Clinical trial · Interventional
PRO-VISION: Patient Reported Outcomes-Based Monitoring of VEGF-Inhibitor Side Effects in ONcology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Survey Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Patient Perspective
- description
- Study participants will complete several questionnaires/assessments related to adverse events and quality of life.
- interventionNames
- Other: Survey Questionnaire
Primary outcomes (1)
- measure
- Relative dose intensity
- timeFrame
- Up to 3 years
- description
- 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 (13)
- measure
- Dose modifications
- timeFrame
- Up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available