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BACKGROUND: Racial and ethnic minorities are often underrepresented in clinical trials, threatening the generalizability of trial results. Several factors may contribute to underrepresentation of minorities in clinical trials, including lack of training for researchers and staff on the importance of diversity in clinical trials and effective strategies for recruiting and retaining minority populations. METHODS: Applying community engaged research principles, we developed a massive open online course (MOOC) to help research team members develop knowledge and skills to enhance the recruitment of minorities in clinical trials. A transdisciplinary working group, consisting of clinical researchers, community engagement specialists, minority clinical trial recruitment and retention educators and specialists, and knowledge management information scientists, was formed to develop an evidence-based curriculum. Feedback from the Recruitment Innovation Center Community Advisory Board was incorporated to help finalize the curriculum. The course was implemented in Coursera, an online learning platform offering MOOCs. A bootstrap paired sample t-test was used to compare pre- and post-assessments of knowledge, attitudes, and intentions as it relates to minority recruitment. RESULTS: The final course, entitled Faster Together, was divided into eight 1-h modules. Each module included video presentations, reading assignments, and quizzes. After 10 months, 382 individuals enrolled in the course, 105 participants completed the pre-test, and 14 participants completed the post-test. Participants' knowledge scores were higher with an increase in the mean number of correct answers from 15.4 (95% CI:12.1-18.7) on the pre-test to 18.7 (95% CI:17.42-20.2) on the post-test. All post-test respondents (n = 14) indicated that the course improved their professional knowledge, and 71.4% of respondents indicated that they were very likely to make changes to their recruitment practices. CONCLUSIONS: Faster Together, a massive open online course, is an acceptable, accessible approach to educating research teams on minority recruitment in clinical trials. Preliminary evidence indicates the course increased knowledge on how to recruit minorities into clinical trials and could promote change in their recruitment practices.
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Educação a Distância , Ensaios Clínicos como Assunto , Etnicidade , Humanos , Grupos Minoritários , Projetos Piloto , PesquisadoresRESUMO
Participation in cancer clinical trials (CCTs) is critical to improving cancer treatments and quality of care. However, rates of patient participation remain low. Research has shown that a trusted physician recommendation is an important influence on patients' decisions to enroll in a CCT. Improving primary care providers' (PCPs') knowledge, attitudes, and beliefs about CCTs is a promising potential path for improving CCT participation. The aim of this pilot study was to test the effect of an online educational course for PCPs about clinical trials on primary care providers' knowledge, attitudes and beliefs, and behavior. Forty-one PCPs in the New York City area participated in a 1-h online training session on cancer clinical trials. These PCPs had self-selected to complete the training in a previous survey. The objectives of the training module were to (1) educate the PCPs about clinical trials, with a focus on overcoming misconceptions; and (2) discuss roles of PCPs in partnering with oncologists to help patients gain access to clinical trials. The training module included didactics, audio excerpts, and case descriptions. Participants completed a pre-test immediately before taking the course, a post-test immediately after taking the course, and a 3-month post-course survey. All three assessments included a general T/F knowledge test, a 7-item attitude/belief scale, and a knowledge test focused specifically on local resources and access for clinical trials. Forty-one PCPs completed the module and the pre-post course surveys. Eighty percent (33/41) also completed the 3-month post-course survey. General knowledge and local knowledge increased significantly (p < .05) from pre- to post-course. At 3 months post-training, both general and local knowledge scores remained significantly increased from baseline. For those who completed the 3-month post-course survey, attitudes and beliefs increased significantly from pre- to post-course, but this change was not sustained at 3 months post-training. At 3 months post-training, 52% of the PCPs who had an interaction with a recently diagnosed cancer patient reported speaking with patients about CCTs as a result of the training. A brief online course showed significant and sustained improvement in PCPs' general and local knowledge about cancer clinical trials, which translated into self-reported behavior change. Future dissemination of the course and further research into its impact are important next steps.
