Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2026-01-03 @ 7:26 PM
Study NCT ID:
NCT03885505
Status:
UNKNOWN
Last Update Posted:
2019-06-25
First Post:
2018-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Analysis of the Quality of Life and Sexual Quality of Life of Cervical Cancer Radiotherapy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'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': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-06-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-22', 'studyFirstSubmitDate': '2018-11-25', 'studyFirstSubmitQcDate': '2019-03-19', 'lastUpdatePostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'using fact-cx4.0 to evaluate the qol of cervical cancer patients undergoing radiotherapy', 'timeFrame': 'through study completion, an average of half a year', 'description': "Functional Assessment of Cancer Therapy-Cervix V4.0 (FACT-Cx V4.0) was used to evaluate patients'quality of life. The scale is composed of general cancer quality of life assessment scale (FACT-G) and cervical cancer specific module (CCS). It contains 5 dimensions and 42 subjects. The higher the score of positive questions, the better the quality of life. The higher the score of reverse questions, the worse the quality of life. If it is a reverse question, the original score of this question is subtracted by 4. The higher the total score, the better the quality of life. The study was conducted by face-to-face investigation of specialist nurses. All patients'investigation data were kept strictly confidential.\n\nAnd follow the principles of medical ethics.using spss to analysis the data."}], 'secondaryOutcomes': [{'measure': 'using fsfi to evaluate the qol of cervical cancer patients undergoing radiotherapy', 'timeFrame': 'through study completion, an average of half a year', 'description': "Female Sexual Function Index (FSFI) was used to measure the quality of sexual life. The higher the score of positive items, the worse the quality of sexual life. If the reverse items were negative, the original score of the item could be subtracted by 5. The higher the total score, the better the quality of sexual life. The study was conducted by face-to-face investigation by specialist nurses. All patients'investigation data were strictly confidential and followed the medical ethics principles.using spss to analysis the data."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer', 'Radiotherapy Side Effect', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'Cervical cancer radiotherapy patients have a decline in quality of life and sexual quality of life', 'detailedDescription': 'Objective: To investigate the quality of life and sexual quality of life and its influencing factors in cervical cancer undergoing radiotherapy patients.\n\nMethods:The cervical cancer cancer scale (FACT-Cx4.0) and the female sexual function index (FSFI) in the cancer treatment function evaluation system were used. The quality of life and sexual quality of life of cervical cancer patients undergoing radiotherapy in PUMC Hospital were analyzed and scored to analyze the effects of age, education level, clinical stage and treatment methods on the quality of life and sexual quality of life of cervical cancer radiotherapy patients'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cervical cancer patients treated by radiotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* adult female\n* diagnosed with cervical cancer' and acquire therapy as part of treatment\n* undertaken or have finished radiotherapy in Peking Union Medical College Hospital\n* agreed with informed consent\n\nExclusion Criteria:\n\n* with cognitive dysfunction or cannot fulfilled the questionaire\n* refuse or quit the research\n* submit questionnaire with missing information"}, 'identificationModule': {'nctId': 'NCT03885505', 'briefTitle': 'An Analysis of the Quality of Life and Sexual Quality of Life of Cervical Cancer Radiotherapy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'An Analysis of the Quality of Life and Sexual Quality of Life of Cervical Cancer Radiotherapy Patients', 'orgStudyIdInfo': {'id': 'ZHN 20181125'}}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'department of radiation oncology', 'investigatorFullName': 'HONGNAN ZHEN', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}