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This study is being done to explore whether acupuncture can improve cognitive difficulties in patients diagnosed with cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental |
| |
| Sham Acupuncture (SA) | Sham Comparator |
| |
| Wait-List Control | Other | This arm is Closed to accrual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | 10 treatments of acupuncture over the course of 10 weeks with a +/- 7 day window |
|
| 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Mao, MD, MSCE | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | United States | ||
| Memorial Sloan Kettering Monmouth |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| Sham Acupuncture | Other | 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. |
|
| 16 week waiting period + optional Acupuncture | Other | Optional real acupuncture after 16 weeks waiting period. This arm is Closed to accrual. |
|
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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