An absence of translated consent forms limits oncologic clinical trial enrollment for limited English proficiency participants

Guo, X. Mona; Neuman, Monica K.; Vallejo, Andrew; Matsuo, Koji; Roman, Lynda D.

doi:10.1016/j.ygyno.2023.11.025

Cited by 4 publications

(3 citation statements)

References 30 publications

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“… 22 Studies at individual sites have shown improvement in clinical trial enrollment racial disparities with the addition of translated consent forms and a trial navigation workforce that mirrors the demographics of the patient population. 23 , 24 Funding for and utilization of these types of resources as part of future clinical trials will be important steps to addressing disproportionate enrollment.…”

Section: Discussionmentioning

confidence: 99%

Racial Disparities in Endometrial Cancer Clinical Trial Representation

Wolf,

Hamilton,

et al. 2024

American Journal of Clinical Oncology

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Background: This study aimed to determine whether Black patients with recurrent endometrial cancer were more likely than White patients to be ineligible for a recently published clinical trial due to specific eligibility criteria. Methods: Patients with recurrent or progressive endometrial cancer diagnosed from January 2010 to December 2021 who received care at a single institution were identified. Demographic and clinicopathologic information was abstracted and determination of clinical trial eligibility was made based on 14 criteria from the KEYNOTE-775 trial. Characteristics of the eligible and ineligible cohorts were compared, and each ineligibility criterion was evaluated by race. Results: One hundred seventy-five patients were identified, 89 who would have met all inclusion and no exclusion criteria for KEYNOTE-775, and 86 who would have been ineligible by one or more exclusion criteria. Patients in the ineligible cohort were more likely to have lower BMI (median 26.5 vs. 29.2, P<0.001), but were otherwise similar with regard to insurance status, histology, and stage at diagnosis. Black patients had 33% lower odds of being eligible (95% CI: 0.33-1.34) and were more likely to meet the exclusion criterion of having a previous intestinal anastomosis, but the result was not statistically significant. If this criterion were removed, the racial distribution of those ineligible for the trial would be more similar (46.4% Black vs. 42.2% White). Conclusions: Clinical trial eligibility criteria may contribute to the underrepresentation of racial groups in clinical trials, but other factors should be explored. Studies to quantify and lessen the impact of implicit bias are also needed.

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Section: Discussionmentioning

confidence: 99%

Racial Disparities in Endometrial Cancer Clinical Trial Representation

Wolf,

Hamilton,

et al. 2024

American Journal of Clinical Oncology

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“…A tension existed between the regulatory requirements to ensure availability of translated consent forms and the allowance of or restrictions on using short forms. Translation service requirements have historically been expensive and time-consuming, delaying the opportunity to enroll persons who speak languages other than English in a trial ( 31 ). Translating consent forms is a multistep process that tends to require costs that are rarely covered in research budgets.…”

Section: Discussionmentioning

confidence: 99%

Clinical trial recruitment of people who speak languages other than English: a Children’s Oncology Group report

Beauchemin,

Ortega,

Santacroce

et al. 2024

JNCI Cancer Spectrum

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Background Persons who speak languages other than English (LOE) are underrepresented in clinical trials; this may be due in part to inadequate multilevel resources. We conducted a survey of institutions affiliated with the Children’s Oncology Group (COG) to characterize current research recruitment practices and resources regarding translation and interpretation services. Methods In October 2022, a 20-item survey was distributed electronically to institutions affiliated with COG to assess consent practices and resources for recruiting participants who speak LOE to COG trials. Descriptive statistics were used to summarize responses; responses were compared by institution size, type, and respondent role. Results The survey was sent to a total of 230 institutions, and the response rate was 60% (n = 139). In total, 60% (n = 83) had access to short form consents. Full consent form translation was required at 50% of institutions, and 12% of Institutional Review Boards restricted use of centrally translated consent forms. Forty-six percent of institutions reported insufficient funding to support translation costs; 15% had access to no-cost translation services. Forty-four percent (n = 61) were required to use in-person interpreters for consent discussions; the most cited barrier to obtaining consent was lack of available in-person interpreters (56%). Forty-six percent (n = 69) reported that recruiting persons who speak LOE to clinical trials was somewhat or very difficult. Conclusions Institutions affiliated with COG face resource-specific challenges that impede recruitment of participants who speak LOE in clinical trials. These findings indicate an urgent need to identify strategies aimed at reducing recruitment barriers to ensure equitable access to clinical trials.

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“…More so, lingering gender-biased misconceptions that women are more difficult to recruit, are less willing to participate in trials, and are more difficult to work with [69] also persist as formidable obstacles to equitable representation [9,69]. For minoritized patient populations, additional barriers include stringent and narrow trial designs that may inadvertently exclude racial and ethnic minorities at a disproportionate rate [76,77], overly complex or lack of translated informational materials [78][79][80][81], and lack of local availability [76]. These patients may be hesitant to participate in clinical trials due to having a lack of trust in clinical research [82,83], as well as due to the financial toxicity [84,85] associated with trial participation, transportation needs, and other social determinants of health [86].…”

Section: Lack Of Inclusion In Clinical Trialsmentioning

confidence: 99%

Precision Immuno-Oncology in NSCLC through Gender Equity Lenses

Marks,

Sridhar,

et al. 2024

Cancers

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Precision immuno-oncology involves the development of personalized cancer treatments that are influenced by the unique nature of an individual’s DNA, immune cells, and their tumor’s molecular characterization. Biological sex influences immunity; females typically mount stronger innate and adaptive immune responses than males. Though more research is warranted, we continue to observe an enhanced benefit for females with lung cancer when treated with combination chemoimmunotherapy in contrast to the preferred approach of utilizing immunotherapy alone in men. Despite the observed sex differences in response to treatments, women remain underrepresented in oncology clinical trials, largely as a result of gender-biased misconceptions. Such exclusion has resulted in the development of less efficacious treatment guidelines and clinical recommendations and has created a knowledge gap in regard to immunotherapy-related survivorship issues such as fertility. To develop a more precise approach to care and overcome the exclusion of women from clinical trials, flexible trial schedules, multilingual communication strategies, financial, and transportation assistance for participants should be adopted. The impact of intersectionality and other determinants of health that affect the diagnosis, treatment, and outcomes in women must also be considered in order to develop a comprehensive understanding of the unique impact of immunotherapy in all women with lung cancer.

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An absence of translated consent forms limits oncologic clinical trial enrollment for limited English proficiency participants

Cited by 4 publications

References 30 publications

Racial Disparities in Endometrial Cancer Clinical Trial Representation

Racial Disparities in Endometrial Cancer Clinical Trial Representation

Clinical trial recruitment of people who speak languages other than English: a Children’s Oncology Group report

Precision Immuno-Oncology in NSCLC through Gender Equity Lenses

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