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Neoplasias , Médicos de Atenção Primária , Atitude do Pessoal de Saúde , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Neoplasias/terapia , Projetos Piloto , Inquéritos e QuestionáriosRESUMO
BACKGROUND/AIMS: Cancer clinical trials give patients access to state-of-the-art treatments and facilitate the translation of findings into mainstream clinical care. However, patients from racial and ethnic minority groups remain underrepresented in clinical trials. Primary care physicians are a trusted source of information for patients, yet their role in decision-making about cancer treatment and referrals to trial participation has received little attention. The aim of this study was to determine physicians' knowledge, attitudes, and beliefs about cancer clinical trials, their experience with trials, and their interest in appropriate training about trials. METHODS: A total of 613 physicians in the New York City area primarily serving patients from ethnic and racial minority groups were invited via email to participate in a 20-min online survey. Physicians were asked about their patient population, trial knowledge and attitudes, interest in training, and personal demographics. Using calculated scale variables, we used descriptive statistical analyses to better understand physicians' knowledge, attitudes, and beliefs about trials. RESULTS: A total of 127 physicians completed the survey. Overall, they had low knowledge about and little experience with trials. However, they generally had positive attitudes toward trials, with 41.4% indicating a strong interest in learning more about their role in trials, and 35.7% indicating that they might be interested. Results suggest that Black and Latino physicians and those with more positive attitudes and beliefs were more likely to be interested in future training opportunities. CONCLUSION: Primary care physicians may be an important group to target in trying to improve cancer clinical trial participation among minority patients. Future work should explore methods of educational intervention for such interested providers.
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Atitude do Pessoal de Saúde , Ensaios Clínicos como Assunto , Conhecimentos, Atitudes e Prática em Saúde , Neoplasias/terapia , Médicos de Atenção Primária/psicologia , Adulto , Negro ou Afro-Americano/psicologia , Negro ou Afro-Americano/estatística & dados numéricos , Asiático/psicologia , Asiático/estatística & dados numéricos , Feminino , Hispânico ou Latino/psicologia , Hispânico ou Latino/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Cidade de Nova Iorque , Pesquisa Qualitativa , Encaminhamento e Consulta , Inquéritos e Questionários , População Branca/psicologia , População Branca/estatística & dados numéricosRESUMO
BACKGROUND: Research has demonstrated that communication and care coordination improve cancer patient outcomes. To improve communication and care coordination, it is important to understand primary care providers' (PCPs') perceptions of communication with oncologists as well as PCPs' communication needs. METHODS: A mixed-methods approach was used in the present study. In the qualitative phase of the study, 18 PCPs practicing in underserved, minority communities were interviewed about their experiences communicating with oncologists. In the quantitative phase of the study, 128 PCPs completed an online survey about their preferences, experiences, and satisfaction with communication with oncologists. RESULTS: Results indicated a PCP-oncologist gap in communication occurred between diagnosis and treatment. PCPs wanted more communication with oncologists, updates on their patients' prognosis throughout treatment, and to be contacted via telephone or email and saw their role as crucial in providing supportive care for their patients. CONCLUSIONS: Although PCPs recognize that they play a critical, proactive role in supporting patients throughout the continuum of their cancer care experience, existing norms regarding postreferral engagement and oncologist-PCP communication often hinder activation of this role among PCPs. Expected standards regarding the method, frequency, and quality of postreferral communication should be jointly articulated and made accountable between PCPs and oncologists to help improve cancer patients' quality of care, particularly in minority communities.
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Atitude do Pessoal de Saúde , Comunicação , Oncologia , Área Carente de Assistência Médica , Médicos de Atenção Primária , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Papel do Médico , Inquéritos e QuestionáriosRESUMO
Participation in cancer clinical trials (CCTs) is a key measure for delivery of quality cancer care. Yet, adult cancer patient participation in CCTs remains at about 3%, and participation rates are even lower among ethnic and racial minorities and the medically underserved. Social justice demands better representation of all populations in CCTs to ensure equal access to clinical trials and to ensure greater generalizability of trial results. Using a conceptual framework, this paper outlines a set of guiding principles deemed essential for effective and ethical implementation of community-based education in CCTs. Also described are examples of interventions related to this framework that have been used to overcome key barriers to trial enrollment among underserved populations. Application of the key principles, combined with ongoing engagement of cancer care institutions, suggests promise in enhancing trial participation.
