Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma
- Conditions
- Advanced Renal Cell Carcinoma
- Interventions
- Other: Carevive software
- Registration Number
- NCT03229083
- Lead Sponsor
- University of Rochester
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Use of Carevive software Carevive software Reporting and management of side effects from oral targeted therapy or immunotherapy, through Carevive software, in patients who have advanced Renal Cell Carcinoma (RCC).
- Primary Outcome Measures
Name Time Method Reasons for Declining Study Participation 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 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 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 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 Outcome Measures
Name Time Method Clinician Reported Toxicities Using CTCAE 48 weeks Toxicities will also be formally assessed in-office every 3-4 months using CTCAE scoring. The categories chosen are common toxicities that occur with oral targeted therapy and immunotherapy: diarrhea, nausea, vomiting, fatigue, hand/foot syndrome, rash, abdominal pain, appetite, mouth sores, cough and shortness of breath
• Health Care Utilization Assessment By Quantification of Health Care Visits or Hospitalizations 48 weeks Health care utilization will be self-reported by the subject through CareVive software monthly, in addition at the end of the study or at time of withdrawal, a search of the electronic medical record will be performed to determine the number of calls made to oncology care providers and the number of visits to the oncologist during the study period.
Patient Reported Toxicities Using PRO-CTCAE Questions 48 weeks Patient reported toxicity data will be collected via Carevive surveys weekly for the first 12 weeks and then every other week for another 36 weeks. We will not deliver the PRO-CTCAE in its entirety but will specifically ask about the following common toxicities that are experienced with oral targeted therapy and immunotherapy: diarrhea, nausea, vomiting, fatigue, hand/foot syndrome, rash, abdominal pain, anorexia, mouth sores, cough and shortness of breath.
Quality of Life Determination Using the FKSI-DRS Survey 48 weeks Subjects will be asked to fill out the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) at baseline and approximately every 3 months in-office.
Distress Level Using the NCCN Distress Thermometer 48 weeks The subject will be asked to rate their distress level in-office using the NCCN Distress Thermometer, which is a 1 to 10 numerical scale. This will be delivered during routine office visits approximately every 3 months on a tablet.
Trial Locations
- Locations (1)
University of Rochester - Wilmot Cancer Institute
🇺🇸Rochester, New York, United States