Rehabilitation After Breast Cancer (REBECCA II)
26. august 2021 oppdatert av: Christoffer Johansen, Danish Cancer Society
Individually Tailored Rehabilitation After Breast Cancer
The aim of the study is to evaluate whether a screening-based individually tailored nurse navigator intervention compared to standard care significantly reduce psychological and physical symptoms among women being treated for breast cancer who had moderate-to-severe distress (score ≥ 7 on the distress thermometer).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
During a 2-year period, 758 patients newly diagnosed with breast cancer will be screened for inclusion at the Section of Breast Surgery at Rigshospitalet, Copenhagen.
Of these 324 participants enter the randomized controlled trial (RCT) and are randomized in a computer-generated sequence of 1:1 to the intervention (nurse-navigation) or control group (standard care).
A total of 432 participants will enter an observational questionnaire study.
All participants are followed for 1,5 years.
Studietype
Intervensjonell
Registrering (Faktiske)
309
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Copenhagen, Danmark, DK-2100
- Rigshospitalet
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Newly diagnosed with breast cancer (i.e. prior to surgery), scheduled for breast cancer surgery at Section of Breast Surgery at Rigshospitalet, 18 years or above, Danish citizen, read, understand and speak Danish, female gender,signed written informed consent. Those who experience high psychological distress (score ≥ 7 on the distress thermometer) will enter the RCT whereas those who experience low psychological distress (score < 7 on the distress thermometer) will be followed in an observational questionnaire study.
Exclusion Criteria:
- no severe cognitive problems or dementia, no severe psychiatric disease requiring treatment, e.g. schizophrenia, alcohol or narcotic dependence,
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Styre
Vanlig omsorg
|
|
|
Eksperimentell: Intervention
Individually tailored nurse navigation
|
The intervention consists of systematic report of symptoms to the nurse and up to six individual, manual-based, face-to-face or telephone nurse navigator sessions depending on individual needs.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Distress
Tidsramme: Change from baseline and to 6,12 months (mixed models)
|
Distress Thermometer
|
Change from baseline and to 6,12 months (mixed models)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Distress
Tidsramme: Change from baseline to 6 months
|
Distress Thermometer
|
Change from baseline to 6 months
|
|
Distress
Tidsramme: Change from baseline to 12 months
|
Distress Thermometer
|
Change from baseline to 12 months
|
|
Distress
Tidsramme: Change from baseline to 18 months
|
Distress Thermometer
|
Change from baseline to 18 months
|
|
Depression
Tidsramme: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
The Patient Health Questionnaire (PHQ9)
|
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
|
Depression
Tidsramme: Change from baseline and to 6 months
|
The Patient Health Questionnaire (PHQ9)
|
Change from baseline and to 6 months
|
|
Depression
Tidsramme: Change from baseline and to 12 months
|
The Patient Health Questionnaire (PHQ9)
|
Change from baseline and to 12 months
|
|
Depression
Tidsramme: Change from baseline and to 18 months
|
The Patient Health Questionnaire (PHQ9)
|
Change from baseline and to 18 months
|
|
Anxiety
Tidsramme: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
Generalized Anxiety Disorder (GAD7)
|
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
|
Anxiety
Tidsramme: Change from baseline and to 6 months
|
Generalized Anxiety Disorder (GAD7)
|
Change from baseline and to 6 months
|
|
Anxiety
Tidsramme: Change from baseline and to 12 months
|
Generalized Anxiety Disorder (GAD7)
|
Change from baseline and to 12 months
|
|
Anxiety
Tidsramme: Change from baseline and to 18 months
|
Generalized Anxiety Disorder (GAD7)
|
Change from baseline and to 18 months
|
|
Health related quality of life summary index
Tidsramme: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
|
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
|
Health related quality of life summary index
Tidsramme: Change from baseline and to 6 months
|
The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
|
Change from baseline and to 6 months
|
|
Health related quality of life summary index
Tidsramme: Change from baseline and to 12 months
|
The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
|
Change from baseline and to 12 months
|
|
Health related quality of life summary index
Tidsramme: Change from baseline and to 18 months
|
The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
|
Change from baseline and to 18 months
|
|
Breast cancer related quality of life summary index
Tidsramme: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
|
Breast cancer related quality of life summary index
Tidsramme: Change from baseline and to 6 months
|
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 6 months
|
|
Breast cancer related quality of life summary index
Tidsramme: Change from baseline and to 12 months
|
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 12 months
|
|
Breast cancer related quality of life summary index
Tidsramme: Change from baseline and to 18 months
|
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 18 months
|
|
Functional related quality of life summary index
Tidsramme: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
|
Functional related quality of life summary index
Tidsramme: Change from baseline and to 6 months
|
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 6 months
|
|
Functional related quality of life summary index
Tidsramme: Change from baseline and to 12 months
|
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 12 months
|
|
Functional related quality of life summary index
Tidsramme: Change from baseline and to 18 months
|
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 18 months
|
|
Physical health related quality of life
Tidsramme: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
|
Physical health related quality of life
Tidsramme: Change from baseline and to 6 months
|
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 6 months
|
|
Physical health related quality of life
Tidsramme: Change from baseline and to 12 months
|
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 12 months
|
|
Physical health related quality of life
Tidsramme: Change from baseline and to 18 months
|
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 18 months
|
|
Social health related quality of life
Tidsramme: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
|
Social health related quality of life
Tidsramme: Change from baseline and to 6 months
|
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 6 months
|
|
Social health related quality of life
Tidsramme: Change from baseline and to 12 months
|
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 12 months
|
|
Social health related quality of life
Tidsramme: Change from baseline and to 18 months
|
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 18 months
|
|
Emotional health related quality of life
Tidsramme: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
|
Emotional health related quality of life
Tidsramme: Change from baseline and to 6 months
|
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 6 months
|
|
Emotional health related quality of life
Tidsramme: Change from baseline and to 12 months
|
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 12 months
|
|
Emotional health related quality of life
Tidsramme: Change from baseline and to 18 months
|
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 18 months
|
|
Self-efficacy
Tidsramme: Change from baseline and to 6,12,18 months (mixed models)
|
Patient Activation Measure (PAM)
|
Change from baseline and to 6,12,18 months (mixed models)
|
|
Self-efficacy
Tidsramme: Change from baseline and to 6 months
|
Patient Activation Measure (PAM)
|
Change from baseline and to 6 months
|
|
Self-efficacy
Tidsramme: Change from baseline and to 12 months
|
Patient Activation Measure (PAM)
|
Change from baseline and to 12 months
|
|
Self-efficacy
Tidsramme: Change from baseline and to 18 months
|
Patient Activation Measure (PAM)
|
Change from baseline and to 18 months
|
|
Fear of recurrence
Tidsramme: 6 months
|
Concerns About Recurrence Questionnaire (CARQ)
|
6 months
|
|
Fear of recurrence
Tidsramme: 12 months
|
Concerns About Recurrence Questionnaire (CARQ)
|
12 months
|
|
Fear of recurrence
Tidsramme: 18 months
|
Concerns About Recurrence Questionnaire (CARQ)
|
18 months
|
|
Pain in the breast surgery area (side of chest, armpit or arm)
Tidsramme: Change from baseline and to 6,12,18 months (mixed models)
|
Self-developed scale
|
Change from baseline and to 6,12,18 months (mixed models)
|
|
Pain in the breast surgery area (side of chest, armpit or arm)
Tidsramme: Change from baseline and to 6 months
|
Self-developed scale
|
Change from baseline and to 6 months
|
|
Pain in the breast surgery area (side of chest, armpit or arm)
Tidsramme: Change from baseline and to 12 months
|
Self-developed scale
|
Change from baseline and to 12 months
|
|
Pain in the breast surgery area (side of chest, armpit or arm)
Tidsramme: Change from baseline and to 18 months
|
Self-developed scale
|
Change from baseline and to 18 months
|
|
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Tidsramme: Change from baseline and to 6,12,18 months (mixed models)
|
Self-developed scale
|
Change from baseline and to 6,12,18 months (mixed models)
|
|
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Tidsramme: Change from baseline and to 6 months
|
Self-developed scale
|
Change from baseline and to 6 months
|
|
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Tidsramme: Change from baseline and to 12 months
|
Self-developed scale
|
Change from baseline and to 12 months
|
|
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Tidsramme: Change from baseline and to 18 months
|
Self-developed scale
|
Change from baseline and to 18 months
|
|
Sleep quality
Tidsramme: Change from baseline and to 6,12,18 months (mixed models)
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change from baseline and to 6,12,18 months (mixed models)
|
|
Sleep quality
Tidsramme: Change from baseline and to 6 months
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change from baseline and to 6 months
|
|
Sleep quality
Tidsramme: Change from baseline and to 12 months
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change from baseline and to 12 months
|
|
Sleep quality
Tidsramme: Change from baseline and to 18 months
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change from baseline and to 18 months
|
|
Cognitive function - Perceived cognitive impairments
Tidsramme: Change from baseline and to 6,12,18 months (mixed models)
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
|
Change from baseline and to 6,12,18 months (mixed models)
|
|
Cognitive function - Perceived cognitive impairments
Tidsramme: Change from baseline and to 6 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
|
Change from baseline and to 6 months
|
|
Cognitive function- Perceived cognitive impairments
Tidsramme: Change from baseline and to 12 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
|
Change from baseline and to 12 months
|
|
Cognitive function - Perceived cognitive impairments
