OncologyONCONECTSAFENCT05968027
Improving Care Pathway Using Simplified Digital Tools for Oncology Patients: a Multicenter "Before-and-after" Study
An observational study of Oncology and Adverse Event, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Developments in the healthcare sector in general, and in oncology in particular, mean that patients are increasingly autonomous. Outpatient treatment raises the issue of home monitoring. One of the solutions proposed by the 2014-2019 Cancer Plan is the development of telemedicine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Adverse Event, Numeric Application
- What is being tested?
- Nouveal numeric application "Onco'nect"
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2024to 2 Jul 2025
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients treated with IV chemotherapy and monitored in the medical oncology departments of participating centres (AP-HP): CHU Henri Mondor Créteil (HMN), CHU Pitié Salpêtrière Paris (PSL), CHU Bichat Paris (BCT), CHU Saint Antoine (SAT) and CHU Georges Pompidou (HEGP).
Who may be able to join
- Age >=18 years
- Initiation of I.V. chemotherapy for solid cancer of any location or metastatic status:
- Either over a period of 12 months before Onco'nect is deployed, covering the year preceding the actual implementation of the solution in each centre.
- Or over a period of 12 months post-deployment of Onco'nect, covering the year following the implementation of the solution within the centre.
- Non-opposition to the study and to the processing of their medical data.
Who cannot join
- Any known difficulty in understanding or reading French that might invalidate the relevance of applying questionnaires
- Known cognitive or psychiatric disorder preventing the protocol from being carried out
- Patient under legal protection
- Patient included in the article 51 programme
Trial locations and contacts
No sites are listed yet.
About this study
Developments in the healthcare sector in general, and in oncology in particular, mean that patients are increasingly autonomous. Outpatient treatment raises the issue of home monitoring. One of the solutions proposed by the 2014-2019 Cancer Plan is the development of telemedicine. Several programmes have been set up in the medical oncology department at Hôpital Mondor, to make patient care more secure and improve the management of undesirable effects of treatment for patients undergoing intravenous (I.V.) chemotherapy or oral anti-cancer treatments.
The preliminary study on the use of the digital solution Onco'nect demonstrated the feasibility of using a dematerialised tool for real-time monitoring and management of chemotherapy-induced adverse events in cancer patients undergoing outpatient treatment. The tool was used to help AP-HP institution deal with the crisis linked to the COVID epidemic. Once it had been configured, Onco'nect was deployed to all institution's hospital groups to ensure that infected patients could remain at home, and that patients hospitalised with symptomatic COVID infection could return home.
Read more
Hypothesis: The digital solution Onco'nect would improve patient compliance and could reduce the occurrence and improve the management of unexpected adverse events.
Primary objective:
In terms of clinical evaluation, the primary objective is to assess the effect of using the Onco'nect solution for ambulatory oncology follow-up on reducing the rate of occurrence at 6 months follow-up of unexpected and unwanted chemo-induced adverse events.
The solution is already on the market and has been integrated (or is in the process of being integrated) into the care systems of the participating AP-HP establishments. The aim of the project is to evaluate its use in routine care and measure the occurrence and management of unexpected and unwanted chemo-induced adverse events in outpatients treated for cancer.
This observational study of care pathway, using retrospective data, aims to include 480 patients in a 18 months period.
Three periods of interest will be considered in this before-and-after study
- Onco'nect pre-deployment (12 months): period covering the year prior to the actual implementation of the solution in each centre; patients receiving I.V. chemotherapy during the first 6 months of the period will be included, in order to assess follow-up at 6 months.
- Onco'nect deployment: this period corresponds to the implementation of the solution in the centre's care pathway. Deployment includes interoperability with other operating systems and setting up the collection interfaces for the user.
- Post-deployment (12 months): period covering the year following the implementation of the solution within the centre (installation, interoperability and configuration validated); patients receiving I.V. chemotherapy during the first 6 months of the period will be included, in order to be able to evaluate the 6-month follow-up.
