Advanced Symptom Palliation Through Integrated Relief Engagement
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTzeela Cohen
About this trial
Beacon is a digital platform that processes objective and subjective aggregated data provided by patients. Objective data is provided by standard wearables, while subjective data is provided by patient-reported outcome measures (PROMs), comprising written and vocal patient reporting.
The ASPIRE.AI study is a prospective study evaluating the feasibility of clinicians' use of aggregated data that was provided by patients and analyzed through "Beacon", and its influence on advanced cancer patients' palliative symptoms management.
Approximately 40 consecutive eligible ambulatory advanced cancer patients first attending the palliative unit in the Davidoff Center will be enrolled. The trial will continue for \~1 year, with each patient participating in this trial for a total of about 12 weeks.
All participants will receive the intervention. The intervention comprises the palliative standard of care treatment along with the usage of the Beacon digital platform, which enables comprehensive data collection and aggregation regarding the patient's biopsychosocial status, and thus, the patient's symptom burden.
Data collected and aggregated through Beacon includes Beacon data provided by the patients via wearables (smartwatch/sensors), smartphones, and written and recorded PROMs.
Researchers will then evaluate physician engagement with the platform, Influence on treatment, and the physician user experience rating as well as patients' adherence, satisfaction with Beacon usage, and changes in patients' symptom burden and quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Outpatients treated and followed at the Davidoff Center
Stage III-IV cancer
Eastern Cooperative Oncology Group (ECOG) 0-3
Age: 18 and older
Disqualifiers
Patient without active disease
Patients are actively engaged with the ambulatory palliative service in the - Davidoff Center or elsewhere
Patient with chronic stable symptoms (>6 months) related to their cancer or treatment
ECOG > 3
Trial design
Design model
Single group
Treatments tested in this trial
Advanced cancer patients' palliative symptoms management using Beacon analysis of patient-provided of objective and subjective data
Other interventionThe study intervention consists of palliative standard of care treatment, including a comprehensive data collection regarding the patient's biopsychosocial status using Beacon digital platform, which aggregates patients' provided data. Data includes objective, continuously recorded physiological parameters using wearables and smartphones, while subjective data consists of written and vocal patient-reported outcome measures.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Cancer patients' palliative symptoms management using Beacon analysis of patient-provided dataExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The number of physician's login into the Beacon platform, per patient, throughout the 12-week study period.
Time frame
Throughout the 12-week study period.2
Percent of clinical palliative care encounters involving the use of the Beacon platform throughout the 12-week study.
Time frame
Throughout the 12-week study3
The number of fields reviewed by the physician per login to the Beacon platform throughout the 12-week study period.
Time frame
Throughout the 12-week study period.4
Beacon platform fields rating according to the physicians' reviewing frequency.
Time frame
Throughout the 12-week study.Secondary outcomes
1
Patient adherence to data provision throughout the study period, assessed by wearable devices wear time in terms of hours/day, throughout the 12-week study period.
Compliance will be defined as wearing the device for ≥50% of the total possible monitoring time throughout the study period.
Time frame
Throughout the 12-week study period.2
Patient adherence to data provision throughout the study period, assessed by the percentage of Patient-Reported Outcome Measures (PROMs) completion throughout the 12-week study period.
Time frame
Throughout the 12-week study period.3
Patient adherence to data provision, assessed by the percentage of audio-recordings/week completion throughout the 12-week study period.
Time frame
Throughout the 12-week study period.4
Patient-rated user experience and perceived burden associated with Beacon-related assignments, assessed using a study-specific questionnaire at week 6 and at the end of the 12-week study period.
Assessed using a study-specific questionnaire.
Time frame
At week 6 and at the end of the 12-week study period.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tzeela Cohen
Lead sponsor
Rabin Medical Center
Sponsor institution
Source ClinicalTrials.gov
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