Rehabilitation After Breast Cancer (REBECCA II)
26 augusti 2021 uppdaterad 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
309
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Copenhagen, Danmark, DK-2100
- Rigshospitalet
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: Kontrollera
Vanlig skötsel
|
|
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Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Distress
Tidsram: Change from baseline and to 6,12 months (mixed models)
|
Distress Thermometer
|
Change from baseline and to 6,12 months (mixed models)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Distress
Tidsram: Change from baseline to 6 months
|
Distress Thermometer
|
Change from baseline to 6 months
|
|
Distress
Tidsram: Change from baseline to 12 months
|
Distress Thermometer
|
Change from baseline to 12 months
|
|
Distress
Tidsram: Change from baseline to 18 months
|
Distress Thermometer
|
Change from baseline to 18 months
|
|
Depression
Tidsram: 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
Tidsram: Change from baseline and to 6 months
|
The Patient Health Questionnaire (PHQ9)
|
Change from baseline and to 6 months
|
|
Depression
Tidsram: Change from baseline and to 12 months
|
The Patient Health Questionnaire (PHQ9)
|
Change from baseline and to 12 months
|
|
Depression
Tidsram: Change from baseline and to 18 months
|
The Patient Health Questionnaire (PHQ9)
|
Change from baseline and to 18 months
|
|
Anxiety
Tidsram: 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
Tidsram: Change from baseline and to 6 months
|
Generalized Anxiety Disorder (GAD7)
|
Change from baseline and to 6 months
|
|
Anxiety
Tidsram: Change from baseline and to 12 months
|
Generalized Anxiety Disorder (GAD7)
|
Change from baseline and to 12 months
|
|
Anxiety
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Change from baseline and to 6 months
|
Patient Activation Measure (PAM)
|
Change from baseline and to 6 months
|
|
Self-efficacy
Tidsram: Change from baseline and to 12 months
|
Patient Activation Measure (PAM)
|
Change from baseline and to 12 months
|
|
Self-efficacy
Tidsram: Change from baseline and to 18 months
|
Patient Activation Measure (PAM)
|
Change from baseline and to 18 months
|
|
Fear of recurrence
Tidsram: 6 months
|
Concerns About Recurrence Questionnaire (CARQ)
|
6 months
|
|
Fear of recurrence
Tidsram: 12 months
|
Concerns About Recurrence Questionnaire (CARQ)
|
12 months
|
|
Fear of recurrence
Tidsram: 18 months
|
Concerns About Recurrence Questionnaire (CARQ)
|
18 months
|
|
Pain in the breast surgery area (side of chest, armpit or arm)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Change from baseline and to 18 months
|
Self-developed scale
|
Change from baseline and to 18 months
|
|
Sleep quality
Tidsram: 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
Tidsram: Change from baseline and to 6 months
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change from baseline and to 6 months
|
|
Sleep quality
Tidsram: Change from baseline and to 12 months
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change from baseline and to 12 months
|
|
Sleep quality
Tidsram: Change from baseline and to 18 months
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change from baseline and to 18 months
|
|
Cognitive function - Perceived cognitive impairments
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Change from baseline and to 6 months
|
Single self-developed items
|
Change from baseline and to 6 months
|
|
Need for support
Tidsram: Change from baseline and to 12 months
|
Single self-developed items
|
Change from baseline and to 12 months
|
|
Need for support
Tidsram: Change from baseline and to 18 months
|
Single self-developed items
|
Change from baseline and to 18 months
|
|
Health care costs
Tidsram: 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
Tidsram: 18 months
|
Single self-developed items
|
18 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Social support
Tidsram: Baseline
|
Modified Medical Outcomes Study Social Support Scale (MOS)
|
Baseline
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Pernille Bidstrup, PhD, Danish Cancer Society Research Center
- Huvudutredare: Christoffer Johansen, DMSc, Rigshispitalet
- Studiestol: Birgitte Mertz, RN, Rigshospitalet, Denmark
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 augusti 2017
Primärt slutförande (Faktisk)
31 mars 2021
Avslutad studie (Faktisk)
31 mars 2021
Studieregistreringsdatum
Först inskickad
31 juli 2017
Först inskickad som uppfyllde QC-kriterierna
16 augusti 2017
Första postat (Faktisk)
21 augusti 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 augusti 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 augusti 2021
Senast verifierad
1 augusti 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- REBECCA II
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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