Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Rare Diseases

Lymphoma

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

Lymphosarcoma

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.

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)

PRO Instruments assessment questionnaire

Baseline Survey completed prior to initiation of chemotherapy

Baseline Survey Clinician- reported (ClinRO) ECOG

Fitbit

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

Hugo Health ("Hugo")

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

6 Minute Walk Test (6MWT)

Cary Gross, MD

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)

The purpose of this prospective observational study is to collect and evaluate 4 different sources of physical functioning (PF) data over the course of systemic anti-cancer therapy in lymphoma and breast cancer patients: clinician-reported Performance Status (PS), Patient Reported Outcomes (PROs), a Performance Outcome (PerfO) and patient wearable device data.

Aim 1: To measure PF using 4 distinct modalities (ClinRo, PRO, PerfO and wearable device data) on Hugo platform

* Characterize assessment challenges by comparing levels of missing data and reasons for missingness across the PF modalities
* Report on trajectories of function as ascertained by the 4 PF modalities

Aim 2: To explore associations between various sources of physical function data and determine change thresholds

* To identify measurement characteristics of the PF modalities including sensitivity to change and identification of meaningful change thresholds
* Compare change over time in data within and between the PF modalities
* Explore associations between changes in the various PF modalities and subsequent patient-reported adverse events (AEs), acute care use (unplanned hospitalizations or emergency department visits), other patient-reported domains of Health Related Quality of Life (HRQOL), and dose delay/reduction

Aim 3: To assess patient acceptability and experience using the different PF assessment modalities

• Administer an exit questionnaire to understand burden and usability of electronic PROs and wearable device data collection from the patient perspective

The allocation for patient recruitment is 18 months, with 9 months for follow up for each patient. The proposed overall project timeline is 3.5 years/39 months. A total of 200 patients will be enrolled at Yale Cancer Center and the Mayo Clinic, as outlined below. Data will be cleaned, reviewed, and analyzed as it is received from the Hugo platform on a rolling basis. Data analysis will be conducted at Mayo Clinic and Yale. Only de-identified data will be provided to the FDA.

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

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.

PRO-CTCAE is a patient-reported outcome (PRO) measurement system of 11 questions plus free text developed to evaluate symptomatic toxicity in patients on cancer clinical trials. Outcome reported as a count of adverse events.

Patient-Reported Outcomes Measurement Information System (PROMIS), version 8c, is a patient reported survey which evaluates a patient physical function before and during treatment. It consists of 8 questions each scored from 5 (without any difficulty) to 1 (Unable to do).

PRO ECOG is 1 question where patients describe their activity in the past month. Score ranges from 0 (normal with no limitations) to 3 (unable to perform activities, very limited).

EORTC Quality of Life questionnaire (QLQ)-F17 is a 17 question survey. The first 15 questions assess the patient's physical function and are scored from 1 (Not at all) to 4 (Very much). The final 2 questions asses the patient overall health and overall quality of life. Scoring ranges from 1 (very poor health/quality of life) to 7 (excellent health/quality of life).

Functional Assessment of Cancer Therapy-General version (FACT-GP5) is a single question in which patients report their bother by side effects of treatment. Scores range from 0 (not at all bothered by side effect) to 4 (very much bothered by side effects).

A two question survey. Question one, PGI-S, describes severity of symptoms of on a scale from 1 (normal severity) to 4 (severe symptoms). Question two, PGI-C, patients report how their physical function has changed from baseline on a scale from 1 (very much improved) to 7 (very much worse).

Performance Outcome measured using a 6-minute walk test. The outcome is distance in meters traveled by the patient in a 6 minute time period at baseline and 3 months to evaluate patient performance before and after chemotherapy.

Count of total daily steps and maximum cadence (steps/minute) with activity data collected using a Fitbit at baseline (7 days prior to the start of chemotherapy) continually until Month 9.

Resting heart rate (beats/minute) and heart rate during moderate to vigorous physical activity (MVPA) data collected using a Fitbit at baseline (7 days prior to the start of chemotherapy) continually until Month 9.

Daily duration of MVPA (in minutes), count of ≥10-minute bouts of MVPA, daily duration of sedentary time (in minutes), and count of ≥ 10-minutes bouts of sedentary time (in minutes) data collected using a Fitbit at baseline (7 days prior to the start of chemotherapy) continually until Month 9.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The In4M Study: Integrating 4 Methods to Assess Physical Function in Cancer Patients	NCT05214144	Physical Functi... Cancer, Breast Lymphoma Patient Empower... Patient Educati... Quality of Life	PRO Instruments... Baseline Survey... Fitbit Hugo Health ("H... 6 Minute Walk T...	18 Years -	Yale University
The In4M Study: Integrating 4 Methods to Assess Physical Function in Cancer Patients	NCT05214144	Physical Functi... Cancer, Breast Lymphoma Patient Empower... Patient Educati... Quality of Life	PRO Instruments... Baseline Survey... Fitbit Hugo Health ("H... 6 Minute Walk T...	18 Years -	Yale University

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