- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02088710
Expectations and Side Effects of Endocrine Therapy in Women With Breast Cancer
Clinical Cohort of Individual Expectations, Side Effects, Quality of Life and Adherence in Postoperative Women With Estrogen Receptor Positive Breast Cancer During Endocrine Therapy
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The majority of breast cancer patients discontinues today's standard adjuvant treatment (endocrine therapy) due to side effects and reduced quality of life. Thereby, most side effects are unspecific, suggesting a role of psychological factors as patients´ expectations (nocebo effects). Moreover, patients are not informed sufficiently about their treatment.
Using a longitudinal design, the nature and onset of adverse side effects and their association to treatment related expectations are investigated. Postoperative patients with hormone receptor-positive breast cancer are assessed before the start of adjuvant treatment. All patients receive standardized, additional information about endocrine therapy. Expectations about side effects, knowledge and satisfaction with the enhanced information are assessed before and after informing patients. Side effects, quality of life and adherence are measured three months, two and five years after start of medication intake.
It will be analyzed if patients' response expectations predict side effects and quality of life during medication intake to provide insights into pathways of clinical nocebo effects. Further, this study examines the effects of a structured treatment information on patients' satisfaction with information, response expectations, knowledge and adherence. The study findings promise significant advances in the clinical nocebo research with strong implications for clinical and research practice.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Hessen
-
Marburg, Hessen, Allemagne, 35032
- Philipps University Marburg Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Post surgery women with estrogen receptor positive breast cancer scheduled to start first-line adjuvant endocrine therapy with Tamoxifen (+/- GnRH) or a third generation Aromatase inhibitor at the Breast Cancer Centre
- Sufficient knowledge of German language and ability to give informed consent
- Age of 18 and more
Exclusion Criteria:
- Presence of a serious comorbid psychiatric condition (schizophrenia or addiction, severe depression or anxiety)
- Presence of a life threatening comorbid medical condition
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adverse Side Effects
Délai: up to 5 years
|
General Assessment of Side Effects (GASE)
|
up to 5 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Quality of Life
Délai: up to 5 years
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with breast module (QLQ-BR23)
|
up to 5 years
|
|
Adherence
Délai: up to 5 years
|
Medication Adherence Report Scale (MARS-D); Adherence with endocrine treatment; reasons for non-adherence
|
up to 5 years
|
|
Knowledge
Délai: up to 5 years
|
Patients' knowledge of hormone receptor status of their tumor
|
up to 5 years
|
|
Satisfaction with Information
Délai: Baseline
|
Satisfaction with Information about Medicines Scale, (SIMS-D)
|
Baseline
|
|
Expectations
Délai: Baseline
|
General Assessment of Side Effects Scale - Expectations Module
|
Baseline
|
|
Coping with Side Effects
Délai: Follow-up (3 months, 2 years, 5 years)
|
General Assessment of Side Effects Scale -Coping Module
|
Follow-up (3 months, 2 years, 5 years)
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Winfried Rief, Prof. Dr., Philipps University Marburg Medical Center
Publications et liens utiles
Publications générales
- Pan Y, Heisig SR, von Blanckenburg P, Albert US, Hadji P, Rief W, Nestoriuc Y. Facilitating adherence to endocrine therapy in breast cancer: stability and predictive power of treatment expectations in a 2-year prospective study. Breast Cancer Res Treat. 2018 Apr;168(3):667-677. doi: 10.1007/s10549-017-4637-2. Epub 2018 Jan 12.
- Nestoriuc Y, von Blanckenburg P, Schuricht F, Barsky AJ, Hadji P, Albert US, Rief W. Is it best to expect the worst? Influence of patients' side-effect expectations on endocrine treatment outcome in a 2-year prospective clinical cohort study. Ann Oncol. 2016 Oct;27(10):1909-15. doi: 10.1093/annonc/mdw266. Epub 2016 Aug 22.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
- BB-2011
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