PRO-VISION: Patient Reported Outcomes-Based Monitoring of VEGF-Inhibitor Side Effects in ONcology
- Conditions
- Renal Cell Carcinoma
- Interventions
- Other: Survey Questionnaire
- Registration Number
- NCT05592665
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 42
- 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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patient Perspective Survey Questionnaire Study participants will complete several questionnaires/assessments related to adverse events and quality of life.
- Primary Outcome Measures
Name Time Method Relative dose intensity 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 Outcome Measures
Name Time Method Duration of treatment on VEGF TKI regimen Up to 3 years 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.
Dose modifications Up to 3 years The proportion of patients who change the dose of VEGF TKI study treatment during the duration of treatment with VEGF TKI therapy.
Health-related quality of life and symptom burden -Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Up to 3 years 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.Dose interruption Up to 3 years The proportion of patients who change the dose of VEGF TKI study treatment during the duration of treatment with VEGF TKI therapy.
Hospital admissions Up to 3 years The proportion of patients requiring hospitalization for a treatment-related side effect.
Emergency department visits Up to 3 years The proportion of patients requiring an emergency department visit for treatment-related adverse events.
Duration of treatment on initial VEGF TKI dose Up to 3 years Duration of treatment on initial VEGF TKI dose is defined from day 1 of treatment until the first dose reduction or dose interruption.
Treatment satisfaction Up to 3 years The proportion of subjects satisfied or very satisfied with the weekly surveys to help manage side effects.
Progression-free survival Up to 3 years 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.
Adherence to Patient Reported Outcome -based symptom Up to 3 years Adherence to Patient Reported Outcome (PRO)-based symptom monitoring will be defined as the proportion of surveys completed per patient.
Health-related quality of life and symptom burden - EuroQol-5 Dimension (EQ-5D-5L) questionnaire. Up to 3 years 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.Health-related quality of life and symptom burden- Functional Assessment of Cancer Therapy Kidney System Index Up to 3 years 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.VEGF TKI treatment adherence Up to 3 years The median number of doses missed in a 4-week treatment period.
Trial Locations
- Locations (1)
Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States