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Adult Patients Initiating Injectable AnticancerOPTIMACURENCT06371911

Benefit of Adding Cureety TechCare Telemonitoring to Usual Care During Injectable Anticancer Treatment

A study testing Cureety telemonitoring and OPTIMA or equivalent programs in people with Adult Patients Initiating Injectable Anticancer, run by Centre Francois Baclesse at 3 sites 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

Currently, during usual care, it is critical to assess whether a patient is apt to receive injectable anticancer treatment in the days prior to the administration. To assess this, blood tests are usually performed in the days leading up to the planned administration. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cureety telemonitoring and OPTIMA or equivalent programs
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
3 sitesFrance
Study dates
3 Apr 2024to 16 Aug 2025
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 provided written informed consent for study participation before any trial-related activities.
  • Patients aged 18 years or older.
  • Patients initiating injectable anticancer treatment (chemotherapy, immunotherapy, targeted therapies etc.).
  • 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 Cureety telemonitoring.
  • Patient affiliated to an appropriate social security system
  • Non-inclusion criteria
Show all 12Show fewer
  • Exclusive oral cancer treatment
  • Patient with dysphonia or difficulty communicating orally
  • Patient benefiting from injectable cancer treatment as part of a clinical trial
  • Inability to undergo trial monitoring for geographical, social or psychological reasons
  • Any associated medical or psychological condition that could compromise the patient's ability to participate in the study
  • Patient deprived of freedom or under guardianship

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

France3 sites
  • Centre hospitalier de Bligny

    Bligny

  • Centre François Baclesse

    Caen, 14000

  • Centre de Radiothérapie et Oncologie Médicale d'Osny

    Osny

Other trials in France

About this study

Official title: Benefit of Adding Cureety TechCare Telemonitoring to Usual Care During Injectable Anticancer Treatment: a Multicentric French Prospective Randomized Study: The OPTIMACURE Protocol

Currently, during usual care, it is critical to assess whether a patient is apt to receive injectable anticancer treatment in the days prior to the administration. To assess this, blood tests are usually performed in the days leading up to the planned administration. A hospital staff member then telephones the patients and evaluates, using the tests results and other patient data (including the presence of adverse events (AEs) and Eastern Cooperative Oncology Group [ECOG] performance status), whether the patient is apt for treatment or whether the treatment needs to be deferred.

In France, the Centre François Baclesse in Caen (France) launched the OPTIMA program to optimize the prescription and preparation of chemotherapy in the ambulatory unit of the hospital.

Read more

A prospective study validating the OPTIMA program found that the prescription of chemotherapy was accurate with significantly reduced waiting times for patients between the planned appointment time and initiation of chemotherapyThe OPTIMA program is now part of usual care at the Centre François Baclesse.

Following the positive impact of both the OPTIMA and "Star" programs, several French healthcare centers have implemented similar programs. However, a large proportion of the data during the program are collected by telephone, particularly outgoing calls (from the hospital staff to patients). Thus, implementing these programs is expected to increase the number and/or duration of outgoing calls and consequently the workload of hospital staff.

Since the deployment of the OPTIMA program (between 2014 and 2016), and other equivalent programs, more and more patients have asked for the telephone calls to be replaced by a web-based application. Indeed, patients do not always respond to the telephone calls made by hospital staff, thus forcing staff to repeat calls several times. Also, some patients with language or hearing difficulties are unable to answer the questionnaires by telephone: a web-based alternative would be more appropriate for these patients.

Telemonitoring can collect blood test results and other patient data required to evaluate whether patients are apt for injectable cancer treatment. Telemonitoring can then identify the few patients that need to be contacted by hospital staff, thus reducing the number of outgoing telephone calls.

There is growing evidence of the benefits of adding telemonitoring to usual care for patients undergoing cancer treatment. The benefits include the early detection of AEs, improved quality of life (QoL), fewer admissions to emergency rooms or hospitalization, the longer remaining on chemotherapy for patients, and extended overall survival.

