Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2025-12-25 @ 8:38 PM
Study NCT ID:
NCT05808569
Status:
COMPLETED
Last Update Posted:
2023-04-11
First Post:
2023-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Breast Cancer Patients Modesty During Radiotherapy. A Multicentric Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 537}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2023-03-02', 'studyFirstSubmitQcDate': '2023-03-30', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary aim of this study is to identify patients perception of modesty during RT for breast cancer through the use of a dedicated 16 items questionnaire validated in a Delphi consensus for the purposes of this study', 'timeFrame': '1-5 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Patients affected by breast cancer undergo radiotherapy with bare chest and can therefore live the moments in which they undress in front of the radiation therapy technologists (RTTs) in charge of their treatment as an extremely embarrassing one.\n\nFurthermore, for some of these patients the relationship with their bodies has indeed changed since surgery (i.e. mutilations, scars), particularly for specific age or socio-economic groups. In this context, sub-standard care in maintaining modesty during breast cancer radiotherapy has been reported in literature, even if poorly studied. Aim of this multicentric observational study is to describe how modesty is perceived by patients undergoing radiotherapy for breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing adjuvant radiotherapy for breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Patients undergoing adjuvant radiotherapy for breast cancer\n* Able to understand and sign informed consent\n\nExclusion criteria\n\n* Patients with inadequate linguistic abilities and inability to express informed consent\n* Patients denying informed consent\n* Patients receiving palliative treatments\n* Patients affected by major psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT05808569', 'acronym': 'MODESTY', 'briefTitle': 'Evaluating Breast Cancer Patients Modesty During Radiotherapy. A Multicentric Study', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Evaluating Breast Cancer Patients Modesty During Radiotherapy. A Multicentric Study', 'orgStudyIdInfo': {'id': '3049'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast cancer patients undergoing radiotherapy in adjuvant setting', 'interventionNames': ['Behavioral: Test']}], 'interventions': [{'name': 'Test', 'type': 'BEHAVIORAL', 'description': 'A specific self-test composed by 16 questions , will be administered to BC patients undergoing adjuvant RT.', 'armGroupLabels': ['Breast cancer patients undergoing radiotherapy in adjuvant setting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'RM', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario "A.Gemelli" IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}