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

NCT02088710 | Unknown

• 1 other identifier: BB-2011
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Breast Cancer

Keywords

Patients´ Expectations; Breast Cancer; Adjuvant Endocrine Treatment; Nocebo; Psycho-oncology; Satisfaction with information

Outcome Measures

Primary Outcomes (1)

• Adverse Side Effects

  General Assessment of Side Effects (GASE)

  up to 5 years

Secondary Outcomes (6)

• Quality of Life

  up to 5 years

• Adherence

  up to 5 years

• Knowledge

  up to 5 years

• Satisfaction with Information

  Baseline

• Expectations

  Baseline

Interventions

Enhanced information about endocrine therapy BEHAVIORAL

Enhanced information about endocrine therapy, extending clinical routine information

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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

You may not qualify if:

• Presence of a serious comorbid psychiatric condition (schizophrenia or addiction, severe depression or anxiety)
• Presence of a life threatening comorbid medical condition

Sponsors & Collaborators

• Philipps University Marburg: lead

Study Sites (1)

Philipps University Marburg Medical Center

Marburg, Hesse, 35032, Germany

Location

Related Publications (2)

• 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.

  PMID: 29330625 DERIVED

• 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.

  PMID: 27551051 DERIVED

Related Links

• Homepage of the research unit (FOR 1328): Expectation and conditioning as basic processes of the placebo and nocebo response: From neurobiology to clinical applications

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yvonne Nestoriuc, Prof. Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Winfried Rief, Prof. Dr.

  Philipps University Marburg

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 17, 2014
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2020
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

DE (1)