Ignite Creation Date:
2025-12-24 @ 4:00 PM
Ignite Modification Date:
2026-06-10 @ 12:16 AM
Study NCT ID:
NCT04270266
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2019-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2019-09-12', 'studyFirstSubmitQcDate': '2020-02-12', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mind-body intervention in (AYAs) Adolescents and Young Adults with Lymphoma Questionnaire', 'timeFrame': 'Up to 12 weeks', 'description': 'We will examine preliminary evidence of intervention efficacy. Meaning and Purpose (1-5) Strongly Disagree 1- Disagree 2, Neither agree or disagree 3, Agree 4, Strongly agree 5.\n\nDay-to-Day Experiences (1-6) Almost Always-1, Very frequently-2, Somewhat Frequently -3, Somewhat Infrequently-4, Very Infrequently-5, Almost Never 6'}], 'secondaryOutcomes': [{'measure': 'Psychological distress and cancer symptoms (tertiary objective) relative to an attention control (AC) group Questionnaire', 'timeFrame': 'Up to 12 weeks', 'description': 'We will examine preliminary evidence of intervention efficacy. Meaning and Purpose (1-5) Strongly Disagree 1- Disagree 2, Neither agree or disagree 3, Agree 4, Strongly agree 5.\n\nDay-to-Day Experiences (1-6) Almost Always-1, Very frequently-2, Somewhat Frequently -3, Somewhat Infrequently-4, Very Infrequently-5, Almost Never 6'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['All types of lymphoma'], 'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'pmid': '41298073', 'type': 'DERIVED', 'citation': 'Cho D, Ahmed S, Snyder S, Kroll J, Chen M, Roth M, Milbury K. Group-Based Support Interventions for Adolescents and Young Adults With Lymphoma: A Pilot Randomized Controlled Trial. Psychooncology. 2025 Dec;34(12):e70343. doi: 10.1002/pon.70343.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This trial studies how well a mind-body intervention works in improving overall quality of life in adolescents and young adults with lymphoma. A meditation based mind-body intervention may help lower distress, depressive symptoms, and anxiety in adolescents and young adults coping with lymphoma.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Examine the feasibility of the mind-body intervention in adolescents and young adults (AYAs) with lymphoma.\n\nSECONDARY OBJECTIVE:\n\nI. Establish the initial intervention efficacy regarding psychological distress and cancer symptoms (tertiary objective) relative to an attention control (AC) group.\n\nEXPLORATORY OBJECTIVE:\n\nI. Explore mediation (e.g., mindfulness, compassion, social connection, inflammatory processes) and moderation (e.g., demographic and medical factors) of the intervention effects.\n\nOUTLINE: Patients are randomized to 1 of 2 groups.\n\nGROUP I: Patients attend meditation group sessions over 75 minutes once weekly for up to 5 weeks.\n\nGROUP II: Patients attend educational group sessions over 75 minutes once weekly for up to 5 weeks.\n\nAfter completion of study intervention, patients are followed at 6 and 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants between the ages of 18-39 diagnosed within 6 months with stage I-IV Lymphoma (all types)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or below\n* Having access to the internet\n* Able to read, write and speak English\n\nExclusion Criteria:\n\n* Major psychiatric or cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team\n* Regular (self-defined) participation in psychotherapy or a formal cancer support group'}, 'identificationModule': {'nctId': 'NCT04270266', 'briefTitle': 'Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Mind-Body Medicine for Adolescents and Young Adults (AYA) Coping With Lymphoma', 'orgStudyIdInfo': {'id': '2019-0282'}, 'secondaryIdInfos': [{'id': 'NCI-2019-05846', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2019-0282', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (meditation)', 'description': 'Patients attend meditation group sessions over 75 minutes once weekly for up to 5 weeks.', 'interventionNames': ['Other: Meditation Therapy', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (educational)', 'description': 'Patients attend educational group sessions over 75 minutes once weekly for up to 5 weeks.', 'interventionNames': ['Other: Educational Intervention', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Educational Intervention', 'type': 'OTHER', 'otherNames': ['Education for Intervention', 'Intervention by Education', 'Intervention through Education', 'Intervention, Educational'], 'description': 'Attend educational sessions', 'armGroupLabels': ['Group II (educational)']}, {'name': 'Meditation Therapy', 'type': 'OTHER', 'otherNames': ['Meditation'], 'description': 'Attend meditation sessions', 'armGroupLabels': ['Group I (meditation)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (meditation)', 'Group II (educational)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Kathrin Milbury', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}