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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Palliative Care, Wearable Electronic Devices, Patient Reported Outcome Measures, Cancer, Caregiver, Digital Health

Intervention / Treatment
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* Device: Garmin VivoSmart 4
* Device: mema - ilumivu


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Palliative care patient attending at Northern Sydney Cancer Centre, RNSH Patient and carer dyad Both patient and carer consent Patient Karnofsky Performance Scale ≥ 50 Patient and carer have compatible smart phone Exclusion Criteria: • Unwilling or unable to give informed consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Eligible patients will be identified by the Nurse Practitioner Cancer & Palliative Care. | Device: Garmin VivoSmart 4<br>* Wearable sensor to record; sleep, stress, heart rate etc.<br>Device: mema - ilumivu<br>* 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.<br>|
| Carers<br>The respective carers who are identified by the Nurse Practitioner Cancer & Palliative Care as eligible participants. | Device: Garmin VivoSmart 4<br>* Wearable sensor to record; sleep, stress, heart rate etc.<br>Device: mema - ilumivu<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wearable compliance | Wearable compliance (compliance defined HR signal detected for >=70% of daytime hours between 7:30am to 7:30 pm) | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative and qualitative exploration of EMA/EMI acceptability | Exploration of EMA/EMI acceptability by patient/carer dyads quantitatively using experience surveys and qualitatively using an (optional) focus group. | 2 hours | 
| Correlative analysis of WS signals and ePRO's | 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 | 5 weeks |