CancerASPIRE AINCT07518797
Advanced Symptom Palliation Through Integrated Relief Engagement
A study testing Advanced cancer patients' palliative symptoms management using Beacon analysis of patient-provided of objective and subjective data in people with Cancer and Symptom, run by Tzeela Cohen at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Symptom, Quality of Life
- What is being tested?
- Advanced cancer patients' palliative symptoms management using Beacon analysis of patient-provided of objective and subjective data
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Davidoff Center, Rabin Medical Center
Petah Tikva, 49100
Sarit Anavi Cohen, +972-503214030, saritanavi@gmail.com, saritana@clalit.org.il
Dorin Golinski Bani, +972-50-2957708 | +3-9376673, doringol@clalit.org.il
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cancer, Symptom, Quality of Life, AI (Artificial Intelligence)
- Being tested
- Advanced cancer patients' palliative symptoms management using Beacon analysis of patient-provided of objective and subjective data
- Keywords
- Palliative care, Biopsychosocial, Physician engagement
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced cancer patients' palliative symptoms management using Beacon analysis of patient-provided of objective and subjective dataOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Advanced cancer patients' palliative symptoms management using Beacon analysis of patient-provided of objective and subjective data |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of physician's login into the Beacon platform, per patient, throughout the 12-week study period.
Measured: Throughout the 12-week study period.
Percent of clinical palliative care encounters involving the use of the Beacon platform throughout the 12-week study.
Measured: 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.
Measured: Throughout the 12-week study period.
Beacon platform fields rating according to the physicians' reviewing frequency.
Measured: 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.
Measured: 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.
Compliance will be defined as wearing the device for ≥50% of the total possible monitoring time throughout the study period.
Measured: 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.
Measured: 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.
Measured: 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.
Assessed using a study-specific questionnaire.
Measured: 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.
Assessed using a study-specific questionnaire
Measured: 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.
FACT-G total score possible range is 0-108, with higher scores indicating better QoL.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Assessed at week 6 and at the end of the 12-week study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tzeela Cohen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tzeela Cohen, Rabin Medical Center
- Investigators
- Tzeela Cohen, MD, MHA, Principal investigator, Davidoff Center, Rabin Medical Center, Petah Tikva, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518797
- Sponsor's protocol ID
- 0795-25- RMC
- Acronym
- ASPIRE AI
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified IPD will be shared upon reasonable request, subjected to approval by the steering committee and IRB regulations, and a data use agreement
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Oncology Symptoms Management Utilizing Beacon© Platform's Analysis of Aggregated Patient-Provided Data - Feasibility Prospective Study
- ClinicalTrials.gov ID
- NCT07518797
- Acronym / sponsor ID
- ASPIRE AI / 0795-25- RMC
- Conditions
- Cancer, Symptom, Quality of Life, AI (Artificial Intelligence)
- Keywords
- Palliative care, Biopsychosocial, Physician engagement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tzeela CohenUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients' palliative symptoms management using Beacon analysis of patient-provided data | Experimental | Other: Advanced cancer patients' palliative symptoms management using Beacon analysis of patient-provided of objective and subjective dataDescription: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced cancer patients' palliative symptoms management using Beacon analysis of patient-provided of objective and subjective dataThe 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 | Cancer patients' palliative symptoms management using Beacon analysis of patient-provided data |
Primary outcome
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.
Assessed according to a study-specific questionnaire, completed by the physicians following each patient's encounter.
13 secondary outcomes
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No. De-identified IPD will be shared upon reasonable request, subjected to approval by the steering committee and IRB regulations, and a data use agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tzeela Cohen, MD, MHA principal investigator
Davidoff Center, Rabin Medical Center, Petah Tikva, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced cancer patients' palliative symptoms management using Beacon analysis of patient-provided of objective and subjective data in people with Cancer and Symptom, run by Tzeela Cohen at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daphna Murvitz, L.L.B. (+972-52-3883885, daphnamur@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.