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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Philipps University Marburg Medical Center
Sponsor:
Collaborator:
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Yvonne Nestoriuc, PhD., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT01741883
First received: December 4, 2012
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Female Breast Cancer
Behavioral: Side effect prevention training (SEPT)
Behavioral: Attention Control group (ACG)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Side Effects (General Assessment of Side Effects, GASE) [ Time Frame: Baseline, 3 and 6 months after the start of adjuvant endocrine therapy (AET) ] [ Designated as safety issue: No ]
    Side Effects 3 and 6 months after the start of adjuvant endocrine therapy, controlled for baseline symptoms, staging, age, medication


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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) ] [ Designated as safety issue: No ]
    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

  • 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) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 165
Study Start Date: November 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Supportive therapy

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01741883

Contacts
Contact: Yvonne Nestoriuc, Prof. Dr. 0049 40428385376 yvonne.nestoriuc@uni-hamburg.de
Contact: Winfried Rief, Prof. Dr. rief@staff.uni-marburg.de

Locations
Germany
Philipps University Marburg Medical Center Recruiting
Marburg, Hessen, Germany, 35032
Contact: Sarah Heisig, Dipl. Psych.    0049 40428385370    sarah.heisig@uni-hamburg.de   
Contact: Pia von Blanckenburg, Dipl. Psych.    0049 6421 2823788    Pia.vonblanckenburg@staff.uni-marburg.de   
Principal Investigator: Yvonne Nestoriuc, Prof. Dr.         
Sub-Investigator: Ute-Susann Albert, Prof. Dr.         
Sub-Investigator: Winfried Rief, Prof. Dr.         
Sponsors and Collaborators
Philipps University Marburg Medical Center
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Yvonne Nestoriuc, Dr. Philipps University Marburg, Department of Psychology, Division of Clinical Psychology and Psychotherapy
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. Philipps University Marburg, Department of Gynecology, Gynecological Endocrinology and Oncology
  More Information

Additional Information:
Publications:
Responsible Party: Yvonne Nestoriuc, PhD., Prof. Dr., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT01741883     History of Changes
Other Study ID Numbers: DFG NE 1635/2-1
Study First Received: December 4, 2012
Last Updated: March 12, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Philipps University Marburg Medical Center:
Randomized Controlled Trial
Patients´ Expectations
Breast Cancer
Adjuvant Endocrine Treatment
Nocebo

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 30, 2014