Advanced Symptom Palliation Through Integrated Relief Engagement

Palliative Oncology Symptoms Management Utilizing Beacon© Platform's Analysis of Aggregated Patient-Provided Data - Feasibility Prospective Study

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.

An interim analysis will be performed at the midway point (approximately 6 weeks) of the first 10 consecutive patients. Feasibility will be measured quantitatively by participants' adherence with the system (i.e., wearing the smartwatch/sensor and answering the questionnaires) as well as physicians' frequency and length of logging into the patient's dashboard.

Inclusion Criteria:

• Outpatients treated and followed at the Davidoff Center
• Stage III-IV cancer
• Eastern Cooperative Oncology Group (ECOG) 0-3
• Age: 18 and older
• Have not been engaged with the ambulatory palliative service over the last three months
• Speaks and reads a language supported by the study protocol (e.g., Hebrew, Arabic, English)
• Able to wear a smartwatch/sensor for prolonged periods and independently operate the app
• Actively symptomatic patients requiring palliative care (not long-term stable survivors)
• Enrolled in another clinical study if the existing study allows

Exclusion Criteria:

• 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
• Does not speak and read languages supported by the study protocol (e.g., Hebrew, Arabic, English)
• Legal incompetence
• Does not or cannot use a smartphone, or is unable to fill out questionnaires/record messages, or is unable to wear a smartwatch/sensor, or operate the app independently