Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT07160933
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of a Psychosocial Intervention to Reduce Post Traumatic Stress in Young Adult Survivors of Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000083626', 'term': 'Psychosocial Intervention'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-30', 'studyFirstSubmitDate': '2025-08-29', 'studyFirstSubmitQcDate': '2025-08-29', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intervention Feasibility: Percent of Identified Prospective Participants Who Enroll', 'timeFrame': 'Post-treatment completion (enrollment to treatment completion is approximately 3 months)', 'description': 'Percent of eligible participants who were offered participation and who enroll in the study by completing consent and baseline assessment.'}, {'measure': 'Intervention Feasibility: Proportion of Participants Completing the Program', 'timeFrame': 'Post-treatment completion (enrollment to treatment completion is approximately 3 months)', 'description': 'Percent of enrolled participants who complete the program, defined as completing 6 out of 8 sessions.'}, {'measure': 'Intervention Acceptability', 'timeFrame': 'Post-treatment completion (enrollment to treatment completion is approximately 3 months)', 'description': 'Acceptability will be assessed by the Client Satisfaction Questionnaire (CSQ-8). The intervention study will be considered acceptable if ≥80% of participants rate it as acceptable (defined as a CSQ-8 score ≥20).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['young adult cancer survivors', 'cancer-related post-traumatic stress', 'post-traumatic stress'], 'conditions': ['Post-traumatic Stress Symptoms']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to develop a virtual group intervention to address post-traumatic stress related to cancer in young adult cancer survivors (YACs, aged 18-39). The study team will do this by integrating evidence-guided treatments and expert clinician feedback (N=10) on the content, delivery, and structure of the intervention. Next, the study team will refine this intervention through a pilot trial with a group of YACs (N=80).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: To be eligible for this study, participants will be:\n\n* Currently aged between 18 - 39;\n* Currently receiving or having completed treatment for cancer at the Mass General Cancer Institute within the past 5 years;\n* Reporting a score denoting at least mild symptoms of PTSD on the Post-traumatic Stress Checklist 5 (PCL-5);\n* English-speaking;\n* Have access to a device with audio/video capabilities to complete virtual intervention sessions.\n\nExclusion Criteria:\n\n* Unable to provide verbal consent\n* Reporting active symptoms of psychosis that preclude safe participation.'}, 'identificationModule': {'nctId': 'NCT07160933', 'briefTitle': 'Development of a Psychosocial Intervention to Reduce Post Traumatic Stress in Young Adult Survivors of Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Adaptation and Refinement of a Psychosocial Intervention to Reduce Post-Traumatic Stress in Young Adult Survivors of Cancer', 'orgStudyIdInfo': {'id': '25-306'}, 'secondaryIdInfos': [{'id': 'CSDG-24-1319592-01-CTPS', 'type': 'OTHER_GRANT', 'domain': 'American Cancer Society Clinician Scientist Development Grant (CSDG)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psychosocial Intervention for Cancer-Related Post-Traumatic Stress in Young Adults', 'description': 'The study team aims to evaluate the feasibility and acceptability of the adapted psychosocial intervention through a pilot trial with a group of 80 YACs, followed by mixed-methods data analysis of feasibility and acceptability outcomes.', 'interventionNames': ['Behavioral: Psychosocial Intervention for Cancer-Related Post-Traumatic Stress in Young Adults']}], 'interventions': [{'name': 'Psychosocial Intervention for Cancer-Related Post-Traumatic Stress in Young Adults', 'type': 'BEHAVIORAL', 'description': 'A new group-based virtual intervention to address post-traumatic stress related to cancer in YACs, integrating evidence-guided treatments from Cognitive Processing Therapy and Mind-Body Resiliency interventions.', 'armGroupLabels': ['Psychosocial Intervention for Cancer-Related Post-Traumatic Stress in Young Adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Blane Zhu, B.S.', 'role': 'CONTACT', 'email': 'xzhu@mgh.harvard.edu', 'phone': '(617) 726-5130'}, {'name': 'Zeba N Ahmad, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mass General Cancer Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Zeba N Ahmad, Ph.D.', 'role': 'CONTACT', 'email': 'zahmad2@mgh.harvard.edu', 'phone': '617-724-1586'}, {'name': 'Xinghan Zhu, B.S.', 'role': 'CONTACT', 'email': 'xzhu@mgh.harvard.edu', 'phone': '617-724-7593'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeba Ahmad, Ph.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Staff Psychologist', 'investigatorFullName': 'Zeba Ahmad, Ph.D.', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}