Clinical trial NCT04650178: Well-being in Cancer Patients With Neuropathy During COVID-19 Who Participated in Prior Clinical Trials
Official title: COVID-19: Well-Being in Cancer Patients With Neuropathy Who Participated in Prior Clinical Trials
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19 Infection
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Neuropathy
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-12-02
Enrollment: 274
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients with neuropathy who have participated in one of the following clinical trials: 2015-0399, 2012-0642, or 2010-0675.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Health-related quality of life and coronavirus disease 2019 (COVID-19)-specific domains of interest
timeFrame: through study completion, an average of 6 months
measure: COVID-19 experiences and COVID-19 specific distress
timeFrame: through study completion, an average of 6 months
measure: Differences in outcomes between neuropathic pain patients
timeFrame: through study completion, an average of 6 months
measure: Coping and resilience factors
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sarah Prinsloo
role: PRINCIPAL_INVESTIGATOR
References: