Advanced Symptom Palliation Through Integrated Relief Engagement

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Other Advanced cancer patients' palliative symptoms management using Beacon analysis of patient-provided of objective and subjective data
  The 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.

Primary outcome measures

• 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.]
• Percent of clinical palliative care encounters involving the use of the Beacon platform throughout the 12-week study. [Time frame: Throughout the 12-week study]
• 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.]
• Beacon platform fields rating according to the physicians' reviewing frequency. [Time frame: Throughout the 12-week study.]
• Physicians' rating of the Beacon-derived data contribution to clinical treatment decision-making/planning following each clinical encounter utilizing the Beacon platform. [Time frame: Throughout the 12-week study period.]

Secondary outcome measures (12)

• 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. [Time frame: Throughout the 12-week study period.]
• 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.]
• 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.]
• 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. [Time frame: At week 6 and at the end of the 12-week study period.]
• Patients' perception of the contribution of Beacon-generated data to their clinical care, assessed using a study-specific questionnaire at week 6 and at the end of the 12-week study period. [Time frame: At week 6 and at the end of the 12-week study period.]
• Health-related quality of life, assessed by The Functional Assessment of Cancer Therapy - General (FACT-G), from baseline throughout the 12-week study period. [Time frame: From baseline throughout the 12-week study period.]
• Screening for adjustment disorder related to cancer diagnosis and treatment, assessed using the Adjustment Disorder-New Module-4 (ADNM-4) questionnaire throughout the 12-week study period. [Time frame: Throughout the 12-week study period.]
• Patient-reported pain, assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ-2) questionnaire throughout the 12-week study period for selected patients. [Time frame: Throughout the 12-week study period for selected patients.]
• Patient-reported depression and anxiety, assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire throughout the 12-week study period for selected patients. [Time frame: throughout the 12-week study period for selected patients.]
• Patient-reported extent to which Beacon-derived findings were discussed and analyzed during encounters with the palliative care clinician, assessed at week 6 and at the end of the 12-week study period. [Time frame: Assessed at week 6 and at the end of the 12-week study period.]
• Patient-reported perceived contribution of Beacon usage as part of the palliative care to improve their ability to cope with their condition, assessed at week 6 and at the end of the 12-week study period. [Time frame: Assessed at week 6 and at the end of the 12-week study period.]
• 8. Patient-reported perception of the potential of systems such as Beacon to contribute to the patient-clinician communication and relationship, assessed at week 6 and at the end of the 12-week study period [Time frame: Assessed at week 6 and at the end of the 12-week study period.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Israel · 1 center

• Davidoff Center, Rabin Medical Center — Petah Tikva

Identifiers

NCT: NCT07518797 · 0795-25- RMC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