Cancer Chronic Pain Predicted by Emotional and Cognitive Status (CanoPEe)

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 ...).

Study Overview

• Status: Completed
• Conditions: Cancer; Chronic Pain
• Intervention / Treatment: Other: chronic pain

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 Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

cancer patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cancer patients	Other: chronic pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): October 15, 2018
• Study Completion (Actual): November 12, 2018

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 19, 2016

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: quality of life; depression; cognitive function; anxiety; cancer treatment protocols; chronic cancer pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: CHU-0262