Integrating 4 methods to evaluate physical function in patients with cancer (In4M): protocol for a prospective cohort...

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 assessment types need characterization for clinical decision-making.

Purpose of the Study:

• To characterize longitudinal measurement properties of physical function assessments in cancer patients.
• To evaluate the feasibility and patient experience of multimodal data collection.
• To inform regulatory and clinical decision-making in cancer clinical trials and practice.

Main Methods:

• Prospective study enrolling 200 patients with breast cancer or lymphoma receiving chemotherapy.
• Longitudinal physical function assessments using clinician-reported outcomes, patient-reported outcomes (PROs), and wearable sensors.
• Data aggregation via a patient-centered platform, followed for 9 months.

Main Results:

• Data analysis focuses on variability, sensitivity, and meaningful change in physical function assessments.
• Evaluation of relationships between physical function measures and key clinical outcomes.
• Assessment of the feasibility, usability, and acceptability of data collection methods.

Conclusions:

• Multimodal data collection using digital health tools is feasible in cancer patients.
• Understanding measurement characteristics of physical function assessments is vital for oncology research and practice.
• Patient-centered data aggregation platforms and wearable sensors show promise for real-world oncology applications.