Laura A. Siminoff - US grants

The rate of recruitment to clinical trials is so low as to pose a major problem for the development of new cancer treatments. Moreover, serious ethical questions have been raised about a system which limits access to some of the most advanced treatments to a small proportion of cancer patients. Previous research seems to indicate that low accrual rates are primarily due to 1) the failure of many trial participating physicians to recommend or even discuss clinical trial participation with their eligible patients; and 2) generally low physician participation in rates in clinical trial groups. The proposed research seeks to describe physicians' treatment and referral decision-making for post-surgical breast cancer patients in the Pittsburgh SMSA as a model system. Approximately 600 patients will be selected from the case records of all consenting physicians who provide primary treatment to breast cancer patients in the Pittsburgh SMSA. Data will be gathered by a variety of techniques including intensive semi-structured interviews, medical record reviews and structured ratings for pre-selected decision-making factors. Data analysis will combine quantitative and qualitative content analysis of text. This content analysis will be greatly facilitated by the use of the UNIX Text Analyst (UTA), a computer program recently developed by one of the investigators on this project. Subsequent statistical analysis will initially rely on bivariate analyses to determine factors which are significantly correlated with the decision-making process. Discriminate analysis will be carried out to test how the selected description variables discriminate between physicians who do or do not participate in clinical trials. If we are to justify both the human and monetary expense of such clinical trials, the goal of all researchers should be to recruit subjects as widely and effectively as possible. Findings from this study will provide a focused knowledge based upon which other studies may test generalizability of findings to treatment of other tumors. These findings should also suggest ways to enhance trial participation by community physicians which can then be tested in future community intervention studies.

This grant is a revision of grant #R01HS08516-01. Older patients (greater than 65 years) receive less aggressive care for cancer, including breast cancer, than younger patients. Despite the potential benefits of postsurgical (adjuvant) chemotherapy in older breast cancer patients, data suggests that older patients are treated much less frequently than younger postmenopausal or premenopausal patients with adjuvant chemotherapy. We believe that this is linked to physicians' beliefs that older patients are more likely to die from other diseases before they die of breast cancer, and that older women, even ones with otherwise good performance status, will generally tolerate chemotherapy poorly or would not consider the benefits worth the risks. The proposed four year study will conduct a randomized trial of an innovative decision aid, the Decision Board (DB), in postmenopausal breast cancer patients. The DB was designed to enhance patient and oncologist decision making about adjuvant therapy. The specific overall goal of this study is to improve the treatment decision making process in older women with breast cancer. The primary objectives of this study are to determine the effectiveness of the DB and to determine if it allows greater and more informed choices about adjuvant therapy for breast cancer. We will also determine how the DB affects communications between oncologists and breast cancer patients. Primary outcomes will include physician's treatment recommendation, patients' choice of treatment, satisfaction with the consultation process and the decision itself. To accomplish this we will determine the treatment preferences of 600 older breast cancer patients and characterize athe base-line treatment patterns of the 13 oncology practices participating in this study. Since the DB is being evaluated to determine its effectiveness in routine clinical practice, we will also analyze the costs and value of the introduction of this tool into the decision making process. During this four year period we will do the following: 1) complete adaptation of the DB for use with older adjuvant breast cancer patients; 2) retrospectively review the records of all participating practices during the previous 12 months to document each practices' treatment patterns; 3) conduct a randomized trial of the DB with 300 older breast cancer patients (greater than 65 years) and 300 younger (50-64 years) postmenopausal breast cancer patients; 4) evaluate how the Board affects the doctor-patient communication process; 5) examine the cost- utility of the Board; and 6) conduct a prospective review of study- eligible patients who were not accrued into the randomized trial to assess any changes in treatment patterns that may occur during the study period.

DESCRIPTION (Adapted from the Investigator's Abstract): Modern informed consent procedures have been shaped by several factors. First, the ethical doctrine of informed consent is derived from a western philosophic tradition that emphasizes individual autonomy and respect for persons. Second, federal regulations governing human experimentation have established specific requirements for the informed consent process. Little data exist, however, concerning what information and presentation style will help potential subjects to understand the purpose and methods of a research study and make decisions that reflect their authentic preferences and values. The focus of this study will be to describe the disclosure and decision making process and to identify how informed decision making can be achieved. To accomplish this objective, the investigators propose to conduct a study that will ask subjects what they believe is important in making research participation decisions; in addition, behavioral decision analysis theory will be used to identify factors and processes that are associated with better outcomes. Three distinct subject populations will be examined: l) adult cancer patients; 2) critically ill children; 3) Alzheimer's disease patients. The specific aims of this study are to: (l) examine and describe clinician-subject interactions during the consent process; (2) determine which factors are associated with informed decision making; (3) determine if there are different information and process needs for different subject populations; (4) update our understanding of the theoretical underpinnings of the informed consent process; (5) suggest alternative or modified mechanisms for enabling patients to make informed decisions about participation in research studies. This study will provide descriptive information about how informed consent is currently being obtained from potential subjects and will assess the different components of the decision making process to pinpoint which pieces are crucial to the ability of potential subjects to make informed choices about participation in a research study.

DESCRIPTION: Family discordance about treatment decisions can greatly compromise the quality of life of cancer patients and family caregivers. Family members often urge advanced cancer patients to accept futile care that can impair their quality of life. Disputes over treatment decisions further undermine caregivers' physical and psychosocial well being. This study will develop a new measure that can validly and reliably assess the likelihood and degree of family discordance about cancer treatment decisions. The new measure will be used by physicians to obtain a clinical assessment and researchers to conduct scientific studies. The creation of this new measure will fill an existing gap in clinical and health services research. During the first study year, a series of focus groups will be conducted among 120 advanced lung cancer patients, family caregivers, and health care providers to identify all aspects of family discordance about treatment decisions. We will develop a Family Concordance Scale that will contain an initial pool of scale items and a Family Concordance Semi-Structured Questionnaire to collect information about family discordance in real life settings. In the first half of Year 2, the pool of scale items will be piloted among 50 family units, consisting of 50 advanced lung cancer patients, as well as 50 primary and 50 secondary family caregivers. Revisions will be made accordingly. In a two-year period, research assistants will conduct two interviews apiece with 250 family units (750 subjects). In addition, several psychometric instruments that measure presumptive correlates of family discordance will be administered at baseline (T1). Following the second interview, a measure that assesses physicians' estimates of family discordance about treatment decisions will be completed by oncologists. Chart review will also be conducted to collect patients' medical and demographic information. The last six months of the study will be devoted to examining the psychometric and statistical properties of the scale, especially its validity and reliability. The final product of this study will be a valid and reliable scale that can be administered within 10 minutes. Cut-off scores will be provided for classifying concordant and discordant families. In addition, rich and detailed descriptive information about the family treatment decision-making process will be provided.

DESCRIPTION (provided by applicant): The overall goal of the proposed R25 training program is to offer a set of instructional and directed research opportunities to exceptional candidates in order to promote their careers as independent researchers in the field of cancer prevention and control. Our proposed Prevention Research Educational Postdoctoral (PREP) training grant will offer a flexible 2-3 year training program to help guide young investigators to this field of study and to provide them with integrated but focused training to conduct basic research and intervention studies in cancer prevention and control. The proposed program will target individuals for training who have received a doctorate in the social and behavioral sciences, public health, nursing and medicine. The training program will consist of the following: 1) A brief, intensive core curriculum of didactic seminars designed to be completed within the first two months of the fellowship by all trainees; 2) An individualized longitudinal curriculum will be offered through relevant academic departments and through the School of Medicine; 3) Trainees will be provided exposure to clinical oncology and basic cancer biology through didactic training and clinical rotations. This will provide trainees with adequate exposure and knowledge to the clinical settings in which cancer care and preventive services are delivered to patients; 4) Development of tailored cancer prevention and control research experiences designed to expose trainees to a variety of research paradigms and disciplines; 5) A mentored cancer prevention and control research project designed by the trainee in collaboration with his/her mentors. As we have conceptualized this program, the training opportunities and needed infrastructure support will be transdisciplinary and focus exclusively on cancer prevention and control research. Upon entry into the program, the fellow will be assigned an initial mentor who will help the trainee orient him/herself to the Cancer Center and University environments, evaluate the trainee's research and clinical experience, and help the trainee choose a permanent primary mentor. During the first two months, trainees will attend and complete the core curriculum and, with their initial mentor's help, select a primary mentor and the package of courses, seminars, clinical and brief research rotations that will prepare the trainee to conduct research in cancer prevention and control. Most trainees will begin designing their research protocol in month 6 of the fellowship and will assemble a multi disciplinary mentoring committee to help direct their research and career development throughout their training period.

