Injections, SpinalQUALITHEC01NCT04388449
Place of Intrathecal Analgesia to Improve the Quality of Life of Painful Cancer Patients
An observational study of Injections, Spinal and Cancer, run by Institut Cancerologie de l'Ouest at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injections, Spinal, Cancer
- How many people
- 24 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Feb 2020to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patient under 18 years-old.
- Patient under guardianship or protection of vulnerable adults
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut de Cancerologie de l'Ouest
Angers, 49055
INSERM U987 CHU A Paré - Institut Curie
Boulogne-Billancourt, 92100
Hopital Foch
Suresnes, 92150
About this study
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
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).
Read the 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.
- Conditions
- Injections, Spinal, Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (5)
Evaluate the mean pain of the past 24 hours
The evaluation will be done through the Brief Pain Inventory-Short Form (BPI-SF) questionnaire. It is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning such as general activity, mood, walking ability, normal work including outside the home and housework, relations with other people, enjoyment of life, and sleep. This questionnaire is a 10 point scale (where 0 = no interference and 10 = interferes completely).
Measured: 3 months
Evaluate the quality of life
The evaluation will be done through the QLQ-C30 questionnaire. It is a 30-item questionnaire composed by 4 dimensions (5 functional scales (cognitive, emotional, physical, role and social functioning), 3 symptom scales (fatigues, nausea/vomiting and pain) a global health status and 5 single items assessing additional symptoms (appetite loss, constipation, diarrhea, dyspnea and sleep disturbance)). The scales measures range score from 0 to 100. A high scale score represents a higher response level
Measured: 3 months
Evaluate the pain catastrophizing
The evaluation will be done through the PCS (Pain Catastrophizing Scale) questionnaire. It is a 13-item questionnaire assessing rumination, magnification and helplessness about the pain. The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. A high scale score represents a clinically relevant level of catastrophizing.
Measured: 3 months
Evaluate the consistency of the feeling of the global clinic improvement of the patient
Using the PGIC (Patient Global Impression of Change) It is a 1-item questionnaire. The scale evaluates all aspects of patient health and assesses if there has been an improvement or decline in clinical status from 0 (much better) to 10 (much worse).
Measured: 3 months
Evaluate the consistency or not of the feeling of the global clinic improvement of the clinician at M1 and M3.
Using the the CGIC (Clinical Global Impression of Change) It is is rated on a 7-point scale, with a severity of illness scale using a range of responses from 1 (very much improved) through to 7 ( very much worse).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start20 Feb 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injections, SpinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie PECHARD, Study director, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388449
- Sponsor's protocol ID
- ICO-2019-18
- Acronym
- QUALITHEC01
- Status last verified
- Apr 2022
- First submitted
- 9 Apr 2020
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04388449
- Acronym / sponsor ID
- QUALITHEC01 / ICO-2019-18
- Conditions
- Injections, Spinal, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patient under 18 years-old.
- Patient under guardianship or protection of vulnerable adults
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the experience of patients who have an intrathecal analgesia treating nociceptive and/or neuropathic pain of cancerous origin in palliative phase.
Time frame: 3 months
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
5 secondary outcomes
Evaluate the mean pain of the past 24 hours
Time frame: 3 months
Evaluate the quality of life
Time frame: 3 months
Evaluate the pain catastrophizing
Time frame: 3 months
Evaluate the consistency of the feeling of the global clinic improvement of the patient
Time frame: 3 months
Evaluate the consistency or not of the feeling of the global clinic improvement of the clinician at M1 and M3.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie PECHARD study director
Institut Curie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Injections, Spinal and Cancer, run by Institut Cancerologie de l'Ouest at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the experience of patients who have an intrathecal analgesia treating nociceptive and/or neuropathic pain of cancerous origin in palliative phase. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.