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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASC | Experimental | Traditional manual acupuncture with standard care (ASC) will be provided. Subjects in the ASC group will receive 9 sessions of acupuncture and standard care for 3 weeks. A semi-standardized acupuncture treatment protocol (combined fixed acupoints with additional acupoints by symptom differentiation) will be employed. The fixed acupuncture points including, Guanyuan (CV4), Xuanzhong(GB39), Sanyinjiao (SP6), Yinlingquan (SP9), Zusanli (ST36), Yingtang (EX-HN3), Baihui (GV20), and Qihai (CV6) will be used in every session. |
|
| SSC | Sham Comparator | Sham acupuncture plus standard care (SSC) will be provided. Subjects in the SSC group will receive 9 sessions of sham acupuncture and standard care for 3 weeks. The Streitberger sham acupuncture will be employed. The selection of acupoints is the same as ASC. |
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| SC | Placebo Comparator | Standard care alone (SC) will be provided. Subjects in the SC group will standard care for 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture and standard care (ASC) | Other | A semi-standardized treatment protocol and standard care will be employed. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of the symptom improvments | 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) | Change from baseline score at 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| EORTC QLQ-C15-PAL | The European Organization for Research and Treatment of Cancer Quality of Life 15 items Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) | weeks 0, 3, 7 and 11 |
| Numeric Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyong CHEN, PhD | Contact | 852-39176413 | haiyong@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Haiyong CHEN, PhD | The University of Hong Kong | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33957783 | Derived | Chen H, So TH, Cho WC, Qin Z, Ma CH, Li SG, Yang Z, Jiang F, Wu J, Zhang ZJ, Kong FM, Lao L. The Adjunctive Effect of Acupuncture for Advanced Cancer Patients in a Collaborative Model of Palliative Care: Study Protocol for a 3-Arm Randomized Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211012749. doi: 10.1177/15347354211012749. |
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Subjects randomly assigned to either ASC group or SSC group will be blinded to their group assignment
| Sham acupuncture and standard care (SSC) | Other | Validated non-insertion sham acupuncture (Streitberger sham acupuncture) and standard care will be applied. |
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| Standard care (SC) | Other | Standard care will be employed. |
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The Numeric Rating Scale measures the pain intensity, which is scored from 0-100mm. (no pain at 0 mm, the worst pain at 100mm)
| weeks 0, 3, 7 and 11 |
| Fatigue | The Chinese version of Brief Fatigue Inventory (BFI) is a 9-item, 11-point rating scale developed to assess subjective fatigue. | weeks 0, 3, 7 and 11 |
| The Hospital Anxiety and Depression Scale | 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. | weeks 0, 3, 7 and 11 |
| The Insomnia Severity Index | The Insomnia Severity Index (ISI) has 7 items. Each item is sored from 0 to 4. Total scale ranges from 0 t0 28. | weeks 0, 3, 7 and 11 |
| Symptom improvments | 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) | weeks 0, 1, 2, 7 and 11 |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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