Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care
- Conditions
- Advanced CancerLung CancerBreast CancerColo-rectal CancerPancreas CancerQuality of LifeSymptoms and SignsCholangiocarcinoma
- Interventions
- Other: Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics)Other: Standard care
- Registration Number
- NCT04584775
- Lead Sponsor
- Medical University of Graz
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
-
One of the following tumor entities
- Colorectal cancer (CRC)
- Lung cancer (SCLC, NSCLC)
- Breast cancer (BC)
- Pancreas/Cholangiocellular cancer
-
Best supportive care (i.e., no currently ongoing tumor-specific therapy)
o Exception: palliative anti-hormonal therapy or palliative radiotherapy
-
Performance status: ECOG 0 to 2
-
Estimated life expectancy > 4 months
- Any serious concomitant systemic disorder
- Pregnancy or breast-feeding
- Impossibility to attend TCM practices in Graz
- Incapacity to comply/consent
- Language barrier
- Brain metastases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Traditional Chinese Medicine plus Standard Care Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics) Participants in this group will receive standard Palliative Care and will additionally see a practitioner of Traditional Chinese Medicine. No strict protocol for the actual intervention exists (pragmatic approach). The participants will at least receive acupuncture and/or chinese herbal medicine. The standard care will include any established medical intervention according to currently available guidelines in palliative care. Standard Care Standard care The standard care will include any established medical intervention according to currently available guidelines in palliative care. Traditional Chinese Medicine plus Standard Care Standard care Participants in this group will receive standard Palliative Care and will additionally see a practitioner of Traditional Chinese Medicine. No strict protocol for the actual intervention exists (pragmatic approach). The participants will at least receive acupuncture and/or chinese herbal medicine. The standard care will include any established medical intervention according to currently available guidelines in palliative care.
- Primary Outcome Measures
Name Time Method Change from baseline in FACT-G at week 4 Baseline and 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.
- Secondary Outcome Measures
Name Time Method Change from baseline in FAMCARE-2 at week 4 and 8 Baseline and 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).Change from baseline in FACT-G at week 8 Baseline and 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.
Change of symptom burden, assessed by ESAS-R Baseline and weekly until week 8 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.
Change in use of Pro re nata medication (P.R.N.M.), assessed by Pro re nata medication diary Daily from baseline to week 8 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.
Change from baseline in PHQ-9 at week 4 and 8 Baseline and 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).
Trial Locations
- Locations (1)
Medical University of Graz
🇦🇹Graz, Styria, Austria