N/A
Completed N=21
Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma
Source: ClinicalTrials.gov NCT03229083 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Number of Participants Who Submitted at Least One Carevive Survey — 13 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Submitted at Least One Carevive Survey |
13 | — |
| PRIMARY Percentage of Carevive Surveys Completed Per Participant |
73 | — |
| PRIMARY Number of Participants Who Utilized at Least One Auto-Generated Carevive Care Plan |
13 | — |
| PRIMARY Percentage of Auto Generated Carevive Care Plans Utilized Per Participant |
36 | — |
| PRIMARY System Usability Scale (SUS) Score for Carevive Software |
5; 2; 1 | — |
| SECONDARY Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score |
30; 36; 36; 36; 35.5 | — |
| SECONDARY Distress Level Assessed by NCCN Distress Thermometer |
10; 6; 4; 7; 1; 12 | — |
| SECONDARY Health Care Utilization Assessment |
3 | — |
| SECONDARY Participants Reporting Diarrhea |
1; 12; 6; 7; 5; 8 | — |
| SECONDARY Participants Reporting Nausea |
1; 12; 4; 9; 5; 8 | — |
| SECONDARY Participants Reporting Vomiting |
0; 13; 0; 13; 2; 11 | — |
| SECONDARY Participants Reporting Fatigue |
4; 9; 9; 4; 7; 6 | — |
| SECONDARY Participants Reporting Rash |
1; 12; 5; 8; 3; 10 | — |
| SECONDARY Participants Reporting Abdominal Pain |
0; 13; 4; 9; 2; 11 | — |
| SECONDARY Participants Reporting Mouth Sores |
2; 11; 4; 9; 2; 11 | — |
| SECONDARY Participants Reporting Cough |
2; 11; 5; 8; 2; 11 | — |
| SECONDARY Participants Reporting Shortness of Breath |
2; 11; 3; 10; 2; 11 | — |
| SECONDARY Participants Reporting Anorexia |
4; 9; 5; 8; 7; 6 | — |
| SECONDARY Clinician Reported Diarrhea |
1; 19; 0; 6; 9; 5 | — |
| SECONDARY Clinician Reported Nausea |
0; 20; 0; 2; 13; 5 | — |
| SECONDARY Clinician Reported Vomiting |
0; 20; 0; 0; 15; 5 | — |
| SECONDARY Clinician Reported Fatigue |
3; 17; 0; 7; 8; 5 | — |
| SECONDARY Clinician Reported Rash |
0; 20; 0; 1; 14; 5 | — |
| SECONDARY Clinician Reported Abdominal Pain |
1; 19; 0; 0; 15; 5 | — |
| SECONDARY Clinician Reported Mouth Sores |
0; 20; 0; 1; 14; 5 | — |
| SECONDARY Clinician Reported Cough |
1; 19; 0; 0; 15; 5 | — |
| SECONDARY Clinician Reported Shortness of Breath |
1; 19; 0; 2; 13; 5 | — |
| SECONDARY Clinician Reported Anorexia |
1; 19; 0; 2; 13; 5 | — |
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
Data sourced from ClinicalTrials.gov (NCT03229083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.