Breast Neoplasm, Ovary Cancer
Conditions
Keywords
Chemotherapy, Side effects of chemotherapy
Brief summary
Chemotherapies often induce side effects. This study examines whether hypnosis, music therapy versus standard therapy influence these side effects.
Detailed description
Primary study goals are differences in quality of life, nausea and vomiting episodes, fatigue, depression and change of taste.
Interventions
OTHERInterventions are self controlled by the patient via a mp3 player and noise reduction headphones.
During premedication and during chemotherapy the patient is connected to a long term ECG recording and allowed to listen to the mp3 Player via noise reduction headphones.
Sponsors
Deutsche Gesellschaft für hypnose und hypnotherapie E.V.
Dr. Horst Schmidt Klinik GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Single blinded. The participant knows which group intervention is being used (music, hypnosis or standard care). This is being told while listening to the Intervention. All care Providers only know which colour mp3 player is being used (white, orange or black).
Intervention model description
Prospective randomised Trial: Intervention 1 = hypnosis (hypnotherapy), Intervention 2 = Music therapy; Intervention 3 (Standard care)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* no previous chemotherapy * compliance of the patient to fill out questionnaires * informed consent and signed forms * histologic secured breast cancer or ovary cancer (residual tumor after surgery equal or less than 0,5 cm) * One of following chemotherapy regime: 4x Epirubicin / Cyclophosphamid, 12x paclitaxel oder 6x Carboplatin / Docetaxel / Perjeta/ Herceptin oder 6x Doxorubicin, docetaxel, Cyclophosphamid oder 6 x Carboplatin / paclitaxel + / - Avastin oder 4x Epirubicin / Cyclophosphamid -\> 12x paclitaxel /herceptin/ perjeta oder 4x Epirubicin / Cyclophosphamid q21-\>12xcarboplatin, paclitaxel 4 Epirubicin / Cyclophosphamid q14-\> 12 carboplatin, paclitaxel
Exclusion criteria
* does not understand the German language * psychosis * not able to sign consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ZSDS = Zung Self-rating Depression Scale | Every three weeks during chemotherapy and one year after last chemotherapy | Change of questionnaire scores |
| Quality of life questionnaire - Core30 | Every three weeks during chemotherapy and one year after last chemotherapy | Change of questionnaire scores |
| Patient diary, number of emetic episodes, the intensity of Nausea and QoL evaluation (functional living index-emesis questionnaire) | Day 1-5 after chemotherapie and before next chemotherapy | Change of questionnaire scores |
| Fatigue assessment questionnaire (FAQ) | Every three weeks during chemotherapy and one year after last chemotherapy | Change of questionnaire scores |
| Screening Scale for Taste Alteration (TA) | Every three weeks during chemotherapy and one year after last chemotherapy | Change of questionnaire scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of heart rate | change of average heart rate after 5 minutes rest, 5 minutes before chemotherapy and 5 minutes into chemotherapy | Long term ECG recording before and during chemotherapy |
Countries
Germany
Outcome results
None listed