Cancer Chronic Pain Predicted by Emotional and Cognitive Status

Cancer Clinical Trial

— CanoPEe  

Official title:

Cancer Chronic Pain Predicted by Emotional and Cognitive Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777697
• Other study ID #: CHU-0262
• Status: Completed
• Start date: March 2016
• Est. completion date: November 12, 2018

Study information

• Verified date: May 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 ...).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: November 12, 2018
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Chronic Pain

Intervention

Other:
• chronic pain

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days before the visit
Secondary	Pain assessment by numerical rating scale and DN4		at baseline
Secondary	Pain assessment by numerical rating scale and DN4		at 6 months
Secondary	Pain assessment by numerical rating scale and DN4		at 12 months
Secondary	Pain assessment by numerical rating scale and DN4		at 24 months
Secondary	Pain assessment by numerical rating scale and DN4		2 days after each cancer treatment protocol
Secondary	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),	at day 1
Secondary	Cognitive assessment by Trail Making Test A and B (TMT)		at baseline
Secondary	Cognitive assessment by Trail Making Test A and B (TMT)		at 24 months
Secondary	Cognitive assessment by Trail Making Test A and B (TMT)		at 6 months
Secondary	Cognitive assessment by Trail Making Test A and B (TMT)		at 12 months
Secondary	Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG		at baseline
Secondary	Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG		at 24 months
Secondary	Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG		at 12 months
Secondary	Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG		at 6 months
Secondary	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	at baseline, 6 months, 12 months and 24 months,
Secondary	Social vulnerability assessment by EPICES questionnaire		at baseline, 6 months, 12 months and 24 months
Secondary	Anxiety and Depression assessment by HAD scale		at baseline, 6 months, 12 months and 24 months
Secondary	Illness perception assessment	Global score ranges from 0 to 200	at baseline, 6 months, 12 months and 24 months
Secondary	Coping strategies assessment by Coping strategies questionnaire (CSQ)		2 days after each cancer treatment protocol.