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Completed

NCT Number: NCT02777697

Cancer Chronic Pain Predicted by Emotional and Cognitive Status

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 ...).

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Key information

Conditions

Chronic Pain Anxiety Disorders Behavior Behavioral Symptoms Cancer Depression Mental Disorders Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chronic pain

Other

Primary outcomes

  1. 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 outcomes

  1. Pain assessment by numerical rating scale and DN4

    Time frame: at baseline

  2. Pain assessment by numerical rating scale and DN4

    Time frame: at 6 months

  3. Pain assessment by numerical rating scale and DN4

    Time frame: at 12 months

  4. Pain assessment by numerical rating scale and DN4

    Time frame: at 24 months

  5. Pain assessment by numerical rating scale and DN4

    Time frame: 2 days after each cancer treatment protocol

  6. 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),

  7. Cognitive assessment by Trail Making Test A and B (TMT)

    Time frame: at baseline

  8. Cognitive assessment by Trail Making Test A and B (TMT)

    Time frame: at 24 months

  9. Cognitive assessment by Trail Making Test A and B (TMT)

    Time frame: at 6 months

  10. Cognitive assessment by Trail Making Test A and B (TMT)

    Time frame: at 12 months

  11. Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG

    Time frame: at baseline

  12. Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG

    Time frame: at 24 months

  13. Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG

    Time frame: at 12 months

  14. Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG

    Time frame: at 6 months

  15. 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

  16. Social vulnerability assessment by EPICES questionnaire

    Time frame: at baseline, 6 months, 12 months and 24 months

  17. Anxiety and Depression assessment by HAD scale

    Time frame: at baseline, 6 months, 12 months and 24 months

  18. Illness perception assessment

    Time frame: at baseline, 6 months, 12 months and 24 months

    Global score ranges from 0 to 200

  19. Coping strategies assessment by Coping strategies questionnaire (CSQ)

    Time frame: 2 days after each cancer treatment protocol.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: CanoPEe

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 19, 2016
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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