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VIEW ROLESCancer patients often experience rapid and long-term declines in physical functioning due to disease symptoms and treatment effects, leading to increased healthcare costs and higher risks of mortality and morbidity. Recognizing its significance, the FDA Oncology Center of Excellence has identified physical functioning as a key outcome in cancer clinical trials. The FDA considers it a direct measure of treatment impact, best assessed through standardized patient-reported outcome (PRO) instruments, which complement other clinical endpoints in cancer drug development.
Several PRO instruments have been used frequently to measure physical functioning in cancer trials, such as the EORTC QLQ-C30 (Fayers 2002), the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning short-forms (Rose 2008), and the SF-36 Health Survey (Ware 1992). These instruments have been shown to be reliable and valid in cancer patients, and there is a lot of overlap in item content between them. Despite the availability of these PRO instruments, there is room for improvement.
IQVIA’s THRIVE Physical Functioning measure was developed to address several limitations with the existing instruments. This includes the need for more diversity in the characteristics of participants involved in qualitative research aimed to develop PRO item content – and more importantly, the need for cancer specific benchmarking and natural history profile data to support trial investigators as they interpret the meaningfulness of cancer trial outcomes.
Join IQVIA's Patient Centered Solutions (PCS) team as we address the following topics:
Fayers P, Bottomley A. Quality of life research within the EORTC – the EORTC QLQ-C30. European Journal of Cancer 2002;38(4)Suppl: 125-133.
Rose M, Bjorner JB, Becker J, Fries JF, Ware JE. Evaluation of a preliminary physical function item bank supported the expected advantages of the Patient-Reported Outcomes Measurement Information System (PROMIS). Journal of Clinical Epidemiology. 2008; 61(1):17–33.
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Medical Care. 1992; 30(6):473–483.
Capture the patient experience across the full trial process, from strategy to dissemination of results.
