Patient-Reported Physical Function Measures in Cancer Clinical Trials

Area of Science:

• Oncology
• Clinical Trials
• Health Outcomes Research

Background:

• Patient-reported outcomes (PROs) are vital for monitoring cancer treatment effects on physical function.
• Assessing PRO physical function is crucial for restoring pre-treatment levels in cancer survivors.

Purpose of the Study:

• To systematically review PRO physical function measures in cancer clinical trials.
• To evaluate the psychometric properties of these measures against FDA guidelines.

Main Methods:

• Systematic review of 5 databases (PubMed/MEDLINE, EMBASE, CINAHL, Health and Psychosocial Instruments, Cochrane) up to October 2015.
• Identified 108 trials capturing PRO physical function from 10,233 initial articles.
• Evaluated psychometric properties based on US Food and Drug Administration (FDA) guidelines.

Main Results:

• The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was used in 67% of trials, and the Medical Outcomes Study Short Form 36 (MOS SF-36) in 25%.
• Both EORTC QLQ-C30 and MOS SF-36 generally meet FDA requirements but lacked direct patient input in item development.
• The Patient-Reported Outcomes Measurement Information System (PROMIS) physical function short form is a potential brief alternative.

Conclusions:

• Clinicians must carefully select PRO measures based on psychometric properties for robust clinical trial design.
• Comprehensive understanding of patient function requires careful consideration of PRO instrumentation.
• PROMIS PF offers a potentially brief and viable option for assessing physical function in cancer trials.