NCT04491292

Brief Summary

This study investigates the impact of the COVID-19 pandemic on the psychosocial health of employees of MD Anderson Cancer Center. Epidemics have been shown to promote psychological stress among medical staff in high risk areas, which may lead to mental health problems. Assessing how the pandemic is affecting employees may allow for more comprehensive actions to be taken to protect the mental health of employees.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

6 years

First QC Date

July 28, 2020

Last Update Submit

January 26, 2026

Conditions

COVID-19 Infection

Outcome Measures

Primary Outcomes (2)

  • Change in psychosocial outcomes

    Will be assessed using the questions administered in the second part of the questionnaire, specifically, the 20 stress-related items and the Impact of Event Scale (IES). Summary statistics will be calculated for each of the individual 20 stress-related questions. The total distress score as well as the scores for the intrusion and avoidance subscales will be calculated and also summarized via descriptive statistics. Summary statistics will be calculated separately for data collected during the pandemic and at follow-up, as well as for change from pandemic to follow-up. Ninety-five percent confidence intervals will be calculated for the mean of the change scores.

    Baseline up to 3 months after the outbreak ends

  • Change in stress-related outcomes

    Will be assessed using the questions administered in the second part of the questionnaire, specifically, the 20 stress-related items and the IES. Summary statistics will be calculated for each of the individual 20 stress-related questions. The total distress score as well as the scores for the intrusion and avoidance subscales will be calculated and also summarized via descriptive statistics. Summary statistics will be calculated separately for data collected during the pandemic and at follow-up, as well as for change from pandemic to follow-up. Ninety-five percent confidence intervals will be calculated for the mean of the change scores.

    Baseline up to 3 months after the outbreak ends

Secondary Outcomes (1)

  • Demographic and occupational factors associated psychological and stress-related outcomes

    Up to 3 months

Study Arms (1)

Observational (questionnaire)

Participants complete 2 online questionnaires over 10 minutes each at baseline and at 3 months after the pandemic ends.

Other: Questionnaire Administration

Interventions

Questionnaire AdministrationOTHER

Complete questionnaires

Observational (questionnaire)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Employees at MD Anderson Cancer Center.

You may qualify if:

  • MD Anderson employees

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-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Priya R Bhosale

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Priya R. Bhosale

CONTACT

713-792-0221priya.bhosale@mdanderson.org

Study Design

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

Study Record Dates

First Submitted

July 28, 2020

First Posted

July 29, 2020

Study Start

May 18, 2020

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

US(1)