Breast Cancer
Conditions
Keywords
Acupuncture, Cancer-Related Cognitive Difficulties, 20-124
Brief 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.
Interventions
PROCEDUREAcupuncture
Each participant will receive 10 treatments of acupuncture (real or sham) over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window.
PROCEDURESham Acupuncture
Each participant will receive 10 treatments of acupuncture (real or sham) over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window.
OTHERWait-List Control (WLC)
Patients in the WLC group will continue to receive their standard medical care as prescribed by their oncologists/primary care physicians.
OTHERQuestionnaires
Will follow patients for 26 weeks from baseline and collect assessments at baseline and Weeks 0, 10, and 26. Average time to complete the surveys is 30 minutes, which has been judged to be acceptable with minimal missing data; 20 minutes of these 30 minutes will be completed during the neurocognitive battery. Patients will complete PROs online using Research Electronic Data Capture (REDCap) or over the phone with the CRC. Biospecimens will be collected in person at assessment visits. The neurocognitive battery will be administered remotely.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
3-arm, parallel, randomized controlled trial comparing acupuncture vs. sham acupuncture vs. wait-list control.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cognitive difficulties | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJun Mao, MD, MSCE
Memorial Sloan Kettering Cancer Center
Outcome results
None listed