The National Expansion of the STEP-1 Program

Principal investigator(s):

    Sarah Cohen-Gogo, Norman Cook & Lisa Goodyear

Despite remarkable strides in the five-year overall pediatric cancer survival rate over the past four decades, survival rates remain low and stagnant for some pediatric cancers, particularly if the disease recurs or does not respond to initial therapy. For these patients, clinical trials may be a lifeline – especially those that provide the opportunity to access promising novel therapies.

Due, in part, to the provincial nature of health care and the tertiary care model adopted for pediatric oncology, most academic early-phase trials currently being conducted in Canada, particularly early-phase clinical trials, are concentrated at the three largest pediatric cancer centres – BC Children’s Hospital, CHU Ste Justine and The Hospital for Sick Children. This, unfortunately, restricts access for many eligible patients unless families are willing, able and can afford to travel.

Finances are one of the main barriers to accessing clinical trials. Many families are already experiencing a huge financial burden, resulting from the loss of income during the prolonged course of illness and many out-of-pocket expenses related to their child’s illness. While budgets for industry-sponsored trials typically include financial assistance/reimbursement for local and long-distance families to assist with some of the larger expenses related to their trial participation, this is not feasible for most academic trials due to their lean budgets. As such, enrolment in academic pediatric cancer clinical trials, particularly early-phase trials, may be limited by this financial aspect for our pediatric patients with cancer in Canada.

Through the support of the Garron Family Cancer Centre, the STEP-1 (Supporting TravEl for Pediatric and adolescent patients to access academic phase 1/2 trials in Canada) pilot program launched in March 2024. The goal is to alleviate the financial burden on families for patients participating in academic early-phase (phase I or II) pediatric cancer clinical trials at The Hospital for Sick Children, by providing upfront support for essential travel, accommodation, meals, gas and parking expenses. The intent of this initiative is to make early phase academic clinical trials available at The Hospital for Sick Children more accessible to a broader range of participants through the reduction of out-of-pocket costs, that might otherwise limit or prohibit participation, and which should result in increased trial diversity and quicker trial recruitment.

The early success of the STEP 1 pilot program at The Hospital for Sick Children, as well as the demonstrated need to better support pediatric patients and their families access academic clinical trials across Canada, has inspired the expansion of STEP 1 into a national program. Through ACCESS support, the program will expand to an additional two clinical trial sites – BC Children’s Hospital and CHU Ste Justine. As such, the national program will provide upfront financial and logistical travel support for each patient and one caregiver participating in a phase I or II academic clinical trial available at any of the three STEP-1 clinical trial sites. To streamline the coordination of travel and travel-related expenses, and promote its long-term sustainability, reach and visibility, the national STEP 1 program has partnered with Hope Air, a national Canadian charity that coordinates non-emergency medical travel and accommodations for patient and caregivers in financial need in Canada, to provide centralized travel coordination.

Find an up-to-date list of studies supported by the STEP 1 program on the U-Link website and connect with the team at step.one@sickkids.ca

For more information, please contact Tricia Schneider.

Principal investigator(s):

    Sarah Cohen-Gogo, Norman Cook & Lisa Goodyear