- Conditions
- Oncology, Adverse Event, Numeric Application, Care Telemonitoring, Compliance, Treatment, Patient Reported Outcome (PRO)
- Being tested
- Nouveal numeric application "Onco'nect"
- Medical subject headings
- Neoplasms, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nouveal numeric application "Onco'nect"Other
A remote monitoring application, Onco'nect® (smartphone /tablet /PC), in partnership with the company Nouveal facilitates communication between patients undergoing Intra Vascular (IV) chemotherapy and the care team. A questionnaire before and after each session can be used to alert the oncology department and adapt patient management.
| Study group | Role | What they receive |
|---|---|---|
| Onco'nect pre-deployment | - Onco'nect pre-deployment (12 months): period covering the year prior to the actual implementation of the solution in each centre; patients receiving I.V. chemotherapy during the first 6 months of the period will be included, in order to assess the 6-month follow-up. | |
| Onco'nect post-deployment | -Onco'nect post-deployment (12 months): period covering the year following the implementation of the solution within the centre (installation, interoperability and parameterisation validated); patients with I.V. chemotherapy implemented during the first 6 months of the period will be included, in order to be able to evaluate the 6-month follow-up. Receives: Other: Nouveal numeric application "Onco'nect" |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
presence of one or more unexpected and undesirable chemo-induced adverse events at 6 months' follow-up after the start of chemotherapy (use of unscheduled hospitalisation, consultation/admission to the emergency department, grade 3 and 4 toxicities according to version 5 of the CTCAE, changes in chemotherapy administration schedules, such as last-minute cancellations, changes in dose and frequency of treatment administration).
Measured: during a 6 months follow-up period starting after chemotherapy injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start2 Jan 2024 (estimated)
- Primary completion2 Jul 2025 (estimated)
- Study completion2 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Nouveal
- Responsible party
- Sponsor
- Investigators
- Christophe TOURNIGAND, MD-PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968027
- Sponsor's protocol ID
- APHP230641
- Acronym
- ONCONECTSAFE
- Status last verified
- Jul 2023
- First submitted
- 21 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: AP-HP, as sponsor, is the owner of the data and no use or transmission to a third party may be made without its prior agreement.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care Pathway Using Simplified Digital Tools for Oncology Patients: a Multicenter "Before-and-after" Study
- ClinicalTrials.gov ID
- NCT05968027
- Acronym / sponsor ID
- ONCONECTSAFE / APHP230641
- Conditions
- Oncology, Adverse Event, Numeric Application, Care Telemonitoring, Compliance, Treatment, Patient Reported Outcome (PRO)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Nouveal
- Study start
- 2 Jan 2024 (estimated)
- Primary completion
- 2 Jul 2025 (estimated)
- Study completion
- 2 Jul 2025 (estimated)
- First posted
- 1 Aug 2023 (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.
Developments in the healthcare sector in general, and in oncology in particular, mean that patients are increasingly autonomous. Outpatient treatment raises the issue of home monitoring. One of the solutions proposed by the 2014-2019 Cancer Plan is the development of telemedicine. Several programmes have been set up in the medical oncology department at Hôpital Mondor, to make patient care more secure and improve the management of undesirable effects of treatment for patients undergoing intravenous (I.V.) chemotherapy or oral anti-cancer treatments.
The preliminary study on the use of the digital solution Onco'nect demonstrated the feasibility of using a dematerialised tool for real-time monitoring and management of chemotherapy-induced adverse events in cancer patients undergoing outpatient treatment. The tool was used to help AP-HP institution deal with the crisis linked to the COVID epidemic. Once it had been configured, Onco'nect was deployed to all institution's hospital groups to ensure that infected patients could remain at home, and that patients hospitalised with symptomatic COVID infection could return home.
Hypothesis: The digital solution Onco'nect would improve patient compliance and could reduce the occurrence and improve the management of unexpected adverse events.
Primary objective:
In terms of clinical evaluation, the primary objective is to assess the effect of using the Onco'nect solution for ambulatory oncology follow-up on reducing the rate of occurrence at 6 months follow-up of unexpected and unwanted chemo-induced adverse events.
