Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-30 @ 4:10 PM
Study NCT ID:
NCT06747533
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-24
First Post:
2024-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Diaphragmatic Breathing Coaching on Deep Inspiration Breath Hold Reproducibility and Organ Protection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009058', 'term': 'Mouth Breathing'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-03', 'size': 194806, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-19T16:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-19', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Adverse Events', 'timeFrame': 'Through study completion; an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breathing, Mouth']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To learn if coaching participants on diaphragmatic breathing will help participants to take larger, more reproducible breaths and feel less anxiety about their treatments.', 'detailedDescription': 'Primary Objectives The primary objective is to compare the average daily shift for participant treatment for participant who have had coaching with https://www.thebreathingclass.com/cancer-center/participant versus participant who had standard clinic teaching.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women over the age of 18 with invasive breast cancer requiring radiation to the left whole breast or treatment of either the right or left breast/chestwall with comprehensive nodal irradiation will be eligible for study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18\n* Left sided breast cancer planned for whole breast radiation or any breast cancer requiring treatment of the regional nodes\n* Treatment planned at the MDACC Mays Breast Radiation Oncology clinic\n\nExclusion Criteria:\n\n* Underlying lung issues that may limit ability to achieve ideal breath hold (COPD on oxygen, etc)\n* Active pregnancy'}, 'identificationModule': {'nctId': 'NCT06747533', 'briefTitle': 'Impact of Diaphragmatic Breathing Coaching on Deep Inspiration Breath Hold Reproducibility and Organ Protection', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Impact of Diaphragmatic Breathing Coaching on Deep Inspiration Breath Hold Reproducibility and Organ Protection', 'orgStudyIdInfo': {'id': '2024-1120'}, 'secondaryIdInfos': [{'id': 'NCI-2024-10404', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard Patient Education', 'description': 'If participants are in the Standard Participants Education group, participants will receive standard of care participants education.', 'interventionNames': ['Other: CT simulation']}, {'type': 'EXPERIMENTAL', 'label': 'Breathe Radiation Protocol Coaching group', 'description': 'If participants are in the Breathe Radiation Protocol Coaching group, you will have access to a video that helps guide you through a relaxed breath hold for the radiation treatment and also access to a coach for questions about the breathing process during radiation. This coaching will take place in the week before you undergo radiation planning.', 'interventionNames': ['Other: CT simulation']}], 'interventions': [{'name': 'CT simulation', 'type': 'OTHER', 'description': 'Given by lung function test (spirometry) and questionnaire about treatment anxiety and satisfaction.', 'armGroupLabels': ['Breathe Radiation Protocol Coaching group', 'Standard Patient Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Melissa Mitchell', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}