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Clinical Trials/NCT04500600
NCT04500600
Active, not recruiting
Not Applicable

Well-Being and Quality of Life in Cancer Patients and Survivors During the COVID-19 Pandemic

M.D. Anderson Cancer Center1 site in 1 country13,378 target enrollmentJune 11, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19 Infection
Sponsor
M.D. Anderson Cancer Center
Enrollment
13378
Locations
1
Primary Endpoint
Experiences during the coronavirus disease 2019 (COVID-19) pandemic
Status
Active, not recruiting
Last Updated
3 months ago

Overview

Brief Summary

This study investigates the well-being and health-related quality of life in cancer patients and survivors during the COVID-19 pandemic. Using questionnaires may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing, isolation, seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.

Detailed Description

PRIMARY OBJECTIVES: I. Assess experiences during the coronavirus disease 2019 (COVID-19) pandemic (e.g., exposure, risk factors, testing, isolation, seropositivity, hospitalization, loss of family or friends); COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms); health, financial and social disruptions; perceived benefits and social support; and health-related quality of life (HRQoL) in a convenience sample of cancer patients and survivors. II. Evaluate the extent to which COVID-19 experiences are associated with COVID-19-specific psychological distress, health, financial and social disruptions, perceived benefits and social support, and HRQoL. III. Evaluate the extent to which resiliency factors such as social support and perceived benefits moderate the effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL. OUTLINE: Patients complete an online questionnaire over 10 minutes 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.

Registry
clinicaltrials.gov
Start Date
June 11, 2020
End Date
April 30, 2027
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • MD Anderson active patient (visit within past 5 years)
  • ICD-10 confirmed cancer diagnosis
  • Documentation of being alive per the cancer registry
  • Patients who have signed consent for one of the following protocols: PA14-0241 or LAB03-0320
  • Has an active email address and/or can be contacted via MyChart
  • English or Spanish speaker

Exclusion Criteria

  • Non-active patient (i.e., no visit within past 5 years)
  • Language other than English or Spanish
  • Patients who have previously consented to the following protocols: 2012-0112, 2009-0976, 2005-0035, or PA15-0336, because they will be contacted through separate IRB protocols to complete this same survey

Outcomes

Primary Outcomes

Experiences during the coronavirus disease 2019 (COVID-19) pandemic

Time Frame: 2 months

This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.

COVID-19-specific financial and social disruptions

Time Frame: Up to 2 months

This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.

COVID-19-specific psychological distress

Time Frame: Up to 2 months

This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.

COVID-19-specific health

Time Frame: Up to 2 months

This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.

COVID-19-specific perceived benefits and social support

Time Frame: Up to 2 months

This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.

COVID-19-specific health related quality of life (HRQoL)

Time Frame: Up to 2 months

This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.

Effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL

Time Frame: Up to 2 months

Will evaluate the extent to which resiliency factors such as social support and perceived benefits moderate the effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL.

Study Sites (1)

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