Abstract PO4-10-02: Implementing Just ASK™ to achieve diverse participation and representation in a RCT of chemotherapy-induced peripheral neuropathy
Authors: Weiss Marisa , Giaddui Muath , Kjelstrom Stephanie , Ghaneie Arezoo , Hong Jennifer , Burrell Jessica , Windawi Sarah , Erebor Ebuwa , Mann Barry , Roberts Shonalie , Bidas Gabrielle , Meske Sam , Saeed Lisa , Ruiz Katherine Aliano , Hibbs Juliana , Marks John , Holtz David , Ali Zonera , Shevade Aarthi , Ciocca Robin , Gilman Paul , Larson Sharon , Shimamoto Shoichi , Martinez Diana , Chino Fumiko , Barrett Nadine 
Published: May 2024

Background:

Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose-limiting complication of cancer treatment which disproportionally affects Black patients, and can negatively impact survival and quality of life. Strategies to improve diverse participation and representation in clinical trials are necessary to reduce this health disparity.

Methods:

To ensure diverse representation in our RCT of CBD vs placebo in patients with grade 2-3 CIPN after treatment with taxane or platinum-based chemotherapy, key evidence-based strategies outlined in the ASCO-ACCC Just ASK™ Training Program were implemented. Eligibility criteria were as inclusive as possible, including CIPN duration up to 2 years and a range of diagnoses: nonmetastatic breast, colorectal, endometrial; and ovarian cancer. Few comorbidities were excluded. The diverse research team engaged every potentially eligible patient with the opportunity to make an informed decision to participate in the study. Using an assets-based approach, the team assessed and addressed social drivers of health (SDoH) and built trust by providing transparency, timely access to all team members, flexible study visits (including telemedicine), and study materials which were comprehensive, understandable, and accessible, within a culture of respect for patient autonomy and privacy.

Results:

Between 6/1/2020 and 8/8/2022, 230 patients were prescreened, 124 met eligibility, 54 consented and joined, and 46 completed ≥8 of the 12-week treatment phase and were included in the analysis. The study successfully enrolled a participant population that was 30% Black and 67% White (Table), reflecting community demographics of the enrolling facility. Attrition was lower than expected (15% vs 30% assumed in statistical plan) and only 5 of 425 planned study visits for the 46-patient cohort were missed.

The most effective strategy to achieve diverse participation was prescreening the electronic medical record (EMR) with daily Epic® and OncoEMR® queries (DQ) by a research assistant. DQ allowed all potentially eligible patients to be approached to participate and yielded about half of enrollees. Also key to success were engaged study champions among medical oncology fellows, oncology nurses, nurse navigators, clinical research coordinators, and research-oriented attending physicians. Some physician referrals were facilitated by the ease of secured texts and EMR messages, and peer recognition; however, few referrals came from non-research-oriented physicians.

Eleven of the 54 consented patients were identified to have essential needs and received facilitated social work assistance, including psychosocial support, financial assistance (for monetary grants for direct expenses or access to medical insurance and other benefits); and support for transportation, nutrition; child and eldercare. Of the 11 patients with essential needs, 4 were unable to complete the study due to either personal (3) or medical issues (1).

Conclusions:

The ASCO-ACCC Just ASK™ approach was successful for diverse clinical trial enrollment with strong protocol adherence and low attrition. Key steps included: study team diversity, a culture of respect and transparency, EMR prescreening, SDoH assessment and solutions, and engagement of research-oriented study champions. As achieving diverse participation in clinical trials is essential to reducing health disparities, the Just ASK™ approach should be considered an essential aspect of clinical trial design and implementation.

Table. Baseline Characteristics Total n = 46 Age (Mean/SD) 59.6 (8.8) Gender Male 5 (10.9%) Female 41 (89.1%) Race White 31 (67.4%) Black 14 (30.4%) Other 1 (2.2%) Ethnicity Hispanic 2 (4.4%) Not Hispanic 44 (95.6%) Cancer Type Breast 29 (63.0%) Colo-rectal 9 (19.6%) Ovarian 7 (15.2%) Uterine 1 (2.2%)

Citation Format: Marisa Weiss, Muath Giaddui, Stephanie Kjelstrom, Arezoo Ghaneie, Jennifer Hong, Jessica Burrell, Sarah Windawi, Ebuwa Erebor, Barry Mann, Shonalie Roberts, Gabrielle Bidas, Sam Meske, Lisa Saeed, Katherine Aliano Ruiz, Juliana Hibbs, John Marks, David Holtz, Zonera Ali, Aarthi Shevade, Robin Ciocca, Paul Gilman, Sharon Larson, Shoichi Shimamoto, Diana Martinez, Fumiko Chino, Nadine Barrett. Implementing Just ASK™ to achieve diverse participation and representation in a RCT of chemotherapy-induced peripheral neuropathy [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-10-02.