- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04491292
Assessment of the Psychosocial Impact of the COVID-19 Pandemic on the MD Anderson Cancer Center Workforce
Psychosocial Impact of COVID-19 Pandemic on MD Anderson Workforce
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Priya R. Bhosale
- Phone Number: 713-792-0221
- Email: priya.bhosale@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Priya R. Bhosale
- Phone Number: 713-792-0221
- Email: priya.bhosale@mdanderson.org
-
Principal Investigator:
- Priya R. Bhosale
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- MD Anderson employees
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational (questionnaire)
Participants complete 2 online questionnaires over 10 minutes each at baseline and at 3 months after the pandemic ends.
|
Complete questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in psychosocial outcomes
Time Frame: Baseline up to 3 months after the outbreak ends
|
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
Time Frame: Baseline up to 3 months after the outbreak ends
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic and occupational factors associated psychological and stress-related outcomes
Time Frame: Up to 3 months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Priya R Bhosale, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-0428 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-04259 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19 Infection
-
Aga Khan UniversityCompletedCOVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Lower Respiratory InfectionPakistan
-
Catalysis SLCompletedRespiratory Tract Infections | Covid19 | SARS-CoV2 Infection | COVID-19 Pneumonia | COVID-19 Respiratory Infection | Viral Infection | Infection, CoronavirusKazakhstan
-
KARE BiosciencesBiomedical Advanced Research and Development Authority; BioLink Life Sciences... and other collaboratorsRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory InfectionIndia
-
bioLytical LaboratoriesCompletedCOVID-19 | SARS-CoV-2 Infection | COVID-19 Pandemic | COVID-19 Virus Infection | Coronavirus Disease-19United States
-
AudibleHealth AI, Inc.Sunrise Research Institute; Analytical Solutions Group, Inc.; Kelley Medical... and other collaboratorsCompletedCoronavirus Disease 2019 | SARS-CoV-2 Infection | COVID-19 Pandemic | COVID-19 Virus Infection | Coronavirus Disease-19 | COVID-19 Virus Disease | 2019 Novel Coronavirus Disease | 2019 Novel Coronavirus Infection | 2019-nCoV DiseaseUnited States
-
Tiziana Life Sciences LTDWithdrawnCovid19 | COVID-19 Respiratory Infection | COVID-19 Lower Respiratory Infection
-
Mahidol UniversityClinixir Co., Ltd.; Program Management Unit-C (PMU-C), governed by Ministry...CompletedCOVID-19 Infection | COVID-19 VACCINEThailand
-
City of Hope Medical CenterNational Cancer Institute (NCI); California Institute for Regenerative Medicine...Active, not recruitingAsymptomatic COVID-19 Infection Laboratory-Confirmed | Symptomatic COVID-19 Infection Laboratory-ConfirmedUnited States
-
Patrick RobinsonRecruitingCovid19 | COVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Acute BronchitisUnited States
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
Clinical Trials on Questionnaire Administration
-
Fondazione Don Carlo Gnocchi OnlusUnknown
-
Centre Oscar LambretCentre Hospitalier Universitaire de BesanconTerminated
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)TerminatedHealth Status UnknownUnited States
-
Istanbul Aydın UniversityCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingBreast Carcinoma | Fallopian Tube Carcinoma | Endometrial Carcinoma | Ovarian Carcinoma | Primary Peritoneal Carcinoma | Deleterious CDH1 Gene Mutation | Deleterious DICER1 Gene Mutation | Deleterious SMARCA4 Gene Mutation | Deleterious STK11 Gene MutationUnited States
-
Hospital Clínico Universitario de ValladolidRed Centinela Sanitaria de Castilla y León (RCSCYL); Centro Nacional de Gripe... and other collaboratorsRecruitingMigraine | Headache Disorders | Viral Infection | Influenza -Like Illness | Head PainSpain
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingBreast Ductal Carcinoma In Situ | Invasive Breast Carcinoma | COVID-19 Infection | Hereditary Breast CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Recurrent Lymphoma | Recurrent Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Recurrent Plasma Cell Myeloma | Caregiver | Recurrent LeukemiaUnited States
-
I.M. Sechenov First Moscow State Medical UniversityAgency of Social Information St. PetersburgActive, not recruiting
-
I.M. Sechenov First Moscow State Medical UniversityActive, not recruitingShoulder ArthropathyRussian Federation