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

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

NCT ID: NCT05592665

Condition: Renal Cell Carcinoma

Conditions: Official terms:
Carcinoma, Renal Cell

Conditions: Keywords:
patient reported outcomes
vascular endothelial growth factor
quality of life
adverse effects

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Survey Questionnaire
Description: Study participants will complete several questionnaires/assessments via PRO-Core standardized email communication or via telephone with a study team member.
Arm group label: Patient Perspective

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Lineberger Comprehensive Cancer Center

Address:
City: Chapel Hill
Zip: 27514
Country: United States

Start date: March 18, 2022

Completion date: January 16, 2031

Lead sponsor:
Agency: UNC Lineberger Comprehensive Cancer Center
Agency class: Other

Collaborator:
Agency: Doris Duke Charitable Foundation
Agency class: Other

Source: UNC Lineberger Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05592665
http://unclineberger.org/patientcare/clinical-trials/clinical-trials