Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-29 @ 5:46 PM
Study NCT ID:
NCT04888195
Status:
UNKNOWN
Last Update Posted:
2022-04-19
First Post:
2021-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symptom Clusters in Hong Kong Chinese Children With Blood Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, '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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-12', 'studyFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2021-05-11', 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The therapy-related symptom checklist for children (TRSC-C)', 'timeFrame': 'Before chemotherapy', 'description': 'For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.'}, {'measure': 'The therapy-related symptom checklist for children (TRSC-C) at 1-week', 'timeFrame': 'At 1-week follow-up', 'description': 'For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.'}, {'measure': 'The therapy-related symptom checklist for children (TRSC-C) at 1-month', 'timeFrame': 'At 1-month follow-up', 'description': 'For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.'}, {'measure': 'The therapy-related symptom checklist for children (TRSC-C) at 3-month', 'timeFrame': 'At 3-month follow-up', 'description': 'For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.'}, {'measure': 'The therapy-related symptom checklist for children (TRSC-C) at 6-month', 'timeFrame': 'At 6-month follow-up', 'description': 'For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.'}, {'measure': 'Demographic sheet', 'timeFrame': 'At baseline', 'description': "collect the background information of our subjects, including their age, gender, educational attainment, parents' marital status and religious belief"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood cancer', 'chemotherapy'], 'conditions': ['Child']}, 'descriptionModule': {'briefSummary': "Pediatric blood cancer is the most common childhood malignancy. Despite its survival has been substantially improved, children still have to pay a high price for numerous distressing symptoms resulted from chemotherapy. Previous studies related to symptom experiences mainly focus on individual symptoms, rather than on multiple symptoms. Understanding these distressing symptoms may help healthcare professionals to develop appropriate and effective interventions with the aims of alleviating symptom severity and thus promoting the child's psychosocial well-being and quality of life.", 'detailedDescription': "A longitudinal study design will be conducted. A sample of 120 patients age 5-17years, diagnosed with blood cancer but not yet receive any chemotherapy and able to communicate with Cantonese and read Chinese will be recruited in the pediatric oncology ward of Hong Kong Children's Hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "We will recruit pediatric patients with blood cancer in the Hong Kong Children's Hospital", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 5 - 17 years old\n* diagnosed with blood cancer but not yet receive any chemotherapy\n* able to communicate with Cantonese and read Chinese\n\nExclusion Criteria:\n\n* who are scheduled to have concurrent cancer treatment\n* with recurrent malignancy\n* medical condition, or cognitive and learning problems in their medical records'}, 'identificationModule': {'nctId': 'NCT04888195', 'briefTitle': 'Symptom Clusters in Hong Kong Chinese Children With Blood Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Symptom Clusters in Hong Kong Chinese Children With Blood Cancer:: A Longitudinal Study', 'orgStudyIdInfo': {'id': 'SC_Blood_cancer'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Questionnaire', 'description': "This study aims to examine the cancer patient's symptom clusters and their changes over chemotherapy among pediatric patients with blood cancer in Hong Kong", 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Participants will complete a set of validated questionnaires (TRSC-C and demographic sheet) before chemotherapy. They also have to complete the same questionnaires (TRSC-C) again within 1 week after the 1st, 2nd, 3rd, 4th , 5th and 6th courses of chemotherapy via telephone interview by our research assistants.', 'armGroupLabels': ['Questionnaire']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Hong Kong', 'state': 'Hong Kong,China', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Ka Yan Ho, Phd', 'role': 'CONTACT', 'email': 'kyeva.ho@polyu.edu.hk', 'phone': '27666417'}], 'facility': 'Ka Yan Ho', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Ka Yan Ho, PhD', 'role': 'CONTACT', 'email': 'kyeva.ho@polyu.edu.hk', 'phone': '27666417'}, {'name': 'Ka Wai Lam, PhD', 'role': 'CONTACT', 'email': 'kwkatlam@polyu.edu.hk', 'phone': '27666420'}], 'overallOfficials': [{'name': 'Ka Yan Ho, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr Eva Ho', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}