- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03254875
Rehabilitation After Breast Cancer (REBECCA II)
Individually Tailored Rehabilitation After Breast Cancer
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Copenhagen, Danemark, DK-2100
- Rigshospitalet
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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,
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: Contrôler
Soins habituels
|
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Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Distress
Délai: Change from baseline and to 6,12 months (mixed models)
|
Distress Thermometer
|
Change from baseline and to 6,12 months (mixed models)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Distress
Délai: Change from baseline to 6 months
|
Distress Thermometer
|
Change from baseline to 6 months
|
Distress
Délai: Change from baseline to 12 months
|
Distress Thermometer
|
Change from baseline to 12 months
|
Distress
Délai: Change from baseline to 18 months
|
Distress Thermometer
|
Change from baseline to 18 months
|
Depression
Délai: 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
Délai: Change from baseline and to 6 months
|
The Patient Health Questionnaire (PHQ9)
|
Change from baseline and to 6 months
|
Depression
Délai: Change from baseline and to 12 months
|
The Patient Health Questionnaire (PHQ9)
|
Change from baseline and to 12 months
|
Depression
Délai: Change from baseline and to 18 months
|
The Patient Health Questionnaire (PHQ9)
|
Change from baseline and to 18 months
|
Anxiety
Délai: 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
Délai: Change from baseline and to 6 months
|
Generalized Anxiety Disorder (GAD7)
|
Change from baseline and to 6 months
|
Anxiety
Délai: Change from baseline and to 12 months
|
Generalized Anxiety Disorder (GAD7)
|
Change from baseline and to 12 months
|
Anxiety
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Change from baseline and to 6 months
|
Patient Activation Measure (PAM)
|
Change from baseline and to 6 months
|
Self-efficacy
Délai: Change from baseline and to 12 months
|
Patient Activation Measure (PAM)
|
Change from baseline and to 12 months
|
Self-efficacy
Délai: Change from baseline and to 18 months
|
Patient Activation Measure (PAM)
|
Change from baseline and to 18 months
|
Fear of recurrence
Délai: 6 months
|
Concerns About Recurrence Questionnaire (CARQ)
|
6 months
|
Fear of recurrence
Délai: 12 months
|
Concerns About Recurrence Questionnaire (CARQ)
|
12 months
|
Fear of recurrence
Délai: 18 months
|
Concerns About Recurrence Questionnaire (CARQ)
|
18 months
|
Pain in the breast surgery area (side of chest, armpit or arm)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: Change from baseline and to 18 months
|
Self-developed scale
|
Change from baseline and to 18 months
|
Sleep quality
Délai: 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
Délai: Change from baseline and to 6 months
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change from baseline and to 6 months
|
Sleep quality
Délai: Change from baseline and to 12 months
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change from baseline and to 12 months
|
Sleep quality
Délai: Change from baseline and to 18 months
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change from baseline and to 18 months
|
Cognitive function - Perceived cognitive impairments
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Change from baseline and to 6 months
|
Single self-developed items
|
Change from baseline and to 6 months
|
Need for support
Délai: Change from baseline and to 12 months
|
Single self-developed items
|
Change from baseline and to 12 months
|
Need for support
Délai: Change from baseline and to 18 months
|
Single self-developed items
|
Change from baseline and to 18 months
|
Health care costs
Délai: 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
Délai: 18 months
|
Single self-developed items
|
18 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Social support
Délai: Baseline
|
Modified Medical Outcomes Study Social Support Scale (MOS)
|
Baseline
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Pernille Bidstrup, PhD, Danish Cancer Society Research Center
- Chercheur principal: Christoffer Johansen, DMSc, Rigshispitalet
- Chaise d'étude: Birgitte Mertz, RN, Rigshospitalet, Denmark
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- REBECCA II
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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