Clinical trial NCT05273580: Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Palliative Care
Official title: Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Advanced Cancer Patients and Their Carers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Palliative Care
Wearable Electronic Devices
Patient Reported Outcome Measures
Cancer
Caregiver
Digital Health
Lead sponsor: Royal North Shore Hospital
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Palliative care patient and their respective carer attending at Northern Sydney Cancer Centre, RNSH.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Wearable compliance
timeFrame: 5 weeks
Secondary outcomes:
measure: Quantitative and qualitative exploration of EMA/EMI acceptability
timeFrame: 2 hours
measure: Correlative analysis of WS signals and ePRO's
timeFrame: 5 weeks
Other outcomes:
Locations:
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
Study officials:
affiliation: Royal North Shore Hospital
name: Thilo Schuler
role: PRINCIPAL_INVESTIGATOR
References: