STEP-1: A SickKids pilot providing upfront financial support for pediatric and adolescent patients travelling to access academic phase 1-2 studies in Canada.

Abstract

e13501 Background: Equitable access to early phase trials for all Canadian children with hard-to-cure cancer is crucial. While industry-sponsored studies cover travel costs, academic trials lack similar resources. STEP-1 provides upfront financial support for patients (pts) to travel and access academic early phase trials at SickKids. Here, we report pt demographics, financial metrics and initial feedback from healthcare providers (HCP) and families for pts supported between Mar-Dec 2024. Methods: Eligible studies were academic-sponsored early phase trials. Pts were eligible for financial support from study consent, without any income-based criteria. STEP-1 covered upfront costs for travel, accommodation, meals, parking and transportation for pt and one caregiver. Data on tumor diagnosis, home address and expenses related to study visits were collected. Our target recruitment was 10 pts in 12 months (mo) (0.8 pt/mo). As part of an approved quality improvement project, electronic surveys were sent to families and referring HCP to evaluate their experience. Results: Ten studies were eligible, with SickKids being the only Canadian site for 5. Fifteen pts (1.6 pt/mo), in 5 studies, were supported for a median time of 4.2 mo (0-9.2). Twelve pts remained on-study at data cut-off. Ten pts were from Ontario, 5 travelled from out-of-province. The median expense per pt was 11,259 CAD (1,165-27,000) for a median of 4 visits (1-46). Ten families were contacted for a baseline survey with a 70% response rate. Three pts had previously participated in trials without any study financial support. All families (7/7) reported that the petty cash provided was sufficient to cover their expenses and rated the accommodation/travel booking process as very good/excellent. Eleven referring HCP teams were contacted with a response rate of 46% (5/11). Seven responses were received for 5 pts, as up to 3 HCP were surveyed per pt. All HCP (7/7) had previously referred a pt for a phase 1-2 study at SickKids. Their most useful resource about early phase studies (7/7) and STEP-1 (5/7) was direct communication with disease expert or study team. Six of 7 families and 3/3 HCP declared that the decision to participate would have been the same without STEP-1. All families (7/7) and HCP (6/6) rated communication with STEP-1 as very good/excellent. All HCP (6/6) declared minimum support was required once pts were enrolled and supported. Conclusions: Recruitment for STEP-1 exceeded our target by 100%, with positive feedback from both families and referring HCP. The demonstrated need to better support pediatric pts in accessing academic early phase trials has inspired a national expansion, supported by the pan-Canadian ACCESS consortium, with new sites in British Columbia and Québec. Our continued goal will be to address access inequities and increase pt diversity in early phase academic trials.