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The Effect of an Inter-Disciplinary Program, Including MBSR, in Breast Cancer Survivors With Chronic Neuropathic Pain (InDepth)

19. juli 2019 opdateret af: Ottawa Hospital Research Institute

The Effect of an Inter-Disciplinary Program, Including Mindfulness-Based Stress Reduction, on Psychosocial Function, Pain Perception, Disability and Quality of Life in Breast Cancer Survivors With Chronic Neuropathic Pain

Chronic neuropathic pain is a common problem for breast cancer survivors. Even with the best medical treatment, some survivors continue to experience disabling pain. It is well-established that an interdisciplinary approach is key to the treatment of some types of chronic pain, but little research has been done on the effectiveness of interdisciplinary treatments for cancer survivors with chronic neuropathic pain. The investigators will evaluate the effectiveness of an interdisciplinary approach combining medical treatment and mindfulness-based stress reduction (MBSR) to reduce disability and improve quality of life among breast cancer survivors with chronic neuropathic pain. The investigators will also evaluate the impact of the program on psychological distress, pain cognitions, biomarkers of stress and immune function, cognitive function, as well as brain structure and function.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The investigators will recruit 108 adult women survivors of breast cancer living with chronic neuropathic pain. All will have their medical treatment optimized by a pain medicine specialist before being randomly assigned to either an 8-week group MBSR program or a wait-list. All participants will complete self-report questionnaires, provide a hair sample for cortisol measurements and a blood sample to measure several markers of immune function at four different time points: before medical treatment, after medical treatment and before randomization to MBSR or waiting, after the completion of MBSR as well as at 3-month follow-up. A sub-sample will complete a series of tasks while undergoing functional magnetic resonance imaging before and after participation in MBSR.

The primary outcome is pain interference. The investigators will compare the proportion of participants who report reduced pain-related disability, as measured by the Brief Pain Inventory-Interference Scale, in each group. The primary hypothesis is that at 3-month follow-up, there will be at least 30% more responders (≥1.0 decrease in mean Brief Pain Inventory Interference score) in the interdisciplinary program in comparison to medical treatment alone.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

118

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital

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

Kvinde

Beskrivelse

Inclusion Criteria:

  • Female.
  • 18 years or older.
  • Completed treatment for breast cancer a minimum of 1 year prior to study enrollment.
  • Have been experiencing neuropathic pain following their cancer treatment for a minimum of 6 months.
  • Report pain intensity levels ≥4 (moderate to severe).

Exclusion Criteria:

