Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-30 @ 8:49 PM
Study NCT ID:
NCT05359718
Status:
COMPLETED
Last Update Posted:
2024-11-14
First Post:
2021-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Psychological Impact of COVID-19 on Patients with Solid Malignancies: a Single-Institution Survey Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2021-03-08', 'studyFirstSubmitQcDate': '2022-05-03', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the levels of anxiety, depression, post-traumatic stress and well-being amongst patients with cancer during the COVID-19 pandemic using Generalised Anxiety Disorder Assessment (GAD-7)', 'timeFrame': '12 months', 'description': 'Psychometric Measure - higher scores indicates greater anxiety'}, {'measure': 'To evaluate the levels of anxiety, depression, post-traumatic stress and well-being amongst patients with cancer during the COVID-19 pandemic using PHQ-9 (Patient Health Questionnaire-9)', 'timeFrame': '12 months', 'description': 'Psychometric Measure, higher score indicates greater depression'}, {'measure': 'To evaluate the levels of anxiety, depression, post-traumatic stress and well-being amongst patients with cancer during the COVID-19 pandemic using The Primary Care Post-Traumatic Stress Disorder (PC-PTSD-5)', 'timeFrame': '12 months', 'description': 'Psychometric Measure, higher scores indicates greater risk of Post-Traumatic Stress Disorder'}, {'measure': 'To evaluate the levels of anxiety, depression, post-traumatic stress and well-being amongst patients with cancer during the COVID-19 pandemic using World Health Organisation Five-Wellbeing Index', 'timeFrame': '12 months', 'description': 'Psychometric Measure, assesses general psychological wellbeing'}, {'measure': 'To evaluate the levels of anxiety, depression, post-traumatic stress and well-being amongst patients with cancer during the COVID-19 pandemic using Well-being thermometer', 'timeFrame': '12 months', 'description': 'Psychometric Measure'}], 'secondaryOutcomes': [{'measure': 'To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires', 'timeFrame': '12 months', 'description': 'GAD-7'}, {'measure': 'To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires', 'timeFrame': '12 months', 'description': 'PHQ-9'}, {'measure': 'To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires', 'timeFrame': '12 months', 'description': 'PC-PTSD-5'}, {'measure': 'To understand the needs of cancer patients during the period of a pandemic in order to help further develop immediate and longer term support measures', 'timeFrame': '12 months', 'description': 'By assessing WHO-5'}, {'measure': 'To understand the needs of cancer patients during the period of a pandemic in order to help further develop immediate and longer term support measures', 'timeFrame': '12 months', 'description': 'By assessing thermometer questionnaires.'}, {'measure': 'To correlate the novel well-being thermometer with existing psychometric scales as a screening tool for future patient assessment.', 'timeFrame': '12 months', 'description': 'Correlating the Well-being thermometer with the above psychometric measures.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'The COVID-19 pandemic and the subsequent government-imposed restrictions have undeniably resulted in unprecedented changes to the life of patients with cancer. It has become more evident that patients with cancer may be at significant risk of higher morbidity and mortality when infected with SARS-CoV-2, which is understandably causing anxiety amongst both patients and their oncology team.\n\nThis project is a single centre, non-interventional observational prospective cohort study; which aims to evaluate the impact of COVID-19 on the mental health and general wellbeing of patients diagnosed with solid malignancies by utilising a range of non-invasive questionnaires (GAD-7, PHQ-9, PC-PTSD-5, WHO-5 and Wellbeing thermometer). Data on patient demographics, treatment and medical history, and medical resource utilization will be obtained through a medical chart review at enrolment for up to 4 months. Participants will be asked to complete five questionnaires regarding their mental health and wellbeing status during their routine clinic visits, but no other additional tests or procedures will be undertaken for the study outside of their routine care.\n\nIt is essential to understand both the short and long term psychological consequences of COVID-19 on cancer patients to better inform the institute and other regional and national stakeholders of the scale of the issue, in order to recommend necessary measures and resources required to address this important issue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Secondary care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 or over.\n2. Cancer diagnosis\n3. Able to fully comprehend the Patient Information Sheet\n\nExclusion Criteria:\n\n1\\. Patients who lack capacity to participate.'}, 'identificationModule': {'nctId': 'NCT05359718', 'acronym': 'PICO SM', 'briefTitle': 'The Psychological Impact of COVID-19 on Patients with Solid Malignancies: a Single-Institution Survey Study', 'organization': {'class': 'OTHER', 'fullName': 'The Christie NHS Foundation Trust'}, 'officialTitle': 'The Psychological Impact of COVID-19 on Patients with Solid Malignancies: a Single-Institution Survey Study', 'orgStudyIdInfo': {'id': 'CFTSp196'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Questionnaire'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Christie NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}