The stakeholder engagement process has been integral across all stages of this trial, from fine-tuning its design, to planning implementation, and eventually advising on knowledge dissemination of study findings. The study PIs have carefully chosen a qualitative approach with four stakeholder groups (patients and caregivers, allied health (AH) clinicians, MD clinicians, and payer and policy makers) in Canada and the US. AH clinicians include a variety of professionals (i.e Speech Language Pathologists, Nurses, Dietitians, etc). Likewise, MDs include Surgeons, Radiation Oncologists, etc. Policy makers include experts who make decisions regarding high level healthcare resource allocation. Finally, patients and caregivers include those who have had the lived experience of head and neck cancer but have now completed treatment.

The Stakeholder Advisory Board (SAB) consists of  two to three representatives from each group who meet to reach a combined opinion across all stakeholders. There is a SAB in Canada and the US. This combined perspective from the SABs is formally presented to the trial Executive Committee for consideration to implement in the study. Finally, in an effort to ensure accountability, study investigators report back to all stakeholders, detailing how their recommendations will be adopted.

PRO-ACTIVE ENGAGEMENT ACTIVITIES (TO-DATE)

• Operationalized the ‘trigger’ criteria for arm one patients, ensuring an accurate, reproducible and feasible initiation of swallowing intervention for patients at all sites not receiving prophylactic swallowing therapy.
• Refined the list of secondary outcome measures used to assess benefits of swallowing therapy across study treatment arms.
• Standardized the consenting process, enabling recruiters and clinicians to provide relevant information during informed consent discussion, yet not contaminate the treatment arms.
• Informed the study team with innovative strategies to mitigate barriers in patient recruitment, retention and overall data collection.
• Advised on how to incorporate public health restrictions due to COVID-19 without compromising study integrity, yet optimize overall study outcomes.