Acupuncture for Psychoneurological Symptoms Among Breast Cancer Survivors
Study Details
Study Description
Brief Summary
The objectives of this study to identify the feasibility and acceptability of acupuncture for symptom management among breast cancer survivors and explore biomarker changes after the acupuncture intervention. Acupuncture treatments will be provided to breast cancer survivors twice weekly for 5 weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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, anxiety, depressive symptoms, sleep disturbance. Subjects will also complete a measure of study acceptability, the Protocol Acceptability Scale for Treating Breast Cancer Psychoneurological Symptoms with Acupuncture at post-treatment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Acupuncture All subjects will receive active acupuncture. The acupuncture intervention will consist of 10 acupuncture sessions, twice weekly for 5 weeks. There will be at least 1 day in between session. |
Other: Acupuncture
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)
|
Outcome Measures
Primary Outcome Measures
- Feasibility and Acceptability for Treating Psychoneurological Symptoms With Acupuncture [Time Frame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)]
Protocol Acceptability Scale is a 10-item instrument with scores ranging from 0 to 20 used to measure acceptability of the study processes and protocols. Items are measured on a 0 to 2 scale, where 0 means "did not like the study/did not like acupuncture/did not enjoy participating", and 2 means "liked the study/liked acupuncture/enjoyed participating". The protocol was deemed to have high acceptability if 80% of participants scored ≥ 80% of possible points on the acceptability scale. The investigators calculated the mean score for each of the 10 questions, divided the total score for the 10 questions by the maximum possible points for the measure, and converted the total mean scores to percentage of participants who liked the study/liked acupuncture/enjoyed participating.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
women with histologically confirmed stage 0, I, II, or III breast cancer
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who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy)
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are able to read and speak English
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with self-reported pain, fatigue, sleep disturbance, depression, and/or anxiety in the last three months and their "worst" severity rating ≥ 3 (0-10 numeric rating scale) for at least two of the five symptoms
Exclusion Criteria:
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have self-reported hospitalization for psychiatric illness within the past 2 years
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have a bleeding disorder
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physically or cognitively unable to complete the study procedures
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pregnant women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Illinois at Chicago College of Nursing | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- University of Illinois at Chicago
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-0840