Development and validation of the functional assessment of cancer therapy: Antiangiogenesis (FACT-AntiA).

Abstract

e20527 Background: Anti-angiogenesis therapies represent a significant and promising advancement in cancer treatment. Side effects from angiogenesis inhibitors, although generally milder than chemotherapy side effects, have the potential to impact Health-related Quality of Life (HRQOL) and may lead to dose reduction or discontinuation. Currently, there are no patient-reported outcomes (PRO) measures that specifically assess HRQOL related to anti-angiogenesis therapy. This study describes the development and validation of a PRO questionnaire for anti-angiogenesis therapy, the FACT-AntiA. Methods: Scale development included identification of 59 anti-angiogenesis side effects from the literature and clinician and patient input. Patient and clinician ratings of the importance of these side effects led to the development of a 24-item scale. Cognitive interviews with 10 patients confirmed item wording and meaning. To assess psychometric properties of the scale, 132 kidney cancer patients completed the FACT-AntiA and other PRO measures including the Functional Assessment of Cancer Therapy-General (FACT-G), the FACT-Kidney Cancer Symptom Index-19 (FKSI-19), and PROMIS Global Health at 3 time points. Patient responses to the FACT-AntiA were analyzed for internal consistency, test-retest reliability, convergent and discriminant validity, and responsiveness to change in clinical status. Results: FACT-AntiA side-effect subscales scores and total score were found to have good internal consistency reliability (most Cronbach’s alpha > 0.70). Test-retest reliability was greater than 0.70 for most subscales and individual items. All single items (except nosebleeds), subscales, and the total score significantly differentiated between groups defined by level of side effect bother. Conclusions: The number of patients who reported a change in their side effect bother was small so evaluation of FACT-AntiA responsiveness to change requires further study. The FACT-AntiA was developed and validated as a tool to enhance treatment decision-making and side effect management for patients receiving anti-angiogenesis therapies and is a reliable and valid index for evaluation of therapy side effects.