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

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ClinicalTrials.gov Identifier: NCT02777697
Recruitment Status : Unknown
Verified May 2016 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : May 19, 2016
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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 ...).

Condition or disease Intervention/treatment
Chronic Pain Cancer 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
Estimated Enrollment : 360 participants
Time Perspective: Prospective
Official Title: Cancer Chronic Pain Predicted by Emotional and Cognitive Status
Study Start Date : March 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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



Primary Outcome Measures :
  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 visit at 1 month after inclusion of patients.


Secondary Outcome Measures :
  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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
cancer patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777697


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Gisèle PICKERING         
Sub-Investigator: Claude DUBRAY         
Sub-Investigator: Laurent GILAIN         
Sub-Investigator: Bernard LAURENT         
Sub-Investigator: Didier AMMAR         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02777697     History of Changes
Other Study ID Numbers: CHU-0262
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016

Keywords provided by University Hospital, Clermont-Ferrand:
cancer treatment protocols
chronic cancer pain
cognitive function
quality of life
anxiety
depression

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms