PRO-VISION: Patient Reported Outcomes-Based Monitoring of VEGF-Inhibitor Side Effects in ONcology
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Cell Carcinoma
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Relative dose intensity
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Relative dose intensity
Time Frame: Up to 3 years
Relative dose intensity is defined as the actual treatment dose taken per unit of time divided by the standard or initially prescribed dose per unit during the duration of treatment with VEGF TKI.
Secondary Outcomes
- Duration of treatment on VEGF TKI regimen(Up to 3 years)
- Dose modifications(Up to 3 years)
- Health-related quality of life and symptom burden -Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events(Up to 3 years)
- Dose interruption(Up to 3 years)
- Hospital admissions(Up to 3 years)
- Emergency department visits(Up to 3 years)
- Duration of treatment on initial VEGF TKI dose(Up to 3 years)
- Treatment satisfaction(Up to 3 years)
- Progression-free survival(Up to 3 years)
- Adherence to Patient Reported Outcome -based symptom(Up to 3 years)
- Health-related quality of life and symptom burden - EuroQol-5 Dimension (EQ-5D-5L) questionnaire.(Up to 3 years)
- Health-related quality of life and symptom burden- Functional Assessment of Cancer Therapy Kidney System Index(Up to 3 years)
- VEGF TKI treatment adherence(Up to 3 years)