Stakeholder Engagement for a Multinational, Multisite Clinical Trial

Research Project Summary

Stakeholder Engagement for a Multinational, Multisite Clinical Trial

Dysphagia (difficulty swallowing) is a common and potentially life-threatening toxicity of radiotherapy (RT) for patients with head and neck cancer (HNC). At least half of HNC patients require feeding tubes during radiation. However, it is unclear how and at what point to implement swallowing therapy to best help HNC patients to regain swallowing function. This multi-national, multi-site pragmatic clinical trial comparatively tests three approaches to swallowing therapy in the HNC population.


Stakeholders convene at multiple points over the life of the trial to discuss, deliberate, and advise on an array of protocol design, recruitment and data analysis questions crucial to the success of this complex pragmatic clinical trial. QHRC designed the stakeholder engagement model in the grant proposal, convenes all stakeholders in the US context, and represents stakeholder engagement on the trial executive committee.

“The one pleasant surprise is how seriously [our stakeholders] take it. They take their role really seriously.”

Kate Hutcheson, PhD, CCC-SLP

Client Team


Kate Hutcheson, PhD, CCC-SLP
MD Anderson Cancer Center

Rosemary Martino, PhD, MSc
University of Toronto


Patient-Centered Outcomes Research Institute (PCORI)

Overview of Qualitative Research Performed

Official Project Title

PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer (PRO-ACTIVE)


  • Grant Writing
  • Data Collection
  • Data Analysis
  • Writing Support


  • Focus Groups
  • Stakeholder Engagement
  • Directed Content Analysis

Research Area

  • Government Contracts
  • Clinical Trials