Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-30 @ 6:40 PM
Study NCT ID:
NCT04872803
Status:
UNKNOWN
Last Update Posted:
2021-05-05
First Post:
2021-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emotional Security and Quality of Life Among Breast Cancer Patient Who Have Undergo Mastectomy
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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 143}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2021-04-27', 'studyFirstSubmitQcDate': '2021-04-29', 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life post mastectomy', 'timeFrame': '6 months', 'description': 'To evaluate the impact of breast cancer on the quality of life'}], 'secondaryOutcomes': [{'measure': 'Stages of breast cancer and emotional security', 'timeFrame': '6 months', 'description': 'Studying the effect of different stages of breast cancer and its duration on the emotional security'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mastectomy', 'breast cancer'], 'conditions': ['Mastectomy']}, 'descriptionModule': {'briefSummary': "Breast cancer is the most common cause of cancer death among women worldwide. Incidence rates are high in more developed countries than rates in less developed countries In Egypt, standardized age of cancers are 166.6per 100.000 in both sexes cancer breast represent 32%in females and 15.4%in both sexes of all cancer Mastectomy is an important treatment method in Brest cancer. But, mastectomy has a deep and stable negative impact on a woman because, mastectomy as a treatment option, can result in a sense of mutilation and diminished self-worth and may threaten perceptions of femininity Body image of a woman includes the symbolic meaning and importance of her breasts. The more she values her breasts, more devastating effects of having a mastectomy can be. it has been reported that cutting off/amputating one or both breasts was associated with several problems in women such as loss of fertility, charm and sexuality, fear of recurrence Social support plays an important role in reducing the pressure and improving health. Cancer patients who lack social support may be more pessimistic and desperate as they are constantly looking for support from others Therefore, it is critical for health care professionals to become familiar with the impact of a breast cancer diagnosis and its treatment on patient's quality of life .", 'detailedDescription': "Breast cancer is the most common cause of cancer death among women worldwide. Incidence rates are high in more developed countries than rates in less developed countries In Egypt, standardized age of cancers are 166.6per 100.000 in both sexes cancer breast represent 32%in females and 15.4%in both sexes of all cancer Mastectomy is an important treatment method in Brest cancer. But, mastectomy has a deep and stable negative impact on a woman because, mastectomy as a treatment option, can result in a sense of mutilation and diminished self-worth and may threaten perceptions of femininity Body image of a woman includes the symbolic meaning and importance of her breasts. The more she values her breasts, more devastating effects of having a mastectomy can be. it has been reported that cutting off/amputating one or both breasts was associated with several problems in women such as loss of fertility, charm and sexuality, fear of recurrence Social support plays an important role in reducing the pressure and improving health. Cancer patients who lack social support may be more pessimistic and desperate as they are constantly looking for support from others Therefore, it is critical for health care professionals to become familiar with the impact of a breast cancer diagnosis and its treatment on patient's quality of life"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'female patient between 18y and 55y with first-time breast cancer diagnosis and post-operative mastectomized patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. female patient between 18y and 55y\n2. a first-time breast cancer diagnosis\n3. post-operative mastectomized patients\n4. clear consent to participate in study\n\nExclusion Criteria:\n\n1. male gender\n2. females patient with concurrent comorbid psychiatric or neurological disorders\n3. age younger than 18y\n4. patients with disease recurrence, patients presenting with other malignancies'}, 'identificationModule': {'nctId': 'NCT04872803', 'briefTitle': 'Emotional Security and Quality of Life Among Breast Cancer Patient Who Have Undergo Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Emotional Security and Quality of Life Among Breast Cancer Patient Who Have Undergo Mastectomy', 'orgStudyIdInfo': {'id': 'Emotional security&mastectomy'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Asmaa Omar', 'role': 'CONTACT', 'email': 'asmaa93omar@gmail.com', 'phone': '+201281272808'}], 'overallOfficials': [{'name': 'Asmaa Omar, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Asmaa Omar', 'investigatorAffiliation': 'Assiut University'}}}}