Eligible patients will be identified by the Nurse Practitioner Cancer \& Palliative Care.

The respective carers who are identified by the Nurse Practitioner Cancer \& Palliative Care as eligible participants.

Wearable sensor to record; sleep, stress, heart rate etc.

Garmin VivoSmart 4

mEMA is the a self-service platform running on both iOS and Android that is specifically designed for the administration of mobile Ecological Momentary Assessment or Experience Sampling research studies.

mema - ilumivu

Thilo Schuler

Non-professional carers (typically family members) play a critical role in providing adequate home care. This research explores the use of wearable sensors (WS) and electronic patient-reported outcome (ePRO) surveys to monitor stress levels of advanced cancer patient/carer dyads. During wear times, WS-triggered ecological momentary assessments (EMAs) were conducted via short smartphone-based surveys. This pilot study investigates the feasibility of EMAs in community palliative care.

Non-professional carers (typically family members) play a critical role in providing adequate home care along with professional caregivers. However, the physical and emotional toll of caring for a family member can lead to distress and burn out of the carer. The latter often results in the need for temporary or permanent institutional care of the patient. This research explores the feasibility of wearable sensors (WS) and electronic patient-reported outcome (ePRO) surveys to monitor activity patterns and stress levels of advanced cancer patient/caregiver dyads in order to understand their needs better.

Throughout the study, wearable sensors are used to passively record physiological data from patient/carer dyads. During wear times, WS recordings trigger ecological momentary assessments (EMAs) conducted via surveys. This pilot investigates the feasibility and acceptability of EMAs in community palliative care and the potential for incorporating EMA-based interventions into routine care. Future studies may explore the possibility of ecological momentary interventions (EMIs) to trigger just-in-time targeted interventions.

Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Palliative Care

Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Advanced Cancer Patients and Their Carers

The results of this trial will be published in a peer reviewed journal. We are targeting high-impact palliative care journals such as 'Palliative Medicine' for publication.

Wearable compliance (compliance defined HR signal detected for \>=70% of daytime hours between 7:30am to 7:30 pm)

Exploration of EMA/EMI acceptability by patient/carer dyads quantitatively using experience surveys and qualitatively using an (optional) focus group.

Correlative analysis of WS signals and ePRO answers with focus on:

* Intra-dyadic longitudinal trends (Is there correlation between metrics of a patient and their carer?)
* EMA trigger incidences and distribution of ePRO-stated trigger reasons including "false alarms" of the whole cohort

Royal North Shore Hospital

Principal Investigator

Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All study participants will be enrolled in a 3-month digital health coaching program. They will also receive a Fitbit device to be worn daily for the capture of physical activity data.

Participants have the option to participate in a one time interview about their treatment experience.

consisting of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.

Digital Health Coaching Program

A wrist-worn activity tracker allowing for the capture of physical activity, including but not limited to step-count and minutes of activity, to be captured daily.

Fitbit

Kelly J Brassil, PhD

Jennifer Loftis, DNP

Jasper Olsem

Melody R Becnel, MD

Trenton Grossfeld, BS

Rahul Banerjee, MD

This descriptive study aims to evaluate the experience of adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc through collection of quantitative, qualitative and wearable data. Fifty adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc will be enrolled across 2 sites, The University of California San Francisco and The University of Texas MD Anderson Cancer Center. Consented participants will be enrolled in a 3-month digital health coaching program through which electronic patient reported outcomes and wearable activity data will be collected. Outcomes include treatment experience, quality of life, financial toxicity, treatment adherence, symptom burden and health self-efficacy. These will be captured by patient reported outcome measures including the Patient's Qualitative Assessment of Treatment- Real World (PQAT-RW), Patient Global Impression of Change/Severity (PGIC/S), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), Quality of Life Questionnaire Multiple Myeloma (QLQ-MY20), and the European QoL-5 Dimensions (EQ5D), Cancer Behavior Inventory-Brief Form (CBI-B), Center for Adherence Support Evaluation (CASE) Medication Adherence Index, Comprehensive Score for Financial Toxicity (COST) Instrument.

