Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-27 @ 5:51 PM
Study NCT ID:
NCT06120335
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Scale for Cancer Patients' Willingness to Voluntarily Participate in Drug Clinical Trials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2023-11-02', 'studyFirstSubmitQcDate': '2023-11-06', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A semi-structured interview', 'timeFrame': '3 months', 'description': 'A semi-structured interview is conducted to investigate the willingness of cancer patients to participate in drug clinical trials and its influencing factors. The researcher will analyze the interview results and summarize several themes that reflect the willingness.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['drug clinical trials', 'cancer patients', 'willingness'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to develop a scale for cancer patients' willingness to voluntarily participate in drug clinical trials and evaluate its reliability and validity.", 'detailedDescription': 'Inclusion Criteria:\n\n1. Age 18-80 years old (including boundary values).\n2. Tumor patients with clear diagnosis.\n3. Whether they finally sign the informed consent form of one drug clinical trial or not, and whether they are finally enrolled in one drug clinical trial or not, patients who have undergone the informed consent process of drug clinical trials conducted by clinicians can be enrolled in this study.\n4. Volunteer to participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Patients with unclear consciousness.\n2. Patients who are unable to correctly understand and answer questions.\n3. Vulnerable subjects include: students and subordinates of researchers, military personnel, prisoners, patients with incurable diseases, patients in critical situations, those admitted to welfare institutions, homeless individuals, minors, and those who are unable to provide informed consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult tumor patients treated at Sun Yat sen Memorial Hospital at Sun Yat sen University', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-80 years old (including boundary values).\n2. Tumor patients with clear diagnosis.\n3. Whether they finally sign the informed consent form of one drug clinical trial or not, and whether they are finally enrolled in one drug clinical trial or not, patients who have undergone the informed consent process of drug clinical trials conducted by clinicians can be enrolled in this study.\n4. Volunteer to participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Patients with unclear consciousness.\n2. Patients who are unable to correctly understand and answer questions.\n3. Vulnerable subjects include: students and subordinates of researchers, military personnel, prisoners, patients with incurable diseases, patients in critical situations, those admitted to welfare institutions, homeless individuals, minors, and those who are unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT06120335', 'briefTitle': "Development of a Scale for Cancer Patients' Willingness to Voluntarily Participate in Drug Clinical Trials", 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': "Development and Reliability and Validity Evaluation of a Scale for Cancer Patients' Willingness to Voluntarily Participate in Drug Clinical Trials", 'orgStudyIdInfo': {'id': 'SYSKY-2023-1029-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Caie Chen', 'role': 'CONTACT', 'email': 'chence3@mail2.sysu.edu.cn', 'phone': '18707657343'}], 'facility': 'Sun Yat-sen Memorial Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Caie Chen', 'role': 'CONTACT', 'email': 'chence3@mail2.sysu.edu.cn', 'phone': '18707657343'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}