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

Female Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02088710
• Other study ID #: BB-2011
• Status: Active, not recruiting
• Phase: N/A
• First received: March 12, 2014
• Last updated: September 24, 2017
• Start date: January 2011
• Est. completion date: February 2020

Study information

• Verified date: September 2017
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 138
• Est. completion date: February 2020
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Female Breast Cancer

Intervention

Behavioral:
• Enhanced information about endocrine therapy
Enhanced information about endocrine therapy, extending clinical routine information

Locations

Country	Name	City	State
Germany	Philipps University Marburg Medical Center	Marburg	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Side Effects	General Assessment of Side Effects (GASE)	up to 5 years
Secondary	Quality of Life	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with breast module (QLQ-BR23)	up to 5 years
Secondary	Adherence	Medication Adherence Report Scale (MARS-D); Adherence with endocrine treatment; reasons for non-adherence	up to 5 years
Secondary	Knowledge	Patients' knowledge of hormone receptor status of their tumor	up to 5 years
Secondary	Satisfaction with Information	Satisfaction with Information about Medicines Scale, (SIMS-D)	Baseline
Secondary	Expectations	General Assessment of Side Effects Scale - Expectations Module	Baseline
Secondary	Coping with Side Effects	General Assessment of Side Effects Scale -Coping Module	Follow-up (3 months, 2 years, 5 years)

External 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