Side Effect Prevention Training (SEPT) for Nocebo Effects in Breast Cancer Patients

September 24, 2017 updated by: Yvonne Nestoriuc, PhD., Philipps University Marburg Medical Center

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
165

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20251
        • University Medical Center Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard Medical Care and Information
Patients receive standard treatment protocol for breast cancer patients and additional oral and written information about adjuvant endocrine treatment.
Experimental: Side effect prevention training (SEPT)
Patients receive standard medical care and a brief behavioral intervention that targets patients' response and coping expectations while starting with adjuvant endocrine treatment.
Behavioral: Side effect prevention training (SEPT)
SEPT is aimed to optimize patients' response expectations before the start of pharmacotherapy to prevent nocebo side effects during adjuvant endocrine treatment. SEPT is a three session cognitive-behavioural training. It includes psychoeducation about AET to provide a realistic view on AET, reduction of concerns about side effects and strengthening of necessity beliefs. Further contents are side effect management training and problem solving to enhance self-efficacy expectations about coping as well as imagination training to integrate positive aspects of medication into daily life.
Active Comparator: Attention Control group (ACG)
Patients receive standard medical care and a comparable amount of therapist´s attention (common and unspecific factors) to the intervention group without targeting patients´ expectations.
Behavioral: Attention Control group (ACG)
Supportive therapy includes common or unspecific factors such as elicitation of affect, a treatment context, empathy, reflective listening, and feeling understood. Supportive therapy thus provides a control condition for common factors and therapist attention, while lacking the specific intervention part. It will be delivered in the same frequency and at the same time points as the side effect prevention training (three individual sessions and three booster telephone calls).
Other Names:
  • Supportive therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Side Effects (General Assessment of Side Effects, GASE)
Time Frame: Baseline, 3 and 6 months after the start of adjuvant endocrine therapy (AET)
Side Effects 3 and 6 months after the start of adjuvant endocrine therapy, controlled for baseline symptoms, staging, age, medication
Baseline, 3 and 6 months after the start of adjuvant endocrine therapy (AET)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Baseline and 5 weeks after surgery, before start of adjuvant endocrine therapy
Change in patients expectations from baseline/pre-intervention (expected average 2 weeks after surgery) to post-intervention (expected average 5 weeks after surgery) and prospective expectations 3 and 6 months after the start of adjuvant endocrine therapy
Baseline and 5 weeks after surgery, before start of adjuvant endocrine therapy
Change in Anxiety and Depression (Hospital Anxiety and Depression Scale, HADS-D)
Time Frame: Baseline, 5 weeks after surgery, 3 months after the start of adjuvant endocrine therapy (AET) and 6 months after the start of AET
Change in anxiety and depression from baseline to 5 weeks after surgery to 3 months after the start of AET to 6 months after the start of AET
Baseline, 5 weeks after surgery, 3 months after the start of adjuvant endocrine therapy (AET) and 6 months after the start of AET
Change in Fear of Progression (Fear of Progression Questionnaire-Short Form, FoP-Q-SF)
Time Frame: Baseline, 5 weeks after surgery, 3 months after the start of adjuvant endocrine therapy (AET) and 6 months after the start of AET
Change in Fear of Progression from baseline to 5 weeks after surgery to 3 months after the start of AET to 6 months after the start of AET
Baseline, 5 weeks after surgery, 3 months after the start of adjuvant endocrine therapy (AET) and 6 months after the start of AET
Change in Adherence Intention and Adherence (Medication Adherence Report Scale, MARS-D)
Time Frame: Baseline, 5 weeks after surgery, 3 months after the start of adjuvant endocrine therapy (AET) and 6 months after the start of AET
Change in Adherence Intention and Adherence from baseline to 5 weeks after surgery to 3 months after the start of AET to 6 months after the start of AET
Baseline, 5 weeks after surgery, 3 months after the start of adjuvant endocrine therapy (AET) and 6 months after the start of AET
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)
Time Frame: Baseline, 3 and 6 months after the start of adjuvant endocrine therapy (AET)
Change in Quality of Life from baseline to 3 months after the start of adjuvant endocrine therapy to 6 months after the start of adjuvant endocrine therapy
Baseline, 3 and 6 months after the start of adjuvant endocrine therapy (AET)
Change in Coping with Side Effects (General Assessment of Side Effects-Cope, GASE-Cope)
Time Frame: 3 and 6 months after the start of adjuvant endocrine therapy (AET)
Change in coping with Side Effects from 3 months after the start of adjuvant endocrine therapy to 6 months after the start of adjuvant endocrine therapy
3 and 6 months after the start of adjuvant endocrine therapy (AET)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philipps University Marburg Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universitätsklinikum Hamburg-Eppendorf
University of Hamburg-Eppendorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Winfried Rief, Prof. Dr., Philipps University Marburg, Department of Psychology, Division of Clinical Psychology and Psychotherapy
  • Principal Investigator: Ute-Susann Albert, Prof. Dr., Krankenhaus Nordwest, Department of Gynecology and Obstetrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DFG NE 1635/2-1

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