Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT07015593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-11
First Post:
2025-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient Journey in Advanced Gynecologic Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], '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': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 780}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment decision making', 'timeFrame': '1 day. At the time of the interview.', 'description': '1. Information seeking in treatment decision\n2. Treatment decision making factors\n3. Clinical trial awareness'}, {'measure': 'Initial treatment experiences', 'timeFrame': '1 day. At the time of the interview.', 'description': "1. Influence of treatment on daily life and work\n2. Information and education during treatment\n3. Coordination of care\n4. Overall impression on care received and doctor/nurses' availability"}, {'measure': 'Unmet needs and gaps from diagnosis to post-treatment surveillance', 'timeFrame': '1 day. At the time of the interview.', 'description': '1. Psychological and emotional needs\n2. Social support needs\n3. Healthcare needs\n4. Gaps during follow-up care'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Genital Neoplasms, Female', 'Uterine Cervical Neoplasms', 'Endometrial Carcinoma']}, 'descriptionModule': {'briefSummary': "This is a mixed-methods survey study including a 2-phased sequential-explanatory design. This study is to understand the patient journey in conventional therapy for newly diagnosed stage III or IV CC or EC in China, including ①patients' treatment decision making factors and treatment experiences and ② patients' unmet needs during post-treatment surveillance.", 'detailedDescription': 'This is a mixed-methods survey study including a 2-phased sequential-explanatory design: Phase 1, Qualitative interview will be done first to explore the treatment decision factors, treatment experiences and unmet needs during post treatment surveillance, to provide components and inform the quantitative data collection. Phase 2, quantitative survey to collect data on a larger scale and allow a statistical generation of the qualitative findings.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'It is estimated that \\~780 patients will be included in this study. For qualitative insights, previous studies have shown that a minimum of 12 respondents (Guest et al. 2006) is required to reach data saturation. A sample size of \\~30 will be sufficient to gather qualitative insights and attain saturation. For quantitative survey, considering most of the variables in quantitative survey are categorical variables, we tend to use 50% in the sample size formula since it will provide us with the maximum sample size required for any question, we calculated the sample size to be \\~750 with a confidence interval of 95% and margin of error 5%. The number of specific experts interviewed may be fine-tuned depending on actual implementation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Newly diagnosed stage III or IV CC or EC\n* Completed their initial conventional therapies which must include at least chemotherapy, radiotherapy or a combination between Dec. 2022 to Dec. 2024 and the therapies were within 6 months after diagnosis.\n* Told by their physician that their disease is stable.\n* Patients must have informed consent form (ICF) signed for the study.\n\nExclusion Criteria:\n\n* Previously treated with targeted biologic therapy anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.\n* Previously participated in or participating in a clinical trial.\n* Patients who received another line of therapy after initial therapy.\n* Unable or unwilling to provide informed consent.\n* Not fluent in local language.\n* Indicates or exhibits hearing difficulties, which would make a conversation challenging.'}, 'identificationModule': {'nctId': 'NCT07015593', 'briefTitle': 'Patient Journey in Advanced Gynecologic Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Patient Journey in Conventional Therapy for Primarily Treated Advanced Gynecologic Cancers in China', 'orgStudyIdInfo': {'id': 'NIS103233'}, 'secondaryIdInfos': [{'id': '[2024]S257', 'type': 'OTHER', 'domain': 'Medical Ethics Committee of Tongji Medical College, HUST'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'experimental group', 'description': '780 patients for interview', 'interventionNames': ['Other: interview']}], 'interventions': [{'name': 'interview', 'type': 'OTHER', 'description': '30 for Qualitative interview and 750 for quantitative survey', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'contacts': [{'name': 'Ying Zhou, PhD', 'role': 'CONTACT', 'email': 'caddie1234@gmail.com', 'phone': '13865901025'}], 'facility': 'Ying Zhou', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Shuzhong Yao, ph.D', 'role': 'CONTACT', 'email': 'yszlfy@163.com', 'phone': '086-020-87755766'}], 'facility': 'Shuzhong Yao', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'Gang Chen', 'role': 'CONTACT', 'email': 'tjchengang@hust.edu.cn', 'phone': '086-027-83662681'}, {'name': 'Yingjie Hu', 'role': 'CONTACT', 'email': 'huyj@hust.edu.cn', 'phone': '086-027-83662681'}, {'name': 'Gang Chen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gang Chen', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430030', 'city': 'Chongqing', 'country': 'China', 'contacts': [{'name': 'Dongling Zou, ph.D', 'role': 'CONTACT', 'email': 'cqzl_zdl@163.com', 'phone': '086-023-65301682'}], 'facility': 'Dongling Zou', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Gang Chen', 'role': 'CONTACT', 'email': 'tjchengang@hust.edu.cn', 'phone': '086-027-83662681'}], 'overallOfficials': [{'name': 'Gang Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Gang Chen (101199)', 'investigatorAffiliation': 'Tongji Hospital'}}}}