Advanced Tumour Diseases, Depression, Fatigue, Pain
Conditions
Keywords
Auricular Acupuncture, advanced tumour diseases
Brief summary
In the present study, the effect of ear acupressure treatment according to the NADA protocol on the quality of life of patients with advanced tumour diseases. (all stages) will be investigated. Furthermore, the effect of ear acupressure on anxiety and depression, pain, fatigue and sleep of the patients will be assessed.
Interventions
OTHERAuricular Acupuncture
Within the NADA protocol, 5 defined points on the patient's ears are treated according to a standardized concept (shen men, kidney, lung, liver, vegetative I).
Sponsors
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients with advanced tumour diseases on current therapy, who suffer from persistent disease- or therapy-associated symptoms and limitations (screening by distress thermometer, score ≥ 5) * Informed consent.
Exclusion criteria
* medical reasons or * a mental condition which, in the opinion of the investigator, does not allow the patient to participate in the study, * a planned radiation therapy in the area of the skull (to avoid potential scattered radiation), * a missing legally binding signature on the informed consent form, * participation in another acupuncture/acupressure study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in disease-specific quality of life (FACT-MM) | after 8 weeks (end of intervention) | The FACT-MM can depict a more comprehensive picture of the patient's health status and collects data on precisely those areas that are most important to the patient himself. The diagnosis-specific subscale developed in this process assesses pain, fatigue, physical activity, emotional health, and cognitive abilities and represents the primary outcome parameter in this study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of individual symptom burden | fourth week of intervention | Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale. |
| Change of pain | fourth week of intervention | Improvement of pain (FACT-MM) questionnaire |
| Change in anxiety and depressiveness | fourth week of intervention | The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale. |
| Change of sleep disorders and sleep quality | fourth week of intervention | The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval |
| Number of pateints with adverse events | through study completion, an average of 3 Years | Tolerability of the application |
| Change of Fatigue | fourth week of intervention | The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions. |
Countries
Germany
Contacts
Primary ContactClaudia Loeffler, Dr
Outcome results
None listed