Integrating 4 Measures to Evaluate Physical Function in Patients with Cancer (In4M): Protocol for a prospective study

Area of Science:

• Oncology
• Digital Health
• Clinical Trials

Background:

• Accurate physical function assessment is crucial for understanding cancer and treatment impacts.
• Digital health technologies offer new methods for measuring patient symptoms and function.
• Longitudinal measurement characteristics of various physical function assessments need characterization for clinical and regulatory use.

Approach:

• Prospective study enrolling 200 patients with breast cancer or lymphoma receiving chemotherapy.
• Utilizing multiple assessment modalities: clinician-reported (ClinRo), patient-reported (PRO), performance outcome tests (PerfO), and wearable sensors.
• Employing a patient-centered health data aggregating platform for longitudinal data collection over 9 months.

Key Points:

• Focus on understanding variability, sensitivity, and meaningful changes across physical function assessments.
• Evaluating the relationship between physical function measures and key clinical outcomes.
• Assessing the feasibility, usability, and acceptability of multi-modal data collection methods.

Conclusions:

• Characterizing multi-modal physical function measures addresses an unmet need in cancer patient assessment.
• Rigorous measurement of physical function is key for assessing cancer treatment tolerability.
• Findings will inform clinical trial design and oncology practice by providing insights into digital health tool performance.