NCT04474301

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,152

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jun 2020Dec 2026

Study Start

First participant enrolled

June 11, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

6.6 years

First QC Date

July 14, 2020

Last Update Submit

April 13, 2026

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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

  • COVID-19-specific psychological distress

    Survey completion Up to 2 months

  • COVID-19-specific health

    Survey completion Up to 2 months

  • COVID-19-specific financial and social disruptions

    Survey completion Up to 2 months

  • COVID-19-specific perceived benefits and social support

    Survey completion Up to 2 months

  • COVID-19-specific health related quality of life (HRQoL)

    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.

    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.

    Survey completion Up to 2 months

Study Arms (1)

Observational (survey administration)

Patients complete a survey over 10 minutes.

Other: Survey Administration

Interventions

Complete survey

Observational (survey administration)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have signed consent for PA15-0336.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

COVID-19Melanoma

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lorenzo Cohen

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 16, 2020

Study Start

June 11, 2020

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations