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

NCT05592665 | Active Not Recruiting DMC

• 1 other identifier: LCCC2126
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Keywords

patient reported outcomes; vascular endothelial growth factor; quality of life; adverse effects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Dose modifications

  Up to 3 years

• Dose interruption

  Up to 3 years

• Hospital admissions

  Up to 3 years

• Emergency department visits

  Up to 3 years

• Duration of treatment on initial VEGF TKI dose

  Up to 3 years

Study Arms (1)

Patient Perspective

OTHER

Study participants will complete several questionnaires/assessments related to adverse events and quality of life.

Other: Survey Questionnaire

Interventions

Survey Questionnaire OTHER

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

Patient Perspective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability for any reason to complete PRO surveys

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Doris Duke Charitable Foundation: collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tracy Rose

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: October 25, 2022
• Study Start: March 18, 2022
• Primary Completion (Estimated): January 16, 2027
• Study Completion (Estimated): January 16, 2031
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)