[unreadable] DESCRIPTION (provided by applicant): The overall goal of this R25 training program is to offer a set of instructional and directed research opportunities to exceptional candidates that promote their careers as independent researchers in the field of cancer prevention and control. This application is a competitive continuation of the Prevention Research Educational Postdoctoral (PREP) training grant that offers a flexible 2-3 year training program. The program targets individuals for training who have received a doctorate in the social and behavioral sciences, public health, nursing and medicine. The training program consists of the following: 1) A brief, intensive core curriculum of didactic seminars designed to be completed within the first two months of the fellowship by all trainees; 2) An individualized longitudinal curriculum offered through relevant academic departments and through the School of Medicine; 3) Exposure to clinical oncology and basic cancer biology through didactic training and clinical rotations. This provides fellows with adequate exposure to and knowledge of the clinical settings in which cancer care and preventive services are delivered to patients; 4) Development of tailored cancer prevention and control research experiences designed to expose fellows to a variety of research paradigms and disciplines; 5) A mentored cancer prevention and control research project designed by the fellow in collaboration with his/her mentors. As conceptualized, the training opportunities and infrastructure support are transdisciplinary and focus exclusively on cancer prevention and control research. Upon entry into the program, the fellow is assigned a mentor who helps the fellow orient him/herself to the Cancer Center and University environments, evaluates the fellow's research and clinical experience, and helps the fellow choose a permanent primary mentor. During the first two months, fellows attend and complete the core curriculum and, with their initial mentor's help, select a primary mentor and the package of courses, seminars, clinical and brief research rotations that will prepare the fellow to conduct research in cancer prevention and control. Most fellows begin designing their research protocol in month 6 of the fellowship and assemble a multidisciplinary mentoring committee to help direct their research and career development throughout their training period. Solving crucial issues in the prevention of cancer and the optimization of treatment and survivorship is hampered by a paucity of researchers working in this field. The PREP addresses this problem by training the next generation of cancer prevention and control researchers. [unreadable] [unreadable] [unreadable] [unreadable]

[unreadable] DESCRIPTION (provided by applicant): Disparities in cancer incidence, prevalence, and mortality have been well-documented for racial/ethnic minorities. These disparities persist despite widespread and targeted cancer education, screening campaigns, and advancements in cancer therapy. Diagnostic delay is significantly and negatively associated with cancer patient outcomes. Substantial barriers to early detection and diagnosis include lower rates of screening by minorities and access issues due to lack of health insurance. Later detection of cancer, however, is not solely explained by structural barriers to obtaining health care. Evidence has accumulated that cultural and communication factors may play a role in outcome disparities caused by late detection. We propose to examine two important factors that are likely to contribute to a delay in the diagnosis of cancer. First, `appraisal delay', defined as patients' inability to identify, interpret, and bring symptoms to the attention of their physicians. Second, 'diagnostic delay', defined as physicians' inaction or incorrect actions to make a diagnosis. We will examine how diagnostic delay may be associated with an inability to understand, interpret, and communicate effectively with patients. The overall goal of this study is to understand how these factors contribute to delay in detecting cancers in African-Americans, using colon cancer as a paradigm for this phenomenon. The study's specific aims are as follows: Aim 1. Identify and examine the factors that influence appraisal delay, e.g., patients' recognition, perception, and response to pre-diagnosis cancer symptoms. We will conduct qualitative interviews with 144 recently diagnosed colon cancer patients to identify their interpretations of the symptoms that eventually result in a diagnosis of cancer. African-American and white cancer patients will be compared. Aim 2. Test whether or not primary care physicians (PCPs) communicate with patients who present pre-diagnosis symptoms of cancer to PCPs differently depending on patient race and gender. To accomplish this, we will use an experimental design to compare the communication patterns and subsequent patient management decisions of a sample of 110 PCPs who will each meet with four unannounced trained patient simulators representing 4 gender-race combinations.This project examines how hard it was for people who are eventually diagnosed with colon cancer to recognize and communicate their symptoms to their physicians. The study's main goal is to improve understanding of the barriers to early diagnosis of cancer, lead to interventions that can help doctors and patients communicate more effectively, and ultimately lead to earlier cancer diagnoses. [unreadable] [unreadable] Public Health Relevance: This project examines how hard it was for people who are eventually diagnosed with colon cancer to recognize and communicate their symptoms to their physicians. The study's main goal is to improve understanding of the barriers to early diagnosis of cancer, lead to interventions that can help doctors and patients communicate more effectively, and ultimately lead to earlier cancer diagnoses. [unreadable] [unreadable] [unreadable]

