Self-management Support in Cancer Pain
7. januar 2015 opdateret af: Maastricht University Medical Center
Effects of a Multifaceted Teleguided Pain Care Program in Patients With Cancer Pain
Pain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life.
Integration of patient self-management and professional care by means of care technology provides new opportunities in the outpatient setting.
In this project a technology based and nurse delivered multicomponent self-management support intervention has been developed.
Important components include monitoring, feedback, education, and nurse support.
Following feasibility evaluation, the primary aim of this randomized controlled trial is to assess the effect of the intervention regarding pain intensity and quality of life as compared to care as usual.
Secondary outcomes of the effect evaluation are self-efficacy, knowledge, anxiety and depression, and pain medication use.
Besides, a cost-evaluation and summative process evaluation will be performed.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
174
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Heerlen, Holland
- Rekruttering
- Atrium Medical Center
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Kontakt:
- Asiong Jie, MD, PhD
- Telefonnummer: +31 455766666
- E-mail: G.Jie@atriummc.nl
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Maastricht, Holland
- Rekruttering
- Maastricht University Medical Center
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Kontakt:
- Annemie Courtens, PhD
- Telefonnummer: +31 433877548
- E-mail: a.courtens@mumc.nl
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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
Beskrivelse
Inclusion Criteria:
- Diagnosis of cancer
- Patients who are under (palliative) anti-tumour treatment in a day clinic or outpatient clinic, or patients who have no treatment options available anymore
- Cancer (treatment related) pain > 2 weeks
- Pain is defined as a patient reported pain score of 4 or more on a numerical rating scale (scale 0-10)
- Living at home
Exclusion Criteria:
- Expected life expectancy < 3 months
- Chronic non-cancer pain
- Known cognitive impairments
- Participation in other studies that interfere with this study
- Not being able to read and understand the Dutch language
- Reduced vision
- Non-reachable by phone
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Kontrolgruppe
Pas på som sædvanlig
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Eksperimentel: Intervention group
Self-management support
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The 12-week intervention consists of an iPad application for patients that is connected to a web application for nurses.
Every morning and evening patients register pain and related symptoms by use of a pain diary.
Patients are also requested to register medication intake.
Graphical feedback is provided based on registered pain scores and medication intakes.
Patients receive education on causes and treatment of pain, symptoms that require action, and methods to better control pain.
Patients communicate with nurses via text message functionality within the application.
Specialized nurses remotely monitor and analyze the patients' situation once every workday.
Nurses have the opportunity to collaborate with the treating physician, pain specialist or multidisciplinary team.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in pain intensity (Brief Pain Inventory - Short Form (BPI-SF)
Tidsramme: 12 weeks
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As measured with the Brief Pain Inventory - Short Form (BPI-SF)
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12 weeks
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Change in cancer related quality of life (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)
Tidsramme: 12 weeks
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As measured with the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ-C30 version 3)
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12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in self-efficacy (Chronic Pain Self-efficacy Scale (CPSS)
Tidsramme: 12 weeks
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As measured with the Chronic Pain Self-efficacy Scale (CPSS)
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12 weeks
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Change in knowledge about cancer pain (Pain Knowledge Questionnaire (PKQ)
Tidsramme: 12 weeks
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As measured with the Pain Knowledge Questionnaire (PKQ)
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12 weeks
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Change in anxiety and depression (Hospital Anxiety and Depression Scale (HADS)
Tidsramme: 12 weeks
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As measured with the Hospital Anxiety and Depression Scale (HADS)
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12 weeks
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Change in pain medication use (Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview)
Tidsramme: 12 weeks
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As measured with the Brief Pain Inventory - Short Form (BPI-SF), a cost diary and a pharmacist's overview
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12 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. februar 2014
Primær færdiggørelse (Forventet)
1. juni 2015
Studieafslutning (Forventet)
1. august 2015
Datoer for studieregistrering
Først indsendt
29. december 2014
Først indsendt, der opfyldte QC-kriterier
7. januar 2015
Først opslået (Skøn)
8. januar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. januar 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. januar 2015
Sidst verificeret
1. januar 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UM 2011-5079
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 .