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The aim of this study is to evaluate the effects and safety of acupuncture on anxiety and/or depression among patients with breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture group | Experimental | Acupoints:Bai Hui acupoint, An Mian acupoint, Shang Yin Tang acupoint, Tai Yang acupoint, Tian Shu acupoint, Zu SanLi acupoint, Tai Chong acupoint, Shen Men acupoint. |
|
| Sham electroacupuncture (SEA) group | Sham Comparator | Acupoints: Bai Hui acupoint, An Mian acupoint, Shang Yin Tang acupoint, Tai Yang acupoint, Tian Shu acupoint, Zu San Li acupoint, Tai Chong acupoint, Shen Men acupoint. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture group | Device | The needles will be inserted to 15-40mm in acupoints through adhesive pads. Needles will be lifted, thrusted and twirled gently for 3 times to achieve deqi sensation and manipulated every ten minutes during 30-minute maintenance. The electronic acupuncture apparatus will be connected to the bileteral Taiyang, Anmian and Baihui, with a continuous wave of 2 Hertz (Hz) and an electric current of 1-3 milliampere (mA). Participants receive acupuncture treatment three times a week in the first two weeks and twice a week in the last six weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in the total score of Hospital Anxiety and Depression Scale (HADS). | The total score of HADS ranges from 0 to 42, with higher scores indicating greater anxiety and depression. | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in the total score of HADS. | The total score of HADS ranges from 0 to 42, with higher scores indicating greater anxiety and depression. | weeks 4, 12, 16 and 20 |
| The change from baseline in the score of HADS-A and HADS-D |
| Measure | Description | Time Frame |
|---|---|---|
| Expectance assessment | Participants will be asked: How do you expect your anxiety and depression will be in 8 weeks? | baseline |
| Assessment of belief in acupuncture | Participants will be asked the question: Do you think your anxiety and depression may be helped by acupuncture? |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuanjie Sun | Contact | +8618810337542 | puzhisun@163.com | |
| Shuai Gao | Contact | +8613128205732 | gaoshuai980314@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Beijing | China |
Deidentified participant data and data dictionary will be available with publication until six months after publication.
Formal request should be sent to puzhisun@163.com with a methodologically sound proposal.
Researchers whose proposal has been approved will sign a data access agreement.
The data will be available with publication until until six months after publication.
Formal request should be sent to puzhisun@163.com with a methodologically sound proposal. Researchers whose proposal has been approved.
Researchers whose proposal has been approved will sign a data access agreement.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Sham electroacupuncture | Device | The needle will be inserted to 2-3mm in Bai Hui acupoint. For the remaining acupoints, needles will be inserted into the pad till reaching but without penetrating the skin. Needles will be lifted, thrusted and twirled gently for 3 times to simulate the effects of the needle tip penetrating the skin. The electronic acupuncture apparatus will be connected to the Baihui acupoint, Shang Yin Tang acupoint, and bilateral An Mian acupoints, with a continuous wave of 2 Hertz (Hz) and an electric current of 0.1-0.3 mA. In about 3-5 seconds, the electric current will be turned down. Participants receive acupuncture treatment three times a week in the first two weeks and twice a week in the last six weeks. |
|
The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
| weeks 4, 8, 12, 16 and 20 |
| Proportion of participants with a total HADS score less than 15, an HADS-A score of less than or equal to 7, and an HADS-D score of less than or equal to 7 | The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression. | weeks 4, 8, 12, 16 and 20 |
| Change from baseline in Hamilton Depression Scale-14 | The Hamilton Depression Scale (HAMD) was developed by Hamilton in 1959 and is a clinical tool used to assess anxiety symptoms. All items use a 5-point rating scale from 0 to 4, with a total score ranging from 0 to 56. The cut-off value is 14 points. Generally, a score of >14 points indicates anxiety, >29 points indicates severe anxiety, and the higher the score, the more severe the anxiety symptoms. | Week 4, 8 and 20 |
| Change from baseline in Hamilton Depression Scale-17 | The Hamilton Depression Scale (HAMD) was developed by Hamilton in 1960 and is the most commonly used scale in clinical assessment of depressive states. All items are scored on a 5-point scale ranging from 0 to 4. The total score is 68. A score of 8-17 indicates mild depression, 18-24 indicates moderate depression, and a score of ≥25 indicates severe depression. | Week 4, 8 and 20 |
| The change from baseline in the Functional Assessment of Cancer Therapy- General and the Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) | The FACT-B is a specific scale designed to measure the quality of life in breast cancer patients. The total score of the questionnaire range from 0 to 144, with higher scores indicating worse quality of life. | weeks 4,8 and 20 |
| The change from baseline in the Fear of Cancer Recurrence Inventory-short form(FCRI-SF) | The FCRI-SF score ranges from 0 to 168, with higher scores indicating a higher level of fear of cancer recurrence among cancer patients. | weeks 4, 8 and 20 |
| The change from baseline in the brief fatigue inventory (BFI) | The BFI score ranges from 0 to 10, with higher scores indicating greater fatigue. | weeks 4, 8 and 20 |
| The change from baseline in the Insomnia Severity Index (ISI) | The ISI score ranges from 0 to 28, with higher scores indicating Insomnia Severity. | weeks 4, 8 and 20 |
| The proportion of responders per the Patient Global Index of Improvement (PGI-I) | The PGI-I evaluates the overall treatment effect perceived by patients themselves. The change can be rated in 7 levels, including "very much better", "much better", "a little better", "no change", "a little worse", "much worse" or "very much worse". The score of the scale ranges from 1 to 7. | weeks 8 and 20 |
| Collection of cranial MRI images. | Data were acquired at the Department of Radiology using a Magneton Skyra 3.0 T MR scanner. | baseline and week 8 |
| baseline and week 8 |
| Blinding assessment | Participants will be asked the question: Do you think you have received traditional electroacupuncture in the past 8 weeks? | week 8 |
| Adherence assessment | Adherence will be assessed via counting treatment sessions. Those who complete over 80% treatment sessions will be defined as of good adherence. | through study completion, an average of five months |
| Proportion of participants using rescue medicine. | The percentage of patients using other medications or therapies that may affect their anxiety and depression. | through study completion, an average of five months |
| Safety assessment | Adverse events and severe adverse events will be recorded in the case report form, whether related to interventions or not. | through study completion, an average of five months |
| D017437 |
| Skin and Connective Tissue Diseases |