Breast Cancer
Conditions
Brief summary
The objectives of this study to explore whether acupuncture can improve the psychoneurological symptom cluster (pain, fatigue, sleep disturbance) in survivors of breast cancer and explore biomarker changes after the acupuncture intervention. Acupuncture treatments will be provided to breast cancer survivors twice weekly for 5 weeks.
Detailed description
The investigators will conduct the study with early stage breast cancer survivors who have completed their primary cancer treatment. They will all receive acupuncture. Treatments will be twice weekly for 5 weeks, for 30 minutes per treatment. At baseline and post-treatment, subjects will be collected blood and stool samples, complete symptom questionnaires that measure pain, fatigue, and sleep disturbance.
Interventions
OTHERAcupuncture
All participants will receive a semi-standardized acupuncture protocol (standardized points for pain, fatigue, depression, anxiety, sleep disturbance, with additional points for patient's particular pain location)
Sponsors
University of Illinois at Chicago
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* women with histologically confirmed stage 0, I, II, or III breast cancer * who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) at least 3 months prior and within 5 years * are currently receiving adjuvant endocrine therapy * are able to read and speak English * with self-reported pain, fatigue, sleep disturbance in the last three months and their worst severity rating ≥ 3 (0-10 numeric rating scale) for at least two of the three symptoms
Exclusion criteria
* have self-reported hospitalization for psychiatric illness within the past 2 years * have a bleeding disorder * physically or cognitively unable to complete the study procedures * pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pain Interference | After 10th acupuncture treatment, at 6 weeks post-baseline (study completion) | Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more |
| PROMIS Fatigue | After 10th acupuncture treatment, at 6 weeks post-baseline (study completion) | Scores range from 4-20; higher scores indicate that severe fatigue |
| PROMIS Sleep Disturbance | After 10th acupuncture treatment, at 6 weeks post-baseline (study completion) | Scores range from 4-20; higher scores indicate that severe sleep disturbance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Depression | After 10th acupuncture treatment, at 6 weeks post-baseline (study completion) | Scores range from 4-20; higher scores indicate that severe depression |
| PROMIS Anxiety | After 10th acupuncture treatment, at 6 weeks post-baseline (study completion) | Scores range from 4-20; higher scores indicate that severe anxiety |
Countries
United States
Outcome results
None listed