Gregory Azzam, MD, PhD
University of Miami
Patient Reported Outcomes/QoL/Survivorship
Purpose/Objective(s): Skin and soft tissue fibrosis of the neck is a common late toxicity of head and neck cancer treatment. To date, no comprehensive patient-reported outcome survey specifically addresses this toxicity. This study documents a patient-reported outcome metric adapted from research in scleroderma that identifies and categorizes patients with symptomatic fibrosis that may be missed on other quality of life (QOL) surveys.
Materials/Methods: As part of an ongoing IRB-approved prospective clinical trial currently accruing at a single-institution, we enrolled patients previously treated with head and neck radiation (RT). Participants completed the EORTC Core QOL Questionnaire (QLQ-C30), QOL Questionnaire Head and Neck Module (QLQ-H&N43), in addition to a modified pre-existing survey initially validated to assess symptom severity in patients with fibrotic disease states (Scleroderma Skin Patient-Reported Outcome, SSPRO). The SSPRO survey was minimally modified from its validated version to be more applicable to our intended cohort and is composed of 22 questions divided into four subdomains including physical effect (PE), emotional effect (E), physical limitation (PL), and social limitation (SL). A correlation between the QLQ-C30 and QLQ-H&N43 scoring against SSPRO was performed using Pearson’s correlation coefficient statistical analysis against the SSPRO survey scores for patients with RT-induced fibrosis.
Results: A total of 35 patients have enrolled in the clinical trial and are included in this analysis. Seven patients received surgery followed by concurrent chemoRT, 7 patients underwent surgery and adjuvant RT, 20 patients had concurrent chemoRT, and 1 patient was treated with RT alone. Using SSPRO raw scores, patients were placed into mild, moderate and severe categories: mild 0-25, n=24 (68.6%); moderate 26-49, n=8 (22.8%); severe 50-100, n=3 (8.6%). Using Pearson’s correlation coefficient, correlations were significant between the SSPRO survey scores and QLQ-C30 (r=0.443, p=0.0076) and QLQ-H&N43 (r=0.601, p=0.0001).
Conclusion: In these preliminary results, we identified the modified SSPRO as a new QOL tool that improves the ability to identify symptomatic fibrosis in head and neck patients. Comparison of this survey to the QLQ-C30 and QLQ-H&N43 indicates significant positive correlations in scoring although of only mild and moderate strength. Relatively few skin-focused questions in the EORTC surveys may account for lack of a stronger correlation with the SSPRO. We propose that the SSPRO more adequately captures QOL detriment after head and neck RT because it provides more detailed fibrosis information. Likewise, since such few skin-directed questions are included in the EORTC surveys, the SSPRO also allows for more precise categorization of patients based on symptom severity. More studies are needed to determine how this tool can be used to follow patients with fibrosis as well as quantify improvements after treatment.
University of Miami
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