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

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 Overview

• Status: Recruiting
• Conditions: Renal Cell Carcinoma
• Intervention / Treatment: Other: Survey Questionnaire

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brianna Castrogivanni; Phone Number: (919) 843-7843; Email: brianna_castrogivanni@med.unc.edu
• Study Contact Backup: Name: Julianna M Maccarone; Phone Number: (919) 445-4922; Email: julmacc@email.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • Lineberger Comprehensive Cancer Center
      • Contact: Catherine Cheng; Phone Number: 919-445-4208; Email: catherine_cheng@med.unc.edu
      • Principal Investigator: Tracy Rose, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: Doris Duke Charitable Foundation
• Investigators: Principal Investigator: Tracy Rose, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2022
• Primary Completion (Estimated): January 7, 2026
• Study Completion (Estimated): January 7, 2031

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; adverse effects; patient reported outcomes; vascular endothelial growth factor
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma, Renal Cell
• Other Study ID Numbers: LCCC2126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No