Well-being in Cancer Patients With Neuropathy During COVID-19 Who Participated in Prior Clinical Trials

Malignant Solid Neoplasm Clinical Trial

Official title:

COVID-19: Well-Being in Cancer Patients With Neuropathy Who Participated in Prior Clinical Trials

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04650178
• Other study ID #: 2020-0508
• Secondary ID: NCI-2020-0601420
• Status: Active, not recruiting
• Start date: May 26, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 274
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Must have participated in one of the following protocols: 2015-0399, 2012-0642, or 2010-0675

• Has an active email address or can be contacted by MyChart or personal email

Exclusion Criteria:

• No evidence of consent from prior clinical trials

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Infection
• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms
• Neuropathy

Intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Complete questionnaire

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   MD Anderson Cancer Center Website