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CancerMINERVANCT06381024

A Study of Telemonitoring in Cancer Patients

A study testing remote patient monitoring in people with Cancer, run by Centre Hospitalier de Bligny at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
remote patient monitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteFrance
Study dates
4 Apr 2023to 4 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

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

  • Patients that have provide written informed consent for study participation.
  • Patients aged 18 years or older.
  • Patients initiating oral or intravenous treatment (chemotherapy, immunotherapy, targeted therapies etc.) for localized or metastatic or recurrent cancer treated at the CH Bligny.
  • Patients with the capacity, personally (e.g., language and capacity to use the application), and in terms of infrastructure (internet access, possessing a smart phone etc.) to perform telemonitoring with Cureety.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

Who cannot join

  • Patients treated for cancer at the CH Bligny in the last 5 years

Trial locations and contacts

1 site in 1 country.

France1 site
  • Centre Hospitalier de Bligny

    Briis-sous-Forges, 91640

Other trials in France

About this study

Official title: 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.

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:

Read more
  • 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)
Read the detailed description

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.
Conditions
Cancer
Being tested
remote patient monitoring
Keywords
remote patient monitoring
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • remote patient monitoringDevice

    Also called Cureety

    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.

Study groups in NCT06381024
Study groupRoleWhat they receive
Standard of care groupNo interventionStandard of care
Standard of care with Cureety groupExperimentalIn-person care with remote patient monitoring with the Cureety application
Receives: Device: remote patient monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of all telephone calls during the first 4 months of oral or intravenous cancer treatment

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

    Measured: 4 months after randomization

Secondary outcomes (6)
  1. Duration of all telephone calls during the first 4 months of oral or intravenous cancer treatment

    Measured: During 4 months after randomization

  2. Numbers of telephone calls during the first 4 months of cancer treatment in subgroups

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

    Measured: During 4 months after randomization

  3. Hospital-free survival rate

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

    Measured: During 4 months after randomization

  4. Quality of life at 2 and 4 months after initiation of cancer treatment.

    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

    Measured: During 4 months after randomization

  5. Patient satisfaction with the healthcare provided

    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.

    Measured: During 4 months after randomization

  6. CH Bligny staff satisfaction with the healthcare provided

    • 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.

    Measured: At 12 months after first inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2024
  2. Study start4 Apr 2023
  3. Primary completion4 Sep 2024
  4. Study completion4 Sep 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06381024
Sponsor's protocol ID
2022 A02702-41
Acronym
MINERVA
Status last verified
Dec 2025
First submitted
28 Feb 2024
Last updated
5 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing remote patient monitoring in people with Cancer, run by Centre Hospitalier de Bligny at 1 site in France.

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 5 inclusion and 1 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: finished, as of the sponsor's last update on 5 Jan 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 France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of all telephone calls during the first 4 months of oral or intravenous cancer treatment (time frame: 4 months after randomization). 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 5 Jan 2026.

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