTHER

PRO Instruments assessment questionnaire

Patient Reported Outcome (PRO) questionnaire consisting of: * PRO-CTCAE (approximately 11 questions plus free text) * Patient-Reported Outcomes Measurement Information System (PROMIS) physical function short form (version 8c) (8 questions) * PRO ECOG question (1 question) * EORTC Quality of Life questionnaire (QLQ)-F17 questions (17 questions) * Functional Assessment of Cancer Therapy-General version, rated on a 5-point Likert scale, (FACT-GP5) (single item global side effect bother question) (1 question) * The Patient Global Impression (PGI)-C and PGI-S items (anchors for physical function) (2 questions)

OTHER

Baseline Survey Clinician- reported (ClinRO) ECOG

Baseline Survey completed prior to initiation of chemotherapy

DEVICE

Fitbit

wearable device

OTHER

Hugo Health ("Hugo")

an electronic platform that aggregates real world EHR data with patient's wearable and PRO data

OTHER

6 Minute Walk Test (6MWT)

A comprehensive performance measure of exercise capacity, encompassing components of mobility, endurance, and functional capacity measure (PerfO)

Sponsors & Collaborators

• Food and Drug Administration (FDA)

  collaborator FED

• Yale University

  lead OTHER

Principal Investigators

• Cary Gross, MD · Yale University

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-27

Primary Completion

2024-08-22

Completion

2024-10-24

Countries

• United States

Study Locations