Project Summary

PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Patients with head and neck cancer often develop problems with swallowing after getting radiation treatment. Problems with swallowing can affect patients’ quality of life and health.

Patients who have problems with swallowing often cannot eat enough to stay healthy. They also sometimes get food or liquid in the lungs, which can cause pneumonia that can be deadly. Up to 7 in 10 patients with head and neck cancer need a feeding tube for many months to get proper nutrition after radiation treatment.

Patients with head and neck cancer may visit a speech pathologist to prevent or fix problems with swallowing. Some doctors suggest that patients get help before problems with swallowing begin. Other patients get help only after they have problems with swallowing. Although both approaches work, doctors do not know if one approach works better than the other. This study compares how well the approaches work to reduce use of a feeding tube in patients with head and neck cancer who get radiation treatment.

Who can this research help?

Patients with head and neck cancer and their doctors can use findings from this study when deciding how to address problems with swallowing after radiation treatment.

What is the research team doing?

The research team is enrolling 952 patients with head and neck cancer at seven university and community treatment centers across the United States and Canada. Eligible patients are planning to receive radiation treatment for their head and neck cancer and have not yet developed problems with swallowing.

The team is assigning patients by chance to one of three approaches with a speech pathologist:

  • Therapy that begins before patients have problems with swallowing. Therapy focuses on having patients eat to keep their head and neck muscles working.
  • Therapy that begins before patients have problems with swallowing. Therapy includes swallowing exercises and eating plans to keep head and neck muscles working.
  • Therapy that begins only if patients have problems with swallowing. Therapy focuses on swallowing exercises and eating plans to keep head and neck muscles working.

The research team is tracking whether patients can eat by mouth without a feeding tube at 3 months and 12 months after stopping radiation treatment. The team is also collecting information about patients’ quality of life, ability to perform tasks of daily living, and problems with swallowing and related health. The team is comparing whether therapies work differently depending on what kind of cancer treatments patients receive.

Patients, caregivers, and healthcare providers and administrators are helping plan and conduct the study.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population Patients with head and neck cancer who plan to get radiation therapy and have not yet developed a swallowing problem
Interventions/
Comparators
  • Proactive eat therapy
  • Proactive eat and exercise therapy
  • Reactive therapy
Outcomes

Primary: ability to eat by mouth without a feeding tube 1 year after the end of radiation treatment

Secondary: swallowing-related quality of life, cancer symptom severity, swallowing strength, secondary symptoms related to swallowing difficulty, such as malnutrition or aspiration; quality of life, weight loss, cancer coping ability

Timeframe 1-year follow-up for primary outcome 

Project Information

Rosemary Martino, PhD
Katherine Hutcheson, PhD, MS
University Health Network (Canada)
$8,817,913
PRO-ACTIVE: Comparing the Effectiveness of Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer

Key Dates

September 2017
August 2025
2017

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
Last updated: March 14, 2022