Clinical trial NCT04667403: Telemedicine in the Management of Pain in Patients With Advanced or Metastatic Pancreatic Cancer
Official title: Telemedicine in the Management of Pain in Patients With Advanced or Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adenocarcinoma
Pancreatic Cancer Metastatic
Pain
Keywords: telemedicine
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Satisfaction of patients with advanced or metastatic pancreatic cancer of the impact of telemedicine in the management of their pain.
timeFrame: at one month, 3 months and 6 months post-inclusion
Secondary outcomes:
measure: Observed feasibility of telemedicine
timeFrame: 3 months post-inclusion.
measure: Satisfaction of healthcare professionals with the use of telemedicine in the management of patients' pain.
timeFrame: at 6 months post-inclusion
measure: Number of "unscheduled" consultations recorded of each patient.
timeFrame: at 3 months and 6 months post-inclusion
measure: Number of unscheduled hospitalizations recorded of each patient.
timeFrame: at 3 months and 6 months post-inclusion
Other outcomes:
Locations:
city: Saint-Herblain
country: France
facility: ICO site St HERBLAIN
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: Julia QUINTIN, MD
role: PRINCIPAL_INVESTIGATOR
References: