Rehabilitation After Breast Cancer (REBECCA II)
26. august 2021 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
309
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Copenhagen, Danmark, DK-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:
- 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
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 |
|---|---|
|
Ingen indgriben: Styring
Sædvanlig pleje
|
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Social support
Tidsramme: Baseline
|
Modified Medical Outcomes Study Social Support Scale (MOS)
|
Baseline
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Pernille Bidstrup, PhD, Danish Cancer Society Research Center
- Ledende efterforsker: Christoffer Johansen, DMSc, Rigshispitalet
- Studiestol: Birgitte Mertz, RN, Rigshospitalet, Denmark
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 (Faktiske)
15. august 2017
Primær færdiggørelse (Faktiske)
31. marts 2021
Studieafslutning (Faktiske)
31. marts 2021
Datoer for studieregistrering
Først indsendt
31. juli 2017
Først indsendt, der opfyldte QC-kriterier
16. august 2017
Først opslået (Faktiske)
21. august 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. august 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. august 2021
Sidst verificeret
1. august 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- REBECCA II
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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