Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma
NCT ID: NCT05135832
Last Updated: 2021-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
174 participants
INTERVENTIONAL
2021-12-13
2022-12-01
Brief Summary
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Detailed Description
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Patients 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.
The 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.
A total of 174 patients will be included with 87 patients in each arm.
Primary 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Patient-reported outcomes arm (experimental arm)
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.
The 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.
The 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.
Patient satisfaction regarding the patient-reported outcomes will be measured with the validated Patient-Reported Experience Measurement questionnaire at termination of participation.
Electronic patient-reported outcomes regarding symptoms and health-related quality of life
Weekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles.
The supportive care (including drugs) is similar in the two treatment arms except for the use of electronic patient-reported outcomes.
Standard of care
This arm will continue standard procedure regarding side effect registration and handling.
The 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.
No interventions assigned to this group
Interventions
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Electronic patient-reported outcomes regarding symptoms and health-related quality of life
Weekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles.
The supportive care (including drugs) is similar in the two treatment arms except for the use of electronic patient-reported outcomes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years
3. Starting 1st or 2nd line treatment at enrolment
4. Performance status (PS) ≤ 2
5. Able to read Danish
6. No serious cognitive impairment
7. Patient has given written informed consent
Exclusion Criteria
2. 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.
3. Persons deprived of liberty or under guardianship or curators
4. 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
5. Earlier participation in PRORECECA (e.g. when changing from 1st to 2nd line of treatment)
18 Years
ALL
No
Sponsors
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Herlev and Gentofte Hospital
OTHER
Responsible Party
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Ida Rasmussen
Principal investigator, MD
Principal Investigators
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Ida Marie L Rasmussen, MD
Role: PRINCIPAL_INVESTIGATOR
Herlev and Gentofte Hospital
Locations
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Department of Oncology, Herlev and Gentofte Hospital
Herlev, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Ida Marie L Rasmussen, MD
Role: primary
Anne Kirstine H Møller, MD, PhD
Role: backup
Other Identifiers
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P-2021-693
Identifier Type: OTHER
Identifier Source: secondary_id
UR 2134
Identifier Type: -
Identifier Source: org_study_id