Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT06161233
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2023-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study of the eHealth Application "Cancer Patients Better Life Experience" (CAPABLE) - Italy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D013274', 'term': 'Stomach 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'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2023-11-30', 'studyFirstSubmitQcDate': '2023-11-30', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in health-related QoL outcomes in RCC patients', 'timeFrame': '6 months after the enrollment', 'description': 'The primary objective of this study is to investigate whether HRQoL of RCC patients eligible for systemic treatment can be improved by a patient-centred mobile coaching- and monitoring system'}], 'secondaryOutcomes': [{'measure': 'User experience of the CAPABLE system in RCC patients', 'timeFrame': '6 months after the enrollment', 'description': "This study will gather qualitative and quantitative information to quantify usefulness, easiness, acceptability and feasibility of the end users' solutions. The patient app will be assessed also in terms of perceived impact and support derived from the digital technologies. The health professional web application will be evaluated to understand to what extent this can be integrated and adopted in the clinical practice"}, {'measure': 'User experience of the CAPABLE system in other cancer types patients', 'timeFrame': '6 months after the enrollment', 'description': 'To evaluate the generalizability of the system on other cancer types, the user experience study is performed also on patients with cancer types different from RCC (e.g Breast, Ovary, Head\\&Neck cancer). The patient app will be assessed also in terms of perceived impact and support derived from the digital technologies. The health professional web application will be evaluated to understand to what extent this can be integrated and adopted in the clinical practice'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Cell Carcinoma Metastatic', 'Breast Cancer', 'Head and Neck Cancer', 'Thyroid Cancer', 'Ovary Cancer', 'Lung Cancer', 'Stomach Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the CAPABLE study is to compare health-related quality of life in renal cell carcinoma patients who use or do not use a mobile-based application to monitor adverse events for cancer treatment at home. As secondary objectives, the study investigates the usability of the system and its generalizability to other cancer types', 'detailedDescription': 'The study is designed as a prospectively enrolling, quasi-experimental cohort study in cancer patients, eligible for systemic treatment.\n\nThe CAPABLE cohort will receive the smartphone application and a multi-sensorial smartwatch (ASUS VivoWatch 5 HC-B05). Patients will be asked to use the system for at least 6 months after enrollment. If, after 6 months, a patient wants to keep using the system, he will be allowed to do so, until the end of the study. Questionnaires on health-related quality of life will be administered to the patients on baseline (T0) and every three months (T1 and T2). Lost to follow-up data will be included in intention-to-treat analysis. Qualitative and quantitative user experience studies will be done at enrollment, after 3 months and at the end of the follow-up period with the CAPABLE system. Results of this interventional study will be compared with a control cohort consisting of renal cell carcinoma patients, recruited in 2021 with the same inclusion criteria as this study population, but receiving standard care (ICSM CE number 2546, dated 13/04/2021 and amended on 09/02/2022).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults (age \\>=18 years)\n* Sufficient understanding of the Italian language\n* Patients or their caregiver (upon patient's consent) can use a smartphone\n* Histologically or cytologically confirmed diagnosis of RCC, lung, breast, thyroid o head and neck cancer\n* Candidate to systemic treatment (targeted agents, immune checkpoint inhibitors, or a combination of the two)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the start of the treatment.\n\nExclusion Criteria:\n\n* Recruitment and consent denial\n* Not able of understanding and complying with the protocol requirements (including basic technological abilities)\n* Given the fact that each subject involved in the clinical study must be able to understand and sign the informed consent presented by the researcher, lack of this capability represents a specific exclusion criterion in the study protocol."}, 'identificationModule': {'nctId': 'NCT06161233', 'acronym': 'CAPABLE-IT', 'briefTitle': 'Pilot Study of the eHealth Application "Cancer Patients Better Life Experience" (CAPABLE) - Italy', 'organization': {'class': 'OTHER', 'fullName': 'Istituti Clinici Scientifici Maugeri SpA'}, 'officialTitle': 'Pilot Study of the eHealth Application "Cancer Patients Better Life Experience" (CAPABLE) - Italy', 'orgStudyIdInfo': {'id': 'CAPABLE-IT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAPABLE cohort', 'description': 'Group that receives the CAPABLE mobile application and a smartwatch during treatment', 'interventionNames': ['Device: CAPABLE cohort']}], 'interventions': [{'name': 'CAPABLE cohort', 'type': 'DEVICE', 'description': 'The CAPABLE cohort receives the mobileapplication and a multi-sensorial smartwatch (ASUS VivoWatch 5 HC-B05). Patients will be asked to use the system for at least 6 months. The CAPABLE app serves three main functionalities for the patient: symptom monitoring, information needs fulfilment and interventions to improve mental- and physical wellbeing', 'armGroupLabels': ['CAPABLE cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Istituti Clinici Scientifici Maugeri Spa SB', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituti Clinici Scientifici Maugeri SpA', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pavia', 'class': 'OTHER'}, {'name': 'Policlinico di Bari Ospedale Giovanni Paolo XXIII', 'class': 'UNKNOWN'}, {'name': 'Biomeris srl', 'class': 'UNKNOWN'}, {'name': 'The Netherlands Cancer Institute NKI', 'class': 'UNKNOWN'}, {'name': 'University of Haifa', 'class': 'OTHER'}, {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, {'name': 'IBM Research', 'class': 'UNKNOWN'}, {'name': 'Bitsens JSC', 'class': 'UNKNOWN'}, {'name': 'Poznań University of Technology', 'class': 'UNKNOWN'}, {'name': 'Deontics LTD', 'class': 'UNKNOWN'}, {'name': 'Associazione Italiana Malati di Cancro AIMAC', 'class': 'UNKNOWN'}, {'name': 'Universidad Politecnica de Madrid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}