Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 11:05 PM
Study NCT ID:
NCT06030427
Status:
COMPLETED
Last Update Posted:
2025-10-24
First Post:
2023-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D006293', 'term': 'Health Promotion'}, {'id': 'D007407', 'term': 'Interviews as Topic'}, {'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D000099024', 'term': 'Mindfulness-Based Stress Reduction'}, {'id': 'D005080', 'term': 'Exercise Test'}], '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': 'D006266', 'term': 'Health Education'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2023-08-28', 'studyFirstSubmitQcDate': '2023-09-01', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'General anxiety disorder-7 (GAD-7)', 'timeFrame': 'Baseline; 12 weeks', 'description': 'Assessed by change in GAD-7 scores from a total score for seven items ranges from 0 to 21: 0-4 (minimal anxiety); 5-9 (mild anxiety); 10-14 (moderate anxiety); 15-21 (severe anxiety).'}, {'measure': 'Patient Health Questionnaire (PHQ)-8', 'timeFrame': 'Baseline; 12 weeks', 'description': 'Assessed by change in PHQ-8 scores, as measured by a total score of 4 items from 0-12: 0-2 (normal); 3-5 (mild depression); 6-8 (moderate depression); 9-12 (severe depression).'}, {'measure': 'Feasibility of virtual mindfulness and weight management program', 'timeFrame': '12 weeks', 'description': 'Assessed by the extent to which participants adhere to the intervention. Will be quantified based on number of sessions attended out of a possible 12.'}], 'secondaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'Baseline; 12 weeks', 'description': 'Assessed by change in body weight'}, {'measure': 'Body composition parameter', 'timeFrame': 'Baseline; 12 weeks', 'description': 'Will be assessed in a fasted state or 3 hour post meal by subjects standing on a scale without socks or shoes.'}, {'measure': 'Daily activity levels - heart rate', 'timeFrame': 'Baseline; 12 weeks', 'description': 'Will be assessed by heart rate monitoring as recorded by a wrist-worn accelerometer (Fitbit Inspire)'}, {'measure': 'Daily activity levels - activity', 'timeFrame': 'Baseline; 12 weeks', 'description': 'Will be assessed from data recorded by a wrist-worn accelerometer monitoring fitness activity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphoid System Neoplasm', 'Malignant Solid Neoplasm', 'Obesity-Related Malignant Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial tests how well a virtual mindfulness and weight management program to mitigate risk of relapse and improve well being for obese cancer survivors in community practice and rural areas. Obesity has been linked to increased risk for certain kinds of cancer and is the second highest modifiable risk factor for cancer. It is also well documented that having a cancer diagnosis and treatment is a stressful experience. It is hoped that an addition of a 10-minute mindfulness-based stress reduction exercise to the virtual positive health habits group focused on weight management can improve wellbeing and distress. Virtual care options continue to extend the reach of medical providers to cancer survivors, particularly those in the rural setting. A virtual behavioral weight management program with an integrated mindfulness component may improve mood, coping strategies, stress management, and weight loss among community practice and rural obese cancer survivors.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To assess if a 12-week virtual weight management program with a mindfulness component will improve well-being of obese cancer patients with a specific focus on self-reported measures of depression and anxiety.\n\nII. To assess if a mindfulness component added to the virtual behavioral weight management will promote weight loss, improve mood, and increase physical activity.\n\nOUTLINE:\n\nPatients participate in a virtual behavioral weight management program with an integrated mindfulness component consisting of 12, 75-minute virtual group sessions over 12 weeks to help improve mood, coping strategies, stress management, and weight loss. Patents also receive patient education handouts, view behavioral educational PowerPoint presentations over 30 minutes, and wear a Fitbit on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 or over\n* Identified stage I, II, or III cancer in remission\n* Body mass index (BMI) of 30 or greater\n* English as a primary language\n* Has access to a device with a camera (computer, tablet, or video capable phone) that has wifi and reliable internet access\n\nExclusion Criteria:\n\n* Unable to provide consent\n* Eastern Cooperative Oncology Group (ECOG) performance status scale score of 3 or above'}, 'identificationModule': {'nctId': 'NCT06030427', 'briefTitle': 'Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Virtual Mindfulness and Weight Management Program for Those With Cancer Histories to Mitigate Risk of Relapse and Improve Wellbeing: A Feasibility Study', 'orgStudyIdInfo': {'id': '23-004890'}, 'secondaryIdInfos': [{'id': 'NCI-2023-06407', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '23-004890', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive care (virtual mindfulness and weight management)', 'description': 'Patients participate in a virtual behavioral weight management program with an integrated mindfulness component consisting of 12, 75-minute virtual group sessions over 12 weeks to help improve mood, coping strategies, stress management, and weight loss. Patents also receive patient education handouts, view behavioral educational PowerPoint presentations over 30 minutes, and wear a Fitbit on study.', 'interventionNames': ['Behavioral: Behavioral Dietary Intervention', 'Other: Educational Intervention', 'Other: Health Promotion and Education', 'Other: Internet-Based Intervention', 'Other: Interview', 'Other: Medical Device Usage and Evaluation', 'Behavioral: Mindfulness Relaxation', 'Other: Physical Performance Testing', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Behavioral Dietary Intervention', 'type': 'BEHAVIORAL', 'description': 'Participate in weight management program', 'armGroupLabels': ['Supportive care (virtual mindfulness and weight management)']}, {'name': 'Educational Intervention', 'type': 'OTHER', 'otherNames': ['Education for Intervention', 'Intervention by Education', 'Intervention through Education', 'Intervention, Educational'], 'description': 'Receive patient education handouts', 'armGroupLabels': ['Supportive care (virtual mindfulness and weight management)']}, {'name': 'Health Promotion and Education', 'type': 'OTHER', 'description': 'View behavioral educational PowerPoint presentation', 'armGroupLabels': ['Supportive care (virtual mindfulness and weight management)']}, {'name': 'Internet-Based Intervention', 'type': 'OTHER', 'description': 'Complete virtual behavioral weight management with an integrated mindfulness component program', 'armGroupLabels': ['Supportive care (virtual mindfulness and weight management)']}, {'name': 'Interview', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (virtual mindfulness and weight management)']}, {'name': 'Medical Device Usage and Evaluation', 'type': 'OTHER', 'description': 'Wear Fitbit', 'armGroupLabels': ['Supportive care (virtual mindfulness and weight management)']}, {'name': 'Mindfulness Relaxation', 'type': 'BEHAVIORAL', 'otherNames': ['MBSR', 'Mindful Meditation', 'Mindfulness Meditation', 'Mindfulness-Based Stress Reduction'], 'description': 'Complete mindfulness components', 'armGroupLabels': ['Supportive care (virtual mindfulness and weight management)']}, {'name': 'Physical Performance Testing', 'type': 'OTHER', 'otherNames': ['Physical Fitness Testing', 'Physical Function Testing'], 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (virtual mindfulness and weight management)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (virtual mindfulness and weight management)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54601', 'city': 'La Crosse', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Mayo Clinic Health System-Franciscan Healthcare', 'geoPoint': {'lat': 43.80136, 'lon': -91.23958}}], 'overallOfficials': [{'name': 'Lisa Howell, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic Health System-Franciscan Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}