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

NCT01741883 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2017-09-26

No results posted yet for this study

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.

Conditions

  • Female Breast Cancer

Interventions

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.

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).

Sponsors & Collaborators

  • University of Hamburg-Eppendorf

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    collaborator OTHER

  • Philipps University Marburg

    lead OTHER

Principal Investigators

  • Yvonne Nestoriuc, Prof. Dr. · Universitätsklinikum Hamburg-Eppendorf

  • Winfried Rief, Prof. Dr. · Philipps University Marburg, Department of Psychology, Division of Clinical Psychology and Psychotherapy

  • Ute-Susann Albert, Prof. Dr. · Krankenhaus Nordwest, Department of Gynecology and Obstetrics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-12-31
Completion
2020-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01741883 on ClinicalTrials.gov