Effect and Mechanism of Acupuncture for Cancer-related Cognitive Difficulties (ENHANCE)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 270
- 试验地点
- 14
- 主要终点
- cognitive difficulties
研究概览
简要总结
The purpose of this study is to test whether acupuncture can improve cognitive difficulties and insomnia in survivors of breast cancer. Researchers will compare the effects of real acupuncture with those of placebo acupuncture and wait-list acupuncture. This study will also look at insomnia's link to cognitive difficulties.
All study participants (receiving real acupuncture, placebo acupuncture, or wait-list acupuncture) will complete study questionnaires and/or have cognitive testing at Weeks 0, 4, 10, 14 and 26. After the Week 26 visit, your participation in this study will end. If you are assigned to receive placebo acupuncture or wait-list acupuncture, you will have the option of receiving up to 10 real acupuncture treatments within the six months after the study finishes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •English-proficient adult women with a history of stage 0, I, II, or III breast cancer
- •Free of oncologic disease by clinical examination or history
- •Moderate or greater CRCD as indicated by a score of "quite a bit" or "very much" on at least one of the two items that specifically assess concentration and memory on the EORTC QLQ-C30 (version 3.0)
- •Report that cognitive functions worsened since cancer diagnosis by replying "Yes" to all 3 questions
- •Do you think or feel that your memory or mental ability has gotten worse since your cancer diagnosis?
- •Do you think your mind isn't as sharp now as it was before your cancer diagnosis?
- •Do you feel like these problems have made it harder to function on your job or take care of things around the home?
- •Presence of insomnia symptoms as indicated by a score ≥8 on the ISI134
- •Willing to adhere to all study-related procedures, including randomization to one of the 3 possible choices: acupuncture, sham acupuncture, or wait-list control
排除标准
- •Metastatic breast cancer (stage IV)
- •Less than 1 month since completion of surgery, chemotherapy or radiation therapy
- •Greater than 10 years since most recent breast cancer diagnosis
- •Use of acupuncture for sleep or cognitive symptom management within the past 3 months
- •Diagnosis of Alzheimer's disease, vascular dementia, Parkinson disease, or other organic brain disorder
- •Score of >10 indicative of overt dementia on the Blessed Orientation-Memory-Concentration (BOMC)135
- •Primary psychiatric disorder not in remission
- •As per medical record or self-report, history of stroke or head injury requiring visit to the emergency room or hospitalization, with confirmed structural lesion on neuroimaging, persistent cognitive difficulties impacting work or daily life, or required cognitive rehabilitation.
- •Pre-existing, uncorrectable visual or auditory impairment that would preclude ability to complete the assessments
- •Initiation or change in hormonal or targeted therapy within the past 4 weeks
- •Plans to initiate or change hormonal or targeted therapy in the coming 8 weeks
- •Altered dose of somnogenic medication (e.g. hypnotics, sedatives, antidepressants) in past 8 weeks
- •Enrolled or plans to enroll on another MSK neurocognitive study
- •Unable to provide informed consent for himself/herself
研究组 & 干预措施
Acupuncture
The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
干预措施: Acupuncture (Procedure)
Acupuncture
The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
干预措施: Questionnaires (Other)
Sham Acupuncture (SA)
The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
干预措施: Sham Acupuncture (Procedure)
Sham Acupuncture (SA)
The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
干预措施: Questionnaires (Other)
Wait-List Control
During the 26-week waiting period, the CRC will contact patients in the WLC group at the same frequency as the acupuncture groups with respect to data collection. Patients in the WLC group will continue to receive their standard medical care as prescribed by their oncologists/primary care physicians. WLC patients will be compensated with real acupuncture treatments after Week 26 (end of study).
干预措施: Wait-List Control (WLC) (Other)
Wait-List Control
During the 26-week waiting period, the CRC will contact patients in the WLC group at the same frequency as the acupuncture groups with respect to data collection. Patients in the WLC group will continue to receive their standard medical care as prescribed by their oncologists/primary care physicians. WLC patients will be compensated with real acupuncture treatments after Week 26 (end of study).
干预措施: Questionnaires (Other)
结局指标
主要结局
cognitive difficulties
时间窗: 26 weeks
measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) instrument. FACT-Cog is a 37-item questionnaire with 4 subscales: perceived cognitive difficulties, impact on quality of life, comments from others, and perceived cognitive abilities. The FACT-Cog perceived cognitive impairment subscale (Cronbach's α 0.94) will be the primary outcome for the study. A subscale score is calculated by summing the 18 items of the subscale. The subscale score ranges from 0 to 72.
次要结局
未报告次要终点