Breast Cancer Clinical Trial
The Effect of Acupuncture on Cancer-Related Cognitive Difficulties
Summary
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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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There are 4 Locations for this study
Commack New York, 11725, United States More Info
Harrison New York, 10604, United States More Info
Uniondale New York, 11553, United States More Info
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