Yzquierdo, Rebecca

Background Hispanic patients continue to be underrepresented in clinical trials. To better understand the factors that impact clinical trial participation, we surveyed patients with NHL receiving care at an academic institution on their perspectives on clinical trials, barriers to care, and helpful aids to encourage clinical trial participation. Here we report the findings of the Hispanic patients and non-Hispanic white patients; accrual is ongoing for other cohorts of patients. Methods Consecutive patients ≥ 18 years old with histologically confirmed NHL who received care at MD Anderson Cancer Center in the Texas Medical Center in Houston, Texas were invited to participate regardless of treatment status. A self-administered questionnaire was used to assess patient sociodemographic factors, perceptions and willingness to participate in different clinical trial scenarios as well as participant perceived barriers to care and facilitators of trial participation. The questionnaire included a total of 53 items with an additional 13 demographic items. The questionnaire was available in English and Spanish. Results Of the 1204 patients invited, 316 consented to participate and 285 ultimately completed the survey (participation rate 23.7%). Among the total participants, this cohort included 100 self-identified Hispanic (H) participants and 103 non-Hispanic white (NHW) participants diagnosed with NHL who completed the survey and were included here. The histology of our cohort included Follicular Lymphoma (FL) [35.6%]; Diffuse Large B-cell lymphoma (DLBCL) [18.2%], Mantle cell lymphoma (MCL) [18.7%], T-cell Lymphoma (TCL) [9.4%] Marginal Zone Lymphoma [7.8%]. Compared with NHW participants, Hispanic patients were younger (Median age of 60 vs 66 years), less likely to be male (H 54% vs NHW 66%), less likely to commute more than an hour away from the doctor's office (54% vs 71.8%), had lower household income (income > $100,000 was 32% vs 41.7%) and less likely to have a bachelors' degree or higher (38% vs 50.5%). There were similar prevalence histologies such as DLBCL (H 20% vs NHW 16.5%) and FL (H 36% vs NHW 35%) compared to rarer histologies such as MCL (H 11.1% vs NHW 26.2%) and MZL (H 12% vs NHW 3.9% ) which had disproportional prevalences. Hispanic patients were less likely to have previously participated in a clinical trial (28% vs 51.5%) and less likely to have discussed clinical trials as an option (49% vs 70.9%). A majority of Hispanic (81.0%) and NHW (92.3%) respondents stated that they understood what was meant by a “clinical research study” or “clinical trial” somewhat well or very well. Less than half of Hispanic participants (38.0%) and NHW participants (48.5%) reported being very willing to participate in a cancer clinical trial as their initial course of treatment. The most prevalent concern of both Hispanic and NHW participants respectively was the cost of a clinical trial (34.0%, 22.3%). Other top concerns included distance to the treatment center (32.0%, 13.6%) and frequency of contact with the care team (26.0%, 14.6%). Participants identified access to written materials (69.0%, 60.2%), insurance aid (65.0%, 68.0%), and access to videos (64.0%, 51.5%) as extremely helpful resources that could reduce the burden of participating in a clinical trial. Participants identified that it was most important that a treatment may improve their quality of life by decreasing pain level, increasing activity level, or other symptoms (76.0%, 91.3%). Conclusions Although most Hispanic and NHW participants reported a very good understanding of clinical trials and similar facilitators/barriers for trial participation, Hispanic patients were less likely to have discussed trials as an option with their care teams and less likely to have previously participated in a trial. Evidence-based interventions to address various barriers to clinical trials exist but data on their effectiveness and application is limited. Implementing strategically designed evidence-based interventions to address identified barriers and facilitators will be necessary to improve participation in lymphoma clinical trials.

Background Underserved patient populations characterized by low income, lack of insurance, low levels of education, and minoritized status face significant barriers when accessing clinical trials. To better understand these challenges, patients from a safety-net county hospital were surveyed on their perspectives on clinical trials, barriers to care, and facilitators of participation. Methods Patients ≥ 18 years old with histologically confirmed non-Hodgkin lymphoma (NHL) who received care at Lyndon B. Johnson Hospital, a safety-net county hospital in Houston, Texas, were invited to participate regardless of treatment status. A self-administered questionnaire was used and offered in English or Spanish. The questionnaire included a total of 53 items with an additional 13 demographic items assessing patient sociodemographic factors and knowledge of clinical trials. Questions also addressed barriers/facilitators of trial participation and respondent willingness to participate in a trial based on certain scenarios. Results Of the 136 patients invited to participate, a total of 49 participants diagnosed with NHL consented to the study and all completed the survey (participation rate 36%). Twenty-seven (55%) surveys were completed in Spanish. Participants self-identified as Hispanic (N=35, 71.4%), African American (N=6, 12.2%), non-Hispanic white (N=7, 14.3%), and Asian/Pacific Islander (N=1, 2%). This cohort included Diffuse Large B-cell lymphoma NOS (DLBCL) [32%], Follicular Lymphoma (FL) [28%], Marginal Zone lymphoma (12%). There were several patients with rare histologies such as Burkitt's lymphoma (4.2%); Mantle Cell lymphoma (4.2%), Plasmablastic lymphoma (4.2%) and T-cell lymphoma (4.1%). The majority of participants reported a commute of less than an hour away to the doctor's office (83%) with almost all participants commuting less than 2 hours (98% with 2% missing an answer). Participants were a median age of 55 years old (range 22-80), majority female (51%), less than a bachelor's degree as highest education (91.8%) and earning < $35,000 (49%). Among respondents, 89.8% had not participated in a clinical trial for their cancer. Only 36.7% of respondents reported that they understood what a clinical research study as “somewhat well,” while 30.6% reported their understanding as “not very well.” Regardless, a majority were very willing (38.8%) or somewhat willing (36.7%) to participate in a trial as their initial course of treatment. Respondents' biggest concerns were the cost of a clinical trial (61.2%), not being able to contact the research team with questions (38.8%), and frequency of clinic visits (32.7%). The most helpful resources that participants identified to reduce participation burden were educational resources such as written materials (77.6%), videos (67.3%), an explanation of the study in their language (65.3%), insurance aid (75.5%), and flexible study visit times (65.3%). Notably, 26.5% of participants responded that they believed they had received medication from a doctor as part of an experiment without their permission. When asked which outcome would most influence their decision to participate in a trial, 79.6% of participants rated the possibility of improving quality of life by decreasing pain and increasing activity levels as very important. Fewer patients (55%) rated other outcomes such as types of side effects (55%) and possibility of pain/discomfort (59%) as very important. Conclusions The majority of patients with NHL who participated in this observational study had little or no previous exposure to or understanding of cancer clinical trials. We identified common barriers to participation including out-of-pocket costs, the ability to contact the research team, and the frequency of clinic visits that should be addressed with specific identified resources to reduce participation burden. Interventions guided by these data should be implemented and evaluated to improve clinical trial participation for patients with lymphoma.