Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05273580
Acronym
wePRO-CASA
Enrollment
30
Registered
2022-03-10
Start date
2021-04-15
Completion date
2021-11-12
Last updated
2023-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEGarmin VivoSmart 4

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

DEVICEmema - ilumivu

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.

Sponsors

Royal North Shore Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Wearable compliance5 weeksWearable compliance (compliance defined HR signal detected for \>=70% of daytime hours between 7:30am to 7:30 pm)

Secondary

MeasureTime frameDescription
Quantitative and qualitative exploration of EMA/EMI acceptability2 hoursExploration 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's5 weeksCorrelative 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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026