Homen Begovic, Dr. Study Director University Hospital, Basel, Switzerland Christian Schwegler, Dr. Principal Investigator University Hospital, Basel, Switzerland
Kontakt
Christian Schwegler, Dr. Kontakt: Phone: +49 (0)170 472 47 47 E-Mail: christian@praxisschwegler.ch» Kontaktdaten anzeigen Gregor Genrich, Msc. Kontakt: Phone: +41 (0)61 422 11 22 E-Mail: gregor@praxisschwegler.ch» Kontaktdaten anzeigen
1. Average Summary Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (Time Frame - 6 times within 18 weeks + baseline at day 1): 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.
Secondary outcome:
1. Summary Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (Time Frame - 7 times within 18 weeks): Summary score of the EORTC QLQ-C30 on all 7 time points including baseline. The summary score ranges from 0 to 100 with higher scores representing a better quality of life. In the statistical analysis the summary score will be compared between all time points to see the development of life quality throughout the chemotherapy.
2. Side Effects of Chemotherapy (Time Frame - 7 times within 18 weeks): Side effects of chemotherapy will also be captured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). It contains three symptom scales (fatigue, pain, nausea and vomiting) and single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation, diarrhea and financial problems). All symptom scales range from 1-4 with higher values representing higher levels of symptoms.
3. Hamilton Anxiety and Depression Scale - German Version (HADS-D) (Time Frame - 7 times within 18 weeks): The HADS-D has two sub-scales for anxiety and depression. Each sub-scale ranges from 0 to 21 with higher values representing more severe symptoms of depression and anxiety respectively.
<= 7 unproblematic
8 - 10 threshold
>= 11 problematic
4. Immune Factors (Time Frame - 3 times within 18 weeks): Count of cells per micro-liter (μL) of:
Natural killer cells (NK)
CD4 (also called T-helper cells)
CD8 (marker for cytotoxic T-cells)
5. Interleukin-6 (Time Frame - 3 times within 18 weeks): Counts of picogram per milliliter (pg/mL) of IL-6 (interleukin-6)
6. Tumor Marker CA 15-3 (Time Frame - 3 times within 18 weeks): Counts of international units per milliliter (IU/mL) of tumor marker CA 15-3
7. Relative Dose Intensity (RDI) (Time Frame - 18 weeks): RDI = % dose x (planned days / used days). Reference values: >85% effective treatment, <=85% ineffective and significantly decreased survival chances.
8. Schedule Modification: Delayed Cycles (Time Frame - 18 weeks): Delayed cycles. Reference value >=2. The less cycles are delayed, the more efficient is the chemotherapy. If two or more cycles have been delayed, we consider it a significant decrease in schedule adherence.
9. Schedule modification: Delayed Days (Time Frame - 18 weeks): Delayed days. Reference value >=14. The less days are delayed, the more efficient is the chemotherapy. If 14 or more days have been delayed, we consider it a significant decrease in schedule adherence.
No Intervention: Standard of Care The control group will receive the standard of psycho-oncological care.
Experimental: Standard of Care + Structured Hypnotherapy The intervention group will receive the standard of psycho-oncological care plus 10 hypnotherapeutic sessions every two weeks.
Structured Hypnotherapy (Structured Psychological Intervention / Hypnosis / ): 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.
Quelle: ClinicalTrials.gov
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"Quality of Life Improvement During Chemotherapy"
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