Jennifer L. Hay

Development of the National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institutes (NCIs) 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.

Measures of Sun Exposure and Sun Protection Practices for Behavioral and Epidemiologic Research

OBJECTIVE 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. Cross-site summaries of methods, response samples, and descriptive data were prepared. SETTING Nine locations across the United States. PARTICIPANTS The study population comprised 81 individuals. RESULTS No unusual response patterns were detected in any of the respondent groups or for any specific question. Some revisions to the survey items resulted from the need for clarification or emphasis of frames of reference such as adding or underlining key phrases in a question. CONCLUSIONS The combination of expert review followed by cognitive interviewing yielded standardized core survey items with good clarity and applicability for measuring sun exposure and sun protection behaviors across a broad range of populations. They are appropriate for studies tracking morbidity and/or mortality and evaluating prevention program effects.

Exposure to mass media health information, skin cancer beliefs, and sun protection behaviors in a United States probability sample

BACKGROUND The mass media is increasingly important in shaping a range of health beliefs and behaviors. OBJECTIVE We examined the association among mass media health information exposure (general health, cancer, sun protection information), skin cancer beliefs, and sun protection behaviors. METHODS We used a general population national probability sample comprised of 1633 individuals with no skin cancer history (Health Information National Trends Survey, 2005, National Cancer Institute) and examined univariate and multivariate associations among family history of skin cancer, mass media exposure, skin cancer beliefs, and sun protection (use of sunscreen, shade seeking, and use of sun-protective clothing). RESULTS Mass media exposure was higher in younger individuals, and among those who were white and more highly educated. More accurate skin cancer beliefs and more adherent sun protection practices were reported by older individuals, and among those who were white and more highly educated. Recent Internet searches for health or sun protection information were associated with sunscreen use. LIMITATIONS Study limitations include the self-report nature of sun protection behaviors and cross-sectional study design. CONCLUSION We identify demographic differences in mass media health exposure, skin cancer beliefs, and sun protection behaviors that will contribute to planning skin cancer awareness and prevention messaging across diverse population subgroups.

Using Confirmatory Factor Analysis to Evaluate Construct Validity of the Brief Pain Inventory (BPI)

CONTEXT The Brief Pain Inventory (BPI) is a frequently used instrument designed to assess the patient-reported outcome of pain. The majority of factor analytic studies have found a two-factor (i.e., pain intensity and pain interference) structure for this instrument; however, because the BPI was developed with an a priori hypothesis of the relationship among its items, it follows that construct validity investigations should use confirmatory factor analysis (CFA). OBJECTIVES The purpose of this work was to establish the construct validity of the BPI using a CFA framework and demonstrate factorial invariance using a range of demographic variables. METHODS A retrospective CFA was completed in a sample of individuals diagnosed with HIV/AIDS and cancer (n=364; 63% male; age 21-92 years, M=51.80). A baseline one-factor model was compared against two-factor and three-factor models (i.e., pain intensity, activity interference, and affective interference) that were developed based on the hypothetical design of the instrument. RESULTS Fit indices for the three-factor model were statistically superior when compared with the one-factor model and marginally better when compared with the two-factor model. This three-factor structure was found to be invariant across disease, age, and ethnicity groups. CONCLUSION The results of this study provide evidence to support a three-factor representation of the BPI, and the originally hypothesized two-factor structure. Such findings will begin to provide clinical trialists, pharmaceutical sponsors, and regulators with confidence in the psychometric properties of this instrument when considering its inclusion in clinical research.

Fears, feelings, and facts: interactively communicating benefits and risks of medical radiation with patients.

OBJECTIVE As public awareness of medical radiation exposure increases, there has been heightened awareness among patients and physicians of the importance of holistic benefit-and-risk discussions in shared medical decision making. CONCLUSION We examine the rationale for informed consent and risk communication, draw on the literature on the psychology of radiation risk communication to increase understanding, examine methods commonly used to communicate radiation risk, and suggest strategies for improving communication about medical radiation benefits and risk.