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Ensaios Clínicos como Assunto/estatística & dados numéricos , Pesquisa Participativa Baseada na Comunidade , Neoplasias/prevenção & controle , Educação de Pacientes como Assunto , Participação do Paciente , Seleção de Pacientes , Adulto , HumanosRESUMO
This paper describes the use of a unique "Learning and FeedbackË® approach to customize cancer clinical trials education programs for Community Bridges, a peer training intervention designed for African-American communities in North Carolina. Generic community education modules were demonstrated with key community leaders who were designated as trainers. Quantitative and qualitative assessments were provided on understanding of content, comfort with material, and cultural relevance. The generic materials were adapted into three revised modules, all featuring key messages about cancer clinical trials, discussion regarding distrust of medical research, common misconceptions about trials, patient protections, and a call to action to prompt increased inquiry about locally available trials. The revised modules were then used as part of a train-the-trainer program with 12 African-American community leaders. ENACCT's use of the Learning and Feedback process is an innovative method for culturally adapting clinical trials education.
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Negro ou Afro-Americano/educação , Ensaios Clínicos como Assunto , Pesquisa Participativa Baseada na Comunidade/organização & administração , Comportamento Cooperativo , Neoplasias/prevenção & controle , Educação de Pacientes como Assunto , Humanos , Participação do PacienteRESUMO
Primary Care Providers (PCPs) can be instrumental in helping to prepare patients for referral to cancer treatment. It has been suggested that PCPs can have an important impact on priming patients about the possibility of receiving care within a cancer treatment clinical trial (CCT). However, little is understood about how to effectively engage primary care providers in educating patients about trials. Data were collected as part of two qualitative research projects about primary care providers' role in referral to treatment and to CCTs. Participants were 27 PCPs who agreed to take part in qualitative face-to-face or telephone interviews and serve predominantly underserved, minority populations. Interviews identified a number of factors influencing referral to oncologists, including patients' insurance coverage, location and proximity to treatment facilities, and the strength of ongoing relationships with and/or previous experience with a specialist. PCPs overwhelmingly expressed disinterest in discussing any treatment options, including CCTs. Misconceptions about quality of care received through trials were also common, presenting a deterrent to discussion. PCPs need targeted, evidence-based educational interventions to appropriately address their concerns about cancer clinical trials, enhance provider communication skills, and alter patient referral behavior. Steps must also be taken to strengthen communication between oncologists and referring PCPs.
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Atitude do Pessoal de Saúde , Ensaios Clínicos como Assunto/estatística & dados numéricos , Comunicação , Conhecimentos, Atitudes e Prática em Saúde , Neoplasias/prevenção & controle , Médicos de Atenção Primária/educação , Padrões de Prática Médica/normas , Defesa do Consumidor , Cultura , Humanos , Participação do Paciente , Papel do Médico , Pesquisa Qualitativa , Encaminhamento e ConsultaRESUMO
Cancer clinical trial (CCT) accrual and retention rates remain disproportionately low among African Americans. Awarenesss and access to trials are crucial facilitators of trial participation. Strategies developed within a community-based participatory framework (CBPR) are potential solutions to increase awareness and access to CCTs. In this study, we describe the pilot phase of three innovative community-centered modules to improve basic CCT knowledge, awareness of locations to access CCT information, and opportunities to participate in CCTs. Four community organizations completed Community Bridges to CCT training-of-the-trainer and recruited adult African American volunteers to participate in one of three CCT education modules: a workshop about CCTs, a role play describing one person's experience with CCTs, or a call and response session reviewing myths and facts about CCTs. Pre- and post-test surveys were collected and analyzed using McNemar agreement statistic to evaluate changes in knowledge and attitudes regarding trials. Trainers enrolled 125 participants in the call and response (n = 22), role play (n = 60), and workshop (n = 43) modules. Module participants were mostly African American, female, and with a mean age of 53 years. Comparison of pre- and post-test responses demonstrates favorable changes in awareness of CCTs and where to access CCTs across the sample. Analysis by module type indicates significant increases for participants in the call and response (p < 0.01) and role play modules (p < 0.001), but not the workshop module. Despite measures taken to increase the participation and retention rate of African Americans in clinical trials, little advancement has been made. Developing tailored community education modules on CCTs within the CBPR framework is a promising innovation to increase knowledge about CCTs and favorable attitudes about participation that are known precursors to trial enrollment.
