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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04491292
Other study ID # 2020-0428
Secondary ID NCI-2020-0425920
Status Recruiting
Phase
First received
Last updated
Start date May 18, 2020
Est. completion date April 30, 2024

Study information

Verified date November 2023
Source M.D. Anderson Cancer Center
Contact Priya R. Bhosale
Phone 713-792-0221
Email priya.bhosale@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

PRIMARY OBJECTIVE: I. To assess psychosocial and stress-related outcomes in employees at MD Anderson Cancer Center during and post the COVID-19 pandemic. SECONDARY OBJECTIVE: I. To identify demographic and occupational factors associated with COVID-19 related psychosocial and stress outcomes. OUTLINE: Participants complete 2 online questionnaires over 10 minutes each at baseline and at 3 months after the pandemic ends.


Recruitment information / eligibility

Status Recruiting
Enrollment 20000
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - MD Anderson employees

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire Administration
Complete questionnaires

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Demographic and occupational factors associated psychological and stress-related outcomes Summary statistics will also be calculated for demographic variables as well as all other questionnaire items. Ninety-five percent confidence intervals will also be calculated for the mean change from the pandemic scores. Summary statistics will also be calculated for subgroups of interest, such as occupation, age, etc. Two-sided two-sample t-tests, analysis of variance or Pearson/Spearman correlation coefficients, as applicable, will be used to determine whether different subgroups are differentially impacted by, or whether different levels of demographics (such as age) or occupational factors (such as years of service at MD Anderson and number of hours worked per week) are associated with, the COVID-19-related stress, with the stress being measured by the total distress score calculated from the IES as well as by the intrusion and avoidance scores, separately during and after the pandemics. Up to 3 months
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