Advanced Symptom Palliation Through Integrated Relief Engagement (ASPIRE AI)

April 2, 2026 updated by: Tzeela Cohen

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cancer patients' palliative symptoms management using Beacon analysis of patient-provided data
Description: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Throughout the 12-week study period.
Beacon platform fields rating according to the physicians' reviewing frequency.
Time Frame: Throughout the 12-week study.
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.
Assessed according to a study-specific questionnaire, completed by the physicians following each patient's encounter.
Throughout the 12-week study period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Compliance will be defined as wearing the device for ≥50% of the total possible monitoring time throughout the study period.
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.
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.
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.
Assessed using a study-specific questionnaire.
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.
Assessed using a study-specific questionnaire
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.
FACT-G total score possible range is 0-108, with higher scores indicating better QoL.
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.
ADNM-4 Total score ranges from 4 to 16. A higher score indicates greater difficulty adjusting. A total score ≥9 (corresponding to the recommended cutoff of 8.5) is indicative of Adjustment Disorder.
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.
SF-MPQ-2 analysis includes 4 subscale scores, which are calculated as the mean of the items in each subscale, and the total score, which is calculated as the mean of all items. Higher subscale/total scale scores indicate more intense symptoms.
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.
The total score on each subscale, anxiety and depression, ranges from 0 to 21. Higher scores represent higher levels of anxiety and depression. The cut-off points for the anxiety and depression subscales are as follows: 0-7 = normal; 8-10 = mild; 11-15 = moderate; 16-21 = severe.
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.
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.
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.
Assessed at week 6 and at the end of the 12-week study period.
Palliative care clinician-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.
Assessed at week 6 and at the end of the 12-week study period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tzeela Cohen

Investigators

  • Principal Investigator: Tzeela Cohen, MD, MHA, Davidoff Center, Rabin Medical Center, Petah Tikva, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

March 29, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0795-25- RMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified IPD will be shared upon reasonable request, subjected to approval by the steering committee and IRB regulations, and a data use agreement

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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