Quality of Life Improvement During Chemotherapy
QoLMa
Quality of Life Improvement of Breast Cancer Patients During Chemotherapy With Structured Psychological Interventions
1 other identifier
interventional
62
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2020
CompletedFirst Posted
Study publicly available on registry
January 5, 2021
CompletedStudy Start
First participant enrolled
July 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
July 9, 2025
July 1, 2025
5.4 years
December 18, 2020
July 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average Summary Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
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.
6 times within 18 weeks + baseline at day 1
Secondary Outcomes (9)
Summary Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
7 times within 18 weeks
Side Effects of Chemotherapy
7 times within 18 weeks
Hamilton Anxiety and Depression Scale - German Version (HADS-D)
7 times within 18 weeks
Immune Factors
3 times within 18 weeks
Interleukin-6
3 times within 18 weeks
- +4 more secondary outcomes
Other Outcomes (1)
Exploratory Analysis of the Correlation between Quality of Life, Anxiety, Depression and Immunfaktors and Tumor Marker
18 weeks
Study Arms (2)
Standard of Care
NO INTERVENTIONThe control group will receive the standard of psycho-oncological care.
Standard of Care + Structured Hypnotherapy
EXPERIMENTALThe intervention group will receive the standard of psycho-oncological care plus 10 hypnotherapeutic sessions every two weeks.
Interventions
The Intervention includes 10 structured hypnotherapy sessions lasting 45 to 60 minutes. During hypnosis, patients reach a trance-like state comparable to a deep relaxation. The therapist guides the patient verbally and also communicates with the patient. Patients will be supported to use their own imagination without suggesting any imagery. By repeatedly asking what the patient is perceiving, and by verbally repeating what the patient is saying, the therapist can help the patient to go deeper into trance. In these trance states the patient learns to reduce negative side effects of the chemotherapy and increase the quality of life by activating both physical and mental resources using imagination and focusing on positive memories and feelings.
Eligibility Criteria
You may qualify if:
- Minimum Age 18 years
- Female
- Primary breast cancer
- Receiving neo-adjuvant or adjuvant chemotherapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Basel
Basel, Canton of Basel-City, 4031, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Isabel Ge, Dr.
University Hospital, Basel, Switzerland
- PRINCIPAL INVESTIGATOR
Christian Schwegler, Dr.
University Hospital, Basel, Switzerland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Scientific Collaborator
Study Record Dates
First Submitted
December 18, 2020
First Posted
January 5, 2021
Study Start
July 31, 2021
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
July 9, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- After publication of first results. Data will be available for 10 years.
- Access Criteria
- Will be evaluated upon request.
Individual request will be evaluated and shared if appropriate.