Building trust and diversity in patient-centered oncology clinical trials: An integrated model.

BACKGROUND/AIMS: Trust is the cornerstone of clinical trial recruitment and retention. Efforts to decrease barriers and increase clinical trial participation among diverse populations have yielded modest results. There is an urgent need to better understand the complex interactions between trust and clinical trial participation. The process of trust-building has been a focus of intense research in the business community. Yet, little has been published about trust in oncology clinical trials or the process of building trust in clinical trials. Both clinical trials and business share common dimensions. Business strategies for building trust may be transferable to the clinical trial setting. This study was conducted to understand and utilize contemporary thinking about building trust to develop an Integrated Model of Trust that incorporates both clinical and business perspectives. METHODS: A key word-directed literature search of the PubMed, Medline, Cochrane, and Google Search databases for entries dated between 1 January 1985 and 1 September 2015 was conducted to obtain information from which to develop an Integrated Model of Trust. RESULTS: Successful trial participation requires both participants and clinical trial team members to build distinctly different types of interpersonal trust to effect recruitment and retention. They are built under conditions of significant emotional stress and time constraints among people who do not know each other and have never worked together before. Swift Trust and Traditional Trust are sequentially built during the clinical trial process. Swift trust operates during the recruitment and very early active treatment phases of the clinical trial process. Traditional trust is built over time and operates during the active treatment and surveillance stages of clinical trials. The Psychological Contract frames the participants' and clinical trial team members' interpersonal trust relationship. The "terms" of interpersonal trust are negotiated through the psychological contract. Contract renegotiation occurs in response to cyclical changes within the trust relationship throughout trial participation. CONCLUSION: The Integrated Model of Trust offers a novel framework to interrogate the process by which diverse populations and clinical trial teams build trust. To our knowledge, this is the first model of trust-building in clinical trials that frames trust development through integrated clinical and business perspectives. By focusing on the process, rather than outcomes of trust-building diverse trial participants, clinical trials teams, participants, and cancer centers may be able to better understand, measure, and manage their trust relationships in real time. Ultimately, this may foster increased recruitment and retention of diverse populations to clinical trials.

Ethics, Cultural Competence, and the Changing Face of America.

The population in the United States is increasingly multicultural. So, too, is the U.S. physician workforce. The combination of these diversity dynamics sets up the potential for various types of cultural conflict in the nation's examining rooms, including the relationship between religion and medicine. To address the changing patient-physician landscape, we argue for a broad scale intervention: interdisciplinary bioethics training for physicians and other health professionals. This approach seeks to promote a common procedural expectation and language which can lead to an improved, patient-centered approach resulting in better patient-physician relationships that contribute to better health outcomes across the U.S. population. The authors illustrate their thesis and solution using a well-known case of cross-cultural dynamics taken from religion and medicine-Anne Fadiman's The Spirit Catches You And You Fall Down.

The Utility of a Connecting Framework to Facilitate Understanding of and Reduce the Disparities in Hospice Care Experienced by Racial and Ethnic Minorities.

Rapidly changing demographics in the United States and diverse cultural beliefs impact hospice utilization and end-of-life care. Healthcare professionals and clinicians need a connecting framework to understand patients' and their family's perspectives regarding utilization of those services. This framework will assist healthcare workers in providing culturally sensitive and appropriate information to patients nearing the end of life, so that they and their loved ones can make informed decisions for optimal care during this passage of life. Considering the variables in this framework may also help facilitate communication between healthcare professionals and patients and reduce misunderstanding among the surviving family members.

Ambivalence: A Key to Clinical Trial Participation?

Trust exerts a multidimensional influence at the interpersonal level in the clinical trials setting. Trust and distrust are dynamic states that are impacted, either positively or negatively, with each participant-clinical trials team interaction. Currently, accepted models of trust posit that trust and distrust coexist and their effects on engagement and retention in clinical trials are mediated by ambivalence. While understanding of trust has been informed by a robust body of work, the role of distrust and ambivalence in the trust building process are less well understood. Furthermore, the role of ambivalence and its relationship to trust and distrust in the clinical trials and oncology settings are not known. Ambivalence is a normal and uncomfortable state in the complex decision making process that characterizes the recruitment and active treatment phases of the clinical trials experience. The current review was conducted to understand the constructs of ambivalence as a mediator of trust and distrust among vulnerable, minority participants through different stages of the oncology clinical trials continuum, its triggers and the contextual factors that might influence it in the setting of minority participation in oncology clinical trials. In addition, the researchers have sought to link theory to clinical intervention by investigating the feasibility and role of Motivational Interviewing in different stages of the clinical trials continuum. Findings suggest that ambivalence can be processed and managed to enable a participant to generate a response to their ambivalence. Thus, recognizing and managing triggers of ambivalence, which include, contradictory goals, role conflicts, membership dualities, and supporting participants through the process of reducing ambivalence is critical to successfully managing trust. Contextual factors related to the totality of one's previous health-care experience, specifically among the marginalized or vulnerable, can contribute to interpersonal ambivalence. In addition, changes in information gathering as a moderator of interpersonal ambivalence may have enormous implications for gathering, assessing, and accepting health information. Finally, motivational Interviewing has widespread applications in healthcare settings, which includes enabling participants to navigate ambivalence in shared-decision making with their clinician, as well as executing changes in participant behavior. Ultimately, the Integrated Model of Trust can incorporate the role of therapeutic techniques like Motivational Interviewing in different stages of the clinical trials continuum. Ambivalence is a key component of clinical trial participation; like trust, ambivalence can be managed and plays a major role in the management of trust in interpersonal relationships over time. The management of ambivalence may play a major role in increasing clinical trial participation particularly among the marginalized or the vulnerable, who may be more susceptible to feelings of ambivalence.

