Clinical Application of Nocebo Research: Optimizing Expectations of Breast Cancer Patients to Prevent Nocebo Side Effects and Decrease of Quality of Life During Adjuvant Endocrine Therapy (DFG, NE 1635/2-1)
18 Years
N/A
Female
Female Breast Cancer, Endocrine Therapy, Patients´ Expectations
Trial Information
Clinical Application of Nocebo Research: Optimizing Expectations of Breast Cancer Patients to Prevent Nocebo Side Effects and Decrease of Quality of Life During Adjuvant Endocrine Therapy (DFG, NE 1635/2-1)
The majority of breast cancer patients discontinue today's standard adjuvant treatment
(endocrine therapy) due to side effects and reduced quality of life. Thereby, most side
effects are unspecific, thus, not related to the specific pharmacological action of the
drug, but to the individual treatment context and patients´ expectations (nocebo effects).
The aim of this study is to evaluate a side effect prevention training (SEPT) that optimizes
patients' response expectations before the start of pharmacotherapy to prevent nocebo side
effects during longer term drug intake. Using a randomized trial, we will study the time
course of response expectations and side effects in breast cancer patients receiving either
SEPT, standard medical care or an attention-control intervention ("supportive therapy")
before the start of adjuvant endocrine therapy. We will analyze the effects of changing
pre-treatment expectations on cancer-treatment related side effects, quality of life and
adherence 3 and 6 months after the start of endocrine therapy. Moderator analyses will be
used to determine predictors of non-specific medication side effects and patients that are
at high risk of experiencing them. Furthermore, we will explore the mediating influence of
coping behaviours, thereby providing insights into pathways of clinical nocebo effects. The
study findings promise significant advances in the clinical application of nocebo research
with strong implications for clinical and research practice.
Inclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Side Effects (General Assessment of Side Effects, GASE)
Outcome Description:
Side Effects 3 and 6 months after the start of adjuvant endocrine therapy, controlled for baseline symptoms, staging, age, medication
Outcome Time Frame:
Baseline, 3 and 6 months after the start of adjuvant endocrine therapy (AET)
Safety Issue:
No
Principal Investigator
Yvonne Nestoriuc, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Philipps University Marburg, Department of Psychology, Division of Clinical Psychology and Psychotherapy
Authority:
Germany: Ethics Commission
Study ID:
DFG NE 1635/2-1
NCT ID:
NCT01741883
Start Date:
November 2012
Completion Date:
Related Keywords:
- Female Breast Cancer
- Endocrine Therapy
- Patients´ Expectations
- Randomized Controlled Trial
- Patients´ Expectations
- Breast Cancer
- Adjuvant Endocrine Treatment
- Nocebo
- Breast Neoplasms
- Carcinoma
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