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COVID-19 pandemic
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This pilot study will include up to 25 patients with cancer experiencing chemotherapy-induced peripheral neuropathy. Patients enrolled in the study will participate in a 10-week QiGong for Chemotherapy-Induced Neuropathy program. Patients will be evaluated before and after their program participation. Within 2 weeks before the program start date, patients will be administered an objective neuropathy assessment by a physician or nurse, and will complete questionnaires assessing chemotherapy-induced peripheral neuropathy, perceived cognitive functioning, quality of life, and cancer-related symptoms. Patients will repeat these assessments at the end of the last QiGong class and will be asked to provide feedback on the QiGong program as a whole. Self-report questionnaires will also be repeated one week after the last class.
Total duration of subject participation will be 11-13 weeks. Total duration of the study is expected to be approximately 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qi Gong | Experimental | Weekly QiGong for Chemotherapy-Induced Neuropathy classes for 10 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qi Gong | Other | Guided Qi Gong class |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Modified Total Neuropathy Scale (mTNS) score | Change in the Modified Total Neuropathy Scale (mTNS) score from Baseline to T1 (last day of class) | 10 weeks |
| Subjective Neurotoxicity Subscale score | Change in the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) Subscale Score from Baseline to T1 (last day of class) and T2 (1-week follow-up). | 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Attendance | Number of QiGong classes attended by those who enroll | 10 weeks |
| Retention | Completion of both pre- and post-assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arash Asher, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D064906 | Qigong |
| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| 10 weeks |
| Patient Interest | Percentage of patients approached who sign consent | 1 week |
| Patient Evaluation of QiGong Program | Scores on the evaluation titled: QiGong Program Evaluation. Study participants will provide a score for 3 questions related to the QiGong intervention. The minimum value is 0 and maximum value is 4, and higher score means a better outcome. Participants will also be asked 4 additional questions about the class. The minimum value is 0 and the maximum value is 10, and higher score means a better outcome. A composite of all the scores for each participant will be calculated, with higher scores indicating a better outcome. | 1 day |
| Perceived cognitive functioning | Change in the Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) score from Baseline to T1 (last day of class) and T2 (1-week follow-up). | 11 weeks |
| Physical Well-Being | Change in the FACT/GOG-NTX Physical Well-Being Subscale Score from Baseline to T1 (last day of class) and T2 (1-week follow-up). | 11 weeks |
| Social/Family Well-Being | Change in the FACT/GOG-NTX Social/Family Well-Being Subscale Score from Baseline to T1 (last day of class) and T2 (1-week follow-up). | 11 weeks |
| Emotional Well-Being | Change in the FACT/GOG-NTX Emotional Well-Being Subscale Score from Baseline to T1 (last day of class) and T2 (1-week follow-up). | 11 weeks |
| Functional Well-Being | Change in the FACT/GOG-NTX Functional Well-Being Subscale Score from Baseline to T1 (last day of class) and T2 (1-week follow-up). | 11 weeks |
| Impact on symptom experience | Change in the ESAS scores from Baseline to T1 (last day of class) and T2 (1-week follow-up). | 11 weeks |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |