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

UNC Lineberger Comprehensive Cancer Center

Status: Active, not recruiting

Conditions: Renal Cell Carcinoma

Treatments: Other: Survey Questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT05592665

LCCC2126

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Patient Perspective

Other group

Description:

Study participants will complete several questionnaires/assessments related to adverse events and quality of life.

Treatment:

Other: Survey Questionnaire