Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT04503018
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2020-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychological Effects of Implant Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2020-07-30', 'studyFirstSubmitQcDate': '2020-08-04', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Experiences and psychological effects of implant loss after immediate breast reconstruction', 'timeFrame': '10 years', 'description': 'Interviews'}, {'measure': 'Effect on quality of life of implant loss: scale', 'timeFrame': '10 years', 'description': 'Breast-Q reconstruction post-operative. It includes different domains: health-related quality of life (HR-QOL; including physical, psychosocial, and sexual well-being) and patient satisfaction (including satisfaction with breasts, outcome, and care). Each scale produces an independent score from 0-100.a higher score means greater satisfaction or better QOL'}, {'measure': 'Effect on body image of implant loss', 'timeFrame': '10 years', 'description': 'Body-Esteem Scale for Adolescents and Adults (BESAA). It consists of three subscales: BE-appearance, BE-weight and BE-attribution.The scale has 23 items and the respondents indicated their degree of agreement on a 5-point Likert scale ranging from 0 (never) to 4 (always).High score indicates higher dimensions of the Body Esteem.'}, {'measure': 'Effect on depression and anxiety of implant loss', 'timeFrame': '10 years', 'description': 'Hospital Anxiety and Depression scale (HAD).The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression.For both scales, scores of less than 7 indicate non-cases. 8-10 mild, 11-14 moderate, 15-21 severe.'}, {'measure': 'Coping strategies', 'timeFrame': '10 years', 'description': "Brief-cope, a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event.Scores are presented for the two overarching coping styles: avoidant and approach.The scale can determine someone's primary coping styles."}, {'measure': 'Coping strategies', 'timeFrame': '10 years', 'description': 'The Life orientation test - revised (Lot-R) is a 10-item scale that measures how optimistic or pessimistic people feel about the future. High values imply optimism.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast reconstruction', 'Plastic surgery', 'Psychology'], 'conditions': ['Breast Cancer Female']}, 'referencesModule': {'references': [{'pmid': '34427538', 'type': 'RESULT', 'citation': 'Weick L, Ericson A, Sandman L, Bostrom P, Hansson E. Patient experience of implant loss after immediate breast reconstruction: An interpretative phenomenological analysis. Health Care Women Int. 2023 Jan;44(1):61-79. doi: 10.1080/07399332.2021.1944152. Epub 2021 Aug 24.'}, {'pmid': '35427208', 'type': 'RESULT', 'citation': 'Weick L, Lunde C, Hansson E. The effect of implant loss after immediate breast reconstruction on patient satisfaction with outcome and quality of life after five years - a case-control study. J Plast Surg Hand Surg. 2023 Feb-Dec;57(1-6):263-270. doi: 10.1080/2000656X.2022.2061501. Epub 2022 Apr 15.'}], 'seeAlsoLinks': [{'url': 'http://liu.diva-portal.org/smash/get/diva2:1591756/FULLTEXT01.pdf', 'label': 'Full text article'}]}, 'descriptionModule': {'briefSummary': "Previous quality of life studies have suggested that long term satisfaction with breast reconstruction may be affected by postoperative complications. Complication frequencies, especially the risk for implant loss, is considerably higher in immediate than in delayed breast reconstruction. Knowledge about how implant loss affects the patient's experience of her breast reconstruction can guide us in the choice between immediate and delayed breast reconstruction in high risk patients and help us better prepare the patients for possible complications. This study will investigate patients' experiences with losing an implant in connection with immediate breast reconstruction."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Purposive criterion sampling technique is used. The population will identified through an operation planning software', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biological women\n* Age \\>18 years\n* Have lost an implant after a mastectomy and immediate breast reconstruction\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* inability to speak and understand Swedish\n* relapse of breast cancer after the reconstruction\n* metastatic disease\n* psychiatric co-morbidity.'}, 'identificationModule': {'nctId': 'NCT04503018', 'briefTitle': 'Psychological Effects of Implant Loss', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vastra Gotaland Region'}, 'officialTitle': 'Psychological Effects of Implant Loss', 'orgStudyIdInfo': {'id': '2019-06214'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Interviewed -implant loss', 'description': 'Patients who have had immediate breast reconstruction and lost the implant due to for example infection.'}, {'label': 'Questionnaires - implant loss', 'description': 'Patients who have had immediate breast reconstruction and lost the implant due to for example infection.'}, {'label': 'Questionnaires - controls', 'description': 'Patients who have had immediate breast reconstruction without complications'}]}, 'contactsLocationsModule': {'locations': [{'zip': '413 45', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Västra Götaland', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Emma Hansson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Göteborg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}