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CONTINUUM+ CONNECT is a web platform, accessible via the internet, which contains the digital medical device (DMN) Continuum+ alert module. This is a medical software intended for the interpretation of clinical constants, symptoms, adverse events and pain, generating alerts with a view to improving the monitoring of patients undergoing anticancer treatment. The "Continuum+ Alert Module" version 1.0.0 dated 30 April 2021 is CE-marked and will be used in accordance with the manufacturer's instructions for use by patients in the experimental group.

CONTINUUM+ CONNECT remote monitoring

Manon VOEGELIN

Julien GRENIER, MD

Yann MOTTAZ, MD

Yann MOTTAZ, Md

Pierre DALLOZ, MD

Leila BENGRINE, MD

Tiffany DARBAS, MD

Laurene GAVOILLE, MD

Jérôme MARTIN-BABAU, MD

Christelle JOUANNAUD, MD

Pierre CORNILLON, MD

Philippe BARTHELEMY, MD

Bertrand MENNECIER, MD

FEGALA is a comparative, multicenter, randomized, prospective, open-label study comparing the results observed at 3 months (± 15 days) on the EORTC QLQ-C30 scale in a group of patients with metastatic cancer followed on an outpatient basis and benefiting from the CONTINUUM+ CONNECT solution (with or without nursing support at home) versus comparable patients benefiting from conventional monitoring.

CONTINUUM+ CONNECT is a platform, accessible from a computer, a smartphone or a tablet, allowing remote monitoring of cancer patients followed on an outpatient basis. The remotely monitored patient is invited to answer questionnaires (regarding adverse events, physiological constants and pain) at home. These questionnaires are either completed by the patient himself, if his condition allows it (self-assessment) or completed with the help of a professional on an outpatient basis (hetero-assessment). The data and alerts are transmitted in real time to the healthcare professionals in charge of the patient who analyze them and then determine the course of action to take.

In order to evaluate the impact of remote monitoring by CONTINUUM+ CONNECT on the quality of life and health of patients with metastatic cancer, the present prospective randomized multicenter study will be carried out.

Four main types of cancer will be studied: Breast, Lung, Colorectal and Prostate cancer.

Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution

Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution: Prospective, Randomized, Multicenter Trial FEGALA

Difference in physical health score from EORTC QLQ-C30 questionnaire at 3 months (± 15 days) in patients with metastatic cancer depending on intervention group

Difference in physical health score from EORTC QLQ-C30 questionnaire at 3 months (± 15 days) in patients with metastatic cancer depending on intervention group (patients using CONTINUUM+ CONNECT solution (hetero- and self-assessment) or with conventional care)

Difference according to intervention group regarding all dimensions of EORTC QLQ-C30 questionnaires

Difference on specific symptom scales QLQ-BR23

Difference on specific symptom scales QLQ-LC13

Difference on specific symptom scales QLQ-PR25

Difference on specific symptom scales QLQ-CR29

Percentage of patients with at least one adverse event (graded 3 or 4 according to NCI-CTCAE V5.0) at evaluation visit at 3 months.

Percentage of patients with at least one adverse event (graded 3 or 4 according to NCI-CTCAE V5.0) at Follow-up (FU) visit at 6 months.

Percentage of patients that required at least one unscheduled hospitalization due to their cancer and/or treatment during the 3 months following their enrollment in the trial based on patient's medical record

Percentage of patients that required at least one unscheduled hospitalization due to their cancer during the 6 months following their enrollment in the trial based on patient's medical record

Dedicated questionnaire available in French from CONTINUUM+ CONNECT solution

Continuum Plus Santé

Plateforme nationale qualité de vie et cancer

WeShare

Institut de cancérologie Strasbourg Europe

All patients enrolled in the study will participate in the Gaido Intervention, which entails wearing the Biovotion Everion continuously and take blood pressure and oral temperature spot checks per clinician orders. Patients will also be responsible for filling out PRO surveys and any surveys that trigger as a result of their vital signs falling outside of tailored thresholds.

Patients will participate for up to 21 days. Over the course of the study, 25-100 patients will be enrolled.

Gaido

Philip Lowry, MD

The goal of this research is to study an intervention, which the investigators call "Remote Electronic Patient Monitoring," that entails vital sign data (enabled with smart algorithms for notification) and patient-reported outcomes (PROs), (such as physical and psychological symptoms) intended to address and manage any concerning issues and or diagnoses identified.

Specifically, the plan is a study of oncology patients who will use the Gaido system for up to 21 days or per physician order.

Gaido Health's Remote Patient Monitoring Solution v1.0 is a wireless remote monitoring system intended for use by healthcare professionals for the collection of physiological data in home and healthcare settings. Patient information is displayed on a computer located at the medical institution. Every 15 minutes, a measurement is plotted on the User Interface of heart rate / respiration rate (by a Biovotion device). A non-invasive blood pressure (by an Omron device) along with an oral digital thermometer reading are taken per clinician orders and displayed on the Gaido dashboard. Wearable data are transmitted wirelessly from the Biovotion sensor (heart rate and respiratory rate) to the patient's smart phone that relays data to a cloud-based server for storage and analysis. Oral temperature and blood pressure are entered by the patient or care-giver into the patient's smart phone that relays data to a cloud-based server for storage.