[unreadable] DESCRIPTION (provided by applicant): Disparities in cancer incidence, prevalence, and mortality have been well-documented for racial/ethnic minorities. These disparities persist despite widespread and targeted cancer education, screening campaigns, and advancements in cancer therapy. Diagnostic delay is significantly and negatively associated with cancer patient outcomes. Substantial barriers to early detection and diagnosis include lower rates of screening by minorities and access issues due to lack of health insurance. Later detection of cancer, however, is not solely explained by structural barriers to obtaining health care. Evidence has accumulated that cultural and communication factors may play a role in outcome disparities caused by late detection. Appraisal delay occurs when patients fail to recognize or interpret symptoms they are experiencing as requiring medical attention. This can ultimately result in short or lengthy delays in making a diagnosis of cancer. We posit that factors that influence the perception and interpretation of symptoms may impede an earlier cancer diagnosis in racial and ethnic minorities and that these factors may further hamper communication between physicians and patients once patients actually present symptoms to their health care provider. The goal of this study is to examine how appraisal delay impedes the reporting of symptoms to their health care providers. We also hypothesize that these patients will have more difficulty effectively communicating these symptoms to their physicians during the clinical encounter. To accomplish this goal, we will interview recently diagnosed colon cancer patients using a semi-structured interview instrument to identify their interpretations and reporting of the symptoms that were indicative of colon cancer to confidantes and their health care providers. Time to delay between patient report of symptoms to their primary care providers and diagnosis (clinical diagnostic delay) will be validated by chart review. African- American men and women and white male and female patients with newly diagnosed colon cancer will be compared. The study's specific aims are: 1) Determine if appraisal delay and clinical diagnostic delay are associated with race/ethnicity and gender and examine factors that subsequently moderate this relationship; 2) Assess the communications between patients and their health care providers about symptom reporting; and 3) Use the results of this study to clarify the need for a communication study using direct observation methods to determine whether and how the communication process between patients and primary care providers contribute to diagnostic delay by communicating differently with patients by race and gender when they present pre-diagnosis symptoms of cancer. PUBLIC HEALTH RELEVANCE: This project can improve understanding of the barriers to early diagnosis of cancer and lead to interventions that can help patients understand their symptoms, communicate them more effectively to their health care providers, and ultimately lead to earlier cancer diagnoses and better outcomes. [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): Deceased donation remains the major source of organs. Despite the public's stated enthusiasm for organ donation, donation consent rates have remained relatively low. In the U.S. no more than 60% of the families of donation-eligible individuals consent. Improving the rates of consent from deceased donor families is a pivotal means for slowing the rise of the supply-demand gap. The proposed five-year study will test the use of a two-part Early Referral and Request Approach (ERRA) intervention to raise consent rates to solid organ donation from the families of deceased patients at the point where requests are made by Organ Procurement Organizations (OPOs). The ERRA consists of a hospital-based evaluation assessment system and a communication intervention. It targets two key factors that can make a difference to consent to organ donation: 1) time-sensitive referrals by hospitals of potential donor patients to the OPO;and 2) use of effective communication techniques by OPO requesters to discuss organ donation with donation-eligible patients'families. The ERRA intervention is based on 15 years of prior research in the area of obstacles to organ donation and is grounded in the results of a recent study. We will use an experimental design to test the overall efficacy of both elements of the ERRA intervention under two conditions (autonomous and assisted) to ascertain best practices for ERRA implementation. The first module of the ERRA is the Rapid Assessment of Hospital Procurement barriers in Donation (RAPiD). The second module is the Communicating Effectively about Donation (CEaD) that teaches OPO requesters communication skills designed to improve the effectiveness of their requests to donor-eligible families. Eight OPOs, located around the United States, and their OPO coordinators who request organ donation, will participate as study sites and participants (n=80). The proposal has the following specific aims: Aim 1. Test the effectiveness of the RAPiD to increase timely identification of potential donors through hospital notification of OPOs and the affect of the RAPiD and CEaD training modules on consent rates. Aim 2. Test OPO implementation of the RAPiD and CEaD modules under two conditions. The two implementation conditions to be tested are: a) a completely autonomous condition in which an OPO does not employ any outside assistance to implement the module, and b) an assisted method whereby trained outside consultants play a role in implementing the modules. PUBLIC HEALTH RELEVANCE: There are over 96,000 patients on the transplantation waiting list but no more than a fraction of these patients will receive an organ transplant in any given year. This study proposes an intervention to help increase the rates of organ donation and alleviate the organ shortage.

