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

Study Overview
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Brief Summary
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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.

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

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Other: Survey Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient Perspective<br>Study participants will complete several questionnaires/assessments related to adverse events and quality of life. | Other: Survey Questionnaire<br>* Study participants will complete several questionnaires/assessments via PRO-Core standardized email communication or via telephone with a study team member.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative dose intensity | 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. | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose modifications | The proportion of patients who change the dose of VEGF TKI study treatment during the duration of treatment with VEGF TKI therapy. | Up to 3 years | 
| Dose interruption | The proportion of patients who change the dose of VEGF TKI study treatment during the duration of treatment with VEGF TKI therapy. | Up to 3 years | 
| Hospital admissions | The proportion of patients requiring hospitalization for a treatment-related side effect. | Up to 3 years | 
| Emergency department visits | The proportion of patients requiring an emergency department visit for treatment-related adverse events. | Up to 3 years | 
| Duration of treatment on initial VEGF TKI dose | Duration of treatment on initial VEGF TKI dose is defined from day 1 of treatment until the first dose reduction or dose interruption. | Up to 3 years | 
| Duration of treatment on VEGF TKI regimen | Duration of treatment on VEGF TKI regimen is defined from day 1 of treatment until the last dose of VEGF TKI treatment at any dose. | Up to 3 years | 
| Progression-free survival | Progression-free survival is defined as day 1 of treatment until progression of disease or death from any cause; patients will be censored at the time of new treatment initiation if progression has not occurred. | Up to 3 years | 
| Health-related quality of life and symptom burden -Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events | Health-related quality of life (HRQoL) and symptom burden will be assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire. The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities that include pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective. | Up to 3 years | 
| Health-related quality of life and symptom burden - EuroQol-5 Dimension (EQ-5D-5L) questionnaire. | Health-related quality of life (HRQoL) and symptom burden will be assessed using the EuroQol-5 Dimension (EQ-5D-5L) questionnaire. The EQ-5D-5L is a QoL assessment that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels ranging from no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5) to extreme problems. | Up to 3 years | 
| Health-related quality of life and symptom burden- Functional Assessment of Cancer Therapy Kidney System Index | Health-related quality of life (HRQoL) and symptom burden will be assessed using the Functional Assessment of Cancer Therapy Kidney System Index (FKSI-19) scores. The FKSI-19 is a 19-item questionnaire specific to kidney cancer. The items include disease-related symptoms(both physical and emotional), as well as treatment side-effects, and function/well-being. The questions are reported on a Likert scale as not at all, a little bit, somewhat, quite a bit, or very much. The questions address lack of energy, pain, weight loss, fatigue, shortness of breath, fevers, bone pain, cough, weakness, blood in urine, appetite, sleep, worry about the condition, nausea, diarrhea, bothered by side effects, ability to work, ability to enjoy life and level of content with the quality of life. | Up to 3 years | 
| Treatment satisfaction | The proportion of subjects satisfied or very satisfied with the weekly surveys to help manage side effects. | Up to 3 years | 
| VEGF TKI treatment adherence | The median number of doses missed in a 4-week treatment period. | Up to 3 years | 
| Adherence to Patient Reported Outcome -based symptom | Adherence to Patient Reported Outcome (PRO)-based symptom monitoring will be defined as the proportion of surveys completed per patient. | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient reported outcomes, vascular endothelial growth factor, quality of life, adverse effects