Effect and Mechanism of Acupuncture for Cancer-related Cognitive Difficulties (ENHANCE)
Overview
- Phase
- Phase 2
- Intervention
- Acupuncture
- Conditions
- Breast Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 270
- Locations
- 14
- Primary Endpoint
- cognitive difficulties
- Status
- Active, not recruiting
- Last Updated
- 10 days ago
Overview
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.
Investigators
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
Arms & Interventions
Acupuncture
The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
Intervention: Acupuncture
Acupuncture
The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
Intervention: Questionnaires
Sham Acupuncture (SA)
The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
Intervention: Sham Acupuncture
Sham Acupuncture (SA)
The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
Intervention: Questionnaires
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).
Intervention: Wait-List Control (WLC)
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).
Intervention: Questionnaires
Outcomes
Primary Outcomes
cognitive difficulties
Time Frame: 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.