Expectations and Side Effects of Endocrine Therapy in Women With Breast Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Adverse Side Effects [up to 5 years]
General Assessment of Side Effects (GASE)
Secondary Outcome Measures
- Quality of Life [up to 5 years]
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with breast module (QLQ-BR23)
- Adherence [up to 5 years]
Medication Adherence Report Scale (MARS-D); Adherence with endocrine treatment; reasons for non-adherence
- Knowledge [up to 5 years]
Patients' knowledge of hormone receptor status of their tumor
- Satisfaction with Information [Baseline]
Satisfaction with Information about Medicines Scale, (SIMS-D)
- Expectations [Baseline]
General Assessment of Side Effects Scale - Expectations Module
- Coping with Side Effects [Follow-up (3 months, 2 years, 5 years)]
General Assessment of Side Effects Scale -Coping Module
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Sufficient knowledge of German language and ability to give informed consent
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Age of 18 and more
Exclusion Criteria:
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Presence of a serious comorbid psychiatric condition (schizophrenia or addiction, severe depression or anxiety)
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Presence of a life threatening comorbid medical condition
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Philipps University Marburg Medical Center | Marburg | Hessen | Germany | 35032 |
Sponsors and Collaborators
- Philipps University Marburg Medical Center
Investigators
- Principal Investigator: Yvonne Nestoriuc, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
- Study Chair: Winfried Rief, Prof. Dr., Philipps University Marburg Medical Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- BB-2011