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The purpose of this study is to examine the effect, mediators and predictors of treatment response of acupuncture in treating the psychoneurological symptom cluster (pain, fatigue, sleep disturbance) among breast cancer survivors.
Aim 1: compared to sham acupuncture and UC, determine the effect of acupuncture on a) the psychoneurological cluster (primary outcome) and b) pain, fatigue, and sleep disturbance as individual symptoms (secondary outcomes).
Aim 2: examine the role of methylsulfonylmethane as mediator in the mechanisms of acupuncture on the psychoneurological cluster and each individual symptom from week 0 to week 6 (primary endpoint) and to week 12 (secondary endpoint).
Aim 3: identify multilevel predictors of treatment response in the acupuncture group, including a) biological (metabolomic signature, age); 2) clinical (previous treatment) and 3) psychosocial (treatment expectancy) characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture group | Experimental | Participants will receive 2 acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each acupuncture treatment will take 30 minutes. |
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| Sham acupuncture group | Sham Comparator | Sham acupuncture group will use a no-touch control needle on non-acupuncture points, with the tip not contacting the skin. Participants will receive 2 sham acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each sham acupuncture treatment will take 30 minutes. |
|
| Usual care group | No Intervention | Participants will continue to receive their usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Behavioral | All participants will receive a semi-standardized acupuncture protocol with additional points for patient's particular pain location |
|
| Measure | Description | Time Frame |
|---|---|---|
| The psychoneurological symptom cluster | The psychoneurological symptom cluster will be calculated as a composite score of pain interference, fatigue, and sleep disturbance. | week 0, week 6, week 12, week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Pain Interference | Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more | week 0, week 6, week 12, week 24 |
| PROMIS fatigue | Scores range from 4-20; higher scores indicate that severe fatigue |
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Inclusion Criteria:
(1) ≥ 18 years of age;(2) with histologically confirmed Stage 0-III ER/PR-positive HER2-negative breast cancer; who (3) are currently receiving adjuvant endocrine therapy; (4) completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) at least 3 months prior to recruitment; (5) are acupuncture-naïve, and (6) have self- reported pain, fatigue, and sleep disturbance in the last month with an average severity rating ≥ 3 (0-10 numeric rating scale) for at least 2 of the 3 symptoms.
Exclusion Criteria:
(1) taking methylsulfonylmethane or glutathione supplements; (2) are physically or cognitively unable to complete the study procedures; (3) are pregnant.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongjin Li, PhD, RN, FAAN | Contact | 312-413-9845 | hongjin@uic.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois Chicago College of Nursing, | Chicago | Illinois | 60612 | United States |
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| week 0, week 6, week 12, week 24 |
| PROMIS sleep disturbance | Scores range from 4-20; higher scores indicate that severe sleep disturbance | Scores range from 4-20; higher scores indicate that severe fatigue |
| Serum methylsulfonylmethane concentration | Change in serum methylsulfonylmethane concentration. | week 0, week 6, week 12 |
| GSH/GSSG | The ratio of glutathione and oxidized glutathione | week 0, week 6, week 12 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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