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

November 2, 2023 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Lorenzo Cohen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have signed consent for PA15-0336.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (survey administration)
Patients complete a survey over 10 minutes.
Other: Survey Administration
Complete survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Survey completion Up to 2 months
COVID-19-specific psychological distress
Time Frame: Survey completion Up to 2 months
Survey completion Up to 2 months
COVID-19-specific health
Time Frame: Survey completion Up to 2 months
Survey completion Up to 2 months
COVID-19-specific financial and social disruptions
Time Frame: Survey completion Up to 2 months
Survey completion Up to 2 months
COVID-19-specific perceived benefits and social support
Time Frame: Survey completion Up to 2 months
Survey completion Up to 2 months
COVID-19-specific health related quality of life (HRQoL)
Time Frame: Survey completion Up to 2 months
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
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
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.
Survey completion Up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lorenzo Cohen, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2020

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

July 14, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 16, 2020

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0470 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2020-04587 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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