Breast Cancer Clinical Trial
The In4M Study: Integrating 4 Measures 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)
Full 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.
Eligibility Criteria
Inclusion Criteria:
Age 18 and over;
English- or Spanish-speaking;
Pregnant and non-pregnant patients are eligible for participation in this study
Eligible cancer type and planned intravenous cytotoxic chemotherapy regimen (defined as including 1 or more cytotoxic agents)
ECOG Performance Score of < 3
Breast cancer patients
Patients with stage 1-3 breast cancer
Planned to receive a curative intent intravenous cytotoxic chemotherapy during their treatment course
Patients with local/regional recurrence for whom curative treatment is planned
Patients with concurrent/prior/future immunotherapy/radiotherapy, targeted therapy and endocrine therapy for breast cancer can be included
Lymphoma patients
Lymphoma patients of any histology, stage or line of treatment planned to receive fixed duration 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 may also be included
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 connect Fitbit to a device that can regularly link to Hugo for data transfer 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
Excluded regimens (due to length of hospitalization required for chemotherapy administration):
R-CODOX-M/IVAC,
DA-R-EPOCH (inpatient)
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
Lack of access to a mobile device (smartphone or tablet) or computer with web access
Unable or unwilling to connect Fitbit to device
Unable or unwilling to use the health data sharing platform
Unable to give consent and be enrolled
Prior receipt of cytotoxic chemotherapy within 6 months of study start date
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