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Because current health-related quality-of-life (HRQOL) measures for patients with cancer often aren't applicable to those with metastatic renal cell carcinoma (mRCC), researchers have been developing a measure specifically for these patients.

"We aimed to develop a tailored HRQOL measure for patients with mRCC through a three-phase approach involving patient engagement, expert input, and advocacy," Cristiane Bergerot, PhD, of the Grupo Oncoclinicas in Brasilia, Brazil, and colleagues explained in an abstract presented at the .

In the following interview, Bergerot, who is director of supportive care at Grupo Oncoclinicas, discussed how and why the team came up with the novel 12-question HRQOL measure.

Where do current HRQOL measures such as FKSI-19 [Functional Assessment of Cancer Therapy-Kidney Symptom Index] or EORTC QLQ-C30 [EORTC Quality-of-Life Core Questionnaire] fall short or not apply to patients with mRCC?

Bergerot: Current HRQOL measures such as the FKSI-19 and EORTC QLQ-C30 have been valuable tools in assessing the impact of RCC and its treatments on patients' well-being. However, our study has revealed certain limitations and areas where these measures may fall short or not fully apply to patients with mRCC.

One significant limitation is the lack of relevance of many items included in these measures to patients with mRCC. Our findings from the first phase of the study indicate that only a small subset of items from these measures were deemed relevant by the majority of our patients.

Specifically, out of 54 items derived from the EORTC QLQ-C30, FKSI-19, and EQ-5D [EuroQol 5 Dimension], only 15 were considered relevant by 66% or more of our patient population. Among these, 10 items were from the FKSI-19, 3 from the QLQ-C30, and 2 from the EQ-5D.

This limited relevance of the existing HRQOL measures to patients with mRCC suggests that these tools may not adequately capture the unique experiences and challenges faced by this patient population. Many of the items included in these measures may not address the specific symptoms, concerns, and priorities of patients with mRCC, thereby limiting their utility in assessing the impact of the disease and its treatment on patients' quality of life.

Furthermore, the focus of existing HRQOL measures on generic aspects of quality of life may overlook important disease-specific symptoms and functional impairments that are particularly relevant to patients with mRCC.

As such, there is a need for the development and validation of more tailored and disease-specific HRQOL measures that better reflect the experiences and priorities of patients with mRCC. These measures should capture not only the physical and emotional aspects of quality of life but also the unique challenges associated with living with metastatic cancer and undergoing targeted therapies.

Can you describe the 3-phase process you used to develop this tailored measure?

Bergerot: Our process for developing this tailored measure involved patient input, expert panel review, and patient advocates validation.

In the initial phase, we gathered feedback directly from patients on each item of existing quality-of-life questionnaires, focusing on relevance, clarity, and importance. This patient-centered approach ensured that the measure accurately reflected the priorities and challenges faced by individuals with mRCC.

Subsequently, an expert panel of healthcare professionals reviewed the patient feedback and offered recommendations for refining the questionnaires to better suit the needs of mRCC patients.

Finally, validation of the tailored measure was sought from patient advocates, ensuring its relevance and applicability across the broader patient community. Through this iterative process, we developed a comprehensive and multidisciplinary measure that effectively captures the unique quality of life concerns of individuals living with mRCC.

Do you have a name for this new HRQOL questionnaire, even a tentative one?

Bergerot: At this stage, we are collaboratively exploring potential names for the new questionnaire in partnership with patients. We believe it's essential to involve patients in this decision-making process to ensure that the chosen name accurately reflects the essence and purpose of the questionnaire while resonating with those who will be using it.

Further validation is planned in a phase III trial. Can you tell us more about this?

Bergerot: We have planned further validation of our new model in a phase III trial to ensure its robustness and reliability. This final model, tailored for advanced disease, will undergo validation in upcoming trials, including a retrospective analysis in the PRISM study and primary assessment of HR-QOL in the CARE-1 study.

Is there anything else you want to make sure oncologists understand about your research or this topic?

Bergerot: Certainly! It's essential for oncologists to recognize that our research aims to address a critical gap in current HR-QOL assessment tools, particularly concerning their applicability to patients with metastatic RCC. By developing a tailored questionnaire through a patient-centered approach, we aim to provide a more accurate representation of the challenges and concerns faced by these patients.

This tailored approach not only enhances the relevance and reliability of HR-QOL assessment, but also fosters a deeper understanding of the holistic impact of treatment on patients' lives.

Furthermore, we believe that involving patients at every stage of the research process is paramount, as it ensures that the resulting questionnaire truly reflects their experiences and priorities. Ultimately, our goal is to equip oncologists with a comprehensive tool that facilitates more effective communication, personalized treatment decisions, and improved patient outcomes in the management of metastatic RCC.

Read the study here and expert commentary about it here.