Cancer Chronic Pain Predicted by Emotional and Cognitive Status

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 15, 2018

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.

Interventions

  • Other: chronic pain

Arms, Groups and Cohorts

  • cancer patients

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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
    • Analgesic consumption is evaluated during all period of the study (name of the specialty, dose, indication, form, administration route, starting date, end date),
  • 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,
    • 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
  • 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
    • Global score ranges from 0 to 200
  • Coping strategies assessment by Coping strategies questionnaire (CSQ)
    • Time Frame: 2 days after each cancer treatment protocol.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Clermont-Ferrand
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gisèle PICKERING, Principal Investigator, University Hospital, Clermont-Ferrand

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