Clinical data, including treatment history, healthcare utilization, and co-morbidities, as well as demographic data will be collected via the electronic health record from each clinical site. This data will be complemented by qualitative data from a selected cohort of study participants with a focus on treatment experience ranging from infusion burden, toxicity management, to overall quality of life. Evaluation of this data in combination will be used to better understand the treatment experience of individuals on standard of care isatuximab-irfc specifically, and with relapsed or refractory multiple myeloma generally, contributing to an existing gap in the literature regarding patient reported outcomes from diverse data sources. Outcomes will be analyzed with attention to the relationship between social determinants of health, including race, ethnicity, and geographic location, and treatment experience as reflected in both the qualitative and quantitative data.

A single cohort of 50 individuals with relapsed/refractory multiple myeloma will be enrolled in the study, all of which will be enrolled in a digital health coaching program and receive a Fitbit device for activity tracking. Individuals from both study sites will be enrolled to this single cohort.

Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma With Isatuximab

Clinical and Patient Reported Outcomes for Individuals With Relapsed/Refractory Multiple Myeloma Treated With Isatuximab: Real-World Insights From Patient Reported, Wearable, and Qualitative Data in the Context of Digital Health Coaching

Physical activity, including step count and minutes of physical activity will be collected via Fitbits provided to study participants

Frequency, types and duration of engagement with the digital health coaching platform

A 6-item survey assessing experience of a drug during clinical trial. The instrument consists of 3-free text and 3 scaled responses assessing the perceived benefits and disadvantages of received treatment and willingness to continue on drug after the study.

A one time interview will be conducted to learn more about the experience of individuals related to their diagnosis, treatment, symptoms, side effects and overall care experience.

A 30-item measure of quality of life across 5 domains, including physical, emotional, social, role and cognitive), 8 symptoms, and items assessing global health and financial toxicity. Recall over the past week is scored primarily on a 4-point scale ranging from "not at all" to "very much". The instrument may be administered either on paper or electronically.

A 20-item measure of quality of life among individuals with multiple myeloma. It assesses a series of symptoms on a 4-point Likert scale ranging from 1 (Not at All) to 4 (Very Much).

A measure of quality of life across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

This 12-item instrument measures self-efficacy in coping with cancer across 7 domains. These include: Seeking and Understanding Medical Information, Emotion Regulation, Coping with Treatment Related Side Effects, Accepting Cancer/ Maintaining a Positive Attitude, Seeking Social Support, and Using Spiritual Coping. The instrument utilizes a 9-point response scale ranging from 1 "Not at all confident" to 9 "Confident".

A 1-item measure of severity of relapsed/refractory multiple myeloma symptoms since the last visit, which is scored a on a 5-response scale ranging from "none" to "very severe".

A 1-item measure of patient perception of change in relapsed/refractory multiple myeloma symptoms since starting a study. Responses are scored on a 7-point scale, ranging from "very much worse" to "very much better".

The Center for Adherence Support Evaluation (CASE) is a three-item questionnaire used to measure antiretroviral therapy adherence. This questionnaire was developed through the Special Projects of National Significance (SPNS) initiative called Assessing Existing Efforts to Increase Adherence to Medication. Patients take less than 5 minutes to answer the three unique questions, asking about their difficulty taking medications on time, average days per week with one dose missed, and the last time they missed a dose.

The Comprehensive Score for Financial Toxicity (COST) is an 11-item instrument used to measure the financial toxicity of cancer treatment, which has been demonstrated to be highly correlated with HRQoL (de Souza et al., 2017). This instrument was validated among individuals with advanced cancer and demonstrated high internal consistency (Cronbach's α \>.90) and highly correlated to HRQol (p=.05). The instrument consists of 11 items, utilizing a five-point ordinal scale ranging from (0- Not at all) to (4- Very much).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Palliative Care	NCT05273580	Palliative Care Wearable Electr... Patient Reporte... Cancer Caregiver Digital Health	Garmin VivoSmar... mema - ilumivu	-	Royal North Shore Hospital
Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Palliative Care	NCT05273580	Palliative Care Wearable Electr... Patient Reporte... Cancer Caregiver Digital Health	Garmin VivoSmar... mema - ilumivu	-	Royal North Shore Hospital
Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma With Isatuximab	NCT05053607	Multiple Myelom... Refractory Mult...	Digital Health ... Fitbit	18 Years -	Pack Health

Spots Global Cancer Trial Database for wearable electronic devices