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.
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
- Conditions the study is for
- Adult Patients Initiating Injectable Anticancer
- 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
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:
- 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.
- Patients undergo biological tests within 48 hours of the appointment and the results are sent by the laboratory to the centre.
- Then, the physician assesses the data and decides whether to anticipate and validate the prescription of injectable treatments.
| Study group | Role | What they receive |
|---|---|---|
| Cureety telemonitoring | Experimental | 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 Receives: Other: Cureety telemonitoring |
| OPTIMA or equivalent programs | Active comparator | 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. Receives: Other: OPTIMA or equivalent programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted17 Apr 2024
- Study start3 Apr 2024
- Primary completion16 Aug 2024
- Study completion16 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult Patients Initiating Injectable AnticancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- Cureety
- Responsible party
- Sponsor
- Investigators
- Audrey FAVEYRIAL, MD, Principal investigator, Centre François Baclesse
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Adding Cureety TechCare Telemonitoring to Usual Care During Injectable Anticancer Treatment: a Multicentric French Prospective Randomized Study: The OPTIMACURE Protocol
- ClinicalTrials.gov ID
- NCT06371911
- Acronym / sponsor ID
- OPTIMACURE / 2023-A02762-43
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- Cureety
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2025 (actual)
- First posted
- 17 Apr 2024 (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.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cureety telemonitoring | Experimental | Other: Cureety telemonitoringThe 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 programs | Active comparator | Other: OPTIMA or equivalent programsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cureety telemonitoringThe 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 | Other | Cureety telemonitoring |
| OPTIMA or equivalent programsThe 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. | Other | OPTIMA or equivalent programs |
Primary outcome
Effectiveness of adding Cureety telemonitoring to usual care
Time frame: 2 months
Measured by number of outgoing calls to patients performing injectable anticancer treatments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Derived from this study: PubMed 41462241Faveyrial 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.
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. This study is not recruiting at the moment.
Audrey FAVEYRIAL, MD principal investigator
Centre François Baclesse
3 sites in 1 country: see every site and its status.
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.