The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE). Because this approach underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as a companion to the CTCAE, called the PRO-CTCAE. This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement properties. A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting. For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity, and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items. These items were refined in a cognitive interviewing study among patients on active cancer treatment with diverse educational, racial, and geographic backgrounds. Favorable measurement properties of the items, including construct validity, reliability, responsiveness, and between-mode equivalence, were determined prospectively in a demographically diverse population of patients receiving treatments for many different tumor types. A software platform was built to administer PRO-CTCAE items to clinical trial participants via the internet or telephone interactive voice response and was refined through usability testing. Work is ongoing to translate the PRO-CTCAE into multiple languages and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial workflow and AE analyses. It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse event reporting in cancer clinical research.

To develop, in a collaborative project, core measures of sun exposure and sun protection habits, since the lack of standard outcome measures hampers comparison of population surveys and interventions used in skin cancer prevention research.Design: A work group of investigators evaluated available questionnaire measures of sun exposure and protection. Their deliberations led to a proposed set of core questionnaire items for adults, adolescents aged 11 to 17 years, and children 10 years or younger. These core items were used in cognitive testing by the investigators. Crosssite summaries of methods, response samples, and descriptive data were prepared.

There is a need to investigate which health information sources are used and trusted by people with limited health literacy to help identify strategies for addressing knowledge gaps that can contribute to preventable illness. We examined whether health literacy was associated with people's use of and trust in a range of potential health information sources. Six hundred participants from a GfK Internet survey panel completed an online survey. We assessed health literacy using the Newest Vital Sign, the sources participants used to get health information, and the extent to which participants trusted health information from these sources. We performed multivariable regressions, controlling for demographic characteristics. Lower health literacy was associated with lower odds of using medical websites for health information and with higher odds of using television, social media, and blogs or celebrity webpages. People with lower health literacy were less likely to trust health information from specialist doctors and dentists, but more likely to trust television, social media, blogs/celebrity webpages, friends, and pharmaceutical companies. People with limited health literacy had higher rates of using and trusting sources such as social media and blogs, which might contain lower quality health information compared to information from healthcare professionals. Thus, it might be necessary to enhance the public's ability to evaluate the quality of health information sources. The results of this study could be used to improve the reach of high-quality health information among people with limited health literacy and thereby increase the effectiveness of health communication programs and campaigns.

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This paper reviews findings regarding the influence of cancer worry on cancer screening behaviors. The role of cancer worry in motivating cancer screening has been pursued for over 30 years. Recent concerns that high levels of cancer worry may impede the screening behavior of high-risk individuals have further prioritized this area of research. Despite heavy attention in the literature, there is currently no theoretical or empirical consensus concerning whether cancer worry motivates or inhibits cancer screening behaviors. We focus the review on four questions: (1) What is cancer worry? (2) To what extent are people worried about cancer? (3) What are the predominant theoretical approaches to understanding the role of cancer worry in cancer screening behaviors? (4) What is the empirical evidence for the role of cancer worry in cancer screening behaviors? We identify factors that have hampered theoretical and empirical advancement, including divergent definitions and measurement strategies for cancer worry, low to moderate levels of cancer worry even among those at high risk, and a reliance on cross-sectional research designs. The review clarifies the current state of this literature, and proposes future research strategies, including an expanded emphasis on cancer worry and cancer screening among men and diverse racial/ethnic groups.