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Background:

Enrollment in oncology trials does not always reflect the range of languages spoken in the communities we serve. One possible barrier is the availability of translated informed consent documents in the patient’s preferred language, as these processes are often built around English-language workflows. Because consent forms are legal documents and can change over the course of a trial, translated versions may also need to be updated and re-translated. This can make the consent process take longer, especially when interpreter coordination and extra document review are also needed. In oncology clinical trials, these delays may affect how quickly eligible patients are able start clinical trials after diagnosis or disease progression.

Objective:

To compare time from cancer diagnosis or documented disease progression to clinical trial consent signing between English and non-English preferred language groups, and to explore whether translated consent availability may help explain these differences.

Methods: 

This retrospective cohort study uses clinical trial enrollment data and ongoing electronic health record chart review from the UCLA Jonsson Comprehensive Cancer Center from 2013 to 2023. The primary outcome was time-to-consent, defined as the documented time from cancer diagnosis or disease progression to signed clinical trial consent. Consent dates were taken from enrollment records. Diagnosis and progression dates were found through structured chart review in Care Connect. Notes were reviewed to confirm whether the case reflected a new diagnosis or progression. For newly diagnosed cases, the date of diagnosis was found using pathology reports, usually biopsy-confirmed malignancy before the consent date. For progression cases, date of progression was found using radiology reports before the consent date showing worsening disease, such as enlarging lesions or new metastases. Data were managed in REDCap under IRB-approved protocol 20-0571

Results:

Preliminary analysis was conducted on the subset of patients with completed chart review to date. Among records reviewed so far, median time from cancer diagnosis or documented disease progression to signed consent was 17 days for English-preferred patients and 23 days for non-English-preferred patients. Among non-English-preferred patients, median time-to-consent was 18 days when consent was available in the patient’s preferred language and 28 days when it was not. Chart review is ongoing for the remaining cohort. 

Conclusions:

Preliminary findings from the partially abstracted cohort suggest longer time-to-consent among patients with non-English preferred language compared with English-preferred patients. Within the patients with non-English preferred language, time-to-consent was longer when consent was not available in the patient’s preferred language. These early findings suggest that translated consent availability may be an important and modifiable systems-level factor in timely clinical trial enrollment. Review of the remaining cohort will help determine whether these patterns persist in the full cohort.