Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT04938505
Status:
UNKNOWN
Last Update Posted:
2021-06-24
First Post:
2021-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Health Related Quality of Life in Women Who Underwent Breast Reconstruction After Radical Surgery
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': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2025-05-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-23', 'studyFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-06-23', 'lastUpdatePostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health related quality of life scores assessed by Breast Q questionnaire', 'timeFrame': '12 months after breast reconstruction'}], 'secondaryOutcomes': [{'measure': 'Number of anxious and depress participants as assessed by Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '12 months after breast reconstruction', 'description': 'HADS has 14 items rated from 0 to 3 and covers 2 dimensions. Seven questions related to the anxiety dimension and seven other related to the depressive dimension, yielding 2 scores, A (Anxiety) and D (Depression). The maximum score for each dimension is 21. A score of 11 or higher indicates the probable presence of the disorder.'}, {'measure': "social support as assessed by Sarason's Social Support Questionnaire 6-item (SSQ6)", 'timeFrame': '12 months after breast reconstruction', 'description': "Social support is measured across 2 dimensions: support availability, through the number of contacts that the patient can count on (0 to 9 people) and quality of support, through patient satisfaction with support received. Each item represents a situation in which the patient may need support. Patient is asked to cite the number of people that she could count on in that particular situation. Concerning the second item, the patient is asked to assess satisfaction with the support provided. The scores are generated according to Sarason's recommendations. A score is calculated for each dimension. Support availability score is calculated as the sum of the number of people available for the 6 items, this score ranges from 0 to 54, with 54 representing the highest availability. The social support satisfaction score is calculated by the sum of the satisfaction of the 6 items. This score ranges from 6 to 36, with 36 representing the highest level of satisfaction"}, {'measure': 'level of the precariousness and the disparities of health at breast reconstruction patient by the questionnaire Evaluation of the Precariousness and the Disparities of Health for the Centers of Examination of Health (EPICES)', 'timeFrame': '12 months after breast reconstruction', 'description': 'EPICES is used to assess individual level of the precariousness. It includes 11 items and generate precariousness score from 0 to 100. Patient which a score EPICES \\>30 is considered as having a high level of precariousness'}, {'measure': 'Health related quality of life scores assessed by Breast Q questionnaire', 'timeFrame': '24 months after breast reconstruction'}, {'measure': 'Health related quality of life scores assessed by Breast Q questionnaire', 'timeFrame': '36 months after breast reconstruction'}, {'measure': 'Health related quality of life scores assessed by Breast Q questionnaire', 'timeFrame': '48 months after breast reconstruction'}, {'measure': 'Health related quality of life scores assessed by Breast Q questionnaire', 'timeFrame': '60 months after breast reconstruction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Reconstruction'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Nowadays, breast reconstruction is an integral care after mastectomy in breast cancer patient.\n\nWith the personalized care, choice a breast reconstructive is an important step involving decisions and mutual accord between patients and their physicians in order to anticipate clinical and psychosocial results.\n\nTwo main families of breast reconstruction techniques are often performed including advantages and complications impacting health related quality of life.\n\nRoutine assessment of health related quality of life in patients underwent breast reconstruction could allow to identify factors of satisfaction o be taken into account in the choice of breast reconstruction technique in order to improve practices and quality of life of patients'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient undergoing breast reconstruction after mastectomy for breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal Breast Checkup ( Mammography, echography and breast magnetic resonance imaging)in the previous 6 months\n* French speaking and writing fluency\n* Agree to participate after receive all information\n\nExclusion Criteria:\n\n* Patients with an inability to complete HRQOL questionnaires (cognitive disorders, language barrier)\n* Patient with a failed first breast reconstruction'}, 'identificationModule': {'nctId': 'NCT04938505', 'acronym': 'RMQOL', 'briefTitle': 'Assessment of Health Related Quality of Life in Women Who Underwent Breast Reconstruction After Radical Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Georges Francois Leclerc'}, 'officialTitle': 'Assessment of Health Related Quality of Life in Women Who Underwent Breast Reconstruction After Radical Surgery (RMQOL)', 'orgStudyIdInfo': {'id': '2018-A011828-47'}}, 'contactsLocationsModule': {'locations': [{'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sandrine DABAKUYO, PHD', 'role': 'CONTACT', 'email': 'sdabakuyo@cgfl.fr', 'phone': '0345348067', 'phoneExt': '33'}, {'name': 'Clémentine JANKOWSKI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Georges Francois Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'centralContacts': [{'name': 'Sandrine DABAKUYO, PHD', 'role': 'CONTACT', 'email': 'sdabakuyo@cgfl.fr', 'phone': '0345348067', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Clementine JANKOWSKI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Georges François Leclerc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Georges Francois Leclerc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}