In this clinical trial we want to investigate the clinical benefit of a complementary therapy using therapeutical modalities of the traditional chinese medicine in patients suffering from advanced cancer.
After giving informed consent, the participants will be randomized into two groups (1:1). Both groups will receive standard care while one group will additionally be assigned to a practitioner of traditional Chinese medicine (TCM) who will deliver a individual treatment according to the needs of the participant (pragmatic approach). Outcome measures will be monitored over the course of eight weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Acupuncture is a physical treatment modality that uses thin needles to stimulate specific points on the body in order to manipulate neurologic mechanisms to control specific symptoms and/or physiologic processes. Chinese herbal medicine is a phytotherapeutic treatment modality that uses herbs, minerals and rarely animal products which are orally administered. Tuina is a form of massage and physical therapy. Chinese dietetics is a nutritional therapy according to the theoretical principle of traditional Chinese medicine.
Standard care includes any medical intervention in palliative care that aims to promote and/or sustain the quality of life of patients suffering from advanced disease (in this case cancer). These may be of pharmaceutical, surgical, psychological and/or spiritual nature.
Medical University of Graz
Graz, Styria, Austria
Change from baseline in FACT-G at week 4
FACT-G ((Functional Assessment of Cancer Therapy - General) is a validated multi-dimensional quality of life (QoL) questionnaire. It consists of 26 items and addresses four dimensions of QoL, including physical wellbeing (PWB), functional wellbeing (FWB), emotional wellbeing (EWB), and social wellbeing (SWB). The scoring system is a five-point Likert scale assessing the QoL of the past seven days. The FACT-G total score has a range of 0-108, whereas higher scores indicate a higher QoL.
Time frame: Baseline and week 4
Change from baseline in FACT-G at week 8
FACT-G is a validated multi-dimensional quality of life questionnaire. It consists of 26 items and addresses four dimensions of QoL, including physical wellbeing (PWB), functional wellbeing (FWB), emotional wellbeing (EWB), and social wellbeing (SWB). The scoring system is a five-point Likert scale assessing the QoL of the past seven days. The FACT-G total score has a range of 0-108, whereas higher scores indicate a higher QoL.
Time frame: Baseline and week 8
Change from baseline in PHQ-9 at week 4 and 8
The PHQ-9 (Patient Health Questionnaire) aims at depressive disorders in medically ill populations. It is a 9-item diagnostic tool based upon the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders IV) criteria for major depressive disorder. The PHQ-9 score has a range of 0-27, whereas a score above 10 indicates major depression, This questionnaire will also be completed by a close caregiver (family or friend).
Time frame: Baseline and week 4 and 8
Change of symptom burden, assessed by ESAS-R
The ESAS-R (Edmonton Symptom Assessment Scale revised) was established specifically for palliative care patients and is a nine-item patient-rated symptom visual analog scale. Each item is rated by a numerical rating scale (0-10), whereas higher numbers indicate a more severe symptom experience. The total score of all symptoms represents the total symptom-burden, whereas a higher score indicates a higher total symptom-burden.
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Time frame: Baseline and weekly until week 8
Change in use of Pro re nata medication (P.R.N.M.), assessed by Pro re nata medication diary
To assess the use of pro re nata medication, the participants will document their usage in a diary. P.R.N.M. may be antiemetics, analgetics, tranquilizers or any other drug used for acute symptom relieve.
Time frame: Daily from baseline to week 8
Change from baseline in FAMCARE-2 at week 4 and 8
To evaluate the satisfaction of advanced cancer care in family or friends caregivers, the family satisfaction with end-of-life care two questionnaire (FAMCARE-2) will be used. It is a 17-item assessment tool using a Likert scale (score: 0-68), including subscales for information giving, physical patient care, psychosocial care, and availability of care. A high score on the FAMCARE-2 is associated with a high satisfaction with the palliative care service. This questionnaire will only be completed by a close caregiver (family or friend).
Time frame: Baseline and week 4 and 8