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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01049 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2017-0309 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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Due to lack of funds, time, and staff cannot activate the study.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how well a home-based neurofeedback program works in treating participants with chemotherapy-induced peripheral neuropathy (nerve damage that affects motor function). Neurofeedback training is a type of therapy that uses an electroencephalograph and a computer software program to measure brain wave activity. It may help teach participants how to change their own brain waves to lower their perception of pain symptoms and improve overall quality of life.
PRIMARY OBJECTIVES:
I. Examine the feasibility of using a home-based neurofeedback system and dry electroencephalography (EEG) cap to treat chemotherapy-induced peripheral neuropathy (CIPN).
SECONDARY OBJECTIVES:
I. Estimate the effects of home-based neurofeedback (HBNF) on symptoms of (CIPN) versus a wait list (WL) control group in cancer patients.
II. Estimate the effects of home-based neurofeedback (HBNF), versus WL, on the cortical and subcortical brain regions associated with CIPN.
III. Estimate the effects of a HBNF on other aspects of pain, cancer-related symptoms, quality of life (QOL), and mental health.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants complete at least neurofeedback training sessions over 30 minutes 2 times a week for up to 5 weeks.
GROUP II: Participants receive standard of care.
After completion of study, participants are followed up at 1 week for Group I and 6 weeks for Group II.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (neurofeedback) | Experimental | Participants complete at least neurofeedback training sessions over 30 minutes 2 times a week for up to 5 weeks. |
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| Group II (standard of care) | Active Comparator | Participants receive standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard of care |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of a Home-Based Neurofeedback (HBNF) System | HBNF intervention feasible if the average number of HBNF sessions completed across patients in the HBNF arm is >= 15.0 (or on average the proportion of sessions completed is >= 75%). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Home-Based Neurofeedback (HBNF) on Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN) Versus a Waitlist (WL) Control Group in Cancer Patients | Summary statistics and 90% confidence intervals calculated for the Pain Quality Assessment Scale (PQAS) rated from 0 - 10 by study arm at baseline and at the end of treatment. | Baseline and at 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Prinsloo | M.D. Anderson Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D058765 | Neurofeedback |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Neurofeedback | Behavioral | Complete neurofeedback training sessions |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Effects of Neurofeedback on the Cortical and Subcortical Brain Regions Associated with Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Effects of Home-Based Neurofeedback (HBNF) versus Waitlist (WL) Control Group determined by EEG, | Baseline and at 6 weeks |
| Effects of Home-Based Neurofeedback (HBNF) on Other Aspects of Cancer-Related Symptoms Using Patient Surveys | Baseline and within 7 days of the conclusion of treatment. |
| Effects of Home-Based Neurofeedback (HBNF) on Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN) Versus a Waitlist (WL) Control Group in Cancer Patients | Summary statistics and 90% confidence intervals calculated for the Brief Pain Inventory Short Form (BPI) by study arm at baseline and at the end of treatment. | Baseline and at 6 weeks |
| Effects of Neurofeedback on the Cortical and Subcortical Brain Regions Associated with CIPN Determined by Changes in EEG as Measured by Low Resolution Electromagnetic Tomography (LORETA). | Baseline and at 6 weeks |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |