Raising Public Awareness of Clinical Trials: Development of Messages for a National Health Communication Campaign.

Clinical trials are essential for developing new and effective treatments and improving patient quality of life; however, many trials cannot answer their primary research questions because they fall short of their recruitment goals. This article reports the results of formative research conducted in two populations, the public and primary care physicians, to identify messages that may raise awareness and increase interest in clinical trials and be used in a national communication campaign. Results suggested that participants were primarily motivated to participate in clinical trials out of a self-interest to help themselves first. Messages illustrated that current treatments were tested via clinical trials, helped normalize trials as routine practices, and reduced concerns over trying something new first. Participants wanted messages that portray trials as state-of-the-art choices that offer some hope, show people like themselves, and are described in a clear, concise manner with actionable steps for them to take. The study revealed some differences in message salience, with healthy audiences exhibiting lower levels of interest. Our results suggest that targeted messages are needed, and that communication with primary health-care providers is an important and necessary component in raising patient awareness of the importance of clinical trials.

NCI's Physician Data Query (PDQ®) cancer information summaries: history, editorial processes, influence, and reach.

In the National Cancer Act of 1971, the Director of the National Cancer Institute (NCI) was given a mandate to "Collect, analyze, and disseminate all data useful in the prevention, diagnosis, and treatment of cancer, including the establishment of an International Cancer Research Data Bank (ICRDB) to collect, catalog, store, and disseminate insofar as feasible the results of cancer research undertaken in any country for the use of any person involved in cancer research in any country" (National Cancer Act of 1971, S 1828, 92nd Congress, 1st Sess (1971)). In subsequent legislation, the audience for NCI's information dissemination activities was expanded to include physicians and other healthcare professionals, patients and their families, and the general public, in addition to cancer researchers. The Institute's response to these legislative requirements was to create what is now known as the Physician Data Query (PDQ®) cancer information database. From its beginnings in 1977 as a database of NCI-sponsored cancer clinical trials, PDQ has grown to include extensive information about cancer treatment, screening, prevention, supportive and palliative care, genetics, drugs, and more. Herein, we describe the history, editorial processes, influence, and global reach of one component of the PDQ database, namely its evidence-based cancer information summaries for health professionals. These summaries are widely recognized as important cancer information and education resources, and they further serve as foundational documents for the development of other cancer information products by NCI and other organizations.

The art and science of cancer education and evaluation: toward facilitating improved patient outcomes.

Cancer education is a constantly evolving field, as science continues to advance both our understanding of cancer and its effects on patients, families, and communities. Moving discoveries to practice expeditiously is paramount to impacting cancer outcomes. The continuing education of cancer care professionals throughout their practice life is vital to facilitating the adoption of therapeutic innovations. Meanwhile, more general educational programs serve to keep cancer patients, their families, and the public informed of the latest findings in cancer research. The National Cancer Institute conducted an assessment of the current knowledge base for cancer education which involved two literature reviews, one of the general literature of the evaluation of medical and health education efforts, and the other of the preceding 5 years of the Journal of Cancer Education (JCE). These reviews explored a wide range of educational models and methodologies. In general, those that were most effective used multiple methodologies, interactive techniques, and multiple exposures over time. Less than one third of the articles in the JCE reported on a cancer education or communication product, and of these, only 70% had been evaluated for effectiveness. Recommendations to improve the evaluation of cancer education and the educational focus of the JCE are provided.

Developing partnerships to reduce disparities in cancer screening.

BACKGROUND: Interventions in scientific settings to improve the well-being of women who are not regularly screened for cancer have failed. Consequently, community-based prevention and control efforts are needed. COMMUNITY CONTEXT: From 2003 through 2007, three federal agencies and 1 nongovernmental agency collaborated with county-level public health counterparts from 6 states to address screening disparities in cervical and breast cancer in counties with the highest prevalence. This case study describes lessons learned from Team Up, a model pilot program. METHODS: We conducted a descriptive qualitative case study including 5 Southern states and 1 Midwestern state: Alabama, Georgia, Kentucky, Missouri, South Carolina, and Tennessee. The 6 states underwent a 5-step process to adopt, adapt, and implement 1 of 3 evidence-based interventions designed for cervical and breast cancer screening. OUTCOME: The 6 participating states had various levels of success. Participating states formed and sustained viable interorganizational public health partnerships throughout the pilot program and beyond. INTERPRETATION: Although this innovative pilot faced many difficulties, participants overcame substantial obstacles and produced many key accomplishments. Team Up brought together 2 challenging public health strategies: the translation of evidence-based approaches to communities and populations, and partnerships among diverse people and organizations. Case study results suggest that using a mix of approaches can promote the transference of evidence from research into practice through local, regional, and national partnerships.

Evaluating a national dissemination approach: The National Cancer Institute's clinical trials education program.

BACKGROUND: Adult participation in clinical trials is low, and many individuals are unaware of trials as an option. Raising awareness about clinical trials and addressing barriers through education is key to increasing enrollment in trials. METHODS: To reach communities, the National Cancer Institute (NCI) worked with partners to disseminate clinical trials education resources. Evaluation was conducted to determine the effectiveness of the dissemination approaches on program goals. RESULTS: Survey results indicated that partners disseminated, used, and were satisfied with the program resources. Focus group results corroborated these findings. CONCLUSIONS: NCI's program successfully used partnerships for broad dissemination of resources to improve clinical trials awareness.

Stakeholder Engagement in Late-Stage Translation Research and Implementation Science: Perspectives From the National Heart, Lung, and Blood Institute.

Stakeholder engagement is crucial for turning discovery into health. Although it is a highly effective approach for research in general, it is an essential component in late-stage translation research and implementation science in which the central objective is to accelerate the sustained uptake and integration of proven-effective interventions into routine clinical and public health practice. Where the stakeholder is an entire community, the term community engagement has often been used and has traditionally been defined as "the process of working collaboratively with groups of people who are affiliated by geographic proximity, special interests, or similar situations with respect to issues affecting their well-being." More recently, this definition has been expanded to specifically incorporate pre-study needs assessment, shared decision making about study themes and specific aims, data collection and analysis, interpretation and dissemination of research findings, and plans for scale-up and spread of research findings. In this article, the authors explore the scientific foundations of stakeholder engagement in biomedical research and public health practice. They highlight the strategic vision goals and objectives of the National Heart, Lung, and Blood Institute and the commitment to advance dissemination and implementation research and community-engaged participatory research. The authors conclude with comments on the stakeholder engagement efforts in the National Heart, Lung, and Blood Institute-funded TREIN/Hy-TREC consortium's work published in this issue of Global Heart and their perspectives on the challenges and opportunities as we chart the future together.

Prostate cancer screening and shared decision-making preferences among African-American members of the Prince Hall Masons.

OBJECTIVES: Shared decision making (SDM) is recommended as one method to assist men in making an informed decision about prostate cancer screening (PCS). SDM preferences for PCS have not been evaluated among African-American (AA) men. Given AA men's increased risk and the uncertainty surrounding screening, it is critical to determine how to assist AA men in making an informed decision. We assessed the extent to which a sample of AA men wished to engage in SDM regarding PCS and the demographic and psychological characteristics associated with SDM preferences. METHODS: Participants completed a telephone interview that covered demographic and medical information, SDM preferences, PCS knowledge, decisional conflict, and satisfaction with previous screening decisions. Subjects included 286 AA men aged 40-70, who were members of a Masonic organization. RESULTS: Fifty-seven percent preferred SDM, 36% preferred to make their own decision, and 7% wanted their doctor to decide. A higher level of education and older age were associated with preferring SDM (p<0.05), while men with greater PCS knowledge were more likely to prefer to make the decision independently (p<0.05). CONCLUSIONS: Results suggest that physicians need to be prepared to discuss PCS with their patients. Further, more attention may be needed to engage younger, less educated, and less knowledgeable men as they may be less likely to discuss PCS. This understanding of AA men's preferences for PCS decisions helps to clarify the issues that health professionals need to consider when attempting to assist AA men in making a PCS decision.

Educating African American men about the prostate cancer screening dilemma: a randomized intervention.

