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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
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.
Davidoff Center, Rabin Medical Center
Petah Tikva, Israel
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.
Assessed according to a study-specific questionnaire, completed by the physicians following each patient's encounter.
Time frame: Throughout the 12-week study period.
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.
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.
Assessed using a study-specific questionnaire.
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.
Assessed using a study-specific questionnaire
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.
FACT-G total score possible range is 0-108, with higher scores indicating better QoL.
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.
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.
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.
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.
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.
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.
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.
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