Adherence to colorectal cancer screening in mammography-adherent older women

Colorectal cancer (CRC) is the third leading cause of cancer mortality among women. Screening can prevent the development of CRC or diagnose early disease when it can effectively be cured, however existing screening methods are underutilized. In this study, we examined the utility of an updated Health Belief Model to explain CRC screening adherence. The present study included 280 older women seeking routine mammography at a large, urban breast diagnostic facility. Overall, 50% of women were adherent to CRC screening guidelines. Multiple regression indicated that self-efficacy, physician recommendation, perceived benefits of and perceived barriers to screening accounted for 40% of variance in CRC screening adherence. However, there was no evidence for two mediational models with perceived benefits and perceived barriers as the primary mechanisms driving adherence to CRC screening. These findings may inform both future theoretical investigations as well as clinical interventions designed to increase CRC screening behavior.

Melanoma Epidemiology and Public Health

This article reviews the research on, and examines the epidemiology and prevention of melanoma. Despite the great quantity of research into environmental and genetic causes, and the ease of diagnosis, incidence and mortality have risen in all developed countries during the last half century. Patient and physician education, and public health programs aimed at prevention, have had varied success. The authors conclude that, until we have better data on how to prevent skin cancer of all types, the best solutions are education of high-risk populations about skin self-evaluation in combination with physician examination to practice; and sun protection.

Sun protection and skin self-examination in melanoma survivors

Objectives: Patients diagnosed with melanoma are at risk for developing recurrent and second primary disease. Skin self‐examination (SSE) and sun protection are standard clinical recommendations to minimize risk. In this study we examined performance of these behaviors in individuals with melanoma drawn from the general population.

Cigarette smoking patterns in patients after treatment of bladder cancer

BACKGROUND Assessment of smoking status and identification of those most likely to continue smoking are important in the management of patients who have bladder cancer, because continued smoking following diagnosis and treatment increases the likelihood of treatment-related complications, recurrence, second primary malignancies, and morbidity and mortality. METHODS Patients (n = 224) receiving follow-up care of previously treated bladder cancers completed a brief written survey assessing their post-diagnosis smoking patterns. RESULTS Despite the risks of continued smoking, 69% of the patients who had been active smokers at the time of diagnosis (n = 84) reported smoking at some point following the diagnosis and 45% reported smoking at the time of assessment. Patients diagnosed at earlier stages were more likely to continue smoking. Patients diagnosed at later stages were 2.80 times more likely to be continuous abstainers than those diagnosed sooner (95% CI, 1.08-7.25). CONCLUSIONS The findings underscore the need to assess smoking status and provide smoking-cessation advice and counseling within routine comprehensive care of bladder cancer patients.

Predictors of perceived risk for colon cancer in a national probability sample in the United States.

This study examines potential predictors of perceived risk for colon cancer in a U.S. sample of 2,949 individuals aged 45 and older with no colon cancer history. We examined perceived comparative risk for colon cancer as the outcome in ordinal regression analyses, and perceived absolute risk for colon cancer in linear regression analyses. Potential predictors included demographics, current risk behaviors, self-reported health, family and personal cancer history, emotion variables (colon cancer worry, general anxiety, and fear of positive screening findings), general cancer beliefs (causes, lack of preventability, information overload), and cancer information seeking. Those who had poorer self-reported health, a family cancer history, and increased colon cancer worry had higher perceived comparative and absolute colon cancer risk (all ps < .05). Those who were younger, interviewed in Spanish, had increased anxiety, and information overload had higher comparative risk; those with a personal history of cancer and fear that colon cancer screening would result in positive findings had higher absolute risk (all ps < .05). We determined that older individuals, those with risk factors, and those with good subjective health may not realize their colon cancer risk. Those distressed about colon cancer and who report cancer prevention information overload may require different messages.