Language as a barrier to cancer clinical trial accrual: assessing consenting team knowledge and practices for cancer clinical trial consent among low English fluency patients

Abstract

Background: Low English fluency in large culturally diverse institutions may contribute to meager minority accrual. Our objective was to: 1) Assess knowledge of proper consenting procedures among the research team when consenting a low English fluency patient. 2) Assess the enrollment rate of participants in cancer therapeutic trials who identify a preferred language other than English. Methods: An anonymous web-based survey was distributed at a single institution to investigators, research staff and translator services to assess knowledge of consenting procedures. Patient enrollment data was retrieved from the clinical trials enrollment tracking system from January 2011 -October 2014 and matched to registration data indicating preferred language (N = 1521). The number and type of cancer cases from January 2011-October 2014 were retrieved from the institutional cancer registry and matched to registration data indicating preferred language. Results: Although there are many organizational in-person and web-based trainings focused on the requirements for consenting low English fluency patients, members of the research team responded correctly to only 64.8% (σ = 24.6%) of the knowledge-based portion of the survey. Of the 12,538 index cancer cases indentified, 10% preferred a language other than English. Trial enrollment rates for cancer clinical trials were similar for English (13%), Spanish (11%), and, Armenian (10%) speakers. Populations speaking Russian and Arabic had the lowest participation at 5% each. Conclusions: In order to increase enrollment into clinical trials, institutions must explore more effective training opportunities for research staff, engage interpreters and adopt recruitment and study materials in different languages.

Documenting Patients’ and Providers’ Preferences When Proposing a Randomized Controlled Trial: A Qualitative Exploration

“…OPs, particularly in regional cancer centres, regretted that the protocol excluded non-English-speaking patients and indicated that for those who spoke English as their second language (ESL), many could not read English written materials. This is consistent with past research highlighting low English uency levels in patients as a barrier to recruitment and warranting institutions to explore more effective training opportunities for research staff to engage interpreters and adopt recruitment and study materials in multiple languages (35). Additionally, their feedback changed some of our inclusion/exclusion criteria and broadened the timing of recruitment, training for recruitment plans, and recruitment personnel to work within these varying structures.…”

Underserved groups remain underserved as eligibility criteria routinely exclude them from breast cancer trials

“…None of the trials assessed had a strict language requirement. However, we know that those who do not speak the language of the majority are often indirectly excluded from trials as there are barriers to reading and understanding medical information, even when this is translated [34,35]. The translation of medical literature into a readable format for patients can be difficult, particularly when done by a commercial company [36].…”

Development and testing of a guideline document to provide essential information for patient decision making regarding cancer clinical trials

“…English speakers comprised 92% ( n = 1,421) of the trial participants. For the remaining 8% of the participants, their first language was not English (Staples et al., 2018). However, if there is a plain language document summarising key information about clinical trial participation, physicians may be more willing to provide the plain language document about trial participation to non‐English speaking patients and to consider them as potentially eligible for inclusion.…”