Chronic PainCanoPEeNCT02777697
Cancer Chronic Pain Predicted by Emotional and Cognitive Status
An observational study of Chronic Pain and Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim of this study is to investigate the predictive dimension of cognitive-emotional status of cancer patients on the chronic pain development 6 months after different cancer treatment protocol (surgery, chemotherapy, radiotherapy, hormone therapy, targeted therapy ...). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Cancer
- What is being tested?
- chronic pain
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to 12 Nov 2018
- 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: cancer patients
Who may be able to join
- Age ≥ 18 years
- Cancer patient with one or more programmed cancer treatment protocols (chemotherapy, surgery, hormone therapy, radiation therapy, targeted therapy, ...)
- Acceptance to sign the non-opposition form
Who cannot join
- History of cancer and cancer treatment protocols (chemotherapy, surgery, hormone therapy, radiation therapy, targeted therapy, ...)
- History and/or presence of primary brain tumors (glioblastoma, meningioma, neurofibroma ...)
- History of neurological disorders (Parkinson's disease, Alzheimer's disease, dementia, epilepsy, moderate to severe head injury, ...)
- History of psychiatric disorders (schizophrenia, bipolar disorder, ...)
- Medical and surgical history incompatible with the study
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the predictive dimension of cognitive-emotional status of cancer patients on the chronic pain development 6 months after different cancer treatment protocol (surgery, chemotherapy, radiotherapy, hormone therapy, targeted therapy ...).
Read the detailed description
This is an observational, longitudinal and multicenter study assessing in cancer patients the link between the cognitive-emotional status and the development of chronic pain.
Cognition, anxiety, depression, quality of life, social vulnerability, cancer perception, pain and analgesic consumption are assessed.
- Conditions
- Chronic Pain, Cancer
- Being tested
- chronic pain
- Keywords
- cancer treatment protocols, chronic cancer pain, cognitive function, quality of life, anxiety, depression
- Medical subject headings
- Chronic Pain, Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chronic painOther
| Study group | Role | What they receive |
|---|---|---|
| cancer patients | Not described Receives: Other: chronic pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of average pain intensity by a numerical rating scale
Measure of average pain intensity by a numerical rating scale assessed 7 days before the 6 months visit after inclusion of patients.
Measured: 7 days before the visit
Secondary outcomes (19)
Pain assessment by numerical rating scale and DN4
Measured: at baseline
Pain assessment by numerical rating scale and DN4
Measured: at 6 months
Pain assessment by numerical rating scale and DN4
Measured: at 12 months
Pain assessment by numerical rating scale and DN4
Measured: at 24 months
Pain assessment by numerical rating scale and DN4
Measured: 2 days after each cancer treatment protocol
Evaluation of analgesic consumption
Analgesic consumption is evaluated during all period of the study (name of the specialty, dose, indication, form, administration route, starting date, end date),
Measured: at day 1
Cognitive assessment by Trail Making Test A and B (TMT)
Measured: at baseline
Cognitive assessment by Trail Making Test A and B (TMT)
Measured: at 24 months
Cognitive assessment by Trail Making Test A and B (TMT)
Measured: at 6 months
Cognitive assessment by Trail Making Test A and B (TMT)
Measured: at 12 months
Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
Measured: at baseline
Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
Measured: at 24 months
Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
Measured: at 12 months
Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
Measured: at 6 months
Quality of life assessment
Quality of life assessment by:
- The European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), at baseline, 6 months, 12 months and 24 months. This questionnaire assesses the quality of life of cancer patients. It is divided in 9 subscales consisting of several items: 5 subscales measuring functional status (physical, role, social, emotional, cognitive), three subscales measuring symptoms (fatigue, pain, nausea and vomiting) and a global subscale of quality of life and health. Finally, six items/isolated symptoms, covering cancer symptoms and frequent side effects of cancer therapies (e.g. loss of appetite) are also included in the EORTC QLQ-C30. The EORTC QLQ-C30 Score ranges from 0 to 126
Measured: at baseline, 6 months, 12 months and 24 months,
Social vulnerability assessment by EPICES questionnaire
Measured: at baseline, 6 months, 12 months and 24 months
Anxiety and Depression assessment by HAD scale
Measured: at baseline, 6 months, 12 months and 24 months
Illness perception assessment
Global score ranges from 0 to 200
Measured: at baseline, 6 months, 12 months and 24 months
Coping strategies assessment by Coping strategies questionnaire (CSQ)
Measured: 2 days after each cancer treatment protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMar 2016
- Primary completion15 Oct 2018
- Study completion12 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777697
- Sponsor's protocol ID
- CHU-0262
- Acronym
- CanoPEe
- Status last verified
- May 2016
- First submitted
- 13 Apr 2016
- Last updated
- 2 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Chronic Pain Predicted by Emotional and Cognitive Status
- ClinicalTrials.gov ID
- NCT02777697
- Acronym / sponsor ID
- CanoPEe / CHU-0262
- Conditions
- Chronic Pain, Cancer
- Keywords
- cancer treatment protocols, chronic cancer pain, cognitive function, quality of life, anxiety, depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 19 May 2016 (estimated)
- 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 aim of this study is to investigate the predictive dimension of cognitive-emotional status of cancer patients on the chronic pain development 6 months after different cancer treatment protocol (surgery, chemotherapy, radiotherapy, hormone therapy, targeted therapy ...).
