Clinical trial · Interventional
Quality of Life Improvement During Chemotherapy
Quality of Life Improvement of Breast Cancer Patients During Chemotherapy With Structured Psychological Interventions
- 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)
This study is a randomized controlled trial, taking place at the University Hospital Basel (CH). It aims at the alleviation of breast cancer patients' life quality during chemotherapy. The intervention group will participate in 10 sessions of structured hypnotherapy during the course of chemotherapy in addition to the standard of care. The control group will have access to the standard of care without any additional treatment. The main goal of the study is to investigate whether quality of life is higher among patients in the intervention group. Additionally, it will be analyzed if the interventions have a positive effect on chemotherapy side effects, symptoms of anxiety and depression and the immune system. Finally, the relative dose intensity (RDI) as well as treatment schedule adherence will be assessed. There are no risks to be expected from the intervention itself. In the case of positive findings, the standard of psycho-oncological care can be updated by integrating structured hypnotherapeutic interventions into the treatment of patients with breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Chemotherapy Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Structured Hypnotherapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- The control group will receive the standard of psycho-oncological care.
- type
- EXPERIMENTAL
- label
- Standard of Care + Structured Hypnotherapy
- description
- The intervention group will receive the standard of psycho-oncological care plus 10 hypnotherapeutic sessions every two weeks.
Primary outcomes (1)
- measure
- Average Summary Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
- timeFrame
- 6 times within 18 weeks + baseline at day 1
- description
- The outcome measure will be the average of all 6 time points on the EORTC QLQ-C30 summary score. The summary score ranges from 0 to 100 with higher scores representing a better quality of life. In the statistical analysis this average summary score will be corrected for values of the summary score at T0.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Minimum Age 18 years * Female * Primary breast cancer * Receiving neo-adjuvant or adjuvant chemotherapy Exclusion Criteria: * Verbal or cognitive deficits that are not compatible with outpatient psychotherapy * Not consenting patients and vulnerable persons * Psychological disorders that prevent patients from participating in the study (e.g. psychotic disorder) * acute suicidality
References
Publications (0)
Data not yet available