COVID-19 InfectionNCT04474301
Well-Being and Health-Related Quality of Life in Melanoma Patients During COVID-19 Pandemic
An observational study of COVID-19 Infection and Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19 Infection, Melanoma
- What is being tested?
- Survey Administration
- How many people
- 1,152 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2020to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have signed consent for PA15-0336.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Lorenzo Cohen, lcohen@mdanderson.org
Lorenzo Cohen
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- COVID-19 Infection, Melanoma
- Being tested
- Survey Administration
- Medical subject headings
- COVID-19, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Observational (survey administration) | Patients complete a survey over 10 minutes. Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiences during the COVID-19 pandemic
Including exposure, risk factors, testing, isolation, seropositivity, hospitalization, or loss of family or friends.
Measured: Survey completion Up to 2 months
COVID-19-specific psychological distress
Measured: Survey completion Up to 2 months
COVID-19-specific health
Measured: Survey completion Up to 2 months
COVID-19-specific financial and social disruptions
Measured: Survey completion Up to 2 months
COVID-19-specific perceived benefits and social support
Measured: Survey completion Up to 2 months
COVID-19-specific health related quality of life (HRQoL)
Measured: Survey completion Up to 2 months
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.
Measured: Survey completion Up to 2 months
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.
Measured: Survey completion Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start11 Jun 2020
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474301
- Sponsor's protocol ID
- 2020-0470
- Other IDs
- NCI-2020-04587, 2020-0470
- Status last verified
- Oct 2026
- First submitted
- 14 Jul 2020
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Well-Being and Quality of Life in Melanoma Patients During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04474301
- Acronym / sponsor ID
- 2020-0470
- Conditions
- COVID-19 Infection, Melanoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,152 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (survey administration) | – | Other: Survey AdministrationPatients complete a survey over 10 minutes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have signed consent for PA15-0336.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey AdministrationComplete survey | Other | Observational (survey administration) |
Primary outcome
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.
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorenzo Cohen principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Infection and Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Cohen ((713) 745-4260, lcohen@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiences during the COVID-19 pandemic (time frame: Survey completion Up to 2 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.