Multidom Remote Monitoring of Patient With Advanced Pancreatic Cancer Treated With Florinox Using the PiCaDo Plateform (MULTIDOM)

April 20, 2023 updated by: Ramsay Générale de Santé

Multidom Remote Monitoring of Patient With Advanced Pancreatic Cancer Treated With Florinox Using the PiCaDo Domomedecine 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • IDF
      • Évry, IDF, France, 91000
        • Recruiting
        • Clinique Du Mousseau
        • Principal Investigator:
          • Mohamed BOUCHAHDA, Dr
        • Principal Investigator:
          • Francis LEVI, Pr

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

-Histological or cytological diagnosis of pancreatic adenocarcinoma

  • Locally advanced or metastatic pancreatic cancer
  • With or without previous surgery (pancreas and / or metastases)
  • Performance status of 0 or 1 according to WHO
  • Age between 18 and 85 years old included
  • No history of prior chemotherapy or radiotherapy
  • Absence of cutaneous or mucosal jaundice or skin pruritus
  • No proven thrombosis
  • Absence of heart disease or other pathology poorly controlled by current treatments
  • Bilirubinemia and alkaline phosphatases <1.5 ULN (with or without stent)
  • Hematological, renal and hepatic laboratory tests authorizing the administration of mFOLFIRINOX
  • Affiliated subject or beneficiary of a social security scheme
  • Patient who freely signed informed consent

Exclusion Criteria:

  • Immediately resectable pancreatic cancer
  • No histological or cytological evidence of pancreatic adenocarcinoma
  • Performance status> 1 (WHO)
  • Age <18 and> 85 years old
  • Prior administration of chemotherapy or radiotherapy
  • Skin jaundice and / or pruritus
  • Uncontrolled venous or arterial thrombosis
  • Co morbidity not controlled by a specific treatment
  • Biological anomalies contraindicating the administration of one or more drugs which make up FOLFIRINOX
  • Lack of GPRS coverage in the home
  • Patient participating in another clinical study
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant, lactating or parturient woman
  • Patient hospitalized without consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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
The system will monitor the circadian rhythms, physical activity, sleep, symptoms and body weight of patients with advanced pancreatic cancer during one week before (baseline) and six weeks after the 1st course of standard mFOLFIRINOX. The reach of preset thresholds for several parameters that are automatically computed will trigger alerts toward approved health professionals, and their responses will be traced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity-related emergency hospitalisation rate
Time Frame: First cycle of treatment of 6 weeks
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
Time Frame: First cycle of treatment of 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramsay Générale de Santé

Collaborators

Assistance Publique - Hôpitaux de Paris
Faculty of Medicine Paris Saclay University
Altran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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 Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

February 7, 2020

First Submitted That Met QC Criteria

February 7, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-12-033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in the original trial report manuscripts will be shared after deidentification. Supportive information will consist in the study protocol.

IPD Sharing Time Frame

Data will be available for two years following article publication at jf.oudet@ecten.eu.

IPD Sharing Access Criteria

Access will be granted to researchers who provide a methodologically sound proposal and only aim toward publicly available scientific publication, and in accordance with the French General Data Protection Regulation."

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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