Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 1:14 AM
Study NCT ID:
NCT07483905
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest in Nighttime Day Hospital Chemotherapy Infusions Among Gynecologic Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057240', 'term': 'Patient Preference'}], 'ancestors': [{'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-12', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of patient interest in a nighttime Day Hospital service for long-duration chemotherapy infusions', 'timeFrame': 'Baseline', 'description': 'Assessment of the level of interest among patients with gynecologic cancers in receiving long-duration chemotherapy infusions during nighttime hours in a Day Hospital setting, as evaluated through responses to an anonymous online survey.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Long-duration Chemotherapy', 'Nighttime Day Hospital', 'Cancer Care Organization', 'Patient Preferences'], 'conditions': ['Gynecologic Cancers']}, 'descriptionModule': {'briefSummary': 'This observational study aims to assess the interest of patients with gynecologic cancers in a nighttime Day Hospital service for the administration of long-duration chemotherapy infusions. An anonymous online survey will be distributed to eligible patients to evaluate their preferences, perceived benefits, and potential barriers related to receiving chemotherapy during nighttime hours. The results of this study will help inform the feasibility and acceptability of implementing a nighttime Day Hospital service for prolonged chemotherapy infusions.', 'detailedDescription': "Long-duration chemotherapy infusions are increasingly used in the treatment of gynecologic cancers. These treatments often require prolonged administration times that may extend over several hours and may affect patients' daily activities and quality of life when delivered during standard daytime hospital schedules. The implementation of a nighttime Day Hospital service for the administration of long-duration chemotherapy infusions could represent an alternative organizational model aimed at improving patient convenience and optimizing hospital resource utilization. However, the acceptability of such a service from the patients' perspective has not been well explored.\n\nThis observational study will evaluate the interest and perceived acceptability of a nighttime Day Hospital service among patients with gynecologic cancers who may receive long-duration chemotherapy infusions. Data will be collected through an anonymous online survey administered to eligible patients. The questionnaire will explore patient preferences, potential advantages and disadvantages, logistical considerations, and willingness to receive chemotherapy during nighttime hours.\n\nThe results of this study may provide preliminary information on patient perspectives and help inform future organizational strategies for the delivery of prolonged chemotherapy infusions."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with gynecologic cancers receiving care at the participating institution who are invited to complete an anonymous online survey assessing their interest in a nighttime Day Hospital service for long-duration chemotherapy infusions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients\n* aged 18 years or older\n* Diagnosis of a gynecologic cancer\n* Receiving care at the participating institution\n* Ability to independently understand and complete complete the anonymous online survey\n\nExclusion Criteria:\n\n* Inability to access or complete the online questionnaire or difficulty with reading and writing\n* Cognitive impairment\n* Patients currently hospitalized or in emergency settings.'}, 'identificationModule': {'nctId': 'NCT07483905', 'acronym': 'CHeMoON', 'briefTitle': 'Interest in Nighttime Day Hospital Chemotherapy Infusions Among Gynecologic Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Assessment of Interest Among Patients With Gynecologic Cancers in a Nighttime Day Hospital (DH) Service for Long-duration Chemotherapy Infusions: an Observational Study Based on an Anonymous Online Survey.', 'orgStudyIdInfo': {'id': '26945'}, 'secondaryIdInfos': [{'id': 'Study ID 26945', 'type': 'OTHER', 'domain': 'CET Lazio Area 3'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with gynecologic cancers', 'description': 'Patients affected by gynecologic cancers receiving care at the participating institution who are invited to complete an anonymous online survey assessing their interest in a nighttime Day Hospital service for long-duration chemotherapy infusions.', 'interventionNames': ['Behavioral: online survey']}], 'interventions': [{'name': 'online survey', 'type': 'BEHAVIORAL', 'description': 'Participants will complete an anonymous online survey designed to assess their interest in a nighttime Day Hospital service for the administration of long-duration chemotherapy infusions.', 'armGroupLabels': ['Patients with gynecologic cancers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario A. Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Anna Fagotti', 'role': 'CONTACT', 'email': 'anna.fagotti@policlinicogemelli.it', 'phone': '+390630153502'}, {'name': 'Serena Maria Boccia', 'role': 'CONTACT', 'email': 'serenamaria.boccia@policlinicogemelli.it'}], 'overallOfficials': [{'name': 'Anna Fagotti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'FAGOTTI ANNA', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}