The Remote Patient Monitoring system uses algorithms that indicate when patient vitals and patient reported outcomes have changed. Automatic patient surveys are sent to the patient with results displayed both on the computer located in the medical institution and the patient's smart phone. The patient surveys gather patient reported symptoms which are intended to be used in combination with vital signs to support decision-making. The system is intended for use with patients 18 years of age and older who are cared for by healthcare professionals.

Remote Electronic Patient Monitoring in Oncology Patients

Feasibility will be measured through utilization of the intervention to track statistics such as wear time, completion of patient reported outcomes patients who are meet the criteria and are enrolled in the study. o Analysis of patient wear time for Gaido, using reporting tools as part of the Gaido solution.

* Proportion of time that patients wear the Gaido solution
* Proportion of participants completing self-reported symptom monitoring through the device
* Proportion of participants completing vital sign data entry (blood pressure and oral temperature) through the device

The research team will conduct semi-structured interviews with patients, to obtain feedback on usability and utility of the Gaido solution.

To describe health care utilization, potential conditions detected on patients receiving Remote Electronic Patient Monitoring.corresponding interventions on patients receiving Remote Electronic Patient Monitoring.The Electronic Health Record (EHR) will be used to validate the potential Gaido conditions/findings. The following information will be gathered from the EHR: clinical factors (e.g. activities of daily living, tumor staging, diagnosis dates, cancer treatment, prior cancer history, medical comorbidities, and current medications), health care utilization (e.g. inpatient admissions and emergency department visits), and end-of-life care (e.g. death date, hospice enrollment, location of death).

The Guthrie Clinic

Gaido Health

In-person care with remote patient monitoring with the Cureety application

Cureety is a digital telemonitoring platform, specifically designed to monitor signs and symptoms of disease progression and AEs in cancer patients. The digital tool is adaptable to specific treatments and disease settings. The platform collects various data including treatment delays, dose reductions, quality of life and safety data. In terms of safety, once configured for the treatment and disease setting, the patient responds to an electronic PRO (ePRO) questionnaire based on the NCI-CTCAE version (v)5.0.10 Depending on the responses, an algorithm classifies patients as either "correct", "compromised", "state to be monitored", or "critical state". Depending on the classification, patients are notified of the actions to be taken.

remote patient monitoring

Ingrid Alexandre, MD

The goal of this prospective, randomized, unblinded, single-centre, interventional study is to assess the effectiveness of standard of care with Cureety, compared to standard of care alone, to reduce the number of all telephone calls during the first 4 months of oral or intravenous cancer treatment for patients older than 18 years of age, initiating oral or intravenous cancer treatment at the Centre Hospitalier de Bligny.

Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 1:1 ratio to either:

* In-person care alone (Standard of care group).
* In-person care with Cureety telemonitoring (Standard of care with Cureety group).

Participants will:

* be monitored with digital application Cureety (Standard of care with Cureety group)
* fill out quality of life questionnaire (baseline, 2 months, 4 months)
* fill out satisfaction questionnaire (2 months, 4 months)
* have the ongoing and incoming phone calls logged (duration and type)

Rationale:

Telemonitoring of cancer patients provides patients with cancer-related information, as well as allowing appointment management, early detection of side-effects/adverse events (AEs), and the collection of safety and quality of life data from the patients' perspectives.1 Several studies have assessed the benefit of telemonitoring from the patients' perspective.1-5 However, few studies have investigated the benefit of telemonitoring for healthcare professionals.4,6,7 The Symptom Tracking and Reporting (STAR) randomized trial, performed at the Memorial Sloan Kettering Institute, randomly allocated patients to either usual care or the patient-reported outcome (PRO) group.8,9 Patients in the PRO group completed a web-based questionnaire concerning 12 common AEs (based on the National Cancer Institute Common Terminology Criteria for AEs \[NCI-CTCAE version (v) 5.0\]10) at or between visits. In the PRO group, 63% of patients reported severe AEs during the study. Patients, in the PRO group, reported improved quality of life, fewer admissions to emergency rooms or hospitalization, extended duration of chemotherapy, and extended overall survival (OS). This increased OS is potentially due to the early response by healthcare professionals to severe AEs identified by the web-based questionnaire. For healthcare professionals, the study reported fewer unscheduled visits for patients allocated to the PRO group.

Interestingly, in the STAR trial, 77% of the nurse interventions (either by email or telephone) were in response to alerts (either counseling or symptom management), 12% were for initiating or changing of supportive treatment, 8% were for referrals to the emergency room or hospital, 2% were for chemotherapy dose modifications, and 2% were for ordering imagery or biological test.11 In France, the Foch hospital initiated the Star program for patients undergoing chemotherapy.12 The program collects patient data within at most 3 days prior to each chemotherapy session and transfer these to healthcare professionals to prepare the chemotherapy. The patient has the choice of completing a questionnaire via the internet or providing the information by telephone with the aid of a nurse. The data includes health status, presence of AEs, and blood test results. These data allow healthcare professionals to adapt or delay the chemotherapy, change treatments, and provide the patient with personalized advice according to the patient's health status. The program has improved the performance of departments involved by increasing the number of patients treated per day, decreasing the waiting times for patients, and by reducing the wastage of healthcare products.