  • Metastatic disease or current evidence of cancer recurrence
  • Pregnancy or breastfeeding
  • Unable to complete questionnaires in English or French.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Tværfagligt program inklusive MBSR
Deltagere tildelt denne gruppe vil blive tilmeldt et Mindfulness-Based Stress Reduction (MBSR) program efter medicinsk behandlingsoptimering. MBSR-programmet vil være sammensat af otte ugentlige 2,5 timers sessioner og en 6 timers session midtvejs i kurset.
Adfærdsmæssigt: Mindfulness-Based Stress Reduction
Consists of eight weekly 2.5 hour sessions and one 6 hour session midway through the course. All sessions will be conducted by a psychologist or social worker with experience in chronic pain, formal MBSR training and 5 years of experience leading MBSR groups. To assess therapist adherence to the protocol, sessions will be recorded. A random selection of 50% of sessions will be rated by an MBSR trainer who completed the University of Massachusetts Centre for Mindfulness in Medicine, Health Care and Society Teacher Development Intensive using a checklist of specified treatment components. A percentage score for each session rated will be calculated to determine therapist adherence.
Ingen indgriben: Ventelistet kontrolgruppe
Deltagere, der tildeles denne gruppe efter medicinsk behandlingsoptimering, vil fungere som ventelistekontroller for MBSR-gruppen. De vil blive tilmeldt MBSR-workshoppen 3 måneder efter, at den tilsvarende interventionsgruppe har afsluttet programmet.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring fra baseline i smerterelateret funktionsnedsættelse, som målt ved Brief Pain Inventory - Pain Interference-skalaen, 3 måneder efter intervention.
Tidsramme: Baseline og 3 måneder efter intervention
Det primære resultat er smerterelateret funktionsnedsættelse, som målt ved Kort smerteopgørelse - Smerteinterferens-skalaen. The Brief Pain Inventory (BPI) - Smerteinterferens består af 7 numeriske skalaer (0 til 10) som vurderer smerteinterferens med generel aktivitet, humør, gangevne, arbejde, relationer til andre mennesker, søvn og livsnydelse.
Baseline og 3 måneder efter intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in neuropathic pain intensity, as measured by the Neuropathic Pain Symptom Inventory, at 3 months post-intervention
Tidsramme: Baseline and 3 months post-intervention
Neuropathic pain intensity will be measured using the Neuropathic Pain Symptom Inventory (NPSI), a self-report questionnaire that consists of 10 pain descriptors and two temporal items. Responses are rated on a numerical scale (0-10) and a total intensity score is calculated. Five sub-scores are also derived: spontaneous burning pain, spontaneous pressing pain, paroxysmal pain, evoked pain and paresthesia/dysesthesia.
Baseline and 3 months post-intervention
Ændring fra baseline i smertens sværhedsgrad, som målt ved Brief Pain Inventory - Pain Severity-skalaen, 3 måneder efter intervention
Tidsramme: Baseline og 3 måneder efter intervention
Smertesværhedsgrad vil blive målt ved hjælp af Brief Pain Inventory (BPI) - Pain Severity. BPI består af 4 numeriske skalaer (0 til 10), der vurderer smertens sværhedsgrad, når det er værst, i det mindste, i gennemsnit og på tidspunktet for udfyldning af målingen. Hvert sværhedsspørgsmål analyseres individuelt.
Baseline og 3 måneder efter intervention
Change from baseline in mood states, as measured by the Profile of Mood States scale, at 3 months post-intervention
Tidsramme: Baseline and 3 months post-intervention
The Profile of Mood States (POMS-2A) will be used to measure mood disturbance. Participants are asked to rate 65 adjectives using a 5-point likert scale ( 0= not at all, to 4 = extremely) based on how they have been feeling during the past week, including the day they are filling out the questionnaire. A total mood disturbance score is calculated, as well as scores for 6 subscales: depression, tension-anxiety, anger-hostility, vigor-activity, fatigue, confusion-bewilderment.
Baseline and 3 months post-intervention
Samlet ændring i status fra baseline, målt ved Patient Global Impression of Change-skala, 3 måneder efter intervention
Tidsramme: Baseline og 3 måneder efter intervention
Deltagernes opfattede grad af ændring i overordnet status vil blive målt ved hjælp af Patient Global Impression of Change (PGIC) skalaen. PGIC bruger en 7-punkts likert-skala (meget værre, til meget bedre) til at måle, hvor meget deltageren føler, at deres generelle status har ændret sig siden starten af ​​undersøgelsen.
Baseline og 3 måneder efter intervention
Change from baseline in stress, as measured by the Perceived Stress Scale, at 3 months post-intervention
Tidsramme: Baseline and 3 months post-intervention
The Perceived Stress Scale (PSS) will be used to measure the participants' perceived stress levels. The PSS uses a 5-point likert scale (0=Never, to 4=Very often) to measure the degree of stress a participant has experienced over the past month. A total perceived stress score is obtained by reversing the scores on items 4, 5, 7, and 8, and then summing across all 10 items. Higher scores indicate higher perceived stress.
Baseline and 3 months post-intervention
Ændring fra baseline i depressive symptomer, målt ved Patient Health Questionnaire - 9-skalaen, 3 måneder efter intervention
Tidsramme: Baseline og 3 måneder efter intervention
Patient Health Questionnaire - 9 (PHQ-9) er en 9-trins skala, der bruges til at vurdere sværhedsgraden af ​​depressive symptomer i løbet af de sidste to uger og er baseret på Diagnostic and Statistical Manual (DSM-IV) diagnostiske kriterier for svær depression. Samlede scorer varierer fra 0 til 27, og kliniske cut-points svarer til mild, moderat, moderat svær og svær depression.
