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Recruiting NCT04474301

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

— Observational COVID-19 Infection Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Survey Administration.
Who it may be relevant to
Registry conditions: COVID-19 Infection, Melanoma. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Survey Administration
    Complete survey

Primary outcome measures

  • Experiences during the COVID-19 pandemic [Time frame: Survey completion Up to 2 months]
  • COVID-19-specific psychological distress [Time frame: Survey completion Up to 2 months]
  • COVID-19-specific health [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]
  • COVID-19-specific health related quality of life (HRQoL) [Time frame: Survey completion Up to 2 months]
  • Effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL [Time frame: Survey completion Up to 2 months]
  • Prior lifestyle data [Time frame: Survey completion Up to 2 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT04474301 · 2020-0470 · NCI-2020-04587 · 2020-0470

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