Purpose
The National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a library of question items that enables patient reporting of adverse events (AEs) in clinical trials. This study contributes content validity evidence of the PRO-CTCAE by incorporating cancer patient input of the relevance and comprehensiveness of the item library.
Methods
Cognitive interviews were conducted among patients undergoing chemotherapy or radiation therapy at multiple sites to evaluate comprehension, memory retrieval, judgment, and response mapping related to AE terms (e.g., nausea); attribute terms (regarding frequency, severity, or interference); response options; and recall period. Three interview rounds were conducted with ≥20 patients completing each item per round. Items were modified and retested if ≥3 patients exhibited cognitive difficulties or if experienced by ≤25% patients.
Results
127 patients participated (35% ≤high school; 28% non-white; 59% female). Most AE terms (63/80) generated no cognitive difficulties. The remaining 17 were modified without further difficulties by Round 3. Terms were comprehended regardless of education level. Attribute terms and response options required no modifications. Patient adherence to recall period (7-days) was improved when the reference period was incorporated.
Conclusions
This study provides evidence confirming comprehension of the U.S. English language versions of items in the PRO-CTCAE library for measuring symptomatic AEs from the patient perspective within the context of cancer treatment. Several minor changes were made to the items to improve item clarity, comprehension, and ease of response judgment. This study helps establish the content validity of PRO-CTCAE items for patient reporting of AEs during cancer treatment.
Skin cancer is highly preventable, but clearly there is a critical need to focus on better ways to disseminate information about known skin cancer prevention. The U.S. Environmental Protection Agency's (EPA) SunWise Program is one channel for reaching children, teachers, and school nurses. In a pilot study designed to increase adoption of school-based sun protection policies, 28 schools were randomly assigned to one of three groups: Control, which included the EPA's original SunWise curriculum toolkit; SunWise Policy, which included a revised toolkit emphasizing policy; and SunWise Policy plus Technical Assistance, which included the policy toolkit and 3 technical assistance phone calls. The enhanced SunWise Policy plus Technical Assistance intervention led to more new sun protection policies. Use of study interventions for improving sun protection practices such as policy toolkits or brief counseling can be easily interwoven into school hours by school nurses and other health educators.
Cancer patient communication is always embedded in a complex background of inter-related parts, i.e., a system. Cancer patients are specifically exposed to a healthcare system. Considering this context, this article summarizes the insight from a roundtable discussion involving behavioral medicine and oncology experts convened at the 2008 Annual Meeting of the Society of Behavioral Medicine as part of an annual pre-conference course entitled "Interpersonal Communication and Cancer Control: Emerging Themes". In this paper we summarize the communication-relevant components of healthcare systems, focusing on the macro level. Next, we review existing theoretical frameworks for systems-based communication, the unique aspects of "systems thinking," and the emerging systems tools that can be integrated in cancer communication. Finally, we propose a research agenda for successful system approaches for patient-centered cancer communication.
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