Circle of Sisters: raising awareness of Native American women to breast cancer.

The Circle of Sisters is a breast cancer education initiative that incorporates free mammography for American Indian women. In two separate but similar initiative-sponsored one-day events, 37 American Indian women underwent screening mammography and experienced a full day of culturally tailored educational activities. Women observed a cooking demonstration, participated in moderate exercise activity, strung beads to learn about the dimensions of breast tumors, and listened to an American Indian breast cancer survivor recount her story of diagnosis and treatment. Significant shifts in opinion included an increase in the understanding that a woman's chances of being diagnosed with breast cancer increase with age (p=.015) and with never bearing children (p <.001) and that breast cancer can be detected early (p=.043). The percentage of those expressing an intention to get a mammogram every year grew from 81.1% to 94.6%.

Young Asian Americans' knowledge and perceptions of cervical cancer and the human papillomavirus.

Cervical cancer is a major health disparity among Asian Americans, with cervical cancer rates of Vietnamese women being significantly higher than for the general US female population and low screening rates reported for Asian American females. Focus groups and interviews were conducted with young Vietnamese, Filipino, and Korean adults (ages 18-29) to collect information on knowledge, perceptions and sources of information regarding cervical cancer, Pap tests and the human papillomavirus. 16 Korean, 18 Vietnamese, and 18 Filipino (50% female) adults participated in the study. Many participants had never heard of HPV, cervical cancer and Pap testing. Cervical cancer screening rates were low for Korean and Vietnamese females and were influenced by moral beliefs and lack of awareness. Culturally relevant education materials that consider specific Asian ethnicity and language are needed to increase awareness of cervical cancer, Pap testing, and HPV among Asian American young adults.

Increase in cruciferous vegetable intake in women previously treated for breast cancer participating in a dietary intervention trial.

Consumption of cruciferous vegetables has been associated with reduced breast cancer risk mechanistically and in population-based studies, although evidence has been inconsistent. This inconsistency may be related to limitations in quantifying and qualifying cruciferous vegetable exposure using standard instruments for dietary assessment (for example, food-frequency questionnaires, FFQs) or due to low levels of intake demonstrated among U.S. population samples. Cruciferous vegetable intake data are presented from a longitudinal study of a high-vegetable dietary intervention to reduce breast cancer recurrence among breast cancer survivors (n=1,156; 536 intervention and 620 comparison group subjects). Intake was assessed using repeat administration of an FFQ and cross-sectional administration of a cruciferous vegetable-specific FFQ (CVFFQ). Mean intake in the intervention group assessed using the standard FFQ was 37.7 g/day at baseline and increased to 57.1 g/day at 12 mo (P=0.0001) and was sustained through 48 mo. Broccoli and cabbage were the most commonly consumed cruciferous vegetables, regardless of the instrument used to assess intake. Differences in intake by group assignment were shown for raw cruciferous vegetables (30.2 g/day vs. 24.6 g/day, assessed using the CVFFQ), suggesting increased exposure to biologically active, cancer-preventive food constituents. These data suggest that this study population will be the first U.S. population sample to provide ample quantity and variety in cruciferous intake to examine whether these vegetables are protective against breast cancer recurrence.

Correlates of physical activity level in breast cancer survivors participating in the Women's Healthy Eating and Living (WHEL) Study.

