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Clinical Trial 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)


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05214144
Study type Observational
Source Yale University
Contact Cary P Gross, MD
Phone 203-785-4662
Email [email protected]
Status Recruiting
Phase
Start date January 27, 2022
Completion date August 2024

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