Advanced Cancer
Conditions
Keywords
advanced cancer, palliative care, acupuncture
Brief summary
The proposed study aims to evaluate the adjunctive effect of MA with standard care (ASC) for relieving cancer-related symptoms in a collaborative model of palliative care compared to sham MA plus standard care (SSC) or standard care alone (SC).
Detailed description
After being informed about the study plan, potential risk and benefits, all subjects will give written informed consent prior to participation and undergo eligibility screening. Eligible participants will be randomized into three arms, ASC, SSC, and SC, in a 2:1:1 ratio.
Interventions
OTHERAcupuncture and standard care (ASC)
A semi-standardized treatment protocol and standard care will be employed.
OTHERSham acupuncture and standard care (SSC)
Validated non-insertion sham acupuncture (Streitberger sham acupuncture) and standard care will be applied.
OTHERStandard care (SC)
Standard care will be employed.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subjects randomly assigned to either ASC group or SSC group will be blinded to their group assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All cases are subject to pathology and (or) cytology for a diagnosis of malignant tumour (pathological type is not restricted) at stage IIIB or IV; * Aged 18 years or above; * Expected survival time longer than 16 weeks;
Exclusion criteria
* Disseminated intravascular coagulation or severe thrombocytopenia with a bleeding tendency, i.e., low platelet count \< 35000/µL; INR \> 1.5; hemoglobin ≤ 90 g/dL; white blood cell count ≤ 4x109/L; * Uncontrolled active skin infection; * Needle phobia; * Inability to read and understand Chinese; * Not signed written informed consent. * Receiving surgery during the whole study period; * Receiving acupuncture treatment in the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the symptom improvments | Change from baseline score at 3 weeks | The Edmonton Symptom Assessment System (ESAS) is used to rate the intensity of nine common symptoms experienced by cancer patients. Each symptom is scored from 0 to 10. (0 indicats no symptom and 10 indicates the worst symptom) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale | weeks 0, 3, 7 and 11 | The Numeric Rating Scale measures the pain intensity, which is scored from 0-100mm. (no pain at 0 mm, the worst pain at 100mm) |
| Fatigue | weeks 0, 3, 7 and 11 | The Chinese version of Brief Fatigue Inventory (BFI) is a 9-item, 11-point rating scale developed to assess subjective fatigue. |
| EORTC QLQ-C15-PAL | weeks 0, 3, 7 and 11 | The European Organization for Research and Treatment of Cancer Quality of Life 15 items Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) |
| The Insomnia Severity Index | weeks 0, 3, 7 and 11 | The Insomnia Severity Index (ISI) has 7 items. Each item is sored from 0 to 4. Total scale ranges from 0 t0 28. |
| Symptom improvments | weeks 0, 1, 2, 7 and 11 | The Edmonton Symptom Assessment System (ESAS) consists of 9 common symptoms experienced by cancer patients. Each symptom is scored from 0 to 10. (0 indicats no symptom and 10 indicates the worst symptom) |
| The Hospital Anxiety and Depression Scale | weeks 0, 3, 7 and 11 | The Hospital Anxiety and Depression Scale (HADS) consists of 14 items. Each item is scored from 0-3. Total score ranges between 0 and 21 for either anxiety or depression. |
Contacts
Primary ContactHaiyong CHEN, PhD
Outcome results
None listed