Baseline og 3 måneder efter intervention
Ændring fra baseline i smertekatastrofer, som målt ved Pain Catastrophizing Scale, 3 måneder efter intervention.
Tidsramme: Baseline og 3 måneder efter intervention
Pain Catastrophizing Scale (PCS) er et instrument med 13 punkter, som vil evaluere, i hvilken grad patienter har negative selvudsagn og katastrofale tanker og ideer, når de har smerter. PCS'en bruger en 5-punkts likert-skala (0=slet ikke, 4=hele tiden) og består af tre underskalaer (drøvtygning, forstørrelse, hjælpeløshed).
Baseline og 3 måneder efter intervention
Ændring fra baseline i mindfulness, som målt ved Five Facet Mindfulness Questionnaire, 3 måneder efter intervention.
Tidsramme: Baseline og 3 måneder efter intervention
Mindfulness vil blive målt ved hjælp af Five Facet Mindfulness Questionnaire (FFMQ). FFMQ er et instrument med 39 punkter, der måler fem aspekter af mindfulness: Ikke-reaktivitet over for indre oplevelse, observation, beskrivelse, handling med bevidsthed og ikke-bedømmelse af erfaring. Deltagerne bliver bedt om at bruge en 5-punkts Likert-skala (1 = aldrig eller sjældent sandt; 5 = meget ofte eller altid sandt) til at vurdere, hvor sandt de mener, at hvert udsagn er.
Baseline og 3 måneder efter intervention
Ændring fra baseline i livskvalitet, målt ved Short-Form-12 Health Survey, 3 måneder efter intervention.
Tidsramme: Baseline og 3 måneder efter intervention
Livskvalitet vil blive målt ved Short-Form-12 Health Survey (SF-12v.2). SF-12v2 er en kort selvrapporteringsforanstaltning med 12 punkter baseret på Short-Form-36. Det omfatter elementer, der vurderer otte sundhedsdomæner, såsom kropslig smerte, social funktion, rollebegrænsninger på grund af fysisk sundhed og generelle sundhedsopfattelser. To opsummerende resultater, den fysiske sammensatte skala (PCS) og den mentale sammensatte skala (MCS) er beregnet ud fra de 12 punkter. Scorer varierer fra 0 til 100, hvor højere score indikerer større livskvalitet.
Baseline og 3 måneder efter intervention
Change from pre-intervention in biomarkers of stress, as measured by hair cortisol levels, at 3 months post-intervention.
Tidsramme: Pre-intervention and 3 months post-intervention
Cortisol is a useful biomarker of stress levels. One cm hair samples will allow us to collect data on cortisol exposure over the past month.
Pre-intervention and 3 months post-intervention
Change from baseline in immune function, as measured by blood levels of interleukin-4, interleukin-6, interleukin-10, tumor necrosis factor - alpha, and C reactive protein, at 3 months post-intervention.
Tidsramme: Baseline and 3 months post-intervention
Six mL whole blood samples will be obtained from participants and the measurement of cytokine secretion and CRP will be performed. The concentrations of interleukin-4 (IL-4), interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor - alpha (TNF-α), as well as C reactive protein (CRP) production will be quantified and recorded. All samples and standards will be analyzed in duplicate.
Baseline and 3 months post-intervention
Change from baseline in biomarkers of stress, as measured by telomere length, at 3 months post-intervention.
Tidsramme: Baseline and 3 months post-intervention
Total genomic DNA will be extracted from 0.2 mL of whole blood. The relative average Telomere Length (TL) will be determined and recorded. Samples will be analyzed in triplicate.
Baseline and 3 months post-intervention
Change from pre-intervention in neuronal health, as measured by white matter integrity, at 2 weeks post-intervention.
Tidsramme: Pre-intervention and 2 weeks post-intervention
Changes in participants' neuronal health will be measured with MRI sessions that include diffusion tensor imaging (DTI). These imaging sessions will provide measures of white matter integrity (fractional anisotropy, mean diffusivity, radial diffusivity).
Pre-intervention and 2 weeks post-intervention
Change from pre-intervention in brain areas associated with emotional regulation, as measured by blood flow in the brain seen in functional magnetic imaging, at 2 weeks post-intervention.
Tidsramme: Pre-intervention and 2 weeks post-intervention
Changes in blood flow to areas of participants' brains known to be associated with emotional regulation will be measured using functional magnetic imaging (fMRI).
Pre-intervention and 2 weeks post-intervention
Change from pre-intervention in brain structure, as measured by changes in structural volume different areas of the brain, at 2 weeks post-intervention.
Tidsramme: Pre-intervention and 2 weeks post-intervention
High resolution magnetic resonance imaging will be used to look at the anatomy of participants' brains and measure changes in structural volume.
Pre-intervention and 2 weeks post-intervention

Samarbejdspartnere og efterforskere

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

Sponsor

Ottawa Hospital Research Institute

Samarbejdspartnere

Canadian Institutes of Health Research (CIHR)
Canadian Breast Cancer Foundation

Efterforskere

  • Ledende efterforsker: Patricia Poulin, PhD, Ottawa Hospital Research Institute

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

1. oktober 2013

Primær færdiggørelse (Faktiske)

1. oktober 2017

Studieafslutning (Faktiske)

1. august 2018

Datoer for studieregistrering

Først indsendt

23. april 2014

Først indsendt, der opfyldte QC-kriterier

24. april 2014

Først opslået (Skøn)

29. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20130525-01H

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

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