Expectations and Side Effects of Endocrine Therapy in Women With Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the role of patients' response expectations for nocebo side effects, quality of life and adherence during adjuvant endocrine treatment (AET). Furthermore, this study analyses the effects of a structured treatment information on patients' satisfaction with information, response expectations, knowledge and adherence.

Detailed Description
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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.

Official Title
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Clinical Cohort of Individual Expectations, Side Effects, Quality of Life and Adherence in Postoperative Women With Estrogen Receptor Positive Breast Cancer During Endocrine Therapy

Conditions
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Female Breast Cancer

Intervention / Treatment
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* Behavioral: Enhanced information about endocrine therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Enhanced information about endocrine therapy|Enhanced information about endocrine therapy, extending clinical routine information|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Side Effects | General Assessment of Side Effects (GASE) | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | 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 | Medication Adherence Report Scale (MARS-D); Adherence with endocrine treatment; reasons for non-adherence | up to 5 years | 
| Knowledge | Patients' knowledge of hormone receptor status of their tumor | up to 5 years | 
| Satisfaction with Information | Satisfaction with Information about Medicines Scale, (SIMS-D) | Baseline | 
| Expectations | General Assessment of Side Effects Scale - Expectations Module | Baseline | 
| Coping with Side Effects | General Assessment of Side Effects Scale -Coping Module | Follow-up (3 months, 2 years, 5 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adjuvant Endocrine Treatment, Nocebo, Psycho-oncology, Satisfaction with information, Patients´ Expectations, Breast Cancer