Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-01 @ 12:35 AM
Study NCT ID:
NCT06145295
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2023-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of an Online Support Group in Enhancing Recovery Identity and Health-Related Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-16', 'size': 103919, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-15T01:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2023-11-15', 'studyFirstSubmitQcDate': '2023-11-21', 'lastUpdatePostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Illness identity', 'timeFrame': 'Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up', 'description': "The acceptance of illness identity was measured using the Illness Identity Questionnaire's acceptance sub-scale, consisting of 6 items (Oris et al., 2016)."}, {'measure': 'Maintenance of identity', 'timeFrame': 'Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up', 'description': 'The maintenance of former social identities was measured using the Maintenance of Group Memberships sub-scale of Exeter Identity Transition Scales (Haslam et al., 2008), encompassing 4 items.'}, {'measure': 'New identity', 'timeFrame': 'Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up', 'description': 'The new meaningful social identity was measured using the New Group Memberships sub-scale of the Exeter Identity Transition Scales, which includes 4 questions. Responses were rated on a scale from 1 to 5, with higher scores indicating a higher level of acceptance of the identity.'}], 'secondaryOutcomes': [{'measure': 'Health related quality of life', 'timeFrame': 'Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up', 'description': "Health related quality of life was measured using the Short Form Health Survey 12 (SF-12) (Jakobusson, 2007), which includes twelve questions. Each item is transformed into a scale ranging from 0 to 100 according to a specific scoring algorithm. These scores are then aggregated to generate two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The resulting scores are norm-based, comparing an individual's health status to population norms. Health related quality of life is calculate as the summary of PCS and MCS. Higher scores indicate better health related quality of life, with scores around 50 representing the average."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '40569778', 'type': 'DERIVED', 'citation': 'Zhao J, Zhu D, Yang Y, Tian C, Liu C, Chang F, Han T. Understanding the effectiveness of an online support group in enhancing recovery identity and health-related quality of life of middle-aged and older ovarian cancer patients: A randomized controlled trial. Psychol Trauma. 2025 Jun;17(Suppl 1):S196-S205. doi: 10.1037/tra0001929.'}]}, 'descriptionModule': {'briefSummary': 'Background Ovarian cancer poses challenges for middle-aged and older patients, impacting physical and self-conceptual aspects. A research gap exists on the impact of online support groups (SPs) on identity synthesis and Health-Related Quality of Life (HRQOL) for these patients.\n\nObjective To assess the feasibility and efficacy of an online SG in influencing recovery identity and HRQOL in middle-aged and older ovarian cancer patients (MDOCP).\n\nMethod A four-week randomized controlled trial, followed by a three-month evaluation, was conducted, employing a mobile online SG and an offline SG both grounded in The Social Identity Model of Identity Change. Recovery identity, HRQOL, and participant engagement were utilized to evaluate the feasibility and efficacy of interventions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 44 years old\n* diagnosis of ovarian cancer\n* expected survival time of greater than four months\n* fluent in using smartphones and the WeChat mini program\n* normal cognitive function\n* capability to participate in follow-up surveys.\n\nExclusion Criteria:\n\n* were currently participating in or had previously participated in other mental treatment groups\n* had been diagnosed with any other type of cancer.'}, 'identificationModule': {'nctId': 'NCT06145295', 'briefTitle': 'The Effectiveness of an Online Support Group in Enhancing Recovery Identity and Health-Related Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Understanding the Effectiveness of an Online Support Group in Enhancing Recovery Identity and Health-Related Quality of Life of Middle-aged and Older Ovarian Cancer Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '507079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experiment group (online support group)', 'description': 'The experimental group engaged with the mobile application use for four weeks, with specific tasks including completing the four mandatory courses within one month and submitting at least two health records and online posts every week.', 'interventionNames': ['Behavioral: mobile online support group (experiment group)']}, {'type': 'OTHER', 'label': 'control group', 'description': 'The control group participates in the offline group intervention that last for four weeks. Participants in the control group will participant in four weekly workshop that last between 1 hour to 1.5 hours.', 'interventionNames': ['Behavioral: offline support group (control group)']}], 'interventions': [{'name': 'mobile online support group (experiment group)', 'type': 'BEHAVIORAL', 'description': 'The experimental group engaged with the mobile application use for four weeks, with specific tasks including completing the four mandatory courses within one month and submitting at least two health records and online posts every week.', 'armGroupLabels': ['experiment group (online support group)']}, {'name': 'offline support group (control group)', 'type': 'BEHAVIORAL', 'description': 'The control group participates in the offline group intervention that last for four weeks. Participants in the control group will participant in four weekly workshop that last between 1 hour to 1.5 hours.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200021', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Jiao Tong Universiy', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Ting Han, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After the article is accepted', 'ipdSharing': 'YES', 'description': 'The data will be available upon reasonable request to the researcher (the private information of the participant will be removed).', 'accessCriteria': 'The data will be available upon reasonable request to the researcher (the private information of the participant will be removed).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jianan Zhao', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}