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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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Clinician Reported Toxicities Using CTCAE

Distress Level Using the NCCN Distress Thermometer

Patient Reported Toxicities Using PRO-CTCAE Questions

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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