Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT04652505
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2020-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of the COVID-19 Public Health Crisis on the Mental Health and Physical Well-Being of Cancer Patients, the Coping With COVID Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], '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'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-13', 'studyFirstSubmitDate': '2020-09-11', 'studyFirstSubmitQcDate': '2020-12-02', 'lastUpdatePostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-reported severity of depression', 'timeFrame': 'Baseline', 'description': 'sum score on the Patient Health Questionnaire, a 9-item scale with a sumscore ranging between 0 and 27, with a higher score indicating more-severe depression.'}, {'measure': 'Patient-reported severity of anxiety', 'timeFrame': 'Baseline', 'description': 'sum score on the generalized anxiety disorder questionnaire, a 7-item scale with sumscore range between 0 and 21. A higher score indicates higher severity of anxiety.'}, {'measure': 'Patient-reported severity of distress', 'timeFrame': 'Baseline', 'description': 'score on the National Comprehensive Cancer Network Distress Thermometer, a one-item 0-10 scale. A higher score indicates higher distress.'}], 'secondaryOutcomes': [{'measure': 'Patient-reported physical symptoms', 'timeFrame': 'Baseline', 'description': 'Physical symptoms are assessed with individual-item response on the Edmonton Symptom Assessment Scale by the clinic. The ESAS includes 6 somatic symptom items, each of which is to be rated on a 0-10 scale, with higher scores indicating higher severity of the symptom.'}, {'measure': 'Substance use', 'timeFrame': 'Baseline', 'description': 'Substance use is documented by the treating physician and will be abstracted from clinic notes.'}, {'measure': 'Patient-reported coping strategy', 'timeFrame': 'Baseline', 'description': 'Assessed using the brief COPE questionnaire. Will examine active versus avoidant coping. Active coping, planning, positive reframing, acceptance, humor, religion, emotional support-seeking, and instrumental support-seeking will be considered active coping strategies. Self-distraction, denial, venting, substance use, behavioral disengagement, and self-blame will be considered maladaptive coping strategies.'}, {'measure': 'Patient-reported levels of apathy', 'timeFrame': 'Baseline', 'description': 'The Apathy evaluation Scale is an 18-item scale with a sum score ranging between 18 and 72. A higher scores indicates higher apathy..'}, {'measure': 'Patient-reported engagement in the 5 health behaviors endorsed by World Health Organization intended to curb the spread of the coronavirus', 'timeFrame': 'Baseline', 'description': 'Patients indicate how often during the pandemic they engaged in the following 5 behaviors endorsed by the World Health Organization to decrease the transmission of coronavirus disease 2019 (COVID-19): washing hands regularly for 20 seconds with soap and water or alcohol-based hand rub, covering nose and mouth with a disposable tissue or flexed elbow when you cough or sneeze, avoiding close contact with people who are unwell, staying home and self-isolating from others in the household when feeling unwell, avoiding touching eyes, nose, and mouth when hands are unclean. The behaviors will be assessed on a Likert scale of 1-5, with 1 being "never" and 5 being "always". A not available (N/A) option will be given for staying home and self-isolating from others when feeling unwell, since participants may not experience a period of feeling unwell.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Infection', 'Hematopoietic and Lymphoid Cell Neoplasm', 'Malignant Solid Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This study determines how the threat of the coronavirus has affected the mental health and physical well-being of cancer patients seen at the psychiatric oncology clinic, and how they have coped with any related stress. Questionnaires that assess coping strategies and behaviors for decreasing disease transmission may help researchers create recommendations for future public health crises and pandemics.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine how the coronavirus disease 2019 (COVID-19) public health crisis affected mental well-being in cancer patients seen at the psychiatric oncology clinic.\n\nSECONDARY OBJECTIVES:\n\nI. To determine how the COVID-19 public health crisis affected physical well-being and substance use in cancer patients seen at the psychiatric oncology clinic.\n\nII. To determine how patient coping strategies and levels of apathy affected mental and physical health symptoms and substance use during COVID-19 in patients seen at the psychiatric oncology clinic.\n\nIII. To determine the association of coping strategies and levels of apathy with proclivity to engage in health behaviors intended to decrease the transmission of the disease during the COVID-19 pandemic in patients seen at the psychiatric oncology clinic.\n\nOUTLINE:\n\nPatients complete 3 questionnaires online over 15 minutes regarding coping strategies that may have been used, mental health and physical well-being in the past month, and if they have been following certain behaviors which the World Health Organization (WHO) has recommended during the coronavirus pandemic, such as regular hand washing and social distancing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer patients who received care at the psychiatric oncology clinic during the COVID-19 pandemic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients seen by providers of the psychiatric oncology clinic at least once between November 1, 2019 and February 29, 2020 and at least once between April 10, 2020 and June 10, 2020\n* Speaking English as indicated in their medical chart\n\nExclusion Criteria:\n\n* Patients who are pregnant as recorded in their medical chart\n* Incarcerated\n* With a recorded diagnosis of a formal thought disorder\n* Unable to consent'}, 'identificationModule': {'nctId': 'NCT04652505', 'briefTitle': 'Effect of the COVID-19 Public Health Crisis on the Mental Health and Physical Well-Being of Cancer Patients, the Coping With COVID Study', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Coping With COVID: The Effect of the COVID-19 Public Health Crisis on Mental Well-Being in Cancer Patients Seen at the Psychiatric Oncology Clinic', 'orgStudyIdInfo': {'id': '2020-0451'}, 'secondaryIdInfos': [{'id': 'NCI-2020-06556', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2020-0451', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (questionnaires)', 'description': 'Patients complete 3 questionnaires online over 15 minutes regarding coping strategies that may have been used, mental health and physical well-being in the past month, and if they have been following certain behaviors which the WHO has recommended during the coronavirus pandemic, such as regular hand washing and social distancing.', 'interventionNames': ['Other: Questionnaire Administration']}], 'interventions': [{'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaires', 'armGroupLabels': ['Observational (questionnaires)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Tamara E Lacourt', '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'}}}}