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

Primary Purpose

Pancreas Cancer

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Picado system internet platform and connected objects

About this trial

This is an interventional supportive care trial for Pancreas Cancer focused on measuring pancreas cancer, Plateform monitoring, metastatic or "borderline", telemedicine, tele monitoring, telecare, emergency hospitalisations, patient-centered medicine, internet platform, circadian rhythms, chronotherapy, physical activity, sleep, patient -reported outcomes, symptoms, quality of life, compliance, sensors, electronic questionnaires

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Clinique du MousseauRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Picado Arm

Arm Description

All the patients undergo multidimensional tele monitoring for 7 weeks using an upgraded version of the Picado internet platform

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04263948

First Posted

February 7, 2020

Last Updated

April 20, 2023

Sponsor

Ramsay Générale de Santé

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04263948

Brief Title

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

Acronym

MULTIDOM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ramsay Générale de Santé

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

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: Clinique du Mousseau, Evry, France Hospital Paul Brousse (Assistance Publique-Hôpitaux de Paris), Villejuif, France Clinique St-Jean L'Ermitage, Melun, France Private Hospital of Antony, Antony, France

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreas Cancer

Keywords

pancreas cancer, Plateform monitoring, metastatic or "borderline", telemedicine, tele monitoring, telecare, emergency hospitalisations, patient-centered medicine, internet platform, circadian rhythms, chronotherapy, physical activity, sleep, patient -reported outcomes, symptoms, quality of life, compliance, sensors, electronic questionnaires

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Picado Arm

Arm Type

Experimental

Arm Description

All the patients undergo multidimensional tele monitoring for 7 weeks using an upgraded version of the Picado internet platform

Intervention Type

Device

Intervention Name(s)

Picado system internet platform and connected objects

Intervention Description

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.

Primary Outcome Measure Information:

Title

Toxicity-related emergency hospitalisation rate

Description

Time Frame

First cycle of treatment of 6 weeks

Title

Rates and grades toxicity and early tumor responses

Description

Secondary objectives include rates and grades of toxicity and early tumor responses, as well as PiCADo platform performances and users perceptions.

Time Frame

First cycle of treatment of 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

JEAN FRANÇOIS OUDET

Phone

0683346567

Ext

0683346567

jeanfrancois.oudet@free.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Marie Barba

Phone

+330664888704

Ext

+330664888704

mh.barba@ecten.eu

Facility Information:

Facility Name

Clinique du Mousseau

City

Évry

State/Province

IDF

ZIP/Postal Code

91000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean Francois OUDET

Phone

+33683346567

Ext

+33683346567

jf.oudet@ecten.eu

First Name & Middle Initial & Last Name & Degree

Marie Barba

Phone

+330664888704

Ext

+330664888704

mh.barba@ecten.eu

First Name & Middle Initial & Last Name & Degree

Mohamed BOUCHAHDA, Dr

First Name & Middle Initial & Last Name & Degree

Francis LEVI, Pr

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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."

Citations:

Citation

Bouchahda M, Komarzynski S, Ulusakarya A, Attari A, Duprès A, Breda G, Fritsch A, Adam R, Lévi F (2020) Improving FOLFIRINOX safety in pancreatic cancer patients through multidimensional remote monitoring and proactive care using a domomedecine mobile platform. J Clin Oncol 38: TPS4673.

Results Reference

background

PubMed Identifier

32708950

Citation

Levi F, Komarzynski S, Huang Q, Young T, Ang Y, Fuller C, Bolborea M, Brettschneider J, Fursse J, Finkenstadt B, White DP, Innominato P. Tele-Monitoring of Cancer Patients' Rhythms during Daily Life Identifies Actionable Determinants of Circadian and Sleep Disruption. Cancers (Basel). 2020 Jul 17;12(7):1938. doi: 10.3390/cancers12071938.

Results Reference

background

PubMed Identifier

30652550

Citation

Innominato P, Komarzynski S, Karaboue A, Ulusakarya A, Bouchahda M, Haydar M, Bossevot-Desmaris R, Mocquery M, Plessis V, Levi F. Home-Based e-Health Platform for Multidimensional Telemonitoring of Symptoms, Body Weight, Sleep, and Circadian Activity: Relevance for Chronomodulated Administration of Irinotecan, Fluorouracil-Leucovorin, and Oxaliplatin at Home-Results From a Pilot Study. JCO Clin Cancer Inform. 2018 Dec;2:1-15. doi: 10.1200/CCI.17.00125.

Results Reference

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Learn more about this trial

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

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