Nephro-oncology Cancer
Conditions
Interventions
Intensive, home-monitoring of creatinine compared to standard renal function monitoring in patients receiving anti-cancer treatments. Randomisation will be 1:1 using an online randomisation tool.
Par
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated, written informed consent prior to participation in the study 2. Aged at least 18 years 3. Receiving treatment for cancer with potentially nephrotoxic anti-cancer therapies (according to the judgement of the CI) 4. Individuals whose medical team consider to be medically stable and able enough to take part or designated carer who would be able to perform the tasks required 5. Willingness and ability to self-monitor creatinine using device at home or have a designated carer who would be able to perform the tasks required. Part A device will be the NovaBiomedical StatSensor® 6. Access to smartphone and willingness to use, without reimbursement of any potential additional costs incurred, their iOS/Android device for the collection and transmission of information
Exclusion criteria
Exclusion criteria: 1. Being an employee, or closely linked with an employee, of the device company 2. Judgment by the Investigator that the individual should not participate if they are unlikely to comply with study procedures and requirements 3. WHO performance status > 2 4. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Patient acceptance of intensive home-monitoring of whole-blood creatinine, assessed using: 1. Questionnaire and interview 2. Absolute number of creatinine readings received - expected vs actual 3. Time sample taken vs. time expected to take 4. Value sent/received vs. value on device (when downloaded at the end of the study period) Assessed at Week 4 Part B: Potential for earlier diagnosis of AKI/change in renal function with intensive home-monitoring of whole-blood creatinine, assessed using: 1. Time from beginning of current cycle treatment to detection of AKI by amended algorithm or clinician/laboratory reading 2. Severity of AKI at detection (as per Kidney Disease Improving Global Outcomes AKI Work Group staging) 3. Overall change in renal function from beginning to end of study period Assessed throughout study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Part B: 1. Kidney function assessed at the beginning and end of the study (Weeks 1 and 6) 2. Quality of life assessed using medical outcomes study short form 36 (SF-36) questionnaire at Week 6 3. Adherence of patients to intensive home monitoring regimen, assessed using: 3.1. Absolute number of creatinine readings received 3.2. Time sample taken vs. time expected to take 3.3. Value sent/received vs. value on device (when downloaded at the end of the study period) Assessed at Week 6 | — |
Countries
England, United Kingdom
Contacts
Public ContactLeanne Phillips
Outcome results
None listed