- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02056483
REBECCA - Research in Rehabilitation After Breast Cancer (REBECCA)
5. august 2015 opdateret af: Christoffer Johansen, Danish Cancer Society
Optimized Rehabilitation: A Randomized Study of Systematic Monitoring and Management of Breast Cancer Patients' Symptoms
The purpose of this study is to examine if a psychosocial intervention including a nurse navigator and systematic symptom screening may reduce psychological and physical symptoms as well as health behavior after breast cancer.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
In this pilot study with a randomized controlled trial design, we examine the effect of an intervention optimizing and integrating rehabilitation for breast cancer on psychological and physical symptoms as well as health behavior after breast cancer.
In the intervention group, we systematically screen for psychological and physical symptoms as well as health behavior (smoking alcohol and physical activity) not in line with the recommendations.
Patients who screen positive are offered a sequence of sessions with a navigator nurse who monitor rehabilitation needs, supports the patient, educate in self-management of symptoms and refer to existing rehabilitation services as well as to up to 6 free sessions with a psychologist specialized in cancer patients.
The rehabilitation services that the nurse refers to include several hospital departments and municipality services as well as general practice and by thorough follow-up on the patients use of these, the intervention aims at developing an integrated treatment and rehabilitation trajectory.
The control group receives standard care.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
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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-
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Copenhagen, Danmark, 2100
- Rigshospitalet
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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
Kvinde
Beskrivelse
Inclusion Criteria:
- diagnosis of primary breast cancer at Breast Oncology Clinic, Rigshospitalet, Copenhagen, Denmark
- lives in Copenhagen municipality
- score ≥7 on distress thermometer
- able to read and understand Danish
- not pregnant
- expected survival more than 6 months
- physically able to participate in rehabilitation
- no severe psychiatric disease demanding treatment
- no severe cognitive problems (e.g. dementia or confusion)
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Sædvanlig pleje
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Eksperimentel: Screening-based nurse navigation
Based on systematic screening for psychological and physical symptoms as well as health behavior a nurse navigator will refer to and monitor use of appropriate rehabilitation programs
|
Screening-based nurse navigation for breast cancer rehabilitation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Psychological distress
Tidsramme: 6 and 12 months
|
Difference in change in psychological distress between patients in the intervention and control group.Psychological distress wil be measured using the Distress Thermometer
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6 and 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Health related quality of life
Tidsramme: 6 and 12 months
|
Difference in change in patient reported health related quality of life between patients in the intervention and control group.
Health related quality of life will be measured using the European Organization for Research and Treatment of Cancer quality of life questionnaire EORTC QLQ C30 and the EORTC BR23 including subscales.
|
6 and 12 months
|
Anxiety and depression
Tidsramme: 6 and 12 months
|
Difference in change in patient reported anxiety and depression between patients in the intervention and control group.
Anxiety and depresison will be measured using the Hospital Anxiety and Depression scale (HADS).
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6 and 12 months
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Smoking
Tidsramme: 6 and 12 months
|
Difference in change in patient reported cigarette smoking measured in grams per day between patients in intervention and control group.
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6 and 12 months
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Alcohol consumption
Tidsramme: 6 and 12 months
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Difference in change in patient reported alcohol consumption measured in grams per day between patients in intervention and control group.
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6 and 12 months
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Body mass index
Tidsramme: 6 and 12 months
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Difference in change in patient reported body masss index between patients in intervention and control group.
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6 and 12 months
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Physical activity
Tidsramme: 6 and 12 months
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Difference in change in patient reported physical activity between patients in intervention and control group.
|
6 and 12 months
|
Use of rehabilitation services
Tidsramme: 6 and 12 months
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Difference in change in patient reported use of rehabilitation services between patients in intervention and control group.
|
6 and 12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Christoffer Johansen, MD, Phd, Danish Cancer Society
- Ledende efterforsker: Pernille E Bidstrup, MA. PhD, Danish Cancer Society
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. juli 2013
Primær færdiggørelse (Faktiske)
1. juli 2015
Studieafslutning (Faktiske)
1. juli 2015
Datoer for studieregistrering
Først indsendt
5. februar 2014
Først indsendt, der opfyldte QC-kriterier
5. februar 2014
Først opslået (Skøn)
6. februar 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
7. august 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. august 2015
Sidst verificeret
1. august 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Rebecca
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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