Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-31 @ 12:14 PM
Study NCT ID:
NCT07013435
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:
A Resilience-Based Approach to Improve Long-term Quality of Life in Post-treatment Lymphoma Survivorship
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', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2030-01', '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': '2029-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation between scores on measures of Resilience (CES) and Quality of Life (PROMIS-29)', 'timeFrame': '3, 6 and 12 months', 'description': 'We will determine how resilience at 3 months correlates to quality-of-life improvements at 6 and 12 months. Resilience will be measured by the Current Experiences Scale (CES), which is a 23-item measure. The CES assesses 6 domains of resilience including appreciation for life, adaptive perspectives, personal strength, spiritual connectedness, relating to others, and health behaviors). Quality of life will be measured by the PROMIS-29 which is a 29-item measure. It assesses physical, functional, emotional, and social quality of life domains. The unit of measurement for both assessments are scores on a scale.'}], 'primaryOutcomes': [{'measure': 'Quality of Life (QoL): Change in PROMIS-29', 'timeFrame': 'From enrollment to 6 month follow up', 'description': 'To examine the effects of the SMART3RP-Lymphoma vs. a Health Education Program (HEP) in improving quality of life in early posttreatment lymphoma survivors. Quality of life will be measured using the PROMIS-29 which assesses physical, functional, emotional, and social quality of life. Each survey item is measured on a 1-5 scale. The unit of measurement is a score on a scale.'}], 'secondaryOutcomes': [{'measure': 'Resilience: Change in Scores on the Current Experiences Scale (CES)', 'timeFrame': 'Enrollment to 3 month follow up', 'description': 'To compare the effects of the SMART3RP-Lymphoma vs. a Health Education Program (HEP) on resilience in posttreatment lymphoma survivors. Resilience will be measured by the Current Experiences Scale (CES). The CES is a 23-item measure that assesses the following domains of resilience on 0-5 scale: appreciation for life, adaptive perspectives, personal strength, spiritual connectedness, relating to others, and health behaviors. The unit of measurement is a score on a scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quality of life', 'psychosocial intervention', 'supportive care', 'cancer survivorship', 'resilience'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "The goal of this trial is to learn if a resilience intervention can lead to improvements in lymphoma survivors' quality of life.", 'detailedDescription': 'The Stress Management and Relaxation Response Resiliency Program for lymphoma survivors (SMART3RP-Lymphoma) was adapted by researchers at the MGH. This group program seeks to buffer stress and promote psychological resiliency and physical well-being through a variety of mind-body approaches, such as imagery, relaxation, and yoga, cognitive behavioral strategies, and positive psychology tools.\n\nThe main questions it aims to answer are:\n\n* Will survivors randomized to SMART3RP-Lymphoma demonstrate greater improvements in quality of life when compared to survivors randomized to a Health Education Program?\n* Will improvements in resiliency lead to improvements in quality of life?\n\nTo answer these questions, researchers will compare a resilience intervention tailored to the needs of lymphoma survivors (SMART3RP-Lymphoma) to a Health Education Program to see how they affect quality of life of lymphoma survivors.\n\nParticipants will:\n\n* Fill out 4 surveys across 12 months\n* Participate in 8 weekly, virtual group sessions\n* Submit hair cortisol samples'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English or Spanish speaking adults (18+ at time of enrollment)\n* Within 2 years of completing active, curative treatment for lymphoma (includes surgery, chemotherapy, immunotherapy, radiation therapy, or other)\n\nExclusion Criteria:\n\n* Active psychiatric or cognitive comorbidity as determined by the site PI or treating clinician'}, 'identificationModule': {'nctId': 'NCT07013435', 'briefTitle': 'A Resilience-Based Approach to Improve Long-term Quality of Life in Post-treatment Lymphoma Survivorship', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Thriving Beyond Treatment: A Resilience-Based Approach to Improve Long-term Quality of Life in Post-treatment Lymphoma Survivorship.', 'orgStudyIdInfo': {'id': '25-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Health Education Program', 'description': 'Participants will participate in 8 weekly sessions.\n\nComponents include:\n\n* education on the co-occurrence of mental and physical problems\n* goal setting for health behavior change\n* self-monitoring\n\nHEP is an active control condition for mind body programs and is structurally equivalent to SMART3RP', 'interventionNames': ['Other: Health Education Program']}, {'type': 'EXPERIMENTAL', 'label': 'SMART3RP-Lymphoma', 'description': 'Participants will participate in 8 weekly sessions.\n\nThe intervention components include:\n\n* Eliciting the relaxation response (RR),\n* CBT strategies to improve stress management\n* Positive psychology strategies to achieve growth enhancement', 'interventionNames': ['Other: SMART3RP-Lymphoma']}], 'interventions': [{'name': 'Health Education Program', 'type': 'OTHER', 'description': '8 weekly sessions that include education on the co-occurrence of mental and physical problems, goal setting for health behavior change, and self-monitoring. Each session includes basic didactic information, interactive application of the information, and open discussion of didactic material.', 'armGroupLabels': ['Health Education Program']}, {'name': 'SMART3RP-Lymphoma', 'type': 'OTHER', 'description': 'The SMART3RP-lymphoma is a group program that, through a variety of mind-body approaches, such as imagery, relaxation, and yoga, seeks to buffer stress and promote psychological resiliency and physical well-being.', 'armGroupLabels': ['SMART3RP-Lymphoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Giselle K Perez, PhD', 'role': 'CONTACT', 'email': 'gperez@mgh.harvard.edu'}, {'name': 'Giselle K Perez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mass General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Information will be made available as required by the NIH in public repository and via clinicaltrials.gov', 'ipdSharing': 'YES', 'description': 'de-identified information as required by the NIH', 'accessCriteria': 'Researchers submitting formal requests as required and allowable by the NIH will be able to access supporting information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Psychologist', 'investigatorFullName': 'Giselle K. Perez Lougee', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}