Using key stakeholder interviews to inform implementation of a cancer center collaborative intervention to improve clinical trial accruals.

person Pakhi Goel Department of Environmental Medicine & Public Health, Icahn School of Medicine at Mount Sinai, New York, NY info_outline Pakhi Goel, Sylvia Lin, Nina A. Bickell, Cardinale B. Smith, Grace C. Hillyer, Karyn A. Goodman, Megan C. Edmonds

Authors person Pakhi Goel Department of Environmental Medicine & Public Health, Icahn School of Medicine at Mount Sinai, New York, NY info_outline Pakhi Goel, Sylvia Lin, Nina A. Bickell, Cardinale B. Smith, Grace C. Hillyer, Karyn A. Goodman, Megan C. Edmonds Organizations Department of Environmental Medicine & Public Health, Icahn School of Medicine at Mount Sinai, New York, NY, Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, Department of Population Health Science and Policy; The Tisch Cancer Institute; Division of General Internal Medicine, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, Icahn School of Medicine at Mount Sinai, Division of Hematology and Medical Oncology, New York, NY, Department of Epidemiology, Mailman School of Public Health; Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai, New York, NY, Division of General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, NY Abstract Disclosures Research Funding Other Stand Up to Cancer Background: Cancer clinical trial (CT) participation rates in the US are low, especially among BIPOC populations. Patient enrollment to CTs is influenced by structural characteristics of the care delivery system, and the nature of individual needs and available resources. We are developing a multi-level intervention across 3 cancer centers in New York City by creating a collaborative pool of, and a referral system for breast, prostate, and liver cancer CTs to increase overall participation, particularly among BIPOC populations. To inform implementation of this intervention, we explored key stakeholder perceptions and attitudes around CT enrollment process across 3 hospitals within one such cancer center. Methods: We conducted semi-structured interviews with 23 key stakeholders to determine the attitudinal and structural factors affecting CT accrual at 1 cancer center and its 2 community hospital affiliates. Stakeholders included oncologists, nurses, informaticists, oncology leadership and research staff, identified using a targeted and snowball sampling approach. Guided by the Behavioral Model of Health Service Use, we identified themes related to enabling, predisposing, and need factors, and coded transcripts until theme saturation in Dedoose. Results: Key approaches to improve CT participation focused on these structural enabling themes: increased availability of CTs, personnel to screen and enroll patients, well-timed and technology-assisted clinician notification of a potential CT match (within or outside home institution), along with an institutional culture encouraging stakeholder engagement, provider outreach, and care coordination. Important predisposing and enabling themes related to stakeholders’ beliefs about patients included: financial access, knowledge and perceptions about CTs, language barriers, motivation, and medical mistrust. Knowledge about open trials, and skepticism or enthusiasm about CTs were important predisposing themes related to clinicians. Need theme affecting implementation was clinician judgment about their patients’ eligibility for CT evaluated based on functional status, comorbidities, age, advanced cancer stage, progression of disease, change in therapy, and drug targets. Conclusions: We identified actionable enabling, predisposing, and need factors that serve as barriers to CT accrual and to successful implementation of our intervention. Major findings were structural and attitudinal, including lack of staffing resources for clinicians, and financial assistance and access for patients. Updated information about open CTs, implementation of e-screening tools for patient enrollment, addressing clinician skepticism for enrollment by increased recognition for their research efforts, as well as delivery of culturally sensitive patient education around CTs may improve CT enrollment.