Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-25 @ 7:37 PM
Study NCT ID:
NCT05135832
Status:
UNKNOWN
Last Update Posted:
2021-11-26
First Post:
2021-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 174}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2021-10-27', 'studyFirstSubmitQcDate': '2021-11-15', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical function', 'timeFrame': 'Within the first 3 months of treatment', 'description': 'Patient-reported physical function in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) - Whether patients using PRO experience a better physical function compared to patients receiving standard care and handling of side effects.'}], 'secondaryOutcomes': [{'measure': 'Health related quality of life', 'timeFrame': 'Within the first 6 months of treatment', 'description': 'Registration of differences in quality of life between the two arms in the study.\n\nThe quality of life questionnaires EORTC QLQ-C30 (scale range 0-100, a higher score indicating better quality of life) will be used for as quality of life measurement.\n\nDifferences between the two arms will be tested using t-test and analysis of covariance (ANCOVA).'}, {'measure': 'Admissions (number)', 'timeFrame': 'Within the first 6 months of treatment', 'description': 'Registration of number of admissions. The registration is made to investigate whether the use of PRO and thereby a closer contact to the clinic between visits can decrease the number of hospital admissions.'}, {'measure': 'Admissions (length)', 'timeFrame': 'Within the first 6 months of treatment', 'description': 'Registration of length of admissions. The registration is made to investigate whether the use of PRO and thereby a closer contact to the clinic between visits can decrease the length of hospital admissions.'}, {'measure': 'Symptom management (number)', 'timeFrame': 'Within the first 6 months of treatment', 'description': 'Registration of differences in number of intervention in the two treatment arms.'}, {'measure': 'Symptom management (type)', 'timeFrame': 'Within the first 6 months of treatment', 'description': 'Registration of differences in types of intervention in the two treatment arms.'}, {'measure': 'Number of contacts to the clinic', 'timeFrame': 'Within the first 6 months of treatment', 'description': 'Registration of number of contacts to the clinic (both phone and attendance). The registration is made to investigate whether the use of PRO de- or increases the number of contacts to the clinic.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient-reported outcomes', 'Electronic reporting of symptoms', 'Physical function'], 'conditions': ['Metastatic Renal Cell Carcinoma', 'Kidney Cancer', 'Kidney Neoplasm', 'Urologic Cancer', 'Urologic Neoplasms', 'Advanced Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of PRORECECA is to test whether adding weekly active patient-reported outcomes to the treatment of patients with metastatic renal cell carcinoma can improve patient-reported physical function.', 'detailedDescription': 'PRORECECA is a two-armed randomized controlled trial for patients with metastatic renal cell carcinoma initiating 1st or 2nd line of standard therapy.\n\nPatients will be randomized to either receiving questions from Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) with a specifically developed alert-algorithm and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) or receiving standard procedure regarding side effect registration and handling.\n\nThe hypothesis is that weekly active patient-reported outcomes in the intervention group can improve physical function 30% compared to the group who receive standard care and standard handling of side effects.\n\nA total of 174 patients will be included with 87 patients in each arm.\n\nPrimary endpoint is physical function reported by the patient after 3 months of treatment. The patients will assess their physical function by completing the EORTC QLQ-C30.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with metastatic renal cell carcinoma\n2. Age ≥ 18 years\n3. Starting 1st or 2nd line treatment at enrolment\n4. Performance status (PS) ≤ 2\n5. Able to read Danish\n6. No serious cognitive impairment\n7. Patient has given written informed consent\n\nExclusion Criteria:\n\n1. No smart phone\n2. Patient participating in other interventional studies. This is only relevant for studies that might interfere with the intervention. Cases of doubt will be settled by the protocol committee.\n3. Persons deprived of liberty or under guardianship or curators\n4. Dementia, mental alteration or psychiatric disease that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial\n5. Earlier participation in PRORECECA (e.g. when changing from 1st to 2nd line of treatment)'}, 'identificationModule': {'nctId': 'NCT05135832', 'acronym': 'PRORECECA', 'briefTitle': 'Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Herlev and Gentofte Hospital'}, 'officialTitle': 'Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma; a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UR 2134'}, 'secondaryIdInfos': [{'id': 'P-2021-693', 'type': 'OTHER', 'domain': 'Videnscenter for Dataanmeldelser / PACTIUS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient-reported outcomes arm (experimental arm)', 'description': 'This arm will be assigned to intervention by weekly electronic reporting of symptoms and side effects in an app. A specifically developed alert-algorithm will in real-time guide the patient to adjust supportive care or contact the hospital.\n\nThe reported symptoms are sent to the hospital to a healthcare professional - depending on the severity of the reported symptoms the healthcare professional can schedule a visit at the clinic.\n\nThe patient will also receive a health-related quality of life questionnaire (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) including the Physical Function domain in the app each month.\n\nPatient satisfaction regarding the patient-reported outcomes will be measured with the validated Patient-Reported Experience Measurement questionnaire at termination of participation.', 'interventionNames': ['Device: Electronic patient-reported outcomes regarding symptoms and health-related quality of life']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'This arm will continue standard procedure regarding side effect registration and handling.\n\nThe patients will receive a health-related quality of life questionnaire (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QOL-C30) at baseline, after 1, 3, and 6 months of participation in the study.'}], 'interventions': [{'name': 'Electronic patient-reported outcomes regarding symptoms and health-related quality of life', 'type': 'DEVICE', 'otherNames': ['ePRO', 'Alert-algorithm', 'active patient-reported outcomes', 'Real-time guidance of patients when symptom reporting'], 'description': 'Weekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles.\n\nThe supportive care (including drugs) is similar in the two treatment arms except for the use of electronic patient-reported outcomes.', 'armGroupLabels': ['Patient-reported outcomes arm (experimental arm)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'contacts': [{'name': 'Ida Marie L Rasmussen, MD', 'role': 'CONTACT', 'email': 'ida.marie.lind.rasmussen@regionh.dk', 'phone': '+45 38683868'}, {'name': 'Anne Kirstine H Møller, MD, PhD', 'role': 'CONTACT', 'email': 'anne.kirstine.hundahl.moeller@regionh.dk', 'phone': '+45 3868 3868'}, {'name': 'Ida Marie L Rasmussen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Oncology, Herlev and Gentofte Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'centralContacts': [{'name': 'Anne Kirstine H Møller, MD, PhD', 'role': 'CONTACT', 'email': 'anne.kirstine.hundahl.moeller@regionh.dk', 'phone': '+4538683868'}, {'name': 'Jesper A Palshof, MD, PhD', 'role': 'CONTACT', 'email': 'jesper.andreas.palshof@regionh.dk', 'phone': '+4538683868'}], 'overallOfficials': [{'name': 'Ida Marie L Rasmussen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herlev and Gentofte Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev and Gentofte Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, MD', 'investigatorFullName': 'Ida Rasmussen', 'investigatorAffiliation': 'Herlev and Gentofte Hospital'}}}}