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

Not Applicable

• Conditions: Pancreatic Cancer Metastatic; Pain; Adenocarcinoma
• Interventions: Other: Telemedicine

• Registration Number: NCT04667403
• Lead Sponsor: Institut Cancerologie de l'Ouest

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-11
• Study First Posted: 2020-12-14
• Study Start: 2022-02-07
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-28
• Primary Completion: 2023-11-08
• Study Completion: 2024-02-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telemedicine	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. Healthcare professionals (nurse coordinator, pain specialist and oncologist) will thus be able to remotely interpret the data collected, enabling them to provide patients with a rapid response to adapt their pain treatment without the patient having to travel to the establishment.

Primary Outcome Measures

Name	Time	Method
Satisfaction of patients with advanced or metastatic pancreatic cancer of the impact of telemedicine in the management of their pain.	at one month, 3 months and 6 months post-inclusion	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.

Secondary Outcome Measures

Name	Time	Method
Number of unscheduled hospitalizations recorded of each patient.	at 3 months and 6 months post-inclusion
Observed feasibility of telemedicine	3 months post-inclusion.	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.
Satisfaction of healthcare professionals with the use of telemedicine in the management of patients' pain.	at 6 months post-inclusion	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.
Number of "unscheduled" consultations recorded of each patient.	at 3 months and 6 months post-inclusion

Trial Locations

Locations (1)

ICO site St HERBLAIN; 🇫🇷 Saint-Herblain, France