The Effect of Acupuncture on Cancer-Related Cognitive Difficulties

Study 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.

Official Title
-----------------
Effect and Mechanism of Acupuncture for Cancer-related Cognitive Difficulties (ENHANCE)

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Acupuncture
* Procedure: Sham Acupuncture
* Other: Wait-List Control (WLC)
* Other: Questionnaires


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3-arm, parallel, randomized controlled trial comparing acupuncture vs. sham acupuncture vs. wait-list control.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol. | Procedure: Acupuncture<br>* 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.<br>Other: Questionnaires<br>* 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.<br>|
| Placebo Comparator: Sham Acupuncture (SA)<br>The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol. | Procedure: Sham Acupuncture<br>* 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.<br>Other: Questionnaires<br>* 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.<br>|
| Experimental: Wait-List Control<br>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). | Other: Wait-List Control (WLC)<br>* Patients in the WLC group will continue to receive their standard medical care as prescribed by their oncologists/primary care physicians.<br>Other: Questionnaires<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive difficulties | 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. | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupuncture, Cancer-Related Cognitive Difficulties, 20-124