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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-06014 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0508 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study investigates the experiences of cancer patients with neuropathy during the COVID-19 pandemic to learn how the COVID-19 pandemic affects their quality of life and clinical outcomes. This study will also explore whether there are differences between patients who received neurofeedback (NFB, a type of therapy that is thought to help normalize brain activity) and those who did not. Learning about quality of life in cancer patients with neuropathy during the COVID-19 pandemic may help guide development of programs and policies to improve chronic pain patient care and outcomes during a major global healthcare crisis.
PRIMARY OBJECTIVES:
I. Assess experiences during the coronavirus disease 2019 (COVID-19) pandemic of the health-related quality of life (HRQOL) (e.g. physical, emotional, social well-being), and other COVID-19-specific domains (e.g. anxiety, social interactions, finances), and the associations between COVID-19 experiences and COVID-19-specific distress, HRQOL and clinical outcomes of patients who participated in one of three clinical trials.
II. Examine differences in outcomes between neuropathic pain patients who participated in one of two trials of NFB and received NFB, and neuropathic pain patients who participated in a non-treatment-related neuropathy study (i.e., who did not receive NFB).
III. Evaluate the extent to which coping and resilience factors moderate the effects of COVID-19 experiences on COVID-19-specific distress, HRQOL and clinical outcomes.
OUTLINE:
Patients complete an online questionnaire over 15 minutes about their experiences regarding the COVID-19 pandemic including testing, risks of exposure, whether people they know have acquired COVID-19, as well as questions on how the pandemic has impacted their quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (questionnaire, quality of life) | Patients complete an online questionnaire over 15 minutes about their experiences regarding the COVID-19 pandemic including testing, risks of exposure, whether people they know have acquired COVID-19, as well as questions on how the pandemic has impacted their quality of life. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life and coronavirus disease 2019 (COVID-19)-specific domains of interest | We will use the COVID-19 Specific questionnaire. This scale will ask 15 questions that are organized into three sections: (a) Questions specific to the COVID-19 pandemic such as testing, serostatus, risk factors, loss of family or friends, isolation; (b) Thoughts, experiences and emotions regarding the COVID-19 pandemic; and (c) Health-related quality of life. This assessment was developed by Lorenzo Cohen (MD Anderson), in collaboration with investigators from the University of Miami and UCLA and is a comprehensive assessment of COVID-19 experiences. | through study completion, an average of 6 months |
| COVID-19 experiences and COVID-19 specific distress | Will evaluate bivariate associations between COVID-19 experiences and COVID-19-specific distress, HRQOL and clinical outcomes, using Pearson product-moment correlation coefficients, chi-squared tests, or analyses of variance (ANOVA) where appropriate. | through study completion, an average of 6 months |
| Differences in outcomes between neuropathic pain patients | Will use linear regression (or generalized linear models, as applicable) to assess differences in the outcomes of interest between neuropathic pain patients who received neurofeedback (NFB) from either of the two NFB trials (principal investigator [PI]: Dr. Prinsloo) and the neuropathic pain patients who participated in Dr. Gibby-Reyes' trial (who, consequently, did not receive NFB). | through study completion, an average of 6 months |
| Coping and resilience factors | Will preliminarily test the interaction effect between each of the coping and resilience factors and COVID-19 experiences on COVID-19-specific distress, HRQOL and clinical outcomes. | through study completion, an average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Cancer patients with neuropathy who have participated in one of the following clinical trials: 2015-0399, 2012-0642, or 2010-0675.
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Cohen | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Questionnaire Administration | Other | Complete questionnaire |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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