Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT07101861
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast Cancer Survivors RESET (Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools): A Pilot, Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2025-07-28', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment Rate', 'timeFrame': 'Baseline', 'description': 'Percentage of participants who are contacted and enroll in the study.'}, {'measure': 'Retention Rate', 'timeFrame': 'Baseline to Month 4', 'description': 'Percentage of participants who enroll and complete assessments at both timepoints (Baseline and Month 4).'}, {'measure': 'Adherence', 'timeFrame': 'Baseline to Month 4', 'description': 'Adherence will be assessed by the number of treatment sessions attended.'}], 'secondaryOutcomes': [{'measure': '4-month mean change in weight', 'timeFrame': 'Baseline to Month 4', 'description': 'Weight change as measured by a SECA scale in kilograms at baseline and month 4 will be calculated and averaged'}, {'measure': '4-month mean change in allostatic load score', 'timeFrame': 'Baseline to Month 4', 'description': 'Allostatic load score will be calculated using a validated equation. Change from baseline to month 4 will be calculated and averaged.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The overall object of this project is to test the feasibility and acceptability of an adapted stress management enhanced behavioral weight loss intervention for Black breast cancer survivors with obesity and elevated stress. We will also conduct pre- and post-intervention assessments of weight, allostatic load, and patient reported outcomes among study participants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-identify as non-Hispanic Black\n* Self-identify as cisgendered female.\n* Are ≥ age 18.\n* Have a history of stage 0-3 breast cancer diagnosis treated for curative intent.\n* Have completed all adjuvant or neoadjuvant chemotherapy, radiation, and surgery at least 21 days prior to study registration but may continue on hormonal therapy and Abemaciclib therapy.\n* Have a measured BMI ≥ 30 kg/m2.\n* Willing to participate for the entire 4-month duration.\n\nExclusion Criteria:\n\n* Are pregnant or are planning to become pregnant during the study period.\n* Have a known major medical or psychological condition known to influence weight loss \\[e.g., medicated or poorly controlled diabetes (HbA1c \\> 8%), uncontrolled hypertension (BP\\>160 mm Hg systolic or BP\\>100 mm Hg diastolic), cardiovascular event in the past 12 months, history of gastric bypass or bariatric surgery\\].\n* History of psychiatric hospitalization in past 2 years.\n* History of substance abuse or eating disorder.\n* Any other condition by which a medical professional has suggested diet modification, physical activity, and/or weight loss would be contraindicated.'}, 'identificationModule': {'nctId': 'NCT07101861', 'acronym': 'RESET', 'briefTitle': 'Breast Cancer Survivors RESET (Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools): A Pilot, Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'Breast Cancer Survivors RESET (Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools): A Pilot, Feasibility Study', 'orgStudyIdInfo': {'id': 'MCC-22616'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Survivors RESET intervention', 'interventionNames': ['Behavioral: Survivors RESET']}], 'interventions': [{'name': 'Survivors RESET', 'type': 'BEHAVIORAL', 'description': '16-session adaptation of the Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training', 'armGroupLabels': ['Survivors RESET intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Tiffany Carson, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}