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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04474301
• Other study ID #: 2020-0470
• Secondary ID: NCI-2020-0458720
• Status: Recruiting
• Start date: June 11, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Lorenzo Cohen
• Phone: (713) 745-4260
• Email: lcohen[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1152
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Infection
• Melanoma

Intervention

Other:
• Survey Administration
Complete survey

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experiences during the COVID-19 pandemic	Including exposure, risk factors, testing, isolation, seropositivity, hospitalization, or loss of family or friends.	Survey completion Up to 2 months
Primary	COVID-19-specific psychological distress		Survey completion Up to 2 months
Primary	COVID-19-specific health		Survey completion Up to 2 months
Primary	COVID-19-specific financial and social disruptions		Survey completion Up to 2 months
Primary	COVID-19-specific perceived benefits and social support		Survey completion Up to 2 months
Primary	COVID-19-specific health related quality of life (HRQoL)		Survey completion Up to 2 months
Primary	Effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL	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.	Survey completion Up to 2 months
Primary	Prior lifestyle data	Will explore the association between prior lifestyle data collected as part of PA15-0336 and COVID-19-specific psychological distress and HRQoL.	Survey completion Up to 2 months

External Links

•   M D Anderson Cancer Center