Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Female Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhanced information about endocrine therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Adverse Side Effects
- timeFrame
- up to 5 years
- description
- General Assessment of Side Effects (GASE)
Secondary outcomes (6)
- measure
- Quality of Life
- timeFrame
- up to 5 years
- description
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with breast module (QLQ-BR23)
- measure
- Adherence
- timeFrame
- up to 5 years
- description
- Medication Adherence Report Scale (MARS-D); Adherence with endocrine treatment; reasons for non-adherence
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDPan 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. PMID 29330625
- DERIVEDNestoriuc 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. PMID 27551051