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

42 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Survey Questionnaire for monitoring kidney cancer treatment side effects?

Research shows that using patient-reported outcomes (PROs) can improve communication between patients and doctors, helping to better monitor and address side effects during cancer treatment. This approach has been validated in studies with kidney cancer patients, indicating it can effectively capture patient experiences and improve care. ^{1 2 3 4 5}

Is the Patient-Reported Outcomes Monitoring for Kidney Cancer Treatment Side Effects generally safe for humans?

The use of patient-reported outcomes to monitor side effects in kidney cancer treatment has been studied, and while it focuses on understanding patient experiences, it does not directly address safety concerns. However, the process of collecting patient-reported outcomes is generally considered safe as it involves surveys and questionnaires to gather information about side effects. ^{2 6 7 8 9}

How does this treatment for kidney cancer differ from other treatments?

This treatment is unique because it focuses on monitoring patient-reported outcomes to understand side effects from the patient's perspective, rather than relying solely on clinician assessments. This approach aims to improve communication between patients and doctors about side effects, potentially leading to better management of symptoms. ^{1 2 4 9 10}

What is the purpose of this trial?

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.

Research Team

Tracy Rose, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Development and initial validation of the NCCN/FACT symptom index for advanced kidney cancer. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Patient-reported experiences with side effects of kidney cancer therapies and corresponding information flow. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of patient-reported outcomes in oncology: a longitudinal analysis of patient-physician communication. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A Comparison of the Renal Cell Carcinoma-Symptom Index (RCC-SI) and the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI). [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of targeted therapies in metastatic renal cell carcinoma on patient-reported outcomes: Methodology of clinical trials and clinical benefit. [2018]

6. Netherlands 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). [2022]

7. United States 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. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Quality of life in patients with metastatic renal cell carcinoma: the importance of patient-reported outcomes. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Factors Affecting Quality of Life at Different Intervals After Treatment of Localized Prostate Cancer: Unique Influence of Treatment Decision Making Satisfaction, Personality and Sexual Functioning. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events: Methods for item selection in industry-sponsored oncology clinical trials. [2019]