Cancer Chronic Pain Predicted by Emotional and Cognitive Status (CanoPEe)
31. mars 2020 oppdatert av: University Hospital, Clermont-Ferrand
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 ...).
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
89
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Clermont-Ferrand, Frankrike, 63003
- CHU Clermont-Ferrand
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
cancer patients
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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kreftpasienter
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Measure of average pain intensity by a numerical rating scale
Tidsramme: 7 days before the visit
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Measure of average pain intensity by a numerical rating scale assessed 7 days before the 6 months visit after inclusion of patients.
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7 days before the visit
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Pain assessment by numerical rating scale and DN4
Tidsramme: at baseline
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at baseline
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Pain assessment by numerical rating scale and DN4
Tidsramme: at 6 months
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at 6 months
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Pain assessment by numerical rating scale and DN4
Tidsramme: at 12 months
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at 12 months
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Pain assessment by numerical rating scale and DN4
Tidsramme: at 24 months
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at 24 months
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Pain assessment by numerical rating scale and DN4
Tidsramme: 2 days after each cancer treatment protocol
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2 days after each cancer treatment protocol
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Evaluation of analgesic consumption
Tidsramme: at day 1
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Analgesic consumption is evaluated during all period of the study (name of the specialty, dose, indication, form, administration route, starting date, end date),
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at day 1
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Cognitive assessment by Trail Making Test A and B (TMT)
Tidsramme: at baseline
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at baseline
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Cognitive assessment by Trail Making Test A and B (TMT)
Tidsramme: at 24 months
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at 24 months
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Cognitive assessment by Trail Making Test A and B (TMT)
Tidsramme: at 6 months
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at 6 months
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Cognitive assessment by Trail Making Test A and B (TMT)
Tidsramme: at 12 months
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at 12 months
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Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
Tidsramme: at baseline
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at baseline
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Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
Tidsramme: at 24 months
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at 24 months
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Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
Tidsramme: at 12 months
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at 12 months
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Rey Auditory-Verbal Learning Test (RAVLT) and FACT-COG
Tidsramme: at 6 months
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at 6 months
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Quality of life assessment
Tidsramme: at baseline, 6 months, 12 months and 24 months,
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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,
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Social vulnerability assessment by EPICES questionnaire
Tidsramme: at baseline, 6 months, 12 months and 24 months
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at baseline, 6 months, 12 months and 24 months
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Anxiety and Depression assessment by HAD scale
Tidsramme: at baseline, 6 months, 12 months and 24 months
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at baseline, 6 months, 12 months and 24 months
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Illness perception assessment
Tidsramme: at baseline, 6 months, 12 months and 24 months
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Global score ranges from 0 to 200
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at baseline, 6 months, 12 months and 24 months
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Coping strategies assessment by Coping strategies questionnaire (CSQ)
Tidsramme: 2 days after each cancer treatment protocol.
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2 days after each cancer treatment protocol.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2016
Primær fullføring (Faktiske)
15. oktober 2018
Studiet fullført (Faktiske)
12. november 2018
Datoer for studieregistrering
Først innsendt
13. april 2016
Først innsendt som oppfylte QC-kriteriene
17. mai 2016
Først lagt ut (Anslag)
19. mai 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. april 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. mars 2020
Sist bekreftet
1. mai 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CHU-0262
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