What do we measure with PROs in head and neck cancer? Pain, QoL, adverse events and more

Redefining Outcomes in Oncology with PROs

Patient-Reported Outcomes (PROs) have become essential in oncology research, bridging the gap between clinical efficacy and patient experience. By prioritizing the patient’s voice, PROs capture the nuanced impacts of treatment, shaping interventions that improve care quality and overall outcomes (Kluetz et al., 2016). Recent studies, such as White et al. (2024), underscore the unique emotional distress experienced by head and neck cancer patients. Traditional clinical outcomes often overlook these dimensions, which can be effectively captured through PROs. This is why oncology Randomized Controlled Trials (RCTs) have gradually moved from non-PRO reporting to a greater focus on PROs (Gode and Faggion, 2024).

In head and neck cancer, where treatments significantly affect physical and psychosocial aspects, PROs provide critical insights into patients’ symptoms, functional impairments, and overall quality of life (QoL). This article explores how PROs enhance research in this area, delves into measurement tools, examines the rise of electronic PROs (ePROs), and addresses challenges in integrating PROs into clinical trials.

The Role of PROs in Head and Neck Cancer Research

Capturing Patient-Centered Data

Treatments for head and neck cancer often impair speech, swallowing, and physical appearance, profoundly affecting patients’ psychosocial well-being. PROs address this gap by capturing direct patient-reported data on symptoms, adverse events, and functional impairments (Strong, 2015). These insights are critical for developing personalized treatments that balance efficacy, tolerability, and patient well-being (Basch et al., 2016).

Rehabilitation efforts further amplify the role of PROs. For instance, Matko et al. (2024) demonstrated significant improvements in QoL and reductions in psychological distress among head and neck cancer patients undergoing rehabilitation programs. Such findings underscore the value of PROs in tailoring interventions to meet patient-specific needs.

Transforming Study Designs and Clinical Practice

The inclusion of PROs in clinical trials drives innovation in study design. Trials can evaluate therapies holistically by incorporating metrics like pain, fatigue, and social functioning. For example, Win et al. (2025) emphasized how ePROs support real-time symptom tracking, enabling better management of acute and chronic toxicities. These innovations facilitate shared decision-making and improve treatment guidelines.

Instruments for Measuring PROs in Head and Neck Cancer

Commonly Used Tools

Validated instruments tailored to specific aspects of the patient experience include:

• Pain Assessment: Visual Analogue Scale (VAS), Numerical Rating Scale (NRS), and McGill Pain Questionnaire (Melzack, 1975; Delgado et al., 2018).
• Quality of Life: EORTC QLQ-C30 and QLQ-H&N35 capture physical, emotional, and social dimensions of QoL (Gode and Faggion, 2024).
• Functional Measures: MD Anderson Dysphagia Inventory (MDADI) and MD Anderson Symptom Inventory for head and neck (MDASI-HN) assess swallowing difficulties (Gode and Faggion, 2024).

Gonçalves et al. (2024) highlighted the importance of these tools in palliative care settings, demonstrating their effectiveness in capturing symptom distress and its impact on QoL. However, standardization is crucial to improve data comparability and facilitate meta-analyses (Strong, 2015).

The Rise of ePRO Platforms: Opportunities, Challenges & Implementation

In clinical trials, adopting electronic Patient-Reported Outcomes (ePROs) can transform how patient-reported data is collected, analyzed, and utilized. However, as with any innovation, ePROs come with advantages and challenges.

Benefits of ePROs

Digital platforms like Castor ePRO are revolutionizing PRO data collection and analysis. By leveraging devices like smartphones, ePROs:

• Enhance data quality through automated capture (Strong, 2015).
• Increase patient participation (Basch et al., 2016).
• Streamline analysis via integration with electronic medical records (EMRs) (Kluetz et al., 2016).

Kiafi et al. (2024) provided comparative evidence that advanced therapies like proton radiation improve PROs. These benefits highlight ePROs’ potential for more effectively managing acute and chronic symptoms.

Challenges and Mitigation Strategies

Despite their benefits, ePROs present challenges:

• Digital Literacy: Patients less familiar with technology may struggle with ePRO platforms. Early assessments and training can address this.
• Data Security: Ensuring patient trust requires robust encryption and compliance with GDPR and HIPAA regulations (Strong, 2015). Reliable platforms with integrated security measures mitigate these risks.
• Technical Issues: Device compatibility and software glitches can hinder data collection. Platforms offering robust support and reliability are essential.

Best Practices for Integrating ePROs in Clinical Trials

Successful implementation of ePRO requires addressing several practical considerations to ensure optimal usability, data quality, and patient engagement. With that in mind, researchers should consider the following strategies:

1. Assess Digital Literacy Early: Evaluate patients’ tech skills and access, providing support as needed.
2. Choose the Right Platform: Prioritize secure, user-friendly tools that integrate with EMRs.
3. Simplify Interfaces: Pilot test tools to reduce barriers to data entry and improve usability.
4. Leverage Real-Time Data: Use immediate feedback to enhance trial outcomes and patient care.

The Future of ePROs in Head and Neck Cancer Research

As ePROs evolve, AI and predictive analytics will take them further. Advanced platforms can:

• Analyze Trends: Identify patterns in large-scale PRO datasets for better clinical decisions (Gudenkauf et al., 2024).
• Personalize Care: AI-powered insights enable tailored interventions based on patient-specific data.

For example, Gudenkauf et al. (2024) demonstrated how AI tools like the FACT-ICM-17 provide more precise symptom tracking, revolutionizing patient management.

Conclusion

The adoption of ePRO platforms is reshaping the landscape of head and neck cancer research. By improving data quality, increasing patient engagement, and enabling real-time analysis, ePROs offer unparalleled opportunities to capture the patient’s voice. However, addressing digital literacy, ensuring robust data security, and selecting reliable platforms remain critical to their success.

The future lies in integrating AI and advanced analytics into ePROs, pushing the boundaries of personalized care. By embracing these innovations, researchers and clinicians can transform oncology research, making patient-centered care not just a goal but a reality.

The goal is clear: Embrace innovation, amplify the patient voice, and transform outcomes.

References

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4. Gudenkauf, L.M., Tometich, D.B., Hoogland, A.I., et al. (2024). Validation of the Functional Assessment of Cancer Therapy–Immune Checkpoint Modulator 17-Item Symptom Index (FACT-ICM-17) to Facilitate Implementation in Oncology. SSRN. Access PDF

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