Clinical trial NCT02088710: Expectations and Side Effects of Endocrine Therapy in Women With Breast Cancer
Official title: Clinical Cohort of Individual Expectations, Side Effects, Quality of Life and Adherence in Postoperative Women With Estrogen Receptor Positive Breast Cancer During Endocrine Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Female Breast Cancer
Keywords: Patients´ Expectations
Breast Cancer
Adjuvant Endocrine Treatment
Nocebo
Psycho-oncology
Satisfaction with information
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Side Effects
timeFrame: up to 5 years
Secondary outcomes:
measure: Quality of Life
timeFrame: up to 5 years
measure: Adherence
timeFrame: up to 5 years
measure: Knowledge
timeFrame: up to 5 years
measure: Satisfaction with Information
timeFrame: Baseline
measure: Expectations
timeFrame: Baseline
measure: Coping with Side Effects
timeFrame: Follow-up (3 months, 2 years, 5 years)
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps University Marburg Medical Center
state: Hessen
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Yvonne Nestoriuc, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Philipps University Marburg
name: Winfried Rief, Prof. Dr.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.