Cureety is a digital telemonitoring platform, specifically designed to monitor signs and symptoms of disease progression and AEs in cancer patients. The digital tool includes questionnaires for each class of medication to monitor patients' adverse events remotely. The data collected include blood results, treatment-related data (including delays, dose reductions), as well as QoL and safety data. In terms of safety, patients respond to an electronic patient-reported outcome (ePRO) questionnaire based on the NCI-CTCAE version (v)5.0. Depending on the responses, the Cureety TechCare algorithm classifies the patient state as "correct", "compromised", "to be monitored", or "critical". The patients are then notified of the actions to be taken according to their classification. In preparation for injectable cancer treatment, Cureety can collect the data necessary to evaluate whether patients are apt for treatment administration. The collection and evaluation of this data is expected to decrease outgoing calls by between 30% to 50%.

This study was designed to evaluate whether adding Cureety telemonitoring to usual care would reduce the number of outgoing calls for hospital staff during the management of patients undergoing injectable at one of the participating centers compared with the usual care including a program for anticipation of injectable treatment (OPTIMA program or equivalent).

Being tested
Cureety telemonitoring, OPTIMA or equivalent programs

What participants receive

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

  • Cureety telemonitoringOther

    The digital telemonitoring platform, Cureety, has been designed to facilitate the monitoring of signs and symptoms of treatment-specific AEs and disease progression. The platform integrates Cureety TechCare, a CE marked algorithm that is a class I medical device

  • OPTIMA or equivalent programsOther

    The programs consist of three stages:

    1. The medical team make structured telephone calls with patients 2 to 3 days before the planned administration of injectable treatment. Adverse events and other relevant data are collected.
    2. Patients undergo biological tests within 48 hours of the appointment and the results are sent by the laboratory to the centre.
    3. Then, the physician assesses the data and decides whether to anticipate and validate the prescription of injectable treatments.
Study groups in NCT06371911
Study groupRoleWhat they receive
Cureety telemonitoringExperimentalThe digital telemonitoring platform, Cureety, has been designed to facilitate the monitoring of signs and symptoms of treatment-specific AEs and disease progression. The platform integrates Cureety TechCare, a CE marked algorithm that is a class I medical device
Receives: Other: Cureety telemonitoring
OPTIMA or equivalent programsActive comparatorThe programs consist of three stages: 1. The medical team make structured telephone calls with patients 2 to 3 days before the planned administration of injectable treatment. Adverse events and other relevant data are collected. 2. Patients undergo biological tests within 48 hours of the appointment and the results are sent by the laboratory to the centre. 3. Then, the physician assesses the data and decides whether to anticipate and validate the prescription of injectable treatments.
Receives: Other: OPTIMA or equivalent programs

What is being measured

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

  1. Effectiveness of adding Cureety telemonitoring to usual care

    Measured by number of outgoing calls to patients performing injectable anticancer treatments

    Measured: 2 months

Timeline

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

  1. First posted17 Apr 2024
  2. Study start3 Apr 2024
  3. Primary completion16 Aug 2024
  4. Study completion16 Aug 2025

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06371911
Sponsor's protocol ID
2023-A02762-43
Acronym
OPTIMACURE
Status last verified
Aug 2024
First submitted
15 Apr 2024
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Faveyrial A, Gernier F, Rouzier R, Grellard JM, Estienne A, Gigan L, Beauguitte J, Montestruc F, Stanbury T, Parnot C, Champoiseau FG, Clarisse B. Benefit of adding Cureety Techcare telemonitoring to usual care during injectable anticancer treatment: the OPTIMACURE multicentric French prospective randomized study. BMC Health Serv Res. 2025 Dec 29;25(1):1622. doi: 10.1186/s12913-025-13661-1.

    PubMed 41462241

Questions about this trial

What is this clinical trial studying?

A study testing Cureety telemonitoring and OPTIMA or equivalent programs in people with Adult Patients Initiating Injectable Anticancer, run by Centre Francois Baclesse at 3 sites 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 12 inclusion and 0 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 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Effectiveness of adding Cureety telemonitoring to usual care (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06371911, which also lists 1 linked publication.

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 22 Sep 2025.

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