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

NCT04667403 | Unknown

• 1 other identifier: ICO-2020-13
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma; Pancreatic Cancer Metastatic; Pain

Keywords

telemedicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Observed feasibility of telemedicine

  3 months post-inclusion.

• Satisfaction of healthcare professionals with the use of telemedicine in the management of patients' pain.

  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

Study Arms (1)

Telemedicine

EXPERIMENTAL

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.

Other: Telemedicine

Interventions

Telemedicine OTHER

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 the past week. The questionnaire consists of 4 questions to which the patient answers using a numerical scale from 0 to 10. If the patient's pain is not controlled, the patient can log on in "emergency" mode as many times as he or she deems necessary. A nurse path coordinator will be informed of each connection. Depending on the type of alert received, she may initiate a telephone consultation with the oncologist or pain specialist: * If necessary within 24 hours of the connection if it is a weekly connection, * Systematic within 3 hours if it is an emergency connection or if the data entered at the time of the weekly connection requires medical intervention.

Telemedicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

ICO site St HERBLAIN

Saint-Herblain, 44805, France

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma; Pain

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Julia QUINTIN, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia QUINTIN, MD

CONTACT

02 40 67 99 33; julia.quintin@ico.unicancer.fr

Emilie DEBEAUPUIS

CONTACT

02 40 67 98 44; emilie.debeaupuis@ico.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 14, 2020
• Study Start: February 7, 2022
• Primary Completion: November 8, 2023
• Study Completion: February 8, 2024
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)