BACKGROUND: Physical activity levels among breast cancer survivors are typically low, and knowledge of the correlates of increased physical activity among cancer survivors is limited. The purpose of this study was to examine factors that are associated with physical activity or inactivity among breast cancer survivors. METHODS: Data from 3088 women participating in the Women's Healthy Eating and Living (WHEL) Study, collected prior to randomization, were the focus of the current analyses. Self-reports of physical activity levels, quality of life, depression, and dietary intakes were collected. Pearson correlation analyses were employed to examine the associations among these variables, and multiple regression analyses were performed to examine the relationship between selected health behaviors and physical activity levels, after controlling for demographic, breast cancer-related, and psychosocial variables. RESULTS: Demographic and psychosocial variables were related to physical activity levels (P < 0.001 for all). Cancer treatment type and cancer stage were correlated with survivors' physical activity levels (P < 0.01), but the associations were no longer significant after controlling for demographic variables. Physical activity levels were strongly associated with other health behaviors, especially dietary intakes (P < 0.001), even after controlling for demographic, cancer-related, and psychosocial factors. CONCLUSION: Low physical activity levels in breast cancer survivors are associated with specific behavioral and other factors, which can be considered as indicators of women at higher risk. Findings of significant differences in physical activity levels based on demographic characteristics suggest the importance of promoting physical activity particularly among breast cancer survivors of ethnic minority or lower education levels.

Between and within: international perspectives on cancer and health disparities.

The purpose of this article is to compare reasons for cancer health disparities in developing and developed countries. By 2010, approximately 60% of new cancer cases will occur in the developing world, higher than rates developed countries. However, disparities exist not only between countries but also within countries. Cancer epidemiology in developing countries is paradoxical: Increased incidence is partially due to increased development resulting in longer life expectancy and unhealthy lifestyle behaviors. Reduced mortality from infectious diseases results in relatively greater mortality from chronic diseases. However, infectious diseases are also risk factors for the leading causes of cancer mortality in these countries. While health disparities in developing versus developed countries are quantitatively worlds apart, they are qualitatively rather similar. They share common causes, such as environmental pollution, the need for social justice, large gaps between the rich and the poor, lack of access to cancer resources, and health services that are available to some but not to all. While industrialization and urbanization elevate a country's economic base while contributing to cancer incidence and mortality. Strategies to reduce international cancer disparities include country- and regional-level interventions, utilizing nongovernmental organizations, and developing long-term inter-institutional partnerships. Although economic aid is undoubtedly necessary, it is not sufficient to control cancer in the developing world. To address these problems, it will be necessary to focus attention on what can be done locally-within countries, not only between countries.

Impact of breast cancer on African American women: priority areas for research in the next decade.

Despite all the gains that have been made in the area of breast cancer research, African American women suffer disproportionately from the effects of the disease. Breast cancer is the second leading cause of cancer death among African American women, exceeded only by lung cancer. Improvements in cancer incidence, mortality, and survival rates among populations are undoubtedly the outcome of quality research. Therefore, there is a need to identify and discuss issues regarding breast cancer among African American women and to determine whether these issues should be a part of the nation's breast cancer research agenda. This commentary summarizes the results of the Summit Meeting Evaluating Research on Breast Cancer in African American Women, which was held September 8-11, 2000, in Washington, DC. Listed are priority areas and some of the questions that fueled this 2-day discussion among 130 participants, including health advocates, cancer survivors, and experts representing various areas of cancer research.

Health-related quality of life in women previously treated for early-stage breast cancer.

This study describes health-related quality of life (HRQOL) in women previously treated for early stage breast cancer relative to general population and breast cancer norms. It also identifies correlates and multivariate predictors of physical and mental HRQOL. 2582 women who were up to four years post-treatment for early stage breast cancer completed the RAND-36 Health Survey and reported personal and cancer-related information. Participants reported generally high HRQOL that was comparable to norms for women in the general population and other women with breast cancer. In multivariate analyses, better physical HRQOL was associated with fewer psychological symptoms, lower body mass index, better sleep quality, and more physical activity. Better mental HRQOL was associated with better sleep quality, fewer life events, less pain, and fewer gastrointestinal symptoms. Interventions targeting psychosocial symptoms, weight reduction, physical activity, sleep hygiene, and pain could result in improved HRQOL in these women.

On the importance of using multiple methods of dietary assessment.

BACKGROUND: Plasma carotenoid concentrations reflect intake of vegetables and fruits, the major food sources of these compounds. This study compared the ability of 2 measures of dietary intake (24-hour diet recalls and food frequency questionnaires [FFQs]) to corroborate plasma carotenoid concentrations in a subset of women participating in a diet intervention trial. METHODS: Plasma carotenoid concentrations and dietary intakes, estimated from 24-hour diet recalls and FFQs, were examined at baseline and 1 year later in a subset of 395 study participants (197 intervention and 198 comparison group). We used longitudinal models to examine associations between estimated intakes and plasma carotenoid concentrations. These analyses were stratified by study group and adjusted for body mass index (BMI), plasma cholesterol concentration, and total energy intake. We conducted simulations to compare mean-squared errors of prediction of each assessment method. RESULTS: In mixed-effects models, the estimated carotenoid intakes from both dietary assessment methods were strongly associated with plasma concentrations of alpha-carotene, beta-carotene, and lutein. Furthermore, modeling the 2 sources of intake information as joint predictors reduced the prediction error. CONCLUSION: These findings underscore the importance of using multiple measures of dietary assessment in studies examining diet-disease associations.