Anxiety and Depression, Breast Cancer Survivor
Conditions
Brief summary
The study aims to primarily investigate the effects and safety of acupuncture on anxiety and depression among patients with breast cancer.
Interventions
DEVICEElectroacupuncture
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 10-minute maintenance in prone and supine position respectively. 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.
DEVICESham electroacupuncture
The needle will be inserted to 2-3mm in Bai Hui acupoint. For the remaining acupoints, needles will be inserted into the pad and reaching the skin. Needles will be lifted, thrusted and twirled gently for 3 times to simulate the effect of the needle tip penetrating the skin. The electronic acupuncture apparatus will be connected to the Baihui acupoint, Shang Yin Tang acupoint, and bilateral Anmian acupoints, with a continuous wave of 2 Hertz (Hz) and an electric current of 0.1-0.3 mA. In about 30 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.
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Female, aged 18 to 70 years old; 2. Meeting the diagnostic criteria for breast cancer and at TMN I-III; 3. Having completed specialized active treatment for at least one month; 4. With an ECOG score of 0-2; 5. Mild to moderate anxiety and/or depression; 6. Voluntarily joining this study and signing the informed consent form.
Exclusion criteria
(1) Starting to take or change the regimen of anti-anxiety and/or -depression disorder medication within one month before enrolment; (2) Received psychological intervention or physical therapy one month before enrolment or planning to use in the next 5 months; (3) With diagnosis of anxiety and/or depression disorder prior to the diagnosis of breast cancer; (4) Patients with suicidal tendencies, bipolar disorder and psychotic symptoms; (5) Patients with severe anxiety and/or depression； (6) Patients received acupuncture treatment within one month before enrolment; (7) Participating in other clinical studies on the treatment of anxiety and depression; (8) Combined with severe underlying diseases; (9) Patients with severe skin ulcers; (10) Pregnant or lactating patients; (11) Poor compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change from baseline in the Hospital Anxiety and Depression Scale (HADS) | week 8 | The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change from baseline in the HADS-A and HADS-D | weeks 4, 8, 12, 16 and 20 | The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression. |
| The change from baseline in the Insomnia Severity Index (ISI) | weeks 4, 8, 12 and 20 | The ISI score ranges from 0 to 28, with higher scores indicating Insomnia Severity. |
| The proportion of responders per the Patient Global Index of Improvement (PGI-I) | weeks 8 and 20 | 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 change from baseline in the Patient Health Questionnaire - 9 (PHQ-9) | weeks 4, 8, 12, 16 and 20 | The PHQ-9 scale is commonly used for screening depressive symptoms. This scale consists of nine items, evaluating depressive symptoms by asking how much of the time the individual has been bothered by each of the nine aspects over the past two weeks. The scoring interpretation is as follows: 0 - 4 points indicate no depressive symptoms, 5 - 9 points indicate mild depressive symptoms, 10 - 14 points indicate moderate depressive symptoms, 15 - 19 points indicate relatively severe depressive symptoms, and 20 - 27 points indicate severe depressive symptoms. It is generally considered that a PHQ-9 score of 10 or higher, or sometimes 8 or higher, is clinically significant. |
| Change from baseline in Hamilton Depression Scale-14 | Week 4, 8, 12, 16, 20 | 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. |
| Change from baseline in Hamilton Depression Scale-17 | Week 4, 8, 12, 16, 20 | 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. |
| The change from baseline in the Functional Assessment of Cancer Therapy- General and the Functional Assessment of Cancer Therapy-Breast Cancer(FACT-B) | weeks 4,8, 12 and 20 | The FACT-B is a specific scale designed to measure the quality of life in breast cancer patients, with higher scores indicating worse quality of life. |
| The change from baseline in the Fear of Cancer Recurrence Inventory-short form(FCRI-SF) | weeks 4, 8, 12 and 20 | The FCRI-SF score ranges from 0 to 168, with higher scores indicating a higher level of fear of cancer recurrence among cancer patients. |
| The change from baseline in the brief fatigue inventory (BFI) | weeks 4, 8, 12, and 20 | The BFI score ranges from 0 to 10, with higher scores indicating greater fatigue. |
| The change from baseline in the HADS | weeks 4, 12, 16 and 20 | The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression. |
| 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 | weeks 4, 8, 12, 16 and 20 | The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression. |
| The change from baseline in the Generalized Anxiety Disorder 7-item scale (GAD-7) | weeks 4, 8, 12, 16 and 20 | The GAD-7 self-assessment scale can be used for the preliminary evaluation of generalized anxiety symptoms. A score of 0 - 4 indicates no anxiety symptoms, a score of 5 - 9 indicates mild anxiety, a score of 10 - 14 indicates moderate anxiety, and a score of 15 or higher indicates severe anxiety. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blinding assessment | week 8 | Participants will be asked the question: Do you think you have received traditional electroacupuncture in the past 8 weeks? |
| Adherence assessment | through study completion, an average of five months | Adherence will be assessed via counting treatment sessions. Those who complete over 80% treatment sessions will be defined as of good adherence. |
| Proportion of participants using rescue medicine. | through study completion, an average of five months | The percentage of patients using other medications or therapies that may affect their anxiety and depression. |
| Safety assessment | through study completion, an average of five months | Adverse events and severe adverse events will be recorded in the case report form, whether related to interventions or not. |
| Assessment of belief in acupuncture | baseline and week 8 | Participants will be asked the question: Do you think your anxiety and depression may be helped by acupuncture? |
| Expectance assessment | baseline | Participants will be asked: How do you expect your anxiety and depression will be in 8 weeks? |
Countries
China
Contacts
Primary ContactYuanjie Sun
Backup ContactShuai Gao
Outcome results
None listed