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PRO-VISION: Patient Reported Outcomes-Based Monitoring of VEGF-Inhibitor Side Effects in ONcology

Recruiting
18 years of age
Both
Phase N/A

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Overview

The purpose of this study is to investigate how collecting information about treatment-related side effects directly from patients can help manage the side effects associated with certain oral chemotherapies. This study is specifically investigating this approach in patients taking oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) for metastatic renal cell carcinoma (mRCC).

Participants in this study will receive a survey via email or telephone once a week while receiving treatment with a VEGFR TKI. The survey will ask about symptoms such as nausea or fatigue and overall quality of life. This survey should take no more than 15 minutes to complete.

The survey will be sent directly to the oncology care team. Participants will receive a follow-up phone call or message from the team when participants have new or worsening symptoms. The participants will continue to receive surveys for as long as they are receiving a VEGF TKI treatment.

Eligibility

Inclusion Criteria:

  • Adult patients aged 18 years or older
  • Histologically confirmed renal cell carcinoma requiring treatment with VEGF TKI.
  • Patients may be receiving other concurrent cancer-directed therapy such as immune checkpoint inhibitors.
  • English or Spanish speaking
  • Ability to complete PRO surveys (i.e. ability to read/write or access to telephone or internet)
  • Willing and able to meet all study requirements

Exclusion Criteria:

        All subjects meeting any of the exclusion criteria at baseline will be excluded from study
        participation.
        • Inability for any reason to complete PRO surveys

Study details

Renal Cell Carcinoma

NCT05592665

UNC Lineberger Comprehensive Cancer Center

26 January 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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