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Software Monitoring for Kidney Cancer Side Effects

N/A

Recruiting

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 weeks

Awards & highlights

Study Summary

This trial will test if a software that monitors treatment-related side effects and creates self-care management plans for these symptoms is feasible to implement among patients with metastatic renal cell carcinoma. Additionally, it will collect preliminary data on treatment-related side effects, quality of life, distress level, and drug adherence.

Who is the study for?

This trial is for adults over 18 with metastatic renal cell carcinoma who are starting oral targeted therapy or immunotherapy. They must be able to consent, read English, have an email or smart device for texts, and visit the Wilmot Cancer Center every 3-4 months. Breastfeeding women and those without internet access can't join.Check my eligibility

What is being tested?

The study tests if Carevive software can effectively monitor treatment-related toxicities in patients with advanced kidney cancer. It aims to see if it's feasible to use this software to create self-care plans based on reported symptoms, affecting quality of life and medication adherence.See study design

What are the potential side effects?

Since the intervention involves monitoring software rather than a drug, there are no direct side effects from its use. However, the treatments being monitored may include typical side effects of cancer therapies such as fatigue, nausea, skin reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have kidney cancer that has spread, confirmed by tests.

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I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average Usability Score Using the Software Usability Scoring System

Carevive Survey Usage Rates

Reasons Participants Do Not Complete Survey or Utilize Care Plans

+1 more

Secondary outcome measures

Clinician Reported Toxicities Using CTCAE

Distress Level Using the NCCN Distress Thermometer

Patient Reported Toxicities Using PRO-CTCAE Questions

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Use of Carevive softwareExperimental Treatment1 Intervention

Reporting and management of side effects from oral targeted therapy or immunotherapy, through Carevive software, in patients who have advanced Renal Cell Carcinoma (RCC).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor

837 Previous Clinical Trials

518,067 Total Patients Enrolled

Media Library

Carevive software Clinical Trial Eligibility Overview. Trial Name: NCT03229083 — N/A

Kidney Cancer Research Study Groups: Use of Carevive software

Kidney Cancer Clinical Trial 2023: Carevive software Highlights & Side Effects. Trial Name: NCT03229083 — N/A

Carevive software 2023 Treatment Timeline for Medical Study. Trial Name: NCT03229083 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers have enrolled in this clinical research endeavor?

"Affirmative. Information found on clinicaltrials.gov displays that this experiment, which was initially uploaded to the website on July 24th 2019, is actively recruiting participants. The trial needs 50 volunteers from a single medical centre to participate in it."

Answered by AI

What results is this research aiming to yield?

"The primary outcome of this clinical trial, assessed over a 48-week period, is the noncompliance rate to survey completion and care plan utilization. Additionally, researchers will track health care visits or hospitalizations (self-reported by patients through CareVive software), patient reported toxicities using PRO-CTCAE questions (collected via weekly surveys for first 12 weeks then every other week) as well as clinician reported toxicities using CTCAE (assessed in office at 3-4 month intervals)."

Answered by AI

Are there any vacancies in this medical trial for prospective participants?

"According to the information available on clinicaltrials.gov, this research is currently recruiting participants and was first posted on July 24th 2019 with a subsequent update taking place November 7th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma

Chunkit Fung 2019. "Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03229083.

All > Renal Cell Carcinoma