- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Hessen
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Marburg, Hessen, Alemanha, 35032
- Philipps University Marburg Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Adverse Side Effects
Prazo: up to 5 years
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General Assessment of Side Effects (GASE)
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up to 5 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quality of Life
Prazo: up to 5 years
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with breast module (QLQ-BR23)
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up to 5 years
|
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Adherence
Prazo: up to 5 years
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Medication Adherence Report Scale (MARS-D); Adherence with endocrine treatment; reasons for non-adherence
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up to 5 years
|
|
Knowledge
Prazo: up to 5 years
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Patients' knowledge of hormone receptor status of their tumor
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up to 5 years
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Satisfaction with Information
Prazo: Baseline
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Satisfaction with Information about Medicines Scale, (SIMS-D)
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Baseline
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Expectations
Prazo: Baseline
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General Assessment of Side Effects Scale - Expectations Module
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Baseline
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Coping with Side Effects
Prazo: Follow-up (3 months, 2 years, 5 years)
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General Assessment of Side Effects Scale -Coping Module
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Follow-up (3 months, 2 years, 5 years)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Winfried Rief, Prof. Dr., Philipps University Marburg Medical Center
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BB-2011
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