Clinical trial NCT01741883: Side Effect Prevention Training (SEPT) for Nocebo Effects in Breast Cancer Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Breast Cancer
Keywords: Randomized Controlled Trial
Patients´ Expectations
Breast Cancer
Adjuvant Endocrine Treatment
Nocebo
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: University of Hamburg-Eppendorf
name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2012-12-05
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate a side effect prevention training (SEPT) that optimizes patients' response expectations before the start of adjuvant endocrine treatment (AET) to prevent nocebo side effects and enhance quality of life during longer term drug intake.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Side Effects (General Assessment of Side Effects, GASE)
timeFrame: Baseline, 3 and 6 months after the start of adjuvant endocrine therapy (AET)
Secondary outcomes:
measure: Change in Patients Expectations (General Assessment of Side Effects-Expect/Cope, Gase-Expect/Cope; Brief Illness Perceptions Questionnaire, B-IPQ; Beliefs about medicine questionnaire, BMQ-D)
timeFrame: Baseline and 5 weeks after surgery, before start of adjuvant endocrine therapy
measure: Change in Anxiety and Depression (Hospital Anxiety and Depression Scale, HADS-D)
timeFrame: Baseline, 5 weeks after surgery, 3 months after the start of adjuvant endocrine therapy (AET) and 6 months after the start of AET
measure: Change in Fear of Progression (Fear of Progression Questionnaire-Short Form, FoP-Q-SF)
timeFrame: Baseline, 5 weeks after surgery, 3 months after the start of adjuvant endocrine therapy (AET) and 6 months after the start of AET
measure: Change in Adherence Intention and Adherence (Medication Adherence Report Scale, MARS-D)
timeFrame: Baseline, 5 weeks after surgery, 3 months after the start of adjuvant endocrine therapy (AET) and 6 months after the start of AET
measure: Change in Quality of Life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire with breast module, EORTC QLQ-C30 and QLQ-BR23)
timeFrame: Baseline, 3 and 6 months after the start of adjuvant endocrine therapy (AET)
measure: Change in Coping with Side Effects (General Assessment of Side Effects-Cope, GASE-Cope)
timeFrame: 3 and 6 months after the start of adjuvant endocrine therapy (AET)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Yvonne Nestoriuc, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Philipps University Marburg, Department of Psychology, Division of Clinical Psychology and Psychotherapy
name: Winfried Rief, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Krankenhaus Nordwest, Department of Gynecology and Obstetrics
name: Ute-Susann Albert, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Blanckenburg P, Schuricht F, Albert US, Rief W, Nestoriuc Y. Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial. BMC Cancer. 2013 Sep 18;13:426. doi: 10.1186/1471-2407-13-426.
citation: Heisig SR, Shedden-Mora MC, von Blanckenburg P, Rief W, Witzel I, Albert US, Nestoriuc Y. What do women with breast cancer expect from their treatment? Correlates of negative treatment expectations about endocrine therapy. Psychooncology. 2016 Dec;25(12):1485-1492. doi: 10.1002/pon.4089. Epub 2016 Feb 23.