Protocol Development

The SAFETY trial utilized a two-step patient-centered approach to the development of a protocol for a large international randomized controlled trial (RCT). The development included both a patient survey and an in-person Steering Committee meeting of international experts. We engaged both patients and international experts in order to assess feasibility and develop strategies to overcome administrative and regulatory challenges through the development of a compelling, feasible and clinically relevant research protocol.

Phase I – Evaluation of Feasibility: Patient Survey
Patient willingness to participate in cancer surveillance research is the ultimate determinant of study feasibility; therefore, investigation into the attitudes and values of patients regarding participation in surveillance research is required to inform the SAFETY study team. To assess the feasibility of conducting an RCT evaluating varying post-operative surveillance regimens, we are conducting a patient questionnaire. Since there is no available validated tool to assess patient opinions and preferences, we have developed a unique patient questionnaire. The primary objectives of this survey are to: A) assess patient knowledge with respect to post-operative surveillance; B) assess and understand what factors influence patient comfort with being randomized to different surveillance protocols; and C) explore patient expectations of their post-operative cancer care. Seven sites in three countries (Canada, Spain and the United States) are currently open to enrolment. Ultimately, 80% of respondents have indicated they would agree to participate in the SAFETY trial if eligible. The results will be critical to establish the direction of the SAFETY trial, as patients will provide unique insights on how to best approach the discussion of the study with patients during the consent process.

Phase II – SAFETY Trial Protocol Development: Steering Committee Meeting
In order to develop a scientifically rigorous research protocol for this international RCT, it was imperative that the trial’s Steering Committee have the opportunity for open dialogue on several issues that may also impede the study’s success. Therefore, we held an in-person Protocol Development Meeting, of expertise in orthopedic oncology, medical oncology, radiology, clinical epidemiology and statistics, as well as two patient representatives, in Toronto, ON, Canada in May 2018 to discuss: A) acceptable international surveillance schedules that account for different standards of clinical practice; B) stratification based on cancer risk; C) ethical considerations; D) patient compliance; and E) strategies to mitigate interference with other active studies. The Steering Committee used preliminary data of the patient survey when developing the trial methodology.