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Negro ou Afro-Americano , Ensaios Clínicos como Assunto/estatística & dados numéricos , Pesquisa Participativa Baseada na Comunidade , Neoplasias/prevenção & controle , Participação do Paciente , Seleção de Pacientes , Adulto , Idoso , Idoso de 80 Anos ou mais , Defesa do Consumidor , Intervenção Educacional Precoce , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Educação de Pacientes como Assunto , Projetos Piloto , Projetos de Pesquisa , Adulto JovemRESUMO
INTRODUCTION: Despite the importance of clinical trial participation among cancer patients, few participate-and even fewer patients from ethnic and racial minoritized groups. It is unclear whether suggested approaches to increase accrual are successful. We conducted a scoping review to identify evidence-based approaches to increase participation in cancer treatment clinical trials that demonstrated clear increases in accrual. Notably, more stringent than other published reviews, only those studies with comparison data to measure a difference in accrual rates were included. METHODS: We searched PubMed/MEDLINE, Embase, CINAHL, and Web of Science for English-language articles published from January 1, 2012, to August 8, 2022. Studies were included if they were conducted in the United States, described single or multicomponent interventions, and provided data to measure accrual relative to baseline levels or that compared accrual rates with other interventions. RESULTS: Sixteen articles were included: six with interventions addressing patient barriers, two addressing provider barriers, seven describing institutional change, and one describing policy change. Key themes emerged, such as a focus on patient education, cultural competency, and building the capacity of clinics. Few studies provide comparative accrual data, making it difficult to identify with certainty any effective, evidence-based approaches for increasing accrual. Some patient- and system-level interventions studies showed modest increases in accrual primarily through pre-post measurement. CONCLUSION: Despite an extensive body of literature about the barriers that impede cancer treatment trial accrual, along with numerous recommendations for how to overcome these barriers, results reveal surprisingly little evidence published in the last 10 years on interventions that increase accrual relative to baseline levels or compared with other interventions. As clinical trials are a primary vehicle through which we improve cancer care, it is critical that evidence-based approaches are used to inform all efforts to increase accrual. Strategies for increasing participation in cancer clinical trials must be developed and rigorously evaluated so that these strategies can be disseminated, participation in trials can increase and become more equitable, and trial results can become more generalizable.
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Ensaios Clínicos como Assunto , Neoplasias , Seleção de Pacientes , Humanos , Neoplasias/terapia , Participação do PacienteRESUMO
Only 3% of cancer patients participate in cancer clinical trials (CCTs). A number of barriers to participation, particularly for minority groups, can be addressed through community-focused education and advocacy efforts. Working with community partnerships, a pilot program sought to change knowledge, attitudes, and role behaviors among community leaders, primary care providers (PCPs), and clinical researchers about CCTs, to increase patient awareness of and participation in CCTs. A mixed method evaluation utilized quantitative analysis of surveys administered to participants during the program period (2006-2008) and qualitative data from interviews with key participants. Programmatic efforts were effective in increasing knowledge and training community leaders and PCPs to disseminate messages about clinical trials, and ultimately increasing patient inquiries about local trials. Training improved cultural competency skills among clinical researchers to recruit and retain CCT participants. Partnerships fostered new processes and structures to facilitate CCT participation in their communities. Clinical trials education and advocacy efforts through community partnerships have an important role in enhancing clinical trial access and in increasing clinical trial participation. Oncologists' involvement in and leadership of such partnerships are critical to promoting CCT accrual, particularly for minority groups.
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Ensaios Clínicos como Assunto/estatística & dados numéricos , Pesquisa Participativa Baseada na Comunidade , Defesa do Consumidor , Neoplasias/prevenção & controle , Educação de Pacientes como Assunto , Seleção de Pacientes , Médicos de Atenção Primária/educação , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Participação do Paciente , Projetos Piloto , Projetos de PesquisaRESUMO
PURPOSE: There are numerous barriers to cancer clinical trial participation in the United States. This paper describes the approach and outcomes of The Leukemia & Lymphoma Society's Clinical Trial Support Center (CTSC), whose nurse navigators assist patients with a blood cancer and their oncologists by identifying all appropriate trials based on clinical data and patient preference, facilitating informed and shared decision making, and minimizing enrollment barriers. METHODS: Data on patients served from October 2017 to October 2019 were analyzed using bivariate and multivariate analyses to determine demographic and clinical characteristics associated with enrollment. Reasons for nonenrollment were examined. RESULTS: The CTSC opened 906 patient cases during this time frame. Among all US patients with a closed case (n = 750), the clinical trial enrollment rate was 16.1%. Among those with a known enrollment outcome after a trial search (n = 537), the enrollment rate was 22.5%. Multivariate analysis controlling for variables significant in bivariate analyses (insurance, treatment status, Eastern Cooperative Oncology Group performance status, and urban or rural residence) revealed that patients with Medicaid were less likely to enroll than those with private or commercial insurance (adjusted odds ratio, 0.054; CI, 0.003 to 0.899), and patients in treatment or maintenance were less likely to enroll than those relapsed or refractory to most recent therapy (adjusted odds ratio, 0.312; CI, 0.139 to 0.702). Primary reasons for nonenrollment were preference for standard of care (66.3%) and patient passed away (16.1%). CONCLUSION: The CTSC is an effective, replicable model for addressing multilevel barriers to clinical trial participation. The findings highlight the need to increase opportunities for trial participation sooner after diagnosis and among patients with Medicaid.