DESCRIPTION (provided by applicant): This application seeks continued support for the Training Program in Behavioral and Health Services Cancer Control Research (application # R25 CA093423-06A1) from the National Cancer Institute R25 mechanism. This Training Program is located within the Massey Cancer Center (MCC) of Virginia Commonwealth University (VCU) and provides transdisciplinary training for predoctoral and postdoctoral candidates in cancer prevention and control research. The overall goal of this training program is to provide an environment that encourages the development of cancer prevention and control research at the highest levels. Training is targeted to individuals in the social sciences (psychology, sociology, economics, anthropology), public health, biostatistics, and those who have completed their clinical requirements for specialty training in medicine and nursing. To accomplish this goal, a training program has been structured to foster transdisciplinary research, something we believe is a precondition to conducting research in this field. The predoctoral training component aims to recruit potential future investigators to this research area at the earliest time in their careers. This is important if we are to speed up the development of focused cancer prevention and control research by creating a cadre of students who are focused on this research area at the outset of their research training. The flexible 2-3 year postdoctoral training component helps guide young investigators to this field of study and provides them with integrated but focused training to conduct fundamental and interventional studies in cancer prevention and control. This program will specifically and especially foster research that contributes to the understanding of the production of health disparities in cancer outcomes. VCU is uniquely positioned to provide this training because of its role as a safety net hospital, the population it serves, and its standing as an NCI-designated cancer center. The goal of this program is to train the next generation of cancer prevention and control researchers. To accomplish this goal we will do the following: 1) Offer a multidisciplinary integrated research training program with a range of research opportunities;2) Meet the needs for training in emerging research areas in cancer prevention and control;3) Provide training to researchers from diverse academic and ethnic backgrounds and intensive mentoring;4) Provide a specialized curriculum that coalesces cancer control strengths at our institution. PUBLIC HEALTH RELEVANCE: This Training Program is to provide training to individuals working on their doctoral degrees and those who have completed their doctoral degrees and desire advanced training in cancer prevention and control research. The training program will provide future researchers with the skills to conduct research into areas that can help populations prevent cancer and improve their lives if they do get cancer.

