Back to resultsImplementing Acupuncture and Chinese Herbal Medicine Into Palliative Care
Primary Purpose
Advanced Cancer, Lung Cancer, Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics)
Standard care
Sponsored by
About this trial
This is an interventional supportive care trial for Advanced Cancer focused on measuring Palliative Care, Traditional Chinese Medicine, Acupuncture, Chinese Herbal Medicine
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- Any serious concomitant systemic disorder
- Pregnancy or breast-feeding
- Impossibility to attend TCM practices in Graz
- Incapacity to comply/consent
- Language barrier
- Brain metastases
Sites / Locations
- Medical University of Graz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Traditional Chinese Medicine plus Standard Care
Standard Care
Arm Description
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.
The standard care will include any established medical intervention according to currently available guidelines in palliative care.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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.
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).
Full Information
NCT ID
NCT04584775
First Posted
October 6, 2020
Last Updated
December 3, 2020
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT04584775
Brief Title
Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care
Official Title
Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care: A Randomized Controlled Open-label Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Lung Cancer, Breast Cancer, Colo-rectal Cancer, Pancreas Cancer, Cholangiocarcinoma, Quality of Life, Symptoms and Signs
Keywords
Palliative Care, Traditional Chinese Medicine, Acupuncture, Chinese Herbal Medicine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Traditional Chinese Medicine plus Standard Care versus Standard Care
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traditional Chinese Medicine plus Standard Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
Other
Arm Description
The standard care will include any established medical intervention according to currently available guidelines in palliative care.
Intervention Type
Other
Intervention Name(s)
Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in FACT-G at week 4
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline in FACT-G at week 8
Description
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
Title
Change from baseline in PHQ-9 at week 4 and 8
Description
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
Title
Change of symptom burden, assessed by ESAS-R
Description
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.
Time Frame
Baseline and weekly until week 8
Title
Change in use of Pro re nata medication (P.R.N.M.), assessed by Pro re nata medication diary
Description
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
Title
Change from baseline in FAMCARE-2 at week 4 and 8
Description
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
Other Pre-specified Outcome Measures:
Title
Change from baseline in Performance Scales at week 4 and 8
Description
The Karnofsky Performance Scale describes a patient's ability to perform daily activities without restrictions due to disease through to death on a scale of 100 to 0, in steps of 10. Additionally, the ECOG (Eastern Cooperative Oncology Group) Performance Scale, which is a six-grade scale that assesses the level of functioning in terms of self-care, activity, and physical ability, will be assessed.
Time Frame
Baseline and week 4 and 8
Title
Number of consultations of the mobile palliative care team
Description
Throughout the course of the study, the number of consultations of the mobile palliative care team will be documented and compared between the two groups.
Time Frame
From baseline to week 8
Title
Number of hospital referrals
Description
Throughout the course of the study, hospital referrals will be documented and compared between the two groups.
Time Frame
From baseline to week 8
Title
Length of hospitalizations
Description
Throughout the course of the study, the length of hospitalizations will be documented and compared between the two groups.
Time Frame
From baseline to week 8
Title
Overall survival
Description
All deaths throughout the course of the study will be documented to calculate the overall survival.
Time Frame
From baseline to week 8.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Any serious concomitant systemic disorder
Pregnancy or breast-feeding
Impossibility to attend TCM practices in Graz
Incapacity to comply/consent
Language barrier
Brain metastases
Facility Information:
Facility Name
Medical University of Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care
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