Tidsramme: Change from baseline and to 18 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
|
Change from baseline and to 18 months
|
|
Cognitive function - Impact of Perceived cognitive impairments on quality of life
Tidsramme: Change from baseline and to 6,12,18 months (mixed models)
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
|
Change from baseline and to 6,12,18 months (mixed models)
|
|
Cognitive function - Impact of Perceived cognitive impairments on quality of life
Tidsramme: Change from baseline and to 6 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
|
Change from baseline and to 6 months
|
|
Cognitive function - Impact of Perceived cognitive impairments on quality of life
Tidsramme: Change from baseline and to 12 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
|
Change from baseline and to 12 months
|
|
Cognitive function - Impact of Perceived cognitive impairments on quality of life
Tidsramme: Change from baseline and to 18 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
|
Change from baseline and to 18 months
|
|
Cognitive function - Perceived cognitive abilities
Tidsramme: Change from baseline and to 6,12,18 months (mixed models)
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
|
Change from baseline and to 6,12,18 months (mixed models)
|
|
Cognitive function - Perceived cognitive abilities
Tidsramme: Change from baseline and to 6 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
|
Change from baseline and to 6 months
|
|
Cognitive function - Perceived cognitive abilities
Tidsramme: Change from baseline and to 12 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
|
Change from baseline and to 12 months
|
|
Cognitive function - Perceived cognitive abilities
Tidsramme: Change from baseline and to 18 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
|
Change from baseline and to 18 months
|
|
Need for support
Tidsramme: Change from baseline and to 6,12,18 months (mixed models)
|
Single self-developed items
|
Change from baseline and to 6,12,18 months (mixed models)
|
|
Need for support
Tidsramme: Change from baseline and to 6 months
|
Single self-developed items
|
Change from baseline and to 6 months
|
|
Need for support
Tidsramme: Change from baseline and to 12 months
|
Single self-developed items
|
Change from baseline and to 12 months
|
|
Need for support
Tidsramme: Change from baseline and to 18 months
|
Single self-developed items
|
Change from baseline and to 18 months
|
|
Health care costs
Tidsramme: Cumulative from baseline to 18 months
|
Costs will be obtained through registries on health care services and combined with information on health status using the 5Q-5D from the EuroQol Research Foundation's
|
Cumulative from baseline to 18 months
|
|
Acceptability
Tidsramme: 18 months
|
Single self-developed items
|
18 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Social support
Tidsramme: Baseline
|
Modified Medical Outcomes Study Social Support Scale (MOS)
|
Baseline
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Pernille Bidstrup, PhD, Danish Cancer Society Research Center
- Hovedetterforsker: Christoffer Johansen, DMSc, Rigshispitalet
- Studiestol: Birgitte Mertz, RN, Rigshospitalet, Denmark
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. august 2017
Primær fullføring (Faktiske)
31. mars 2021
Studiet fullført (Faktiske)
31. mars 2021
Datoer for studieregistrering
Først innsendt
31. juli 2017
Først innsendt som oppfylte QC-kriteriene
16. august 2017
Først lagt ut (Faktiske)
21. august 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. august 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. august 2021
Sist bekreftet
1. august 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- REBECCA II
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Brystkreft
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital og andre samarbeidspartnereFullførtThe Clinical Application Guide of Conebeam Breast CTKina
-
Novartis PharmaceuticalsFullførtMetastatisk brystkreft (MBC) | Locally Advance Breast Cancer (LABC)Storbritannia, Spania
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UkjentHR-positiv, HER2-negativ og PIK3CA Mutation Advanced Breast CancerKina
-
Cancer Institute and Hospital, Chinese Academy...Har ikke rekruttert ennå
-
Emory UniversityNational Cancer Institute (NCI)TilbaketrukketPrognostisk stadium IV brystkreft AJCC v8 | Metastatisk malign neoplasma i hjernen | Metastatisk brystkarsinom | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
NRG OncologyNational Cancer Institute (NCI)FullførtAnatomisk stadium IV brystkreft AJCC v8 | Prognostisk stadium IV brystkreft AJCC v8 | Metastatisk malign neoplasma i beinet | Metastatisk malign neoplasma i lymfeknutene | Metastatisk malign neoplasma i leveren | Metastatisk brystkarsinom | Metastatisk malign neoplasma i lungen | Metastatisk malign neoplasma... og andre forholdForente stater, Canada, Saudi-Arabia, Sør -Korea
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Fondazione... og andre samarbeidspartnereRekrutteringBrystkreft | Brystneoplasmer | Bryst sykdommer | Neoplasma i brystet | Brystsvulster | Brystkarsinom | Brystneoplasmer, mannlige | Brystkreft stadium IV | Hormonreseptorpositiv ondartet neoplasma i brystet | HR-positiv brystkreft | Hormonreseptorpositivt brystkarsinom | Hormonreseptor (HR)-positiv brystkreft | Hormonreseptorpositiv... og andre forholdItalia
-
University of California, DavisNational Cancer Institute (NCI)RekrutteringAnatomisk stadium III brystkreft AJCC v8 | Avansert malignt solid neoplasma | Stadium III lungekreft AJCC v8 | Stadium IV lungekreft AJCC v8 | Stadium III nyrecellekreft AJCC v8 | Stadium IV nyrecellekreft AJCC v8 | Klinisk stadium III kutant melanom AJCC v8 | Trinn IV tykktarmskreft AJCC v8 | Klinisk stadium... og andre forholdForente stater