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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Study participants will complete several questionnaires/assessments via PRO-Core standardized email communication or via telephone with a study team member.
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
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.
Time frame: Up to 3 years
Dose modifications
The proportion of patients who change the dose of VEGF TKI study treatment during the duration of treatment with VEGF TKI therapy.
Time frame: 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.
Time frame: Up to 3 years
Hospital admissions
The proportion of patients requiring hospitalization for a treatment-related side effect.
Time frame: Up to 3 years
Emergency department visits
The proportion of patients requiring an emergency department visit for treatment-related adverse events.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 years
Treatment satisfaction
The proportion of subjects satisfied or very satisfied with the weekly surveys to help manage side effects.
Time frame: Up to 3 years
VEGF TKI treatment adherence
The median number of doses missed in a 4-week treatment period.
Time frame: 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.
Time frame: Up to 3 years
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