Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-30 @ 10:24 AM
Study NCT ID:
NCT07014293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 254}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2030-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2025-05-23', 'studyFirstSubmitQcDate': '2025-06-02', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Coping Scores on the Measure of Current Status Scale (MOCS-A)', 'timeFrame': 'Baseline to 3 month follow up', 'description': 'The Measure of Current Status Scale (MOCS-A) measures coping processes on 4 domains: ability to relax, recognize stress, elicit support, and restructure thoughts. It is a 13-item scale where each item is measured on a 0-4 scale.'}], 'secondaryOutcomes': [{'measure': 'Change in Emotional Distress (anxiety and depression) based on the PROMIS-Anxiety 8a and PROMIS-Depression 8a', 'timeFrame': 'Enrollment to 3 month follow up', 'description': 'The PROMIS-Anxiety 8a and PROMIS-Depression 8a measure anxiety symptoms and depression symptoms, respectively. The measures are 8 items, where each item is scored on a scale of 1 (Never) - 5 (Always).'}, {'measure': 'Change in Physical Health (PROMIS Physical Function-8b)', 'timeFrame': 'Enrollment to 3 month follow up', 'description': 'The PROMIS Physical Function-8b is an 8-item measure that assesses the ability to perform daily living activities. Each item is scored on a scale of 1 (Unable to do) to 5 (Without any difficulty).'}, {'measure': 'Change in Quality of Life scores (Functional Assessment of Cancer Therapy (FACT-G))', 'timeFrame': 'Enrollment to 3 month follow up', 'description': 'The FACT-G is a 27 item measure of quality of life on 4 domains: physical, functional, emotional, and social. Each item is measured on a 0 (not at all) to 4 (very much) scale.'}, {'measure': 'Change in Resilience scores (Current Experiences Scale (CES-23))', 'timeFrame': 'Enrollment to 3 month follow up', 'description': 'The CES-23 is a 23-item measure that assesses resilience on 6 dimensions: appreciation for life, adaptive perspectives, personal strength, spiritual connectedness, relating to others, and health behaviors. Each item is scored on a 0 (not at all) to 5 (to a very great degree) scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coping', 'psychosocial intervention', 'survivorship', 'resilience'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn if a mind body resilience group program can help increase lymphoma survivors' ability to cope with and manage the challenges that come with the transition into early post treatment survivorship.", 'detailedDescription': 'This is a randomized controlled trial assessing the effects of the Stress Management and Resiliency Training: Relaxation Response Resiliency-Lymphoma (SMART3RP-Lymphoma) compared to Enhanced Usual Care on 254 early post treatment lymphoma survivors. The SMART-3RP is a comprehensive, evidence-based mind body group program designed to help individuals adapt to chronic stress (i.e., increase their resilience). It understands the adjustment to chronic stress as a dynamic process, blending CBT, positive psychology and mind body tools to target key coping processes.\n\nThis trial seeks to answer the following questions:\n\n* Will survivors randomized to SMART3RP-Lymphoma demonstrate greater improvements in coping skills when compared to survivors randomized to enhanced usual care?\n* Do factors, such as age, sex, race/ethnicity, rural/urban living, socioeconomic status, impact how survivors respond to the treatment?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking adult (18 years or older at enrollment)\n* Within 5 years of completing active, curative treatment for lymphoma (includes surgery, chemo-/immuno-/radiation therapy, or other)\n\nExclusion Criteria:\n\n* Active Psychiatric or cognitive comorbidity as determined by site PI or treating clinician\n* Unwilling or unable to participate using telehealth platform'}, 'identificationModule': {'nctId': 'NCT07014293', 'briefTitle': 'Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors', 'orgStudyIdInfo': {'id': '25-161'}, 'secondaryIdInfos': [{'id': 'RSGHE-24-1325325-01-CTPS', 'type': 'OTHER_GRANT', 'domain': 'American Cancer Society'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Enhanced Usual Care', 'description': 'Participants randomized to EUC will be referred to their site social work team. This most closely resembles the real-world care available to survivors on an outpatient basis. It is an enhanced version of usual care because proactive identification and referral of posttreatment survivors is not routinely done.', 'interventionNames': ['Other: Enhanced Usual Care']}, {'type': 'EXPERIMENTAL', 'label': 'SMART3RP-Lymphoma', 'description': "Participants will participate in 8 weekly group sessions, delivered virtually. The intervention components include: 1. Eliciting the relaxation response (RR) involves sustained mental focus with an attitude of open receptive awareness. 2. CBT to improve stress management involves increasing awareness and identification of the components of one's stress response (negative thoughts, emotions, physical reactions, behaviors, and relational) and learning skills at each session to alter these components (e.g., cognitive restructuring). 3. Positive psychology strategies to achieve growth enhancement focus on utilizing techniques and skills to promote positive growth. Skills focus on increasing social support, positive affect, and compassion.", 'interventionNames': ['Other: SMART3RP-Lymphoma']}], 'interventions': [{'name': 'Enhanced Usual Care', 'type': 'OTHER', 'description': 'Participants will receive a singleevaluation with a site social worker along with a list of mental health, social or community resources . This most closely resembles the real-world care available to survivors on an outpatient basis, however, we call this enhanced usual care since proactive identification and referral of posttreatment survivors is not routinely done.', 'armGroupLabels': ['Enhanced Usual Care']}, {'name': 'SMART3RP-Lymphoma', 'type': 'OTHER', 'description': "The intervention components include: 1. Eliciting the relaxation response (RR) involves sustained mental focus with an attitude of open receptive awareness. 2. CBT to improve stress management involves increasing awareness and identification of the components of one's stress response (negative thoughts, emotions, physical reactions, behaviors, and relational) and learning skills at each session to alter these components (e.g., cognitive restructuring). 3. Positive psychology strategies to achieve growth enhancement focus on utilizing techniques and skills to promote positive growth. Skills focus on increasing social support, positive affect, and compassion.", 'armGroupLabels': ['SMART3RP-Lymphoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Giselle Perez, PhD', 'role': 'CONTACT', 'email': 'gperez@mgh.harvard.edu', 'phone': '617-724-0765'}, {'name': 'Giselle Perez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mass General Brigham', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Psychologist', 'investigatorFullName': 'Giselle K. Perez Lougee', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}