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Clinical Trials/NCT04667403
NCT04667403
Unknown
Not Applicable

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

Institut Cancerologie de l'Ouest1 site in 1 country50 target enrollmentFebruary 7, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adenocarcinoma
Sponsor
Institut Cancerologie de l'Ouest
Enrollment
50
Locations
1
Primary Endpoint
Satisfaction of patients with advanced or metastatic pancreatic cancer of the impact of telemedicine in the management of their pain.
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 7, 2022
End Date
February 8, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Institut Cancerologie de l'Ouest
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Satisfaction of patients with advanced or metastatic pancreatic cancer of the impact of telemedicine in the management of their pain.

Time Frame: 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 Outcomes

  • Number of unscheduled hospitalizations recorded of each patient.(at 3 months and 6 months post-inclusion)
  • 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)

Study Sites (1)

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