Consequently, numerous French healthcare centers want to implement programs like the Star program. However, a substantial portion of the data collection occurs via the telephone, particularly outgoing calls (from the hospital staff to patients). This increase in telephone communication means more work for healthcare professions. A digital telemonitoring platform, like Cureety that can collect this data before chemotherapy, is expected to decrease outgoing calls by between 30% to 50% and facilitate the implementing of these programs.

Furthermore, healthcare centers in France are continually facing budget restrictions. At the same time, treating cancer patients is associated with an increase in incoming calls from patients during cancer treatment, particularly for minor AEs. The treating of these incoming calls is often repetitive and time consuming for hospital staff. The collection of data concerning AEs, of varying severity, can be integrated in a digital platform. Patients with minor AEs can be provided with the actions to be followed via the platform. This will allow staff to concentrate on patients with severe AEs needing urgent attention.

Cureety is a digital telemonitoring platform, specifically designed to monitor signs and symptoms of disease progression and AEs in cancer patients. The digital tool is adaptable to specific treatments and disease settings. The platform collects various data including treatment delays, dose reductions, quality of life and safety data. In terms of safety, once configured for the treatment and disease setting, the patient responds to an electronic PRO (ePRO) questionnaire based on the NCI-CTCAE version (v)5.0.10 Depending on the responses, an algorithm classifies patients as either "correct", "compromised", "state to be monitored", or "critical state". Depending on the classification, patients are notified of the actions to be taken.

This study will assess the benefit of adding Cureety telemonitoring to standard of care, compared to standard of care alone, for monitoring cancer patients undergoing oral or intravenous cancer treatments.

Methodology:

The MINERVA study was designed as a prospective, randomized, unblinded, single-centre, interventional study with minimal risks and constraints for patients.

Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 1:1 ratio to either:

* In-person care alone (Standard of care group).
* In-person care with telemonitoring (Standard of care with Cureety group).

The randomization will be stratified by:

• Oral versus intravenous cancer treatment. The number of patients initiating oral treatment at randomization will be restricted to 20 patients.

Data concerning the telephone calls between study patients and the staff at the CH Bligny will be collected. The incoming and outgoing calls from the CH Bligny will be classified in the following categories:

* Cancer treatments information (including the use of associated prophylactic treatments, e.g., granulocyte colony-stimulating factor \[G-CSF\], antihistamines etc.)
* Appointments, in the following subcategories:

  * Administration of cancer therapy (including oral and intravenous treatments, etc.).
  * Consultations for a reason other than administering therapy.
  * Blood tests and other examinations.
* Prescriptions.
* Biological examinations (in preparation for cancer treatment).
* Psychological support.
* Patient education and supportive care.
* Cancer treatment-related AEs.
* Non-cancer treatment-related AEs, excluding COVID-related.
* COVID-related.
* Related to Cureety.
* Other calls. The planned enrolment period is 5 months. The planned follow-up period for each patient is 4 months.

Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 1:1 ratio to either:

* In-person care alone (Standard of care group).
* In-person care with telemonitoring (Standard of care with Cureety group).

The randomization will be stratified by:

• Oral versus intravenous cancer treatment. The number of patients initiating oral treatment at randomization will be restricted to 20 patients.

A Study of Telemonitoring in Cancer Patients

A Study of the Benefit of Telemonitoring for Hospital Staff Treating Patients With Oral or Intravenous Cancer Treatments: a French Prospective, Randomized, Unblinded, Single-centre Study.

Number of calls, defined as the number of incoming and outgoing calls that occurs during the 4 months from randomization

Numbers of telephone calls during the first 4 months of cancer treatment in subgroups: Incoming calls, Outgoing calls, categories of calls

Hospital-free survival (HFS) is defined as the time interval (in days) without any hospitalization from randomization until death of any cause.

Quality of life (QoL) in the study groups will be compared using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire14 measured relative to baseline at 2 and 4 months (±3 weeks) after randomization. The QoL will be compared overall and according to the scales

Patient satisfaction with the healthcare provided, in the study groups, will be compared using 4-point Likert scale (1 for not at all satisfied to 4 completely satisfied), measured at 2 and 4 months (±3 weeks) after randomization.

• CH Bligny staff satisfaction with the healthcare provided, in the study groups, will be compared using a specific questionnaire provided to the staff at the end of the study period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution	NCT06379880	Prostatic Neopl... Lung Neoplasms Breast Neoplasm... Colorectal Neop...	CONTINUUM+ CONN...	18 Years -	Institut de cancérologie Strasbourg Europe
Remote Electronic Patient Monitoring in Oncology Patients	NCT04086251	Cancer	Gaido	18 Years -	Gaido Health
A Study of Telemonitoring in Cancer Patients	NCT06381024	Cancer	remote patient ...	18 Years -	Centre Hospitalier de Bligny

Spots Global Cancer Trial Database for remote patient monitoring