Dysphagia (difficulty swallowing) is a common and potentially life-threatening toxicity of radiotherapy (RT) for patients with head and neck cancer (HNC). Dysphagia can lead to aspiration pneumonia. HNC survivors have a lifetime risk of pneumonia of 20–24 percent after RT, which is associated with a 42 percent excess risk of death in survivorship. Moreover, dysphagia predisposes individuals to malnutrition, and up to 70 percent of HNC patients require feeding tubes for at least several months after RT.
Patients are commonly referred for swallowing therapy with a speech pathologist. Some patients receive early intervention, before the swallowing problem begins—PRO-ACTIVE therapy. Other patients are monitored and prescribed dysphagia interventions only if and when a swallowing problem occurs—RE-ACTIVE therapy. Thus, RE-ACTIVE therapy aims to reverse an already impaired swallowing ability, whereas PRO-ACTIVE therapy aims to prevent or reduce severity of dysphagia. These two broad categories of therapy represent the most common types of intervention offered to HNC patients across North America. Although there is single-institution evidence to support each practice, it is yet unknown which is most effective.
To address this gap, our primary aim is to compare the effectiveness of PRO-ACTIVE (high and low intensity) versus RE-ACTIVE swallowing therapy among patients with HNC planning to undergo RT, using their ability to eat by mouth (without a feeding tube) three months after RT as the primary outcome. Our secondary and third aims propose to compare the relative benefit or harm of these swallowing interventions on all outcomes considered relevant to our stakeholder partners and according to differences in patient characteristics and other treatments. Our fourth aim is to establish the first-ever international data network to compare the relative effectiveness of these swallowing interventions according to radiation dose.
This study is patient centered because it will directly inform patients and their clinicians which swallow therapy is most effective. Furthermore, the resulting data network from our study will guide radiation oncologists to plan a curative cancer therapy that will have the least harm to patients’ swallowing ability.
Stakeholder partners include patients, caregivers, clinical providers, and administrators and policy makers. Stakeholders will be heavily integrated throughout the entire study to collaborate on core study decisions; review study progress and provide advice to enhance enrollment, retention, and feasibility; and review study findings and draw conclusions related to effectiveness of interventions and readiness for change and implementation. Together with stakeholders, we will design and execute the dissemination plan to communicate findings with the multidisciplinary HNC team.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.