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Clinical Trials/NCT04474301
NCT04474301
Recruiting
Not Applicable

Well-Being and Quality of Life in Melanoma Patients During COVID-19 Pandemic

M.D. Anderson Cancer Center1 site in 1 country1,152 target enrollmentJune 11, 2020

Overview

Phase
Not Applicable
Intervention
Survey Administration
Conditions
COVID-19 Infection
Sponsor
M.D. Anderson Cancer Center
Enrollment
1152
Locations
1
Primary Endpoint
COVID-19-specific health
Status
Recruiting
Last Updated
16 days ago

Overview

Brief Summary

The primary purpose of this study is to gain an understanding of how experiences during the COVID-19 pandemic, regardless of COVID-19 status, may have impacted multiple domains of health-related quality of life and other areas such as COVID-19 specific psychological distress, and disruptions to health care, finances and social interactions. We will also evaluate the extent to which resiliency factors such as social support, perceived benefits under times of stress, and ability to manage stress may buffer associations between COVID-19 experiences and HRQoL. To meet these objectives, we have developed a 10-minute questionnaire that taps into these areas and is based on prior work addressing concerns of other pandemics or national crises. Participants will have previously consented to protocol PA15-0336 and have provided prior lifestyle data. This will allow us to connect the COVID-19 survey data with prior existing data.

Detailed Description

PRIMARY OBJECTIVES: I. Assess experiences during the 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 melanoma patients who participated in protocol PA15-0336. 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. IV. Explore the association between prior lifestyle data collected as part of PA15-0336 and COVID-19-specific psychological distress and HRQoL. OUTLINE: Patients complete a survey over 10 minutes.

Registry
clinicaltrials.gov
Start Date
June 11, 2020
End Date
December 30, 2026
Last Updated
16 days ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who have signed consent for PA15-0336
  • Has an active email address and can be contacted via MyChart
  • Documentation of being alive per the cancer registry

Exclusion Criteria

  • Not provided

Arms & Interventions

Observational (survey administration)

Patients complete a survey over 10 minutes.

Intervention: Survey Administration

Outcomes

Primary Outcomes

COVID-19-specific health

Time Frame: Survey completion Up to 2 months

Prior lifestyle data

Time Frame: Survey completion Up to 2 months

Will explore the association between prior lifestyle data collected as part of PA15-0336 and COVID-19-specific psychological distress and HRQoL.

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

Time Frame: Survey completion Up to 2 months

Experiences during the COVID-19 pandemic

Time Frame: Survey completion Up to 2 months

Including exposure, risk factors, testing, isolation, seropositivity, hospitalization, or loss of family or friends.

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

Time Frame: Survey completion 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.

COVID-19-specific psychological distress

Time Frame: Survey completion Up to 2 months

COVID-19-specific financial and social disruptions

Time Frame: Survey completion Up to 2 months

COVID-19-specific perceived benefits and social support

Time Frame: Survey completion Up to 2 months

Study Sites (1)

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