Clinical trial NCT02777697: Cancer Chronic Pain Predicted by Emotional and Cognitive Status
Official title: Cancer Chronic Pain Predicted by Emotional and Cognitive Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Cancer
Keywords: cancer treatment protocols
chronic cancer pain
cognitive function
quality of life
anxiety
depression
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cancer patients

Brief 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 ...).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Measure of average pain intensity by a numerical rating scale
timeFrame: 7 days before the visit
Secondary outcomes:
measure: Pain assessment by numerical rating scale and DN4
timeFrame: at baseline
measure: Pain assessment by numerical rating scale and DN4
timeFrame: at 6 months
measure: Pain assessment by numerical rating scale and DN4
timeFrame: at 12 months
measure: Pain assessment by numerical rating scale and DN4
timeFrame: at 24 months
measure: Pain assessment by numerical rating scale and DN4
timeFrame: 2 days after each cancer treatment protocol
measure: Evaluation of analgesic consumption
timeFrame: at day 1
measure: Cognitive assessment by Trail Making Test A and B (TMT)
timeFrame: at baseline
measure: Cognitive assessment by Trail Making Test A and B (TMT)
timeFrame: at 24 months
measure: Cognitive assessment by Trail Making Test A and B (TMT)
timeFrame: at 6 months
measure: Cognitive assessment by Trail Making Test A and B (TMT)
timeFrame: at 12 months
measure: Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
timeFrame: at baseline
measure: Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
timeFrame: at 24 months
measure: Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
timeFrame: at 12 months
measure: Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
timeFrame: at 6 months
measure: Quality of life assessment
timeFrame: at baseline, 6 months, 12 months and 24 months,
measure: Social vulnerability assessment by EPICES questionnaire
timeFrame: at baseline, 6 months, 12 months and 24 months
measure: Anxiety and Depression assessment by HAD scale
timeFrame: at baseline, 6 months, 12 months and 24 months
measure: Illness perception assessment
timeFrame: at baseline, 6 months, 12 months and 24 months
measure: Coping strategies assessment by Coping strategies questionnaire (CSQ)
timeFrame: 2 days after each cancer treatment protocol.
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle PICKERING
role: PRINCIPAL_INVESTIGATOR
References: