Monitoring of Treatment Related Toxicities from Oral Targeted Agents and Immunotherapy Among Patients with Advanced Renal Cell Carcinoma (RCC) Using Carevive Software, a Single-Arm Phase II Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced Renal Cell Carcinoma
- Sponsor
- University of Rochester
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Reasons for Declining Study Participation
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Chunkit Fung
Doctor
University of Rochester
Eligibility Criteria
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
Outcomes
Primary Outcomes
Reasons for Declining Study Participation
Time Frame: 48 weeks
If a subject declines to participation in the study, he/she will be asked to provide a reason for declination. If willing, we will have them sign a separate consent with a space to write in their reason. The reason provided will be sorted into pre-specified categories and presented as a percentage.
Carevive Survey Usage Rates
Time Frame: 48 weeks
Carevive software will track subject compliance with survey logins and whether they access the generated care plans. The percentage of times logged in out of the number of study recommended logins will be tabulated. Also, the percentage of times a careplan was accessed out of the number of times it was offered will be determined. * To determine the practicality of the intervention, by analyzing the reasons why subjects fail to self-report treatment-related toxicities or utilize software generated care plans after enrollment. * To assess the acceptability of this intervention with validated patient reported usability scores of the software. * To determine potential implementation obstacles of the intervention, by assessing the reasons eligible study candidates decline participation.
Average Usability Score Using the Software Usability Scoring System
Time Frame: 48 weeks
At the 48 week time point or at the point of subject withdrawal from study, they will be asked to take the System Usability Scale. The survey provides us with a score of between 0 and 40 which is then multiplied by 2.5 to convert to a scale of 0 to 100. A SUS score above a 68 would be considered above average and anything below 68 is below average.
Reasons Participants Do Not Complete Survey or Utilize Care Plans
Time Frame: 48 weeks
After missing a survey, subjects will be asked the reason at their following login. The reason provided will be sorted into pre-specified categories and presented as a percentage.
Secondary Outcomes
- Clinician Reported Toxicities Using CTCAE(48 weeks)
- • Health Care Utilization Assessment By Quantification of Health Care Visits or Hospitalizations(48 weeks)
- Patient Reported Toxicities Using PRO-CTCAE Questions(48 weeks)
- Quality of Life Determination Using the FKSI-DRS Survey(48 weeks)
- Distress Level Using the NCCN Distress Thermometer(48 weeks)