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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

  • Danmark
      • Copenhagen, Danmark, 2100
        • Rigshospitalet

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
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
Andet: Screening-based nurse navigation
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
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).
6 and 12 months
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.
6 and 12 months
Alcohol consumption
Tidsramme: 6 and 12 months
Difference in change in patient reported alcohol consumption measured in grams per day between patients in intervention and control group.
6 and 12 months
Body mass index
Tidsramme: 6 and 12 months
Difference in change in patient reported body masss index between patients in intervention and control group.
6 and 12 months
Physical activity
Tidsramme: 6 and 12 months
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
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

Danish Cancer Society

Samarbejdspartnere

Rigshospitalet, Denmark
TRYG Foundation
Center for Kræft og Sundhed

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

Nøgleord

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 .

Kliniske forsøg med Depression

Kliniske forsøg med Screening-based nurse navigation

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner