Place of Intrathecal Analgesia to Improve the Quality of Life of Painful Cancer Patients

NCT04388449 | Completed

• 1 other identifier: ICO-2019-18
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 3

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).

Conditions

Injections, Spinal; Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate the experience of patients who have an intrathecal analgesia treating nociceptive and/or neuropathic pain of cancerous origin in palliative phase.

  The evaluation will done through a semi-structured interview by a psychologist. After the patient agreement, the interview is recorded so that can be fully transcribed. The recordings will be erased as soon as the transcription has been carried out completely anonymously. The data will be processed by a content analysis. It is a method of interpreting qualitative data which consists of an objective, exhaustive, methodical and if possible quantitative examination of communication material to classify its elements

  3 months

Secondary Outcomes (5)

• Evaluate the mean pain of the past 24 hours

  3 months

• Evaluate the quality of life

  3 months

• Evaluate the pain catastrophizing

  3 months

• Evaluate the consistency of the feeling of the global clinic improvement of the patient

  3 months

• Evaluate the consistency or not of the feeling of the global clinic improvement of the clinician at M1 and M3.

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (3)

Institut de Cancerologie de l'Ouest

Angers, 49055, France

Location

INSERM U987 CHU A Paré - Institut Curie

Boulogne-Billancourt, 92100, France

Location

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Marie PECHARD

  Institut Curie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: May 14, 2020
• Study Start: February 20, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-04

Locations

FR (3)