DESCRIPTION (provided by applicant): The goal of this study will be to assess whether cancer communication between patients and their family caregivers is an important and independent factor in specific cancer care outcomes, including economic outcomes, especially labor market participation, quality of life and decisional outcomes. This study focuses on patients with hematological malignancies in adults which are important to study for a number of reasons. These cancers have been steadily increasing in the U.S. with an estimated 137,266 new cases in 2010. In addition, hematological cancer patients' social and psychological challenges and outcomes have not been adequately studied. Hematological cancers are particularly challenging because of their chronicity. How patients survive with this disease, including their ability to maintain their social and family commitments is critical. Few studies, however, have examined how hematologic cancers affect patients' and their caregivers' labor market participation. Strikingly, in comparison to the productivity cost of other cancers, hematological cancers are among the most costly cancers in terms of productivity loss due to premature death. This study will follow 250 pairs of employed hematologic cancer patients and their family caregivers over a two-year period to assess how they communicate about treatment and care decisions, which lead to specific psychosocial, economic, and healthcare outcomes. This study has the following aims: Aim 1. Test longitudinally how cancer communication between caregivers and patients are associated with short and long-term economic, psychosocial, and healthcare outcomes. Aim 2. Examine patient and family characteristics that are associated with decreased levels of cancer communication. !

? DESCRIPTION (provided by applicant): As health systems and insurers emphasize increased system efficiencies and reduced hospital days, the responsibility of care for cancer patients is shifting to informal caregivers (CGs) in the home. An estimated 4 million CGs spend an average of 8 hours per day providing care for adults with cancer in the United States. Caregiving includes emotional support, financial assistance, and personal care, as well as coordination of services and skilled nursing6-10. Negative effects include emotional, social and financial disruptions and lessened quality of life and intensify as a cancer patient approaches death. Current research does not fully describe the extensive range of care provided by CGs, how care changes as disease progresses, and whether and when care needs exceed CGs' skills and emotional and financial resources. High subjective burden, such as stress and distress, has been documented for CGs. However, little is known about CGs' objective burden in this population, specifically number and hours of CG tasks and scope and intensity of tasks. This proposed study would be the first to comprehensively examine the lived experiences of CGs of PTs with advanced solid tumor cancers. To accomplish this, the multi-site cohort study will employ a prospective, longitudinal design that will follow CGs of PTs with life limiting cancer for up to 12 months or until 1 month after PT death. Data will be collected bi-weekly and in-person from CGs in their homes using qualitative interviews, quantitative surveys, CG diaries, and structured observation. The overall goal of this study is to understand CG objective burden, a key and understudied contributor to overall CG burden and how it affects both health and economic outcomes of CGs and to identify potentially modifiable factors impacting CG overall burden.

PROJECT SUMMARY As a collective group, Asian American Populations (AAPs) account for only 5.4% of the population, but they have become the fastest growing racial group with an estimated growth of 128% in the next 20 years. This group's relatively small proportion of the population, combined with mainstream perspectives of AAPs as a ?model minority? group, has led to a dangerous omission of AAPs in national conversations about health and organ transplantation as a therapeutic modality to End Stage Renal Disease (ESRD) and End Stage Liver Disease (ESLD). Specifically, they comprise 7.6% of all individuals on the national organ waitlist as of October 14, 2016, but only account for 2.7% of all deceased donors. The need for livers among AAPs is also great due to high incidence of Hepatitis C infection and resultant hepatic failure. An estimated one in 12 AAPs also have Hepatitis B, and half of all Americans with Hepatitis B are AAPs. Thus, transplantation may be an underutilized avenue, and advanced knowledge of liver transplantation may ultimately reduce the prevalence of eventual death due to ESLD and also associated cancers. In response to the dearth of available studies about organ donation related attitudes and knowledge among AAPs, this study proposes to extend our understanding of the factors that affect donation from AAP families through a rigorous series of focus groups and a national probability survey. The findings will constitute the most the first national-level body of knowledge about AAPs' attitudes and knowledge about organ donation. The process will also be guided by a Community Advisory Board (CAB), composed of community and religious leaders from locally based Asian American communities. The CAB will allow for the development and testing of a culturally appropriate pilot intervention that can assist in increasing donor designation for deceased donation and consideration of living donation. The results will also serve as the basis for future, larger scale interventions for increasing deceased and living donation designations among AAPs.