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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA251470 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to test whether yoga can reduce nerve pain caused by cancer treatment (chemotherapy-induced peripheral neuropathy, or CIPN). Participants will take one of three approaches:
The researchers will compare how these different approaches affect participants' balance, their risk of falls, and their quality of life. This study will also measure how much yoga can help the reduced sense of touch caused by CIPN.
The functional assessments Timed Up and Go (TUG) and Chair to Stand (CTS) can be safely completed either virtually and in-person and will be mandatory for all patients. The functional assessment Functional Reach Test (FRT) and Quantitative Sensory Testing (QST) assessments that can only be completed in-person are optional at these time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga | Experimental | Participants will receive twice weekly yoga over the course of 8 weeks. |
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| Education control (EC) | Experimental | Participants will receive twice weekly education over the course of 8 weeks |
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| Usual care (UC) | Active Comparator | 8 weeks of usual care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga | Other | Participants will have instructional yoga classes twice each week over the course of 8 weeks. Each yoga class will be 60 minutes, and it will be taught by an experienced yoga instructor. Participants will be provided with a home-based guided program for days classes are not held. Participants in the yoga group will also have the option to participate in a recorded final check-in session after they have completed their 16 yoga classes. The discussion facilitator will follow the Semi-Structured Interview Guide to further understand participants' experiences in the yoga group. |
| Measure | Description | Time Frame |
|---|---|---|
| measuring Chemotherapy-Induced Peripheral Neuropathy pain severity after Yoga | as measured by the Brief Pain Inventory-Short Form (BPI-SF) compared to EC and UC arms at week 8 response choices of 0 ("no pain") to 10 ("pain as bad as you can imagine"). | up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ting Bao, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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3-arm parallel randomized controlled trial (RCT) comparing yoga to a non-physical education control (EC) and usual care.
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The PI and investigators will be blinded to the patient's group assignment.
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| Education control | Other | Participants will have educational sessions over 8 weeks. The sessions will be on the causes and impact of Chemotherapy-Induced Peripheral Neuropathy (CIPN), how yoga may help with CIPN, and how different therapies may help with CIPN. To encourage participation and adherence, patients in the EC group will receive sixteen free yoga sessions after completing the study. Patients in the EC group will be asked to not go for their own yoga classes locally until their participation in the study is completed. |
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| Usual care | Other | Participants in the usual care control group will complete the same assessments as the other two arms. To encourage participation and adherence, patients in the UC group will receive sixteen free yoga sessions after completing the study. Patients in the UC group will be asked to not go for their own yoga classes locally until their participation in the study is completed. |
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| Basking Ridge |
| New Jersey |
| 07920 |
| United States |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Rockville Centre | New York | 11553 | United States |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| C564945 | Neuropathy, Painful |
| D010146 | Pain |
| D059350 | Chronic Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
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