Head and neck cancer patients who are treated with large-field radiation are at high risk to develop permanent swallowing disorders. To prevent this, patients can perform motor exercises that strengthen the tongue and increase range of motion in oropharyngeal structures. However, adherence to swallowing exercises is low in dysphagic patients;our preliminary data indicated that just 9.5% of the participants were adherent to swallowing exercises during radiation (n=97). Our intervention pilot intervention, PREPARE (n=16) indicates that it is highly effective and feasible. Identifying key mediators and moderators in adherence to swallowing exercises would be valuable to head and neck cancer patients. Primary Aims Aim1) To compare the efficacy of a Self- Regulation intervention with an Enhanced Usual Care control group in increasing adherence to prescribed swallowing exercises in a sample of irradiated head and neck cancer patients.
Aim1 a) To evaluate the mediators of the proposed intervention on adherence to self-reported swallowing exercises at 6 week and twelve month follow-up. The mediators to be tested will be perception of illness, coping procedures and appraisal of coping procedures.
Aim1 b) To determine whether depression, pain, fatigue and social support moderate the impact of the intervention on adherence at 6 week follow-up or 12 month follow-up or both.
Aim 2 a) To test the impact of the PREPARE intervention on anatomic swallowing function as assessed by gold-standard radiographic Modified Barium Swallow (MBS), which is scored with the OPSE.
Aim 2 b) To test the impact of the PREPARE intervention on self-reported swallowing function as assessed by the MDADI and the PSS-HN. Study design: 288 patients recruited from M. D. Anderson and Lyndon Baines Johnson Community hospital, which serves primarily minority, low-income patients, will be randomized into one of two groups: 1) Enhanced Usual care plus an informational brochure about the importance of swallowing exercises, and 2) PREPARE, an intervention based on the Theory of Self-Regulation delivering objective and motivational coping strategies for mucositis, xerostomia, fatigue, nausea and dysphagia. Assessment timepoints are at baseline entry into the study, 6 weeks after the end of radiation therapy, and 12 months post-radiation. To measure the impact of the intervention on swallowing anatomic function, a subsample of 100 participants will be measured by modified barium swallow at baseline and at 12 month follow-up. Summary: The resulting longitudinal data will yield important information about adherence to swallowing exercises and its relationship to anatomic swallowing function within a theoretical framework.

Public Health Relevance

Identifying key factors and successful strategies in adherence to swallowing exercises would be valuable to head and neck cancer patients, who are at risk for permanent swallowing disorders. This project will also provide useful information on whether an adherence intervention can increase adherence and improve anatomic function as assessed by gold-standard videofluoroscopic assessment.

Agency
National Institute of Health (NIH)
Institute
National Institute of Dental & Craniofacial Research (NIDCR)
Type
Research Project (R01)
Project #
5R01DE019141-04
Application #
8322196
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
Riddle, Melissa
Project Start
2009-09-18
Project End
2014-08-31
Budget Start
2012-09-01
Budget End
2013-08-31
Support Year
4
Fiscal Year
2012
Total Cost
$421,474
Indirect Cost
$136,221
Name
University of Texas MD Anderson Cancer Center
Department
None
Type
Schools of Medicine
DUNS #
800772139
City
Houston
State
TX
Country
United States
Zip Code
77030