Feasibility of Implementing Acupuncture Into Federally Qualified Health Center Among Breast Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the feasibility of implementing acupuncture intervention in federally qualified health centers oncology clinics for breast cancer survivors.

Detailed Description
-----------------
This study has the following specific aims: Aim 1: Test the feasibility and acceptability of implementing a 5-week acupuncture intervention within federally qualified health center oncology clinic to manage multiple symptoms (pain, hot flashes, fatigue, sleep disturbance, depression, anxiety) among breast cancer survivors receiving endocrine therapy. Aim 2: Use a mixed methods approach to identify barriers and facilitators associated with implementing acupuncture in federally qualified health center oncology clinic.

Official Title
-----------------
Feasibility of Implementing Acupuncture Into a Federally Qualified Health Center to Alleviate Multiple Symptoms Among Breast Cancer Survivors

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with histologically confirmed stage 0, I, II, or III breast cancer > 18 years of old who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) in the past 1 month and currently taking endocrine therapy are able to read and speak English with self-reported pain, fatigue, sleep disturbance, depression, hot flashes and/or anxiety in the last month and their average severity rating ≥ 3 (0-10 numeric rating scale) for at least 3 of the 6 symptoms, and experience at least 2 physical symptoms (pain, fatigue, sleep disturbance). Exclusion Criteria: Metastatic breast cancer (stage IV) have a bleeding disorder (e.g. hemophilia, Von Willebrand's disease, thrombocytopenia) failure to comply with weekly visits to the acupuncture clinic during the interventional phase of the study Psychiatric or medical disorders which would affect study assessments, such as, dementia, Alzheimer's disease, a history of any neurological condition, traumatic brain injury, stroke, and the use of psychotropic medication Breastfeeding, pregnant or are planning get pregnant during the study period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br>Participants will receive 2 acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each acupuncture treatment will take 30 minutes. | Behavioral: Acupuncture<br>* All participants will receive a semi-standardized acupuncture protocol with additional points for patient's particular pain location,<br>|
| No Intervention: Usual care group<br>Participants will continue to receive their usual care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability for Treating Multiple Symptoms with Acupuncture | Protocol Acceptability Scale is a 9-item instrument with scores ranging from 0 to 18 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 9 questions, divided the total score for the 9 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. | At week 6 after finishing the 10th acupuncture treatment | 
| The numbers of study participants being recruited and retained (Feasibility) | The numbers of study participants being recruited and retained during the study period will be documented as planned | : from the activation of the study to the completion of the recruitment, week 12 | 
| Identify barriers and facilitators associated with implementing acupuncture in federally qualified health center oncology clinics. | Specific questions will be asked during a face-to-face interview to identify factors favoring or barriers to implementing acupuncture into federally qualified health center oncology clinics among breast cancer survivors and providers. | Through study completion, an average of 1 year |