Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 10:09 AM
Study NCT ID:
NCT05503160
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-22
First Post:
2022-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Hormone-sensitive Breast Cancer: Need-driven Health Care Improvement by Patient-centred Digital Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2022-08-08', 'studyFirstSubmitQcDate': '2022-08-12', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life (QOL)', 'timeFrame': '24 Months', 'description': 'Change in EORTC QLQ-C30 subscale'}], 'secondaryOutcomes': [{'measure': 'Quality of Life (QOL)', 'timeFrame': '24 Months', 'description': 'Change in EORTC QLQ-BR23'}, {'measure': 'Quality of Life (QOL)', 'timeFrame': '6, 12, 18 Months', 'description': 'Change in EORTC QLQ-BR23'}, {'measure': 'Quality of Life (QOL)', 'timeFrame': '6, 12, 18 Months', 'description': 'Change in EORTC QLQ-C30'}, {'measure': 'Adherence', 'timeFrame': '24 Months', 'description': 'Number of days missing tablets'}, {'measure': 'Mental health', 'timeFrame': '24 Months', 'description': 'Change in GAD-2'}, {'measure': 'Mental health', 'timeFrame': '24 Months', 'description': 'Change in Distress thermometer'}, {'measure': 'Mental health', 'timeFrame': '24 Months', 'description': 'Change in PHQ-2'}, {'measure': 'Adverse effect of therapy', 'timeFrame': '24 Months', 'description': 'Count of side effects cat. 3/4'}, {'measure': 'Assessment of new digital form of care', 'timeFrame': '24 Months', 'description': 'Usefulness of application'}, {'measure': 'Progression free survival', 'timeFrame': '24 Months', 'description': 'PFS rate'}, {'measure': 'Overal survival', 'timeFrame': '24 Months', 'description': 'OS rate'}, {'measure': 'Total cost', 'timeFrame': '24 Months', 'description': 'Cost difference'}, {'measure': 'Disease-specific costs', 'timeFrame': '24 Months', 'description': 'Cost difference'}, {'measure': 'Effectiveness (QOL)', 'timeFrame': '24 Months', 'description': 'Change in EORTC QLQ-C30 subscale'}, {'measure': 'Efficiency (QALY)', 'timeFrame': '24 Months', 'description': 'Qaly-Index from EQ-5D-5L'}, {'measure': 'Patient Satisfaction', 'timeFrame': '6, 24 Months', 'description': 'Short Assessment of Patient Satisfaction - Satisfaction Index'}, {'measure': 'Stakeholder perspective', 'timeFrame': '12, 24 Months', 'description': 'Stakeholder perspective questionnaires'}, {'measure': 'Number of Interventions', 'timeFrame': '24 Months', 'description': 'Automatically initiated reasons for interventions'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quality of life', 'adherence'], 'conditions': ['New Healthcare Approach']}, 'descriptionModule': {'briefSummary': 'The investigators designed a prospective, 2-armed, cluster-randomized multicenter clinical trial on the effect of a by a digital application triggered intervention on quality of life and therapy-adherence among breast cancer patients, compared to standard of care.', 'detailedDescription': 'With validated questionnaires, patient reported outcome monitoring data on quality of life, distress and therapy-adherence are collected. In case of pathologic values, the attending breast center gets advised to intervene according to individual requirements.\n\nFor women with breast cancer, disease and therapy come along with loss of quality of life. Therapy and its side effects often result in unauthorized discontinuation of therapy by patients. Non-adherence rates to endocrine therapy (ET) range from 31% to 73%. These patients have a poorer prognosis due to recurrence, progression and cancer deaths. Positive effects to increase therapy-adherence were shown for bidirectional communication. Furthermore the use of apps with reminder functions can increase adherence to cancer therapy. The intention within this project is to improve care of patients with primary breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary, hormone-sensitive breast cancer\n* indication for adjuvant endocrine therapy (aromatase-inhibitor, tamoxifen, GnRH-analogue allone or in combination with tamoxifen/ aromatas inhibitor; combination of endocrine therapy with CDK 4/6-inhibitor/ antibody therapy/ radiotherapy)\n* start of endocrine therapy \\<= 3 months ago\n* patients with public health ensurance\n* patients who are legally competent and able to understand and follow instructions of the study staff\n* present informed consent\n\nExclusion Criteria:\n\n* no use of internet or digital applications\n* advanced, metastatic breast cancer\n* simultaneous serious disease\n* life expectancy \\< 2 years'}, 'identificationModule': {'nctId': 'NCT05503160', 'acronym': 'PRISMA', 'briefTitle': 'Primary Hormone-sensitive Breast Cancer: Need-driven Health Care Improvement by Patient-centred Digital Application', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Primäres Hormon-Sensitives Mammakarzinom: Bedarfsgerechte Optimierung Der Versorgung Durch Eine Patientenzentrierte, Digitale Anwendung', 'orgStudyIdInfo': {'id': 'PRISMA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'With validated questionnaires, patient reported outcome monitoring data on quality of life, distress and therapy-adherence are collected. In case of pathologic values, the attending breast center gets advised to intervene according to individual requirements.', 'interventionNames': ['Behavioral: Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard of care'}], 'interventions': [{'name': 'Intervention', 'type': 'BEHAVIORAL', 'description': 'Structured (video-)call by qualified nursing staff with breast cancer patients, with the intention to overcome side effects, distress or non-adherence to endocrine therapy.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Germany', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar, Frauenklinik, Technische Universität München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Marion Kiechle, Prof. Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Technical University of Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal Joint Committee', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}