Side Effect Prevention Training (SEPT) for Nocebo Effects in Breast Cancer Patients
NCT ID: NCT01741883
Last Updated: 2017-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
165 participants
INTERVENTIONAL
2012-11-30
2020-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Standard Medical Care and Information
Patients receive standard treatment protocol for breast cancer patients and additional oral and written information about adjuvant endocrine treatment.
No interventions assigned to this group
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.
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.
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.
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).
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Sufficient knowledge of German language and ability to give informed consent
* Age of 18 and more
Exclusion Criteria
* Presence of a life threatening comorbid medical condition
18 Years
80 Years
FEMALE
No
Sponsors
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University of Hamburg-Eppendorf
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Philipps University Marburg
OTHER
Responsible Party
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Yvonne Nestoriuc, PhD.
Prof. Dr.
Principal Investigators
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Yvonne Nestoriuc, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Winfried Rief, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Philipps University Marburg, Department of Psychology, Division of Clinical Psychology and Psychotherapy
Ute-Susann Albert, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Krankenhaus Nordwest, Department of Gynecology and Obstetrics
Locations
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University Medical Center Hamburg-Eppendorf
Hamburg, , Germany
Countries
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References
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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.
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.
Related Links
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Homepage of the transregional DFG research unit FOR 1328: Expectation and conditioning as basic processes of the placebo and nocebo response: From neurobiology to clinical applications
Other Identifiers
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DFG NE 1635/2-1
Identifier Type: -
Identifier Source: org_study_id