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Trial record 1 of 5 for:    covid-19 | Melanoma
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Well-Being and Health-Related Quality of Life in Melanoma Patients During COVID-19 Pandemic

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ClinicalTrials.gov Identifier: NCT04474301
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : July 16, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
COVID-19 Infection Melanoma Other: Survey Administration

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.

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Study Type : Observational
Estimated Enrollment : 1152 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Well-Being and Quality of Life in Melanoma Patients During COVID-19 Pandemic
Actual Study Start Date : June 11, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

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




Primary Outcome Measures :
  1. 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.

  2. COVID-19-specific psychological distress [ Time Frame: Survey completion Up to 2 months ]
  3. COVID-19-specific health [ Time Frame: Survey completion Up to 2 months ]
  4. COVID-19-specific financial and social disruptions [ Time Frame: Survey completion Up to 2 months ]
  5. COVID-19-specific perceived benefits and social support [ Time Frame: Survey completion Up to 2 months ]
  6. COVID-19-specific health related quality of life (HRQoL) [ Time Frame: Survey completion Up to 2 months ]
  7. 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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have signed consent for PA15-0336.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04474301


Contacts
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Contact: Lorenzo Cohen (713) 745-4260 lcohen@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lorenzo Cohen       lcohen@mdanderson.org   
Principal Investigator: Lorenzo Cohen         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lorenzo Cohen M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04474301    
Other Study ID Numbers: 2020-0470
NCI-2020-04587 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0470 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas