Abstract B116: Overcoming barriers in recruiting medically underserved patients with lung cancer: The NutriCare study, a "Food is Medicine" intervention

Abstract Despite recent efforts to expand clinical trial eligibility criteria to involve traditionally underserved patient populations, less than 5% of patients diagnosed with cancer choose to participate in clinical trials (lifestyle, behavioral or pharmaceutical), of which only a small fraction represents underserved or vulnerable populations. The barriers that contribute to these trends are multifactorial. Examining sociodemographic and clinical characteristics may provide insight into successful participant recruitment and retention of underrepresented groups in clinical trials. The NutriCare study (NCT04986670) is a national, multisite, randomized controlled trial evaluating the impact of medically tailored meals plus weekly nutritional counseling on the outcomes of vulnerable patients with treatment-naïve lung cancer initiating treatment. Eligibility criteria defining vulnerability included: ≥65 years of age; underrepresented minority; rural resident; no health insurance; or income ≤130% of federal poverty line. To remain on study, eligible participants also completed a 90-minute baseline assessment within 8 weeks of study consent. A comprehensive list of screened patients was maintained throughout the course of the study, including approach attempts and refusal reasons for participation. Strategies to improve recruitment included obtaining referrals from the treating physician and inclusion of the study dietitian during the informed consent process. Descriptive statistics were used to summarize the recruitment and retention of vulnerable patients. Overall, 438 participants were screened in Phase I of this study at The Ohio State University and MD Anderson (Nov, 2020 – Aug, 2022), of which 116 (26%) participants consented to the study. Of these 116 participants, 76 (66%) were 65 years of age or older, 42 (36%) lived in a rural area, 21 (18%) identified as a racial or ethnic minority, and 27 (23%) met federal poverty levels. As the study progressed, 44 (38%) patients withdrew between baseline to 3-months,18 (16%) patients withdrew between the 3-month to 8-month timepoints, and a total of 54 (47%) participants completed the study. The highest retention rates were identified among those 65 years (58%), males (52%), early-stage lung cancer (69%), racial or ethnic minorities (62%), non-rural residents (50%) and those above the federal poverty line (48%). Barriers to completing the study included rapid decline in performance status among those diagnosed with late/extensive stage lung cancers (16%), treatment impacting taste and appetite (8%), and logistical complications with the meal intervention (3%). Barriers to recruitment and willingness to participate during the NutriCare trial were similar across recruiting sites. Future trials should consider implementation of a crossover study design, local and customized food delivery services, and measurements of time toxicity related to survey completion as an outcome. These efforts may improve clinical trial participation and provide more supportive care needs for vulnerable patients with lung cancer. Citation Format: Hazel M. Antao, Kenneth Kwan Ho Chui, Jade Smith, Pooja Vibhakar, Mary Kathryn Cohen, Jessica Bauman, Saumil Gandhi, Joya Chandra, Lori Pai, Fang Fang Zhang, Colleen Spees, Carolyn Presley. Overcoming barriers in recruiting medically underserved patients with lung cancer: The NutriCare study, a "Food is Medicine" intervention abstract. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B116.