Clinical trial · Interventional
Side Effect Prevention Training (SEPT) for Nocebo Effects in Breast Cancer Patients
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)
NCT01741883CI-TRIAL-00029660unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Female Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Attention Control group (ACG) | Behavioral | — | UNRESOLVED |
| Side effect prevention training (SEPT) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Standard Medical Care and Information
- description
- Patients receive standard treatment protocol for breast cancer patients and additional oral and written information about adjuvant endocrine treatment.
- type
- EXPERIMENTAL
- label
- Side effect prevention training (SEPT)
- description
- Patients receive standard medical care and a brief behavioral intervention that targets patients' response and coping expectations while starting with adjuvant endocrine treatment.
- interventionNames
- Behavioral: Side effect prevention training (SEPT)
- type
- ACTIVE_COMPARATOR
- label
- Attention Control group (ACG)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDvon 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. PMID 24047450
- DERIVEDHeisig 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. PMID 26913587