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Neoplasias Hematológicas , Neoplasias , Humanos , Medicaid , Neoplasias/terapia , Preferência do Paciente , Estados UnidosRESUMO
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.
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Ensaios Clínicos como Assunto , Educação em Saúde , Conhecimentos, Atitudes e Prática em Saúde , Disseminação de Informação/métodos , Neoplasias , Medicina Baseada em Evidências , Grupos Focais , Inquéritos Epidemiológicos , Humanos , National Cancer Institute (U.S.) , Avaliação de Programas e Projetos de Saúde , Estados UnidosRESUMO
In response to the need for linguistically and culturally appropriate cancer survivorship materials for Latinos, the Office of Education and Special Initiatives and the Office of Cancer Survivorship at the National Cancer Institute (NCI) set out to test, adapt, and refine a Spanish translation of an English-language booklet for adult cancer survivors titled Facing Forward: Life After Cancer Treatment (Siga adelante: la vida después del tratamiento del cáncer). The authors used a process called "transcreation," which involves translating existing English-language materials into Spanish and then adapting them for Latino audiences. The Spanish version of the booklet was reviewed by nine Spanish-speaking reviewers who were cancer survivors. The multistage transcreation process reinforced the importance of conducting formative research as well as adjusting the methodology to address the needs of changing demographics.
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Diversidade Cultural , Hispânico ou Latino , Idioma , Neoplasias , Folhetos , Sobreviventes , Adulto , Humanos , Estados UnidosRESUMO
BACKGROUND: Clinical trials are a critical resource for the discovery of new prevention, diagnostic, and treatment methods for cancer. The most effective prevention and treatment modalities are based on previous clinical trial results. However, participation in clinical trials is underrepresented by racial/ethnic minority populations, Asian Americans in particular. Asian Americans are the least represented of any ethnic groups in clinical trials. The purpose of this study is to develop and evaluate a culturally and linguistically appropriate community-based educational intervention to increase knowledge of and intent to participate in cancer clinical trials among underrepresented Chinese Americans. METHODS: Community-Based Participatory Research approach was used to guide the development, cultural tailoring, implementation, and evaluation of clinical trial intervention. First, 22 Asian community representatives were recruited as community health educators (CHE) who received 12-hour training on clinical trial education. Second, 262 members were recruited from 11 Chinese community organizations. Of those recruited, a total of 247 eligible Chinese enrolled and participated in the clinical trial education delivered by trained CHEs. Participants completed pretest before and posttest after the intervention. RESULTS: Fifteen of 21 measures of clinical trial knowledge showed significant changes post the intervention (P < 0.05). Education remained the sole demographic factor increasing clinical trial knowledge in multivariate analysis. CONCLUSION: Clinical trial education should emphasize both benefits to science and the larger Asian community. This community-based clinical trial intervention demonstrated promising results and has potential to enhance recruitment and participation in clinical trial research among the underrepresented Asian Americans. IMPACT: Improving clinical trial participation in the fast-growing Asian American population is key to dissemination of health innovations targeted to diminish health disparities.
