Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma (NCT03229083) | Clinical Trial Compass
CompletedNot Applicable
Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma
United States21 participantsStarted 2019-07-24
Plain-language summary
To determine if Carevive software, which monitors treatment-related toxicities and then generates self-care management plans for these symptoms, will be feasible to implement among patients with metastatic renal cell carcinoma (RCC). Additionally for collection of preliminary data on treatment-related toxicities, quality of life, distress level, and drug adherence.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of histologically confirmed renal cell carcinoma of any subtype with either pathological or radiographic evidence of metastatic disease
* Greater than 18 years of age
* A participating Wilmot Cancer Center oncologist has determined that candidate should be started on either oral targeted therapy or immunotherapy for treatment of their advanced RCC; this can be for first-line or any subsequent line therapy
* Able to provide written informed consent
* Proficient in the English language and self-reports as literate
* Must have an active email address or access to a smart device on which text messages can be received
Exclusion Criteria:
* Women cannot be breast-feeding
* Does not have regular access to the internet
* Unable to come to the Wilmot Cancer Center for appointments every 3-4 months for routine visits with their primary oncologist
* Subjects who were on the study previously will not be allowed to re-enroll in the event of a treatment change
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Submitted at Least One Carevive Survey
Timeframe: From enrollment through 48 weeks
2
Percentage of Carevive Surveys Completed Per Participant
Timeframe: From enrollment through 48 weeks
3
Number of Participants Who Utilized at Least One Auto-Generated Carevive Care Plan
Timeframe: From enrollment through 48 weeks
4
Percentage of Auto Generated Carevive Care Plans Utilized Per Participant
Timeframe: From enrollment through 48 weeks
5
System Usability Scale (SUS) Score for Carevive Software