Patient-Reported Outcomes Monitoring for Kidney Cancer Treatment Side Effects

(PRO-VISION Trial)

Overseen By Julianna M Maccarone

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Must be taking: VEGF TKIs

Disqualifiers: Inability to complete surveys

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather information directly from patients about the side effects of certain oral cancer medications to improve management of those effects. It focuses on individuals with metastatic renal cell carcinoma (a type of kidney cancer) who are taking specific oral treatments. Participants will complete a short weekly survey about symptoms such as nausea or fatigue, which will be sent to their care team for follow-up if needed. Patients with kidney cancer undergoing treatment and able to complete surveys are well-suited for this trial. As an unphased trial, it offers patients the opportunity to contribute valuable insights that could enhance symptom management for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients may be receiving other cancer treatments alongside the study medication.

What prior data suggests that this survey questionnaire is safe for monitoring treatment side effects?

Research has shown that the oral treatments used in this study have been previously tested in individuals with advanced kidney cancer. These treatments are generally well-tolerated, though some patients may experience side effects such as nausea or fatigue. While these side effects can be uncomfortable, proper medical care often manages them effectively.

In similar studies, many participants continued their treatment without major issues. Although no treatment is without risk, evidence suggests that these oral treatments are relatively safe for people with kidney cancer.

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on understanding kidney cancer treatment side effects from the patient's perspective. While current treatments for kidney cancer typically involve surgery, targeted therapy, or immunotherapy, they don't always account for how patients personally experience side effects. This trial's unique approach of using survey questionnaires allows for direct feedback from patients about adverse events and quality of life. By capturing this data, researchers hope to develop more patient-centered treatment strategies that could ultimately improve care and outcomes for kidney cancer patients.

What evidence suggests that this survey questionnaire is effective for managing side effects in kidney cancer treatment?

Research has shown that certain oral medications, known as VEGFR TKIs, effectively treat advanced kidney cancer. These drugs block signals that help cancer cells grow the blood vessels they need to survive and spread. Studies have found that these medications can slow kidney cancer progression and sometimes shrink tumors. Patients taking these treatments often experience better outcomes compared to those not taking the drugs. However, side effects like nausea and tiredness can occur. In this trial, participants will complete several questionnaires to monitor these side effects and assess quality of life, which may aid in better management and improve patients' quality of life.

Who Is on the Research Team?

Tracy Rose, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with renal cell carcinoma who need VEGF TKI treatment. They must be able to complete surveys in English or Spanish and have internet or phone access. Those unable to do the surveys are excluded.

Inclusion Criteria

I am willing and able to follow all study requirements.

My kidney cancer needs treatment targeting blood vessel growth.

I am currently receiving treatment that helps my immune system fight cancer.

Exclusion Criteria

You are unable to complete surveys about how you feel for any reason.

All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VEGFR TKI treatment and complete weekly surveys to monitor side effects and quality of life

Up to 3 years

Weekly surveys (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Survey Questionnaire

Trial Overview The study tests if monitoring side effects through weekly patient-reported outcomes via survey can help manage symptoms from oral VEGFR TKI chemotherapies used in metastatic kidney cancer.

How Is the Trial Designed?

Group I: Patient Perspective Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Doris Duke Charitable Foundation

Collaborator

Trials

65

Recruited

264,000+

Published Research Related to This Trial

In a multicenter clinical trial involving 152 lung cancer patients, the use of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) allowed for high compliance in self-reporting adverse events, particularly during treatment (86% compliance).

The study demonstrated that patients were willing to self-report their symptoms using tablet computers, and identified that improving data collection methods, such as allowing electronic reporting between visits, could further enhance compliance and data quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial. Basch, E., Pugh, SL., Dueck, AC., et al.[2022]

The study involved 127 cancer patients undergoing chemotherapy or radiation therapy, and it confirmed that most adverse event (AE) terms in the PRO-CTCAE library were easily understood by patients, regardless of their education level.

Minor modifications were made to 17 AE terms to enhance clarity and comprehension, ultimately supporting the content validity of the PRO-CTCAE for accurately capturing patient-reported outcomes during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Hay, JL., Atkinson, TM., Reeve, BB., et al.[2022]

Citations