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Asiático , Pesquisa Participativa Baseada na Comunidade/métodos , Educação em Saúde/métodos , Educação de Pacientes como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Idoso , Idoso de 80 Anos ou mais , China/etnologia , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Neoplasias/etnologia , Resultado do TratamentoRESUMO
The Cancer Support Community (CSC) provides psychosocial support to people facing cancer in community settings. The purpose of this study was to evaluate the compatibility, effectiveness, and fidelity of the Situation-Choices-Objectives-People-Evaluation-Decisions (SCOPED) question-listing intervention at three CSC sites. Between August 2008 and August 2011, the Program Director at each CSC site implemented question-listing, while measuring patient distress, anxiety, and self-efficacy before and after each intervention. We analyzed the quantitative results using unadjusted statistical tests and reviewed qualitative comments by patients and the case notes of Program Directors to assess compatibility and fidelity. Program Directors implemented question-listing with 77 blood cancer patients. Patients reported decreased distress (p = 0.009) and anxiety (p = 0.005) and increased self-efficacy (p < 0.001). Patients and Program Directors endorsed the intervention as compatible with CSC's mission and approach and feasible to implement with high fidelity. CSC effectively translated SCOPED question-listing into practice in the context of its community-based psychosocial support services at three sites.
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INTRODUCTION: Many challenges to clinical trial accrual exist, resulting in studies with inadequate enrollment and potentially delaying answers to important scientific and clinical questions. METHODS: The National Cancer Institute (NCI) and the American Society of Clinical Oncology (ASCO) cosponsored the Cancer Trial Accrual Symposium: Science and Solutions on April 29-30, 2010 to examine the state of accrual science related to patient/community, physician/provider, and site/organizational influences, and identify new interventions to facilitate clinical trial enrollment. The symposium featured breakout sessions, plenary sessions, and a poster session including 100 abstracts. Among the 358 attendees were clinical investigators, researchers of accrual strategies, research administrators, nurses, research coordinators, patient advocates, and educators. A bibliography of the accrual literature in these three major areas was provided to participants in advance of the meeting. After the symposium, the literature in these areas was revisited to determine if the symposium recommendations remained relevant within the context of the current literature. RESULTS: Few rigorously conducted studies have tested interventions to address challenges to clinical trials accrual. Attendees developed recommendations for improving accrual and identified priority areas for future accrual research at the patient/community, physician/provider, and site/organizational levels. Current literature continues to support the symposium recommendations. CONCLUSIONS: A combination of approaches addressing both the multifactorial nature of accrual challenges and the characteristics of the target population may be needed to improve accrual to cancer clinical trials. Recommendations for best practices and for future research developed from the symposium are provided.
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Ensaios Clínicos como Assunto/métodos , Oncologia , National Cancer Institute (U.S.) , Neoplasias/terapia , Seleção de Pacientes , Sociedades Médicas , Atitude do Pessoal de Saúde , Humanos , Liderança , Educação de Pacientes como Assunto , Padrões de Prática Médica , Estados UnidosRESUMO
By building relationships with referring physicians and educating them about the clinical trial process, oncologists can help increase trial accrual among patients with cancer.
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Although an estimated 20% of adult cancer patients are medically eligible for a cancer treatment clinical trial (CCT), adult trial participation in the U.S. remains under 3%.- Participation rates are even lower among ethnic and racial minorities and the medically underserved, who tend to have higher cancer mortality rates than the population as a whole.- Given persistent cancer health disparities in these populations, cancer clinical trial participation is increasingly an issue of social justice. Community-based participatory research (CBPR) approaches have been repeatedly recommended as a key strategy for increasing and diversifying cancer clinical trial participation and enhancing their relevance and quality. In 2006, Community-Campus Partnership for Health (CCPH) and the Education Network to Advance Cancer Clinical Trials (ENACCT) received funding from the Agency for Healthcare Research and Quality and the National Cancer Institute (NCI), along with industry and nonprofit partners, to develop the first set of national recommendations to employ CBPR approaches in multisite, phase III cancer clinical trials. The Communities as Partners in Cancer Clinical Trials: Changing Research, Practice and Policy final report, developed through a national advisory committee, two stakeholder meetings and a public vetting process, makes more than fifty detailed recommendations to engage communities in specific and meaningful ways throughout the cancer clinical trial process.1 The report is the first to provide specific guidance as to how and why clinical trials should involve communities affected by cancer-from trial design to implementation to dissemination of results. This paper describes the background and rationale for the initiative, the process used to develop and disseminate the report, and the challenges and opportunities for implementing the report's community-based approaches to cancer clinical research.