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

31. marts 2020 opdateret af: 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 ...).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

89

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Clermont-Ferrand, Frankrig, 63003
        • Chu Clermont-Ferrand

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
kræftpatienter
Andet: chronic pain

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measure of average pain intensity by a numerical rating scale
Tidsramme: 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.
7 days before the visit

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Clermont-Ferrand

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2016

Primær færdiggørelse (Faktiske)

15. oktober 2018

Studieafslutning (Faktiske)

12. november 2018

Datoer for studieregistrering

Først indsendt

13. april 2016

Først indsendt, der opfyldte QC-kriterier

17. maj 2016

Først opslået (Skøn)

19. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. marts 2020

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHU-0262

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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