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

Cancer Clinical Trial

— wePRO-CASA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05273580
• Other study ID #: wePRO-CASA
• Status: Completed
• Start date: April 15, 2021
• Est. completion date: November 12, 2021

Study information

• Verified date: February 2023
• Source: Royal North Shore Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 12, 2021
• Est. primary completion date: August 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Garmin VivoSmart 4
Wearable sensor to record; sleep, stress, heart rate etc.
• mema - 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.

Locations

Country	Name	City	State
Australia	Royal North Shore Hospital	St Leonards	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Royal North Shore Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wearable compliance	Wearable compliance (compliance defined HR signal detected for >=70% of daytime hours between 7:30am to 7:30 pm)	5 weeks
Secondary	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
Secondary	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

External Links

•   Project website