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2021-06-01
2023-07
2025-12-31
42
NCT04263948
Ramsay Générale de Santé
Ramsay Générale de Santé
INTERVENTIONAL
Multidom Remote Monitoring of Patient With Advanced Pancreatic Cancer Treated With Florinox Using the PiCaDo Plateform
Pancreatic cancer is a rapidly developing cancer with a poor prognosis. The mFOLFIRINOX protocol has become the standard medical treatment for this pathology. However, mFOLFIRINOX is the cause of severe toxicities including leukoneutropenia, thrombocytopenia, diarrhea, nausea-vomiting, anorexia, asthenia, weight loss and peripheral sensory neuropathy. Therefore, its indication is limited to patients in good general condition. In practice, it is often interrupted upon the occurrence of hematological and/or clinical grade 3-4 toxicities, Remote patient tele-monitoring of symptoms (Patient Reported Outcomes), body weight, circadian rhythms, sleep and activity would allow the identification of early warning signals reflecting deterioration or improvement in the health of these fragile patients, and trigger proactive interventions, while they are outside the hospital. Thus, the MultiDom study proposes a comprehensive tele-monitoring and telecare strategy that would complement standard of care over a 7-weeks period to 42 consenting patients. The patients receive neoadjuvant or first line chemotherapy with mFOLFIRINOX for advanced or metastatic pancreatic cancer at one of four centres in Ile-de-France region (France).
MultiDom stands up among the very first prospective patient-entered and multidimensional, multiactor and multicenter study, that assesses the qualitative and quantitative impact of mFOLFIRINOX on the daily life of patients with pancreatic cancer in real time. Main endpoint is the rate of patients undergoing toxicity-related emergency hospitalisations, and the objective is to reduce it to <10%. Telemonitored data-based proactive interventions will expectedly prevent worsening of patients 'health, and maintain their chances of disease control on effective mFOLFIRINOX chemotherapy. Participating patients have usual follow up and treatments for their disease, but also: wear a chest sensor that measures and teletransmits accelerometry, surface temperature and 3D-orientation every min, weigh themselves daily on a BLE-balance, with immediate weight tele transmission, and fill out electronic PRO questionnaires daily using a telecommunicating tablet. All data are tele transmitted to an approved health data hub, and automatically analysed for physical activity, sleep, circadian rhythms, symptoms scores trends in real time. Visualization screens and alerts are generated according to preset thresholds, and medical team responses are traced. Currently recruiting centres: 1. Clinique du Mousseau, Evry, France 2. Hospital Paul Brousse (Assistance Publique-Hôpitaux de Paris), Villejuif, France 3. Clinique St-Jean L'Ermitage, Melun, France 4. Private Hospital of Antony, Antony, France
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-02-07 | N/A | 2023-04-20 |
2020-02-07 | N/A | 2023-04-24 |
2020-02-11 | N/A | 2023-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Picado Arm All the patients undergo multidimensional tele monitoring for 7 weeks using an upgraded version of the Picado internet platform | DEVICE: Picado system internet platform and connected objects
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Toxicity-related emergency hospitalisation rate | The main objective is to assess the toxicities occurring during the 6 weeks following the start of the 1st cycle of FOLFIRINOX in conventional administration in patients benefiting from the PiCADo telemonitoring system. | First cycle of treatment of 6 weeks |
| Rates and grades toxicity and early tumor responses | Secondary objectives include rates and grades of toxicity and early tumor responses, as well as PiCADo platform performances and users perceptions. | First cycle of treatment of 6 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: JEAN FRANÇOIS OUDET Phone Number: 0683346567 Email: jeanfrancois.oudet@free.fr |
Study Contact Backup Name: Marie Barba Phone Number: +330664888704 Email: mh.barba@ecten.eu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
