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

NCT ID: NCT04667403

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2024-02-08

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Telemedicine

Intervention Type: 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.

Interventions

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 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia QUINTIN, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de l'Ouest

Locations

ICO site St HERBLAIN

Saint-Herblain, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Julia QUINTIN, MD

Role: CONTACT

julia.quintin@ico.unicancer.fr

02 40 67 99 33 ext. +33

Emilie DEBEAUPUIS

Role: CONTACT

emilie.debeaupuis@ico.unicancer.fr

02 40 67 98 44 ext. +33

Facility Contacts

Julia QUINTIN, MD

Role: primary

julia.quintin@ico.unicancer.fr

Other Identifiers

ICO-2020-13

Identifier Type: -

Identifier Source: org_study_id