Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-03-02 @ 4:06 AM
Study NCT ID:
NCT03684135
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2018-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Satisfaction Assessment of Patients With Local Breast Cancer When Using Cosmetics During Chemotherapy and Post-treatment Thermal Cure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003358', 'term': 'Cosmetics'}], 'ancestors': [{'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D006795', 'term': 'Household Products'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2018-09-24', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean satisfaction related to the use of cosmetics during chemotherapy using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).', 'timeFrame': '6 months', 'description': 'The mean satisfaction will be assessed using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).'}, {'measure': 'Mean compliance related to the use of cosmetics during chemotherapy by asking if yes or no the products was stopped.', 'timeFrame': '6 months', 'description': 'The compliance will be measured by questions asking if patients stopped the use of cosmetics.'}, {'measure': 'Percentage of patients declaring skin problems after the use of these 2 cosmetics', 'timeFrame': '6 months', 'description': 'Skin problems will be measured by questions asking if yes or no the skin was moisturized, oily, tugging or nice at touching.'}, {'measure': 'Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good', 'timeFrame': '6 months', 'description': 'The qualitative assessment of cosmetics will be measured by questions asking about the texture, the odour, the oiliness, the application and the absorption of the 2 cosmetic products'}, {'measure': 'Patient expectations related to the use of cosmetics during chemotherapy', 'timeFrame': '6 months', 'description': 'Patient expectations will be measured by questions asking about the reason why the stopped the use of these 2 cosmetics and by all answers given for the odour, the texture, the oiliness, the application and the absorption'}], 'secondaryOutcomes': [{'measure': 'Mean satisfaction related to the use of cosmetics during post-treatment thermal cure using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).', 'timeFrame': '1 year', 'description': 'The mean satisfaction will be assessed using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).'}, {'measure': 'Mean compliance related to the use of cosmetics during post-treatment thermal cure by asking if yes or no the products was stopped', 'timeFrame': '1 year', 'description': 'The compliance will be measured by questions asking if patients stopped the use of cosmetics'}, {'measure': 'Percentage of patients declaring skin problems after the use of these 2 cosmetics', 'timeFrame': '1 year', 'description': 'Skin problems will be measured by questions asking if yes or no the skin was moisturized, oily, tugging or nice at touching.'}, {'measure': 'Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good', 'timeFrame': '1 year', 'description': 'The qualitative assessment of cosmetics will be measured by questions asking about the texture, the odour, the oiliness, the application and the absorption of the 2 cosmetic products'}, {'measure': 'Patient expectations related to the use of cosmetics during post-treatment thermal cure', 'timeFrame': '1 year', 'description': 'Patient expectations will be measured by questions asking about the reason why the stopped the use of these 2 cosmetics and by all answers given for the odour, the texture, the oiliness, the application and the absorption'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Cosmetics', 'Satisfaction', 'Chemotherapy', 'Thermal cure'], 'conditions': ['Local Breast Cancer Patients']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the satisfaction, the observance, the intolerance, the qualitative appreciation and the expectations of the patients related to the use of the cosmetic products ("Tendre Caresse au cold cream" body cream and "Crème de douche" face and body cleanser from Cosmétosource) during chemotherapy and post-treatment thermal cure'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman,\n* Age \\> or = 18 years,\n* Performance status \\> or = 1 (according to WHO criteria),\n* Patient with histologically proven breast cancer, not metastasized,\n* Patient treated with neoadjuvant or adjuvant chemotherapy,\n* Absence of cutaneous lesions related to the pathology,\n* Patient fluent in the French language,\n* Patient affiliated to a social security scheme,\n* Obtaining written, signed and dated informed consent.\n\nExclusion Criteria:\n\n* Metastatic breast cancer,\n* Local relapse of breast cancer\n* History of cancer in the 5 years preceding the entry into the trial,\n* Patient already treated with chemotherapy,\n* Medical contraindications to the use of cosmetic products and the prescription of a spa treatment,\n* Patient deprived of liberty or under guardianship.'}, 'identificationModule': {'nctId': 'NCT03684135', 'acronym': 'COSMIK', 'briefTitle': 'Satisfaction Assessment of Patients With Local Breast Cancer When Using Cosmetics During Chemotherapy and Post-treatment Thermal Cure', 'organization': {'class': 'OTHER', 'fullName': 'Centre Jean Perrin'}, 'officialTitle': 'Satisfaction Assessment of Patients With Local Breast Cancer When Using Cosmetics During Chemotherapy and Post-treatment Thermal Cure', 'orgStudyIdInfo': {'id': '2017-004938-28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Use of cosmetics during chemotherapy and thermal cure', 'description': 'Use of cosmetics during chemotherapy and post-treatment thermal cure', 'interventionNames': ['Other: Cosmetics']}], 'interventions': [{'name': 'Cosmetics', 'type': 'OTHER', 'description': '"Tendre Caresse au cold cream" body cream from Cosmétosource "Crème de douche" face and body cleanser from Cosmétosource', 'armGroupLabels': ['Use of cosmetics during chemotherapy and thermal cure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Xavier DURANDO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Jean Perrin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Jean Perrin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}