Clinical trial NCT04474301: Well-Being and Health-Related Quality of Life in Melanoma Patients During COVID-19 Pandemic
Official title: Well-Being and Quality of Life in Melanoma Patients During COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19 Infection
Melanoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-07-16
Enrollment: 1152
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have signed consent for PA15-0336.

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.

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

Primary outcomes:
measure: Experiences during the COVID-19 pandemic
timeFrame: Survey completion Up to 2 months
measure: COVID-19-specific psychological distress
timeFrame: Survey completion Up to 2 months
measure: COVID-19-specific health
timeFrame: Survey completion Up to 2 months
measure: COVID-19-specific financial and social disruptions
timeFrame: Survey completion Up to 2 months
measure: COVID-19-specific perceived benefits and social support
timeFrame: Survey completion Up to 2 months
measure: COVID-19-specific health related quality of life (HRQoL)
timeFrame: Survey completion Up to 2 months
measure: Effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL
timeFrame: Survey completion Up to 2 months
measure: Prior lifestyle data
timeFrame: Survey completion Up to 2 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: Lorenzo Cohen
role: PRINCIPAL_INVESTIGATOR
References: