Clinical trial NCT04388449: Place of Intrathecal Analgesia to Improve the Quality of Life of Painful Cancer Patients
Official title: Multicenter Study on the Place of Intrathecal Analgesia to Improve the Quality of Life of Painful Cancer Patients: Development of a Grid for Analysing Life and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Injections, Spinal
Cancer
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 patients having pain treated by analgesic administrated through an intrathecal way with an implantable pump will be included in this study.

The inclusion of patients will be done with a consecutive way to avoid the selection bias. Each patient file will be presented to the pain multidisciplinary consultation meeting. It will have the validation of an antalgic treatment by an intrathecal way. The investigator will verify the inclusion and non-inclusion criteria to offer the study to all the corresponding patients

Brief summary: The intrathecal analgesia is a recommended technic to treat persistent pain in cancer patient but little used, whose the technical conditions require hospital multidisciplinary expertise and coordination associated to a link between city and hospital. The experience of patients who benefit of this technic in this situation of advanced cancer (loco-regional or metastatic) is little known. So far, it doesn't exist developed tools to know it.

In literature, 2 qualitative studies have been published on the quality of life with intrathecal analgesia. A study realised in 2009 with 6 Canadian patients (3 interview per patients) and nurses in palliative unit shows the positive impact on the quality of life of patients. Recently, a qualitative study has approached the question of the quality of life of patients who had an intrathecal analgesia with the point of view of nursing staff. The results confirm the improvement of quality of life and suggest an establishment more premature of technic in the care process.

Given the development of this technic in cancerology in France and more premature in the care process of patients, it seems interesting to know better the experience of patients with cancer and for who the pain is treated by this technic and the impact on the quality of life of these patients sometimes dependent of some expert centres. This study is done to answer to theses questions on the experience of patients and their close relations and the impact of the quality of life according to a qualitative approach. An independent psychologist of process care of patients will realised semi-directed before putting on the equipment allowing the administration of analgesic by intrathecal pathway, at 1 month, then 3 months to know the experience when the balance of the pain is generally reached (M1) and the impact in long-term (M3).

Detailed description: The referent algologist informs the patient of the retained offer in the pain multidisciplinary consultation meeting. Following the consultation, the investigator sees the patient to explain the study and to verify all the inclusion and non-inclusion criteria, to give and explain the information note and to be sure of the non-opposition.

A psychologist comes in each centre to realise the semi-directed interviews before putting on the catheter, at 1 month and at 3 months after the establishment of this technic. The interview will be recorded with the agreement of the patient then totally transcribed. A double analysis will allow to extract the verbatim record and to construct the thematic tree with under-themes.

The same day of the interviews, 4 questionnaires will allow to evaluate to the 3 periods of measurement (before putting on the catheter, M1 et M3) : the mean pain of the past 24 hours by the BPI-SF (Brief Pain Inventory-short form) questionnaire, the anxiety and the depression by the HAD (Hospital Anxiety and Depression scale) questionnaire, the quality of life by the QLQ-C30 questionnaire, the catastrophism by the PCS (Pain Catastrophizing Scale) questionnaire.

The evaluation by the patient and the algologist of the global clinic improvement after the establishment of the analgesic treatment by intrathecal way will be realised at M1 and M3 with the help of the questionnaire P-GIC and C-GIC (Patient or Clinical- Global Impression of Change).

The study does not interfere with the treatment of the patient and his usual care. No biological exams or imagery will be realise in this study.

Eligibility criteria: Inclusion Criteria:

* Patient is more than 18 years old with pain linked to the evolution of locoregional or distanced cancer justifying an analgesic treatment administrated by an intrathecal pathway with an implantable pump.
* Patient is able to answer to the questions during the semi-directed interview
* Patient has valid health insurance
* Having given written informed consent prior to any procedure related to the study

Exclusion Criteria:

* Patient under 18 years-old.
* Patient under guardianship or protection of vulnerable adults

Primary outcomes:
measure: Evaluate the experience of patients who have an intrathecal analgesia treating nociceptive and/or neuropathic pain of cancerous origin in palliative phase.
timeFrame: 3 months
Secondary outcomes:
measure: Evaluate the mean pain of the past 24 hours
timeFrame: 3 months
measure: Evaluate the quality of life
timeFrame: 3 months
measure: Evaluate the pain catastrophizing
timeFrame: 3 months
measure: Evaluate the consistency of the feeling of the global clinic improvement of the patient
timeFrame: 3 months
measure: Evaluate the consistency or not of the feeling of the global clinic improvement of the clinician at M1 and M3.
timeFrame: 3 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancerologie de l'Ouest
city: Boulogne-Billancourt
country: France
facility: INSERM U987 CHU A Paré - Institut Curie
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Institut Curie
name: Marie PECHARD
role: STUDY_DIRECTOR
References: