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Clinical Trials/NCT05273580
NCT05273580
Completed
Not Applicable

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

Royal North Shore Hospital1 site in 1 country30 target enrollmentApril 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Palliative Care
Sponsor
Royal North Shore Hospital
Enrollment
30
Locations
1
Primary Endpoint
Wearable compliance
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2021
End Date
November 12, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thilo Schuler

Principal Investigator

Royal North Shore Hospital

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

Outcomes

Primary Outcomes

Wearable compliance

Time Frame: 5 weeks

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

Secondary Outcomes

  • Correlative analysis of WS signals and ePRO's(5 weeks)
  • Quantitative and qualitative exploration of EMA/EMI acceptability(2 hours)

Study Sites (1)

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