BACKGROUND: Until there is a definitive demonstration that early diagnosis and treatment of prostate cancer reduces disease-related mortality, it is imperative to promote informed screening decisions by providing balanced information about the potential benefits and risks of prostate cancer screening. Within a community/academic collaboration, we conducted a randomized trial of a printed booklet and a videotape that were designed for African American (AA) men. The purpose of the trial was to determine the effect of the interventions on knowledge, decisional conflict, satisfaction with the screening decision, and self-reported screening. METHODS: Participants were 238 AA men, ages 40 to 70 years, who were members of the Prince Hall Masons in Washington, DC. Men were randomly assigned to the (a) video-based information study arm, (b) print-based information study arm, or (c) wait list control study arm. Intervention materials were mailed to men at home. Assessments were conducted at baseline, 1 month, and 12 months postintervention. Multivariate analyses, including ANCOVA and logistic regression, were used to analyze group differences. RESULTS: The booklet and video resulted in a significant improvement in knowledge and a reduction in decisional conflict about prostate cancer screening, relative to the wait list control. Satisfaction with the screening decision was not affected by the interventions. Self-reported screening rates increased between the baseline and the 1-year assessment, although screening was not differentially associated with either of the interventions. In exploratory analyses, prostate-specific antigen testing at 1 year was more likely among previously screened men and was associated with having low baseline decisional conflict. CONCLUSIONS: This study represents one of the first randomized intervention trials specifically designed to address AA men's informed decision making about prostate cancer screening. We have developed and evaluated culturally sensitive, balanced, and disseminable materials that improved knowledge and reduced decisional conflict about prostate cancer screening among AA men. Due to the high incidence and mortality rates among AA men, there is a need for targeted educational materials, particularly materials that are balanced in terms of the benefits and risks of screening.

AccrualNet: Addressing Low Accrual Via a Knowledge-Based, Community of Practice Platform.

PURPOSE: Present the design and initial evaluation of a unique, Web-enabled platform for the development of a community of practice around issues of oncology clinical trial accrual. METHODS: The National Cancer Institute (NCI) conducted research with oncology professionals to identify unmet clinical trial accrual needs in the field. In response, a comprehensive platform for accrual resources, AccrualNet, was created by using an agile development process, storyboarding, and user testing. Literature and resource searches identified relevant content to populate the site. Descriptive statistics were tracked for resource and site usage. Use cases were defined to support implementation. RESULTS: ACCRUALNET HAS FIVE LEVELS: (1) clinical trial macrostages (prestudy, active study, and poststudy); (2) substages (developing a protocol, selecting a trial, preparing to open, enrolling patients, managing the trial, retaining participants, and lessons learned); (3) strategies for each substage; (4) multiple activities for each strategy; and (5) multiple resources for each activity. Since its launch, AccrualNet has had more than 45,000 page views, with the Tools & Resources, Conversations, and Training sections being the most viewed. Total resources have increased 69%, to 496 items. Analysis of articles in the site reveals that 22% are from two journals and 46% of the journals supplied a single article. To date, there are 29 conversations with 43 posts. Four use cases are discussed. CONCLUSION: AccrualNet represents a unique, centralized comprehensive-solution platform to systematically capture accrual knowledge for all stages of a clinical trial. It is designed to foster a community of practice by encouraging users to share additional strategies, resources, and ideas.

Variations in breast carcinoma treatment in older medicare beneficiaries: is it black or white.

BACKGROUND: To evaluate associations between race and breast carcinoma treatment. METHODS: Data from 984 black and 849 white Medicare beneficiaries 67 years or older with local breast carcinoma and a subset of 732 surviving women interviewed 3-4 years posttreatment were used to calculate adjusted odds of treatment, controlling for age, comorbidity, attitudes, region, and area measures of socioeconomic and health care resources. RESULTS: Sixty-seven percent of women received a mastectomy and 33% received breast-conserving surgery. The odds of radiation omission were 48% higher (95% confidence interval [CI] 1.01-2.19) for blacks than for whites after considering covariates, but the absolute number of women who failed to receive this modality was small (11%). In race-stratified models, the odds of having radiation omitted were significantly higher among blacks living greater distances from a cancer center (vs. lesser) or living in areas with high poverty (vs. low), but these factors did not affect radiation use among whites. Among those interviewed, blacks reported perceiving more ageism and racism in the health care system than whites (P = 0.001). The independent odds of receiving mastectomy (vs. breast conservation and radiation) were 2.72 times higher (95% CI 1.25-5.92) among women reporting the highest quartile of perceived ageism scores, compared with the lowest, and higher perceived ageism tended to be associated with higher odds of radiation omission (P = 0.06). CONCLUSIONS: Older black women with localized breast carcinoma may have a different experience obtaining treatment than their white counterparts. The absolute number of women receiving nonstandard care was small and the effects were small to moderate. However, if these patterns persist, it will be important to evaluate whether such experiences contribute to within-stage race mortality disparities.