Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT04491292
Status:
RECRUITING
Last Update Posted:
2025-08-01
First Post:
2020-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Psychosocial Impact of the COVID-19 Pandemic on the MD Anderson Cancer Center Workforce
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2020-07-28', 'studyFirstSubmitQcDate': '2020-07-28', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in psychosocial outcomes', 'timeFrame': 'Baseline up to 3 months after the outbreak ends', 'description': '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.'}, {'measure': 'Change in stress-related outcomes', 'timeFrame': 'Baseline up to 3 months after the outbreak ends', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Demographic and occupational factors associated psychological and stress-related outcomes', 'timeFrame': 'Up to 3 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To assess psychosocial and stress-related outcomes in employees at MD Anderson Cancer Center during and post the COVID-19 pandemic.\n\nSECONDARY OBJECTIVE:\n\nI. To identify demographic and occupational factors associated with COVID-19 related psychosocial and stress outcomes.\n\nOUTLINE:\n\nParticipants complete 2 online questionnaires over 10 minutes each at baseline and at 3 months after the pandemic ends.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Employees at MD Anderson Cancer Center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MD Anderson employees'}, 'identificationModule': {'nctId': 'NCT04491292', 'briefTitle': 'Assessment of the Psychosocial Impact of the COVID-19 Pandemic on the MD Anderson Cancer Center Workforce', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Psychosocial Impact of COVID-19 Pandemic on MD Anderson Workforce', 'orgStudyIdInfo': {'id': '2020-0428'}, 'secondaryIdInfos': [{'id': 'NCI-2020-04259', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2020-0428', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (questionnaire)', 'description': 'Participants complete 2 online questionnaires over 10 minutes each at baseline and at 3 months after the pandemic ends.', 'interventionNames': ['Other: Questionnaire Administration']}], 'interventions': [{'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaires', 'armGroupLabels': ['Observational (questionnaire)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Priya R. Bhosale', 'role': 'CONTACT', 'email': 'priya.bhosale@mdanderson.org', 'phone': '713-792-0221'}, {'name': 'Priya R. Bhosale', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Priya R. Bhosale', 'role': 'CONTACT', 'email': 'priya.bhosale@mdanderson.org', 'phone': '713-792-0221'}], 'overallOfficials': [{'name': 'Priya R Bhosale', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}