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

Primary Purpose

Adenocarcinoma, Pancreatic Cancer Metastatic, Pain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Telemedicine
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adenocarcinoma focused on measuring telemedicine

Eligibility Criteria

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

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.

Sites / Locations

  • ICO site St HERBLAINRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telemedicine

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Number of "unscheduled" consultations recorded of each patient.
Number of unscheduled hospitalizations recorded of each patient.

Full Information

First Posted
December 1, 2020
Last Updated
April 21, 2022
Sponsor
Institut Cancerologie de l'Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT04667403
Brief Title
Telemedicine in the Management of Pain in Patients With Advanced or Metastatic Pancreatic Cancer
Acronym
PANTELO
Official Title
Telemedicine in the Management of Pain in Patients With Advanced or Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
November 8, 2023 (Anticipated)
Study Completion Date
February 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma, Pancreatic Cancer Metastatic, Pain
Keywords
telemedicine

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
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telemedicine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Satisfaction of patients with advanced or metastatic pancreatic cancer of the impact of telemedicine in the management of their pain.
Description
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.
Time Frame
at one month, 3 months and 6 months post-inclusion
Secondary Outcome Measure Information:
Title
Observed feasibility of telemedicine
Description
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.
Time Frame
3 months post-inclusion.
Title
Satisfaction of healthcare professionals with the use of telemedicine in the management of patients' pain.
Description
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.
Time Frame
at 6 months post-inclusion
Title
Number of "unscheduled" consultations recorded of each patient.
Time Frame
at 3 months and 6 months post-inclusion
Title
Number of unscheduled hospitalizations recorded of each patient.
Time Frame
at 3 months and 6 months post-inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia QUINTIN, MD
Phone
02 40 67 99 33
Ext
+33
Email
julia.quintin@ico.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie DEBEAUPUIS
Phone
02 40 67 98 44
Ext
+33
Email
emilie.debeaupuis@ico.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia QUINTIN, MD
Organizational Affiliation
Institut de Cancérologie de l'Ouest
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICO site St HERBLAIN
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia QUINTIN, MD
Email
julia.quintin@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Julia QUINTIN, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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