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

Renal Cell Carcinoma Clinical Trial

— PRO-VISION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05592665
• Other study ID #: LCCC2126
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2022
• Est. completion date: January 7, 2031

Study information

• Verified date: March 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Brianna Castrogivanni
• Phone: (919) 843-7843
• Email: brianna_castrogivanni[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: January 7, 2031
• Est. primary completion date: January 7, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Other:
• Survey Questionnaire
Study participants will complete several questionnaires/assessments via PRO-Core standardized email communication or via telephone with a study team member.

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	Doris Duke Charitable Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Hospital admissions	The proportion of patients requiring hospitalization for a treatment-related side effect.	Up to 3 years
Secondary	Emergency department visits	The proportion of patients requiring an emergency department visit for treatment-related adverse events.	Up to 3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Treatment satisfaction	The proportion of subjects satisfied or very satisfied with the weekly surveys to help manage side effects.	Up to 3 years
Secondary	VEGF TKI treatment adherence	The median number of doses missed in a 4-week treatment period.	Up to 3 years
Secondary	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

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