Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT06658912
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2024-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Planning Grant for TOPS for Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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': 'D001836', 'term': 'Body Weight Changes'}, {'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': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2024-10-23', 'studyFirstSubmitQcDate': '2024-10-23', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of invitations sent through the electronic health record to get 25 individuals consented to the study', 'timeFrame': '1-2 months'}, {'measure': 'Percentage of TOPS group session attendance', 'timeFrame': '12 months', 'description': 'This will be calculated as number of sessions attended divided by total number of sessions offered'}, {'measure': 'Number of participants who stay in the study', 'timeFrame': '3 months, 6 months, 9 months, 12 months'}, {'measure': 'Number of participants who transition from the initiation phase to the maintenance phase', 'timeFrame': '12 months'}, {'measure': 'Number of participants who continue to transmit weight and BP data once they transition to the maintenance phase', 'timeFrame': '9 months, 12 months'}, {'measure': 'Percent of Weight Loss', 'timeFrame': 'Up to 12 Months'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular Disease (CVD) risk factors as measured by blood pressure', 'timeFrame': 'up to 12 months'}, {'measure': 'Cardiovascular Disease (CVD) risk factors as measured by hemoglobin A1c', 'timeFrame': 'up to 12 months'}, {'measure': 'Cardiovascular Disease (CVD) risk factors as measured by glucose', 'timeFrame': 'up to 12 months'}, {'measure': 'Percentage of participants who get blood drawn', 'timeFrame': 'Baseline, 3 months, 6 months,12 months'}, {'measure': 'Quality of Life (QOL) as measured by survey', 'timeFrame': 'up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Weight Loss']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to help make a community led weight loss program known as Take Off Pounds Sensibly (TOPS) more relevant for breast cancer survivors.\n\nThis study is made up to two parts. The first part includes using focus groups to review current materials that the investigators plan to use in upcoming TOPS classes and provide feedback. Focus groups will be made up of women who are breast cancer survivors.\n\nThe second part includes taking the feedback received from these focus groups and use this feedback to tailor TOPS classes for breast cancer survivors.\n\nThis ClinicalTrials.gov record is specific to the second part of the study.', 'detailedDescription': "The purpose of this study is to help make a community led weight loss program known as Take Off Pounds Sensibly (TOPS) more relevant for breast cancer survivors.\n\nThis study is made up to two parts. The first part includes using focus groups to review current materials that the investigators plan to use in upcoming TOPS classes and have the groups provide feedback. Focus groups will be made up of breast cancer survivors that have recruited from local support group chapters. The goal is to recruit approximately 25 people to take part in these focus groups. Meetings of focus groups will be conducted remotely through Zoom and will be recorded. A meeting of the focus group will last anywhere from 60-90 minutes.\n\nThe information gathered from these groups will be used to improve the materials which lead to part two of the study.\n\nThe second part includes using these materials in TOPS classes that are tailored for breast cancer survivors and determining if the TOPS classes are effective on those who attend the classes. Effectiveness of the class will be determined by the weight loss of the participant and an impact on their heart health.\n\nFor the first 6 months, participants will attend dietician-led TOPS sessions conducted virtually through Zoom. Participants' weight will be measured as instructed using a Bluetooth scale that will send their weight measurements back to the team. Participants will also measure their blood pressure through a Bluetooth device provided by the study team.\n\nAfter 6 months, participants will be asked to join a TOPS chapter in their community. The study team will help them local a chapter that is convenient for them. They must attend these classes for another 6 months. Total time in this portion of the study will be approximately 12 months.\n\nWhile on study, in addition to measuring their weight and blood pressure via the Bluetooth devices, the study team asks that participants also have their blood collected. Participants will have to go to their local LabCorp facility to have blood drawn at baseline visit, 3 months, 6 months, and 12 months. Participants will also be asked to complete surveys via their email. Surveys will ask about participant's current medications and ask them to score their overall health at that time.\n\nThis ClinicalTrials.gov record is specific to the second part of the study."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Aim 2 Inclusion Criteria:\n\n* women diagnosed with breast cancer with BMI ≥ 25 kg/m2 after completion of primary therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy).\n\nAim 2 Exclusion Criteria:\n\n* Those whose oncology providers do not agree with their participation in a weight loss program\n* History of Type II Diabetes Mellitus\n* those participating in another weight loss program\n* those taking a weight loss medication\n* those without smart phones or internet connections or the ability to attend meetings via Zoom'}, 'identificationModule': {'nctId': 'NCT06658912', 'briefTitle': 'Planning Grant for TOPS for Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Planning Grant for Take Off Pounds Sensibly (TOPS) Classes for Breast Cancer Survivors', 'orgStudyIdInfo': {'id': 'Pro00116571'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'TOPS Classes', 'interventionNames': ['Other: TOPS Classes']}], 'interventions': [{'name': 'TOPS Classes', 'type': 'OTHER', 'description': 'Attend Dietician-Led Sessions', 'armGroupLabels': ['TOPS Classes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'contacts': [{'name': 'Nia S Mitchell, MD', 'role': 'CONTACT', 'email': 'nia.s.mitchell@duke.edu', 'phone': '833-637-8839'}], 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Nia S Mitchell, MD', 'role': 'CONTACT', 'email': 'nia.s.mitchell@duke.edu', 'phone': '833-637-8839'}], 'overallOfficials': [{'name': 'Nia S Mitchell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}