Background: Patients treated for early stage breast cancer (BC) have a 30% lifetime risk of developing metastatic disease. Numerous studies have demonstrated that dormant bone marrow disseminated tumor cells (DTCs) are independently associated with risk of recurrence and death, yet interventions targeting these cells are lacking. The PENN-SURMOUNT (Surveillance Markers of Utility for Recurrence after (Neo)adjuvant Therapy) Screening Study was launched in 2016 to screen high risk BC survivors for DTCs using bone marrow aspirate (BMA) and identify eligible DTC positive patients for clinical trials. Given the novelty of this approach, we concurrently developed and pilot tested a PRO measurement strategy to study how the screening method of BMA and disclosure of DTC results impacts early-stage BC patients. Methods: PENN-SURMOUNT is a single center prospective, longitudinal cohort study examining BM and blood biomarkers of MRD among patients within 5 years of BC diagnosis who have high risk criteria (positive axillary nodes, triple negative biology, ER+ with Oncotype Dx ≥ 25 and/or high risk Mammaprint, or pathologic residual disease after neoadjuvant chemotherapy). From May 2019 – August 2021, we recruited patients on SURMOUNT to complete PRO surveys at baseline (T0), after BMA (T1), and after disclosure of DTC results (T2). Surveys were administered in paper form initially, then electronic form starting Feb 2021. PRO survey instruments were selected through literature review, followed by consensus among multidisciplinary clinical and research experts and patient advocates. PRO measures assess recurrence distress (Quality of Life in Adult Cancer Survivors, QLACS), illness intrusiveness (Illness Intrusiveness Ratings Scale, IIRS), and decision making (Decision Regret Scale). Additional survey items assess tolerability of the BMA and patients’ risk perception and cognitive understanding after DTC results disclosure. Descriptive statistics summarize PRO survey compliance and responses at T0, T1, and T2 in the total population and the population who reported longitudinal data for T2. Results: 61 of 66 eligible patients on the SURMOUNT trial enrolled in the PRO pilot study and completed a baseline survey, of which 47 (77%) tested negative for DTCs. Mean completion rates were 0.92 at T0, 0.85 at T1, and 0.56 at T2. After electronic survey implementation, completion rates increased to 0.94 (T0), 0.97 (T1) and 0.81 (T2). At T0, 36 (59%) patients reported a high risk perception of developing BC recurrence at 5 years and 42 (69%) during their lifetime. Mean T0 recurrence distress using the QLACS subscale was 14.6 (SD 6.3) out of possible score 4-28, compared to an expected mean of 11.42 (SD 5.48) in a general survivorship population. Mean T0 illness intrusiveness was 27.3 (SD 13.9) out of possible score 13-91. At T1, approximately 85% of patients agreed that they correctly understood the purpose of the bone marrow procedure and what the procedure would entail. 44 (72%) of patients reported a maximum pain score <= 4 in the week post-procedure and 42 (69%) reported the BMA was same or better than expected tolerability. Exploratory subset analysis of patients with complete longitudinal data at T2 (n = 34) showed average scores of 13.4 (SD 6.0), 30.1 (SD 14.0), and 2.8 (SD 6.2) for recurrence distress, illness intrusive, and decision regret scores (scale 0-100), respectively. At T2, 26 (76%) of patients reported no decision regret for undergoing testing for DTCs; 27 (79%) reported feeling less anxious after DTC results disclosure. Conclusions: Participants of PENN-SURMOUNT perceived risk of recurrence as high. The BMA procedure was well-tolerated and better than expected among the majority of this cohort, and most did not regret having undergone BMA after DTC status disclosure. Longitudinal completion rates were low, limiting assessment of PROs at later time points, a major focus of future work in this setting. Citation Format: Tara Kaufmann, Patrick Chang, Shoshana Rosenberg, Elizabeth Frank, Brian Hobbs, Lauren J. Bayne, Isoris Nivar, Brooke L. Goodspeed, Killian M. Rohn, Emily M. Kugler, Kevin Fox, Susan Domchek, Angela Bradbury, Payal Shah, Hayley Knollman, Rachel C. Jankowitz, Igor Makhlin, Amy S. Clark, Lewis A. Chodosh, Angela DeMichele, Katherine Goodfellow. Pilot study of a patient-reported outcome (PRO) measurement strategy to determine impact of screening for minimal residual disease (MRD) in high-risk breast cancer survivors [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-08-01.

Studies have suggested that autistic individuals are as much as 30% more likely to receive a cancer diagnosis which may be associated with co-occurring IDD or birth defects. Following a diagnosis of cancer, outcomes have been documented to be significantly worse for autistic individuals. Autistic individuals experience numerous barriers to care across healthcare settings, including a lack of appropriate communication with providers, a lack of accommodating healthcare environments, lack of mental health support, and too few providers who are trained in working with individuals with autism or IDD. This leads to numerous negative health outcomes, including lower likelihood of having a regular source of care, lower satisfaction with healthcare, reduced screening utilization, delays in recognizing early symptoms of disease, higher ED utilization, and anxiety and stress associated with healthcare visits. We report on the results of a recent Medical Oncology provider survey conducted from 10/31/22 - 12/16/22 to evaluate for opportunities to address barriers to care facing individuals with autism and/or IDD. Of the 49 respondents comprised of physicians and nurse practitioners, 93.9% (46) noted receiving five or fewer hours of specific training or education regarding caring for populations with IDD. Additionally, providers cited the following barriers most commonly related to delivery care to patient with IDD: Lack of strategies to enhance communication on site (32, 65.3%), Inadequate time allotted for visits (28, 57.1%), Inadequate staff training and education related to this group (27, 55.1%), Limited resources to support vulnerable or lower socio-economic status populations (22, 44.9%), and Fragmentation of care (19, 38.8%). The Sidney Kimmel Cancer Center and the Jefferson Center for Autism & Neurodiversity have collaborated to develop a culturally competent care design aimed at understanding the needs of our neurodiverse population through a joint research effort. The results of our Medical Oncology provider survey identified the need for training of providers and staff to optimize the patient experience, creation of accessible cancer screenings, and the adoption of an environment that supports the sensory and communication abilities and needs of neurodivergent patients. Providers that adopt best practices in the care of autistic and/or IDD individuals have noted that patients and families report marked improvement in the rating of their patient experience in the visit. The desired product is care plans, appropriate medical settings, and trained providers that will meet the needs of this population and improve overall health outcomes. Citation Format: Avnish K. Bhatia, Alexander Fossi, Brooke L. Goodspeed, Jane Tobias, Christopher McNair, Dwight McBee, Wendy Ross. The conception of an Oncology Neurodiversity Work Group to address cancer disparity for individuals with autism and intellectual or developmental disability (IDD) at the Sidney Kimmel Cancer Center [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr LB138.