Feasibility of Implementing Acupuncture Into a Federally Qualified Health Center to Alleviate Multiple Symptoms Among Breast Cancer Survivors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Acceptability for Treating Multiple Symptoms with Acupuncture
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Acceptability for Treating Multiple Symptoms with Acupuncture
时间窗: At week 6 after finishing the 10th acupuncture treatment
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.
The numbers of study participants being recruited and retained (Feasibility)
时间窗: : from the activation of the study to the completion of the recruitment, week 12
The numbers of study participants being recruited and retained during the study period will be documented as planned
Identify barriers and facilitators associated with implementing acupuncture in federally qualified health center oncology clinics.
时间窗: Through study completion, an average of 1 year
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.
次要结局
未报告次要终点
研究者
Hongjin Li
Assistant Professor
University of Illinois at Chicago