A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy

Study Overview
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Brief Summary
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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.

Official Title
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IIT2019-07-ASHER-QIGONG: A Mind-Body Intervention for Chemotherapy-Induced Peripheral Neuropathy

Conditions
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Chemotherapy-induced Peripheral Neuropathy, Cancer

Intervention / Treatment
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* Other: Qi Gong


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with cancer, stage 1-4. Completed taxane- or platinum-based chemotherapy at least three months (90 days) ago but within 24 months of signing consent. Current use of anti-estrogen therapy, Herceptin, or PARP inhibitors is okay. Experiencing at least grade 1 peripheral sensory neuropathy, peripheral motor neuropathy, or dysesthesias based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 (NCI CTCAE v4.0). Age ≥ 18 years. Concomitant use of analgesics is permitted if the dose has been stable for at least 2 weeks prior to study enrollment (no new analgesics have been added, discontinued, or changed in the 2 weeks prior to study enrollment). Reasonable functional stability as assessed by the evaluating physician. Must be able to understand and communicate proficiently in English. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: Syphilis, alcoholic neuropathy, diabetic neuropathy, neurological disorders, brain injury, or stroke, as assessed by the treating physician. Medical history of neuropathy from any type of nerve compression (e.g., carpal tunnel or tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy, leptomeningeal carcinomatosis), as assessed by the treating physician. Neuropathy related to abnormal TSH or B12 levels as assessed by treating physician Current severe depression, suicidal ideation, bipolar disease, alcohol abuse, or major eating disorder, as assessed by the treating physician. Severe personality disorder or psychiatric disorder that would interfere with participation in a QiGong program, as assessed by the evaluating physician. Currently participating in another QiGong or Tai Chi program.

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qi Gong<br>Weekly QiGong for Chemotherapy-Induced Neuropathy classes for 10 weeks | Other: Qi Gong<br>* Guided Qi Gong class<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance | Number of QiGong classes attended by those who enroll | 10 weeks | 
| Retention | Completion of both pre- and post-assessments | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Qi Gong