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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2020-02-29

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.

Conditions

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Female Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Enhanced information about endocrine therapy

Enhanced information about endocrine therapy, extending clinical routine information

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Yvonne Nestoriuc, PhD.

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yvonne Nestoriuc, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Winfried Rief, Prof. Dr.

Role: STUDY_CHAIR

Philipps University Marburg

Locations

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Philipps University Marburg Medical Center

Marburg, Hesse, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED

PMID: 29330625 (View on PubMed)

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.