Telemedicine In The Management Of Pain In Patients With Advanced Or Metastatic Pancreatic Cancer

Study Overview

Telemedicine in the Management of Pain in Patients With Advanced or Metastatic Pancreatic Cancer

Adenocarcinoma of the pancreas is a major public health issue because of its disastrous prognosis. The symptomatology of locally advanced or metastatic forms, particularly painful, is often major and difficult to balance, impacting both the quality of life of patients (and those around them) and the course of treatment (chemotherapy). The objective of this study is to evaluate the interest and feasibility of telemedicine in the management of pain in patients undergoing treatment for advanced or metastatic pancreatic cancer.

N/A

Adenocarcinoma
Pancreatic Cancer Metastatic
Pain

OTHER: Telemedicine

ICO-2020-13

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-12-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-04-21
First Submitted that Met QC Criteria 2020-12-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-04-28
First Posted (ACTUAL) 2020-12-14	Results First Posted N/A	Last Verified 2022-04

Study Plan

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

Design Details

Primary Purpose:
Supportive Care

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Telemedicine Pain is monitored, from the patient's home, using a computer application accessible from a smartphone or a computer with internet access. This application will allow the patient to describe his or her pain by means of a self-questionnaire. Healthcar	OTHER: Telemedicine In addition to his standard follow-up, the patient benefits from a home follow-up of his pain for 6 months from his inclusion in the study. The patient has to log on via the application, every week. to fill in the questionnaire to evaluate the pain over

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Telemedicine

Pain is monitored, from the patient's home, using a computer application accessible from a smartphone or a computer with internet access. This application will allow the patient to describe his or her pain by means of a self-questionnaire. Healthcar

OTHER: Telemedicine

In addition to his standard follow-up, the patient benefits from a home follow-up of his pain for 6 months from his inclusion in the study. The patient has to log on via the application, every week. to fill in the questionnaire to evaluate the pain over

Primary Outcome Measures	Measure Description	Time Frame
Satisfaction of patients with advanced or metastatic pancreatic cancer of the impact of telemedicine in the management of their pain.	Satisfaction is measured using the Patient Global Clinical Impression of Change (P-GIC) questionnaire. The questionnaire consists of a single question posed to the patient via the application asking the patient what impact he or she believes telemedicine has had on the overall management of his or her pain. The patient has the following 8 propositions among which he must indicate the one that best corresponds to the perceived change: Don't know, Very strongly positive, Strongly positive, Slightly positive, No change, Slightly negative, Strongly negative, Very strongly negative.	at one month, 3 months and 6 months post-inclusion

Secondary Outcome Measures	Measure Description	Time Frame
Observed feasibility of telemedicine	Feasibility will be assessed by collecting : Number of weekly connections actually made and validated up to 3 months post -inclusion. Number of weekly connections actually made and not validated up to 3 months post-inclusion. Number of emergency connections actually made and validated up to 3 months post-inclusion. Number of emergency connections actually made and not validated up to 3 months post-inclusion. A validated connection means that the patient has answered all the questions defined for the type of weekly or emergency connection chosen and that the application has acknowledged the connection.	3 months post-inclusion.
Satisfaction of healthcare professionals with the use of telemedicine in the management of patients' pain.	Satisfaction is measured using the healthcare professionals Global Clinical Impression of Change (C-GIC) questionnaire. The questionnaire includes a single question asked to the medical staff taking care of the patient (Nurse pathway coordinators and oncologists or algologists) asking them to estimate the impact of telemedicine on the overall pain management of patients. They are given the following 8 propositions, among which they must indicate the one that best corresponds to the perceived change: Don't know, Very strongly positive, Strongly positive, Slightly positive, No change, Slightly negative, Strongly negative, Very strongly negative.	at 6 months post-inclusion
Number of "unscheduled" consultations recorded of each patient.		at 3 months and 6 months post-inclusion
Number of unscheduled hospitalizations recorded of each patient.		at 3 months and 6 months post-inclusion

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

Name: Julia QUINTIN, MD

Phone Number: 02 40 67 99 33

Email: julia.quintin@ico.unicancer.fr

Study Contact Backup

Name: Emilie DEBEAUPUIS

Phone Number: 02 40 67 98 44

Email: emilie.debeaupuis@ico.unicancer.fr

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patient ≥ 18 years old ;
Patient with histologically or cytologically proven locally advanced and/or metastatic adenocarcinoma of the pancreas;
Patient undergoing or failing medical treatment and comfort care only;
Patient with EVA ≥ 4 and/or requiring analgesics level 3;
Performans Status (ECOG) < 3 ;
Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator;
Patient affiliated or beneficiary of the social security system

Patient does not have a smartphone, tablet or computer;
Patient with no personal internet access at home (WIFI, wired), or via his smartphone;
Patient does not feel able to fill out an electronic questionnaire;
Patient cannot read or write French;
Patient does not speak and understand French;
Persons deprived of liberty or under guardianship or trusteeship ;
Dementia, mental alteration or psychiatric pathology that could compromise the patient's informed consent and/or compliance with the protocol and follow-up of the trial ;
Inability to submit to trial protocol follow-up for geographical, social, or other reasons ;
Patient participating in another interventional study evaluating treatment and pain management.

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Julia QUINTIN, MD, Institut de Cancérologie de l'Ouest

Publications

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

General Publications

No publications available

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Resources

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Clinical Trial Record