Patient Reported Outcomes/Quality of Life
PV QA 4 - Poster Viewing Q&A 4
Purpose/Objective(s): Assessment of patient-reported outcomes (PROs) is increasingly recognized as an important facet of patient care and treatment decision making. Measuring symptom severity and its effects on functioning based on PRO are widely accepted in clinical research and are endorsed by the US Food and Drug Administration (FDA) for use in drug labeling-claim trials. However, the use of PROs has not kept pace with recent rapid advances in esophageal cancer treatment, such as proton therapy. Verified with both quantitative and qualitative data from targeted patients, disease- and treatment-specific versions of the MD Anderson Symptom Inventory (MDASI) have been developed for use in multiple cancers, but not esophageal cancer. This qualitative study, which uses a standardized method to delineate patient outcomes that is recommended by the FDA for PRO tool development, aims to define most impactful symptoms experienced by esophageal cancer patient with radiotherapy, in order to generate a treatment-specific module of the MD Anderson Symptom Inventory (MDASI-Eso).
Materials/Methods: Patients with esophageal cancer (N=20) enrolled during or within 6-months after radiotherapy (IMRT 15, Proton 5) participated in a face-to-face, semi-structured qualitative interview. Qualitative analysis generated a list of symptoms that patients reported. To refine the list, radiation/medical oncologist, and patients and their caregivers commented on the relative importance of these symptoms during and after radiotherapy. Final candidate items were added to the 13 MDASI core symptoms to form a provisional MDASI-Eso module.
Results: The qualitative study identified 51 symptoms. The 3 most frequently reported disease and treatment symptom was fatigue, difficulty swallowing and pain; most of the 13 core MDASI symptoms were mentioned as well. After input from the expert panel (4 oncologist, 8 patients, 5 caregivers), 8 candidate module items were selected: difficulty swallowing, weakness, inability to eat, constipation, regurgitation (acid reflux), sore mouth or throat, diarrhea and hoarseness or voice change.
Conclusion: This study produced a set of symptoms for inclusion in the MDASI-Eso, now under psychometric validation in the same patient cohort for the examination of reliability, validity and sensitivity. The validated MDASI-Eso will be a concise but adequate assessment applicable to esophageal cancer patients undergoing radiotherapy. It will be utilized for routinely monitoring patients and will be rapidly evolved in clinical trials for new treatments, e.g. Proton therapy, along with conventional clinical outcomes.
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