Acupuncture Pilot Study for Cancer-related Cognitive Function

Study Overview
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Brief Summary
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This study is being done to explore whether acupuncture can improve cognitive difficulties in patients diagnosed with cancer.

Official Title
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Cancer-related Cognitive Function Acupuncture Pilot Study (CLARITY

Conditions
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Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Stage I Colorectal Cancer, Stage II Colorectal Cancer, Stage III Colorectal Cancer, Gynecologic Cancer, Stage I Gynecologic Cancer, Stage II Gynecologic Cancer, Stage III Gynecologic Cancer, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer

Intervention / Treatment
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* Other: Acupuncture
* Other: Sham Acupuncture
* Other: 16 week waiting period + optional Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking Age 18 ≥ years old Diagnosis (breast, colorectal, prostate or gynecological cancer) Completed initial cancer treatment (surgery, chemotherapy, and/or radiation therapy) at least one month prior to study enrollment (patients receiving maintenance cancer treatment with hormonal or targeted therapies are permitted) Must report moderate or greater perceived CD as indicated by a score of quite a bit or very much on at least one of the two items that specifically assess concentration (item #20) and memory (item #25) on the EORTC QLQ-C30 instrument (version 3.0) Must indicate that their cognitive functions have worsened since their cancer diagnosis by replying Yes to all of the following 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? Must be willing to adhere to all study-related procedures, including randomization to one of the 2 possible choices: acupuncture or sham acupuncture Exclusion Criteria: Active disease Use of acupuncture for 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 on the Blessed Orientation-Memory-Concentration (BOMC) screening instrument Primary psychiatric disorder not in remission Initiation or change in medication (e.g., hypnotics, sedatives, and/or antidepressants) in the past 8 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br> | Other: Acupuncture<br>* 10 treatments of acupuncture over the course of 10 weeks with a +/- 7 day window<br>|
| Sham Comparator: Sham Acupuncture (SA)<br> | Other: Sham Acupuncture<br>* 10 treatments of sham acupuncture over the course of 10 weeks with a +/- 7 day window. After the 16-week study concludes patients in this group will have the option of receiving up to 10 sessions of real acupuncture; however, these sessions must be completed within 6 months of study conclusion.<br>|
| Other: Wait-List Control<br>This arm is Closed to accrual. | Other: 16 week waiting period + optional Acupuncture<br>* Optional real acupuncture after 16 weeks waiting period. This arm is Closed to accrual.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive difficulties as measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) | The perceived cognitive difficulties subscale score of the Functional Assessment of Cancer / FACT-Cog will be the primary outcome for the study. | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Colorectal Cancer, Gynecologic Cancer, Acupuncture, Memorial Sloan Kettering Cancer Center, 19-179, Prostate Cancer