Patient barriers to cancer clinical trial participation and navigator activities to assist

Cartmell, Kathleen B.; Bonilha, Heather Shaw; Simpson, Kit N.; Ford, Marvella E.; Bryant, Deborah; Alberg, Anthony J.

doi:10.1016/bs.acr.2020.01.008

Cited by 37 publications

(36 citation statements)

References 18 publications

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“…Health care systems can ensure that physicians have access to support staff to help screen and enroll patients as well as to set expectations for minimum accrual. The engagement of patient navigators familiar with clinical trial availability can also improve enrollment 54‐57 …”

Section: Resultsmentioning

confidence: 99%

“…The engagement of patient navigators familiar with clinical trial availability can also improve enrollment. [54][55][56][57] Select patients with early stage or low-grade cancers may not require chemotherapy, and surgery alone with follow-up evaluation may suffice as primary treatment. 13 However, for most patients with ovarian cancer, initial treatment involves systemic chemotherapy and often includes other targeted therapy as standard and maintenance therapies.…”

Section: Treatment Planningmentioning

confidence: 99%

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Improving the quality of care for patients with advanced epithelial ovarian cancer: Program components, implementation barriers, and recommendations

Temkin

Smeltzer

Dawkins

et al. 2021

Cancer

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The high lethality of ovarian cancer in the United States and associated complexities of the patient journey across the cancer care continuum warrant an assessment of current practices and barriers to quality care in the United States. The objectives of this study were to identify and assess key components in the provision of high-quality care delivery for patients with ovarian cancer, identify challenges in the implementation of best practices, and develop corresponding quality-related recommendations to guide multidisciplinary ovarian cancer programs and practices. This multiphase ovarian cancer quality-care initiative was guided by a multidisciplinary expert steering committee, including gynecologic oncologists, pathologists, a genetic counselor, a nurse navigator, social workers, and cancer center administrators. Key partnerships were also established. A collaborative approach was adopted to develop comprehensive recommendations by identifying ideal quality-of-care program components in advanced epithelial ovarian cancer management. The core program components included: care coordination and patient education, prevention and screening, diagnosis and initial management, treatment planning, disease surveillance, equity in care, and quality of life. Quality-directed recommendations were developed across 7 core program components, with a focus on ensuring high-quality ovarian cancer care delivery for patients through improved patient education and engagement by addressing unmet medical and supportive care needs. Implementation challenges were described, and key recommendations to overcome barriers were provided. The recommendations emerging from this initiative can serve as a comprehensive resource guide for multidisciplinary cancer practices, providers, and other stakeholders working to provide quality-directed cancer care for patients diagnosed with ovarian cancer and their families.

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Section: Resultsmentioning

confidence: 99%

Section: Treatment Planningmentioning

confidence: 99%

Improving the quality of care for patients with advanced epithelial ovarian cancer: Program components, implementation barriers, and recommendations

Temkin

Smeltzer

Dawkins

et al. 2021

Cancer

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“…We are applying this model in one of our newly initiated clinical trials program for an investigational new hematology compound, where we are offering study sites augmented staffing with a clinical recruitment coordinator matched to the race/ethnicity of the community groups they are targeting. Navigators could support clinical trial recruitment by making referrals and handling communications on behalf of patients, arranging transportation, and managing documentation, finances, and visits 7 . We are also exploring collaboration with multicultural centers and professional associations representative of minority and ethnically diverse nurses to promote recruitment activities in the community setting.…”

Section: What Can We Do About It?mentioning

confidence: 99%

“…6 Less than 10% of patients with cancer in the United States participate in a cancer clinical trial, implying that racial/ ethnic minority group participation is expected to be alarmingly low. 7 In a recent study evaluating the frequency of race reporting and proportional race representation in trials supporting Food and Drug Administration (FDA) approvals of cancer therapeutics between 2008 to 2018, only 7.8% of 230 trials (recruiting 112,293 patients) documented the four major races in the United States, and only 25.2% reported race subgroup analyses. Comparing 2008-2013 to 2013-2018, the number of trials reporting race and race subgroup analyses changed minimally.…”

Section: Where Do We Stand?mentioning

confidence: 99%

“…Navigators could support clinical trial recruitment by making referrals and handling communications on behalf of patients, arranging transportation, and managing documentation, finances, and visits. 7 We are also exploring collaboration with multicultural centers and professional associations representative of minority and ethnically diverse nurses to promote recruitment activities in the community setting.…”

Section: Optimizing Patients' Access To Clinical Trials In the Communitymentioning

confidence: 99%

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Addressing racial/ethnic disparities in cancer clinical trials: Everyone has a role to play

Habr

Ferdinand

2021

Cancer

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Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials

et al. 2022

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ome racial and ethnic populations, particularly Black and Hispanic individuals, have a greater burden of heart failure (HF), are less likely to receive optimal disease-modifying therapies, and are more likely to die from HF. [1][2][3][4][5] Despite this excess risk, these same populations are often the least studied in HF clinical trials. [6][7][8][9][10] The importance of addressing the systemic underenrollment of some racial and ethnic groups has been previously highlighted 11 and remains an important directive of the US Food and Drug Administration (FDA) Safety and Innovation Act as well as the Inclusion Policy of the National Institutes of Health (NIH). 12 The Heart Failure Collaboratory, a consortium of stakeholders convened to enhance therapeutic development and delivery to patients with HF, 13 has been dedicated to improving recruitment strategies for diverse patient populations. This article is the direct result of virtual and in-person discussions among Collaboratory stakeholders with the goal of proposing strategies to improve enrollment in HF clinical trials of underrepresented racial and ethnic groups. We focus on the US perspective in the HF clinical trial landscape (with specific attention to enrollment of Black and Hispanic participants) and highlight US federal policies and initiatives to promote improved racial and ethnic representation. We recognize the need as well for improving enrollment of other populations of interest, including women, older adults, and people in rural areas of the United States [14][15][16][17] ; however, this call to action focuses on building sustainable pathways to improve future diverse participation with respect to race and ethnicity. Barriers in Underrepresented HF Trial EnrollmentMany racial and ethnic populations continue to experience socioeconomic deprivation, chronic discrimination, and stress that worsen health outcomes across the lifespan. [18][19][20][21] The ability and willingness of patients with HF to actively participate in clinical trials is intricately tied to social determinants of health, such as access to health care, education, income equality, and food security as well as cultural and community values. 22 This underrepresentation likely results from limited access both to clinical care and the current clinical IMPORTANCE Despite bearing a disproportionate burden of heart failure (HF), Black and Hispanic individuals have been poorly represented in HF clinical trials. Underrepresentation in clinical trials limits the generalizability of the findings to these populations and may even introduce uncertainties and hesitancy when translating trial data to the care of people from underrepresented groups. The Heart Failure Collaboratory, a consortium of stakeholders convened to enhance HF therapeutic development, has been dedicated to improving recruitment strategies for patients from diverse and historically underrepresented groups.OBSERVATIONS Despite federal policies from the US Food and Drug Administration and National Institutes of Health aimed at i...

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Patient barriers to cancer clinical trial participation and navigator activities to assist

Cited by 37 publications

References 18 publications

Improving the quality of care for patients with advanced epithelial ovarian cancer: Program components, implementation barriers, and recommendations

Improving the quality of care for patients with advanced epithelial ovarian cancer: Program components, implementation barriers, and recommendations

Addressing racial/ethnic disparities in cancer clinical trials: Everyone has a role to play

Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials

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