Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-31 @ 6:36 PM
Study NCT ID:
NCT06531135
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-31
First Post:
2024-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A RCT of Psychosocial Interventions Facilitating Positive Psychological Adaptation in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012657', 'term': 'Self-Help Groups'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-28', 'studyFirstSubmitDate': '2024-07-28', 'studyFirstSubmitQcDate': '2024-07-28', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'posttraumatic growth by the PTGI', 'timeFrame': 'Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)', 'description': 'the PTGI a 21-item questionnaire each scored on a range of 0-5.'}, {'measure': 'Distress by the HADS', 'timeFrame': 'Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)', 'description': 'The HADS is a 14-item scale, with seven items relating to anxiety and seven relating to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.'}], 'secondaryOutcomes': [{'measure': 'Positive and Negative affect', 'timeFrame': 'Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)', 'description': 'The Affect Balance Scale includes 20 adjectives assessing negative and positive mood. Possible scores range from 1-5.'}, {'measure': 'Perceived Stress Management Abilities', 'timeFrame': 'Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)', 'description': 'The Measure of Current Status questionnaire and self-designed items were used to measure abilities learned from the group interventions.'}, {'measure': 'Quality of Life by the SF-36', 'timeFrame': 'Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)', 'description': 'SF-36'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Female']}, 'descriptionModule': {'briefSummary': 'To test the effects of a 10-wk stress management interventions vs. a 5-wk control condition on positive psychosocial adaptation in women being treated for breast cancer. Participants assigned to either of the stress management groups will show better positive psychosocial adaptation compared to those in the control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 20 and 70 years\n* Newly diagnosed breast cancer patients in stages I, II, or III (with no prior history of cancer)\n* Literate, without significant cognitive impairments\n* Capable of writing and expressing themselves in Chinese\n\nExclusion Criteria:\n\n* Major psychiatric disorders (such as schizophrenia), personality disorders, and substance addiction (excluding smoking)\n* Currently participating in other breast cancer-related psychotherapy studies'}, 'identificationModule': {'nctId': 'NCT06531135', 'briefTitle': 'A RCT of Psychosocial Interventions Facilitating Positive Psychological Adaptation in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Koo Foundation Sun Yat-Sen Cancer Center'}, 'officialTitle': 'A Randomized Controlled Trial of Psychosocial Interventions Facilitating Positive Psychological Adaptation in Patients With Breast Cancer', 'orgStudyIdInfo': {'id': '20210628A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stress management', 'description': '10 weeks of group intervention of Taiwanese version stress management intervention.', 'interventionNames': ['Behavioral: T-CBSM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Support group', 'description': '5 weeks of supportive group intervention.', 'interventionNames': ['Behavioral: Support group']}], 'interventions': [{'name': 'T-CBSM', 'type': 'BEHAVIORAL', 'otherNames': ['stress management'], 'description': 'A 10-week remotely-delivered group, lasting about 120 minutes each session.', 'armGroupLabels': ['stress management']}, {'name': 'Support group', 'type': 'BEHAVIORAL', 'otherNames': ['Supportive-Expressive Group'], 'description': 'Participants will receive weekly supportive-expressive group intervention for two hours per week for five weeks total.', 'armGroupLabels': ['Support group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11259', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Koo Foundation Sun Yat-Sen Cancer Center', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ashley Wei TIng Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soochow University ITaipei)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Koo Foundation Sun Yat-Sen Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Soochow university taipei', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Psychiatric department, KFSYSCC, Taiwan', 'investigatorFullName': 'Chihtao Cheng', 'investigatorAffiliation': 'Koo Foundation Sun Yat-Sen Cancer Center'}}}}