Home monitoring of kidney function in cancer patients: assessing acceptability and clinical benefit

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2019
INTERVENTION: 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. Part A aims to enrol 12 patients to use the device at home when they are receiving their treatment, 3 times per week for 4 weeks, this is in addition to their standard of care monitoring. There is no change to the treatment they are receiving. Participants will take a small sample of blood and use a small device to check their kidney function. Using an app on their smartphone they will send their result to the researchers who will look for evidence of kidney damage. Part B of the study will have 2 arms. The intervention arm will use the device at home to check their kidney function 3 times per week for 6 weeks. This is in addition to the standard of care monitoring and treatment. The standard of care arm will have standard monitoring during their treatment. Neither arm will have a change to their planned treatment. There is no follow‐up period. CONDITION: Nephro‐oncology ; Cancer PRIMARY OUTCOME: ; 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 OUTCOME: ; 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; ; 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
Epistemonikos ID: e5a23809a850ca6e8c705926d847ed3a5991a81e
First added on: Aug 24, 2024