The solution is already on the market and has been integrated (or is in the process of being integrated) into the care systems of the participating AP-HP establishments. The aim of the project is to evaluate its use in routine care and measure the occurrence and management of unexpected and unwanted chemo-induced adverse events in outpatients treated for cancer.
This observational study of care pathway, using retrospective data, aims to include 480 patients in a 18 months period.
Three periods of interest will be considered in this before-and-after study
- Onco'nect pre-deployment (12 months): period covering the year prior to the actual implementation of the solution in each centre; patients receiving I.V. chemotherapy during the first 6 months of the period will be included, in order to assess follow-up at 6 months.
- Onco'nect deployment: this period corresponds to the implementation of the solution in the centre's care pathway. Deployment includes interoperability with other operating systems and setting up the collection interfaces for the user.
- Post-deployment (12 months): period covering the year following the implementation of the solution within the centre (installation, interoperability and configuration validated); patients receiving I.V. chemotherapy during the first 6 months of the period will be included, in order to be able to evaluate the 6-month follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Onco'nect pre-deployment | – | –- Onco'nect pre-deployment (12 months): period covering the year prior to the actual implementation of the solution in each centre; patients receiving I.V. chemotherapy during the first 6 months of the period will be included, in order to assess the 6-month follow-up. |
| Onco'nect post-deployment | – | Other: Nouveal numeric application "Onco'nect"-Onco'nect post-deployment (12 months): period covering the year following the implementation of the solution within the centre (installation, interoperability and parameterisation validated); patients with I.V. chemotherapy implemented during the first 6 months of the period will be included, in order to be able to evaluate the 6-month follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients treated with IV chemotherapy and monitored in the medical oncology departments of participating centres (AP-HP): CHU Henri Mondor Créteil (HMN), CHU Pitié Salpêtrière Paris (PSL), CHU Bichat Paris (BCT), CHU Saint Antoine (SAT) and CHU Georges Pompidou (HEGP).
Key inclusion criteria (5 listed)
- Age >=18 years
- Initiation of I.V. chemotherapy for solid cancer of any location or metastatic status:
- Either over a period of 12 months before Onco'nect is deployed, covering the year preceding the actual implementation of the solution in each centre.
- Or over a period of 12 months post-deployment of Onco'nect, covering the year following the implementation of the solution within the centre.
- Non-opposition to the study and to the processing of their medical data.
Key exclusion criteria (4 listed)
- Any known difficulty in understanding or reading French that might invalidate the relevance of applying questionnaires
- Known cognitive or psychiatric disorder preventing the protocol from being carried out
- Patient under legal protection
- Patient included in the article 51 programme
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 |
|---|---|---|
| Nouveal numeric application "Onco'nect"A remote monitoring application, Onco'nect® (smartphone /tablet /PC), in partnership with the company Nouveal facilitates communication between patients undergoing Intra Vascular (IV) chemotherapy and the care team. A questionnaire before and after each session can be used to alert the oncology department and adapt patient management. | Other | Onco'nect post-deployment |
Primary outcome
adverse events
Time frame: during a 6 months follow-up period starting after chemotherapy injection
presence of one or more unexpected and undesirable chemo-induced adverse events at 6 months' follow-up after the start of chemotherapy (use of unscheduled hospitalisation, consultation/admission to the emergency department, grade 3 and 4 toxicities according to version 5 of the CTCAE, changes in chemotherapy administration schedules, such as last-minute cancellations, changes in dose and frequency of treatment administration).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No. AP-HP, as sponsor, is the owner of the data and no use or transmission to a third party may be made without its prior agreement.
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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.
Christophe TOURNIGAND, MD-PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology and Adverse Event, run by Assistance Publique - Hôpitaux de Paris.
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 4 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie THÉVENIN ((0)1 44 84 17 63 ext. 0033, sophie.thevenin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (time frame: during a 6 months follow-up period starting after chemotherapy injection). 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 1 Aug 2023.