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Rehabilitation After Breast Cancer (REBECCA II)

26 augustus 2021 bijgewerkt door: 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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

309

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Denemarken
      • Copenhagen, Denemarken, DK-2100
        • Rigshospitalet

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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,

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Controle
Gebruikelijke zorg
Experimenteel: Intervention
Individually tailored nurse navigation
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Distress
Tijdsspanne: Change from baseline and to 6,12 months (mixed models)
Distress Thermometer
Change from baseline and to 6,12 months (mixed models)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Distress
Tijdsspanne: Change from baseline to 6 months
Distress Thermometer
Change from baseline to 6 months
Distress
Tijdsspanne: Change from baseline to 12 months
Distress Thermometer
Change from baseline to 12 months
Distress
Tijdsspanne: Change from baseline to 18 months
Distress Thermometer
Change from baseline to 18 months
Depression
Tijdsspanne: 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
Tijdsspanne: Change from baseline and to 6 months
The Patient Health Questionnaire (PHQ9)
Change from baseline and to 6 months
Depression
Tijdsspanne: Change from baseline and to 12 months
The Patient Health Questionnaire (PHQ9)
Change from baseline and to 12 months
Depression
Tijdsspanne: Change from baseline and to 18 months
The Patient Health Questionnaire (PHQ9)
Change from baseline and to 18 months
Anxiety
Tijdsspanne: 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
Tijdsspanne: Change from baseline and to 6 months
Generalized Anxiety Disorder (GAD7)
Change from baseline and to 6 months
Anxiety
Tijdsspanne: Change from baseline and to 12 months
Generalized Anxiety Disorder (GAD7)
Change from baseline and to 12 months
Anxiety
Tijdsspanne: 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
Tijdsspanne: 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:

  • Physical well-being (PWB)
  • Functional wellbeing (FWB)
  • 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)
Health related quality of life summary index
Tijdsspanne: Change from baseline and to 6 months

The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:

  • Physical well-being (PWB)
  • Functional wellbeing (FWB)
  • BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 6 months
Health related quality of life summary index
Tijdsspanne: Change from baseline and to 12 months

The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:

  • Physical well-being (PWB)
  • Functional wellbeing (FWB)
  • BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 12 months
Health related quality of life summary index
Tijdsspanne: Change from baseline and to 18 months

The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:

  • Physical well-being (PWB)
  • Functional wellbeing (FWB)
  • BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 18 months
Breast cancer related quality of life summary index
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Change from baseline and to 6 months
Patient Activation Measure (PAM)
Change from baseline and to 6 months
Self-efficacy
Tijdsspanne: Change from baseline and to 12 months
Patient Activation Measure (PAM)
Change from baseline and to 12 months
Self-efficacy
Tijdsspanne: Change from baseline and to 18 months
Patient Activation Measure (PAM)
Change from baseline and to 18 months
Fear of recurrence
Tijdsspanne: 6 months
Concerns About Recurrence Questionnaire (CARQ)
6 months
Fear of recurrence
Tijdsspanne: 12 months
Concerns About Recurrence Questionnaire (CARQ)
12 months
Fear of recurrence
Tijdsspanne: 18 months
Concerns About Recurrence Questionnaire (CARQ)
18 months
Pain in the breast surgery area (side of chest, armpit or arm)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Change from baseline and to 18 months
Self-developed scale
Change from baseline and to 18 months
Sleep quality
Tijdsspanne: 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
Tijdsspanne: Change from baseline and to 6 months
Pittsburgh Sleep Quality Index (PSQI)
Change from baseline and to 6 months
Sleep quality
Tijdsspanne: Change from baseline and to 12 months
Pittsburgh Sleep Quality Index (PSQI)
Change from baseline and to 12 months
Sleep quality
Tijdsspanne: Change from baseline and to 18 months
Pittsburgh Sleep Quality Index (PSQI)
Change from baseline and to 18 months
Cognitive function - Perceived cognitive impairments
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Change from baseline and to 6 months
Single self-developed items
Change from baseline and to 6 months
Need for support
Tijdsspanne: Change from baseline and to 12 months
Single self-developed items
Change from baseline and to 12 months
Need for support
Tijdsspanne: Change from baseline and to 18 months
Single self-developed items
Change from baseline and to 18 months
Health care costs
Tijdsspanne: 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
Tijdsspanne: 18 months
Single self-developed items
18 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Social support
Tijdsspanne: Baseline
Modified Medical Outcomes Study Social Support Scale (MOS)
Baseline

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Danish Cancer Society

Medewerkers

Rigshospitalet, Denmark
Copenhagen University Hospital at Herlev

Onderzoekers

  • Hoofdonderzoeker: Pernille Bidstrup, PhD, Danish Cancer Society Research Center
  • Hoofdonderzoeker: Christoffer Johansen, DMSc, Rigshispitalet
  • Studie stoel: Birgitte Mertz, RN, Rigshospitalet, Denmark

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 augustus 2017

Primaire voltooiing (Werkelijk)

31 maart 2021

Studie voltooiing (Werkelijk)

31 maart 2021

Studieregistratiedata

Eerst ingediend

31 juli 2017

Eerst ingediend dat voldeed aan de QC-criteria

16 augustus 2017

Eerst geplaatst (Werkelijk)

21 augustus 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 augustus 2021

Laatste update ingediend die voldeed aan QC-criteria

26 augustus 2021

Laatst geverifieerd

1 augustus 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • REBECCA II

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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