Detailed description
This is an observational, longitudinal and multicenter study assessing in cancer patients the link between the cognitive-emotional status and the development of chronic pain.
Cognition, anxiety, depression, quality of life, social vulnerability, cancer perception, pain and analgesic consumption are assessed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cancer patients | – | Other: chronic pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cancer patients
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Cancer patient with one or more programmed cancer treatment protocols (chemotherapy, surgery, hormone therapy, radiation therapy, targeted therapy, ...)
- Acceptance to sign the non-opposition form
Key exclusion criteria (5 listed)
- History of cancer and cancer treatment protocols (chemotherapy, surgery, hormone therapy, radiation therapy, targeted therapy, ...)
- History and/or presence of primary brain tumors (glioblastoma, meningioma, neurofibroma ...)
- History of neurological disorders (Parkinson's disease, Alzheimer's disease, dementia, epilepsy, moderate to severe head injury, ...)
- History of psychiatric disorders (schizophrenia, bipolar disorder, ...)
- Medical and surgical history incompatible with the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chronic pain | Other | cancer patients |
Primary outcome
Measure of average pain intensity by a numerical rating scale
Time frame: 7 days before the visit
Measure of average pain intensity by a numerical rating scale assessed 7 days before the 6 months visit after inclusion of patients.
19 secondary outcomes
Pain assessment by numerical rating scale and DN4
Time frame: at baseline
Pain assessment by numerical rating scale and DN4
Time frame: at 6 months
Pain assessment by numerical rating scale and DN4
Time frame: at 12 months
Pain assessment by numerical rating scale and DN4
Time frame: at 24 months
Pain assessment by numerical rating scale and DN4
Time frame: 2 days after each cancer treatment protocol
Evaluation of analgesic consumption
Time frame: at day 1
Cognitive assessment by Trail Making Test A and B (TMT)
Time frame: at baseline
Cognitive assessment by Trail Making Test A and B (TMT)
Time frame: at 24 months
Cognitive assessment by Trail Making Test A and B (TMT)
Time frame: at 6 months
Cognitive assessment by Trail Making Test A and B (TMT)
Time frame: at 12 months
Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
Time frame: at baseline
Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
Time frame: at 24 months
Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
Time frame: at 12 months
Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
Time frame: at 6 months
Quality of life assessment
Time frame: at baseline, 6 months, 12 months and 24 months,
Social vulnerability assessment by EPICES questionnaire
Time frame: at baseline, 6 months, 12 months and 24 months
Anxiety and Depression assessment by HAD scale
Time frame: at baseline, 6 months, 12 months and 24 months
Illness perception assessment
Time frame: at baseline, 6 months, 12 months and 24 months
Coping strategies assessment by Coping strategies questionnaire (CSQ)
Time frame: 2 days after each cancer treatment protocol.
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 2 Apr 2020.
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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.
Gisèle PICKERING principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Cancer, run by University Hospital, Clermont-Ferrand at 1 site 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 3 inclusion and 5 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 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Measure of average pain intensity by a numerical rating scale (time frame: 7 days before the visit). 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 2 Apr 2020.