Advanced Symptom Palliation Through Integrated Relief Engagement

NCT07518797 | Not Yet Recruiting

• 1 other identifier: 0795-25- RMC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Symptom; Quality of Life; AI (Artificial Intelligence)

Keywords

Palliative care; Biopsychosocial; Physician engagement

Outcome Measures

Primary Outcomes (5)

• The number of physician's login into the Beacon platform, per patient, 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.

  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.

  Throughout the 12-week study period.

• Beacon platform fields rating according to the physicians' reviewing frequency.

  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.

  Assessed according to a study-specific questionnaire, completed by the physicians following each patient's encounter.

  Throughout the 12-week study period.

Secondary Outcomes (13)

• 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.

  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.

  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.

  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.

  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.

  At week 6 and at the end of the 12-week study period.

Study Arms (1)

Cancer patients' palliative symptoms management using Beacon analysis of patient-provided data

EXPERIMENTAL

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

Interventions

Advanced cancer patients' palliative symptoms management using Beacon analysis of patient-provided of objective and subjective data OTHER

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.

Cancer patients' palliative symptoms management using Beacon analysis of patient-provided data

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tzeela Cohen: lead

Study Sites (1)

Davidoff Center, Rabin Medical Center

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Tzeela Cohen, MD, MHA

  Davidoff Center, Rabin Medical Center, Petah Tikva, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daphna Murvitz, L.L.B.

CONTACT

+972-52-3883885; daphnamur@clalit.org.il

Sarit Anavi Cohen, PhD

CONTACT

+972-50-3214030; saritanavi@gmail.com, saritana@clalit.org.il,

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Tzeela Cohen, MD, MHA

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)