Impact of Compliance on Dysphagia Rehabilitation in Head and Neck Cancer Patients: Results from a Multi-center Clinical Trial

Gintas P Krisciunas; Kerlly Castellano; Timothy M McCulloch; Cathy L Lazarus; Barbara R Pauloski; Tanya K Meyer; Darlene Graner; Douglas J Van Daele; Alice K Silbergleit; Lisa R Crujido; Denis Rybin; Gheorghe Doros; Tamar Kotz; Susan E Langmore

doi:10.1007/s00455-016-9760-4

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Impact of Compliance on Dysphagia Rehabilitation in Head and Neck Cancer Patients: Results from a Multi-center Clinical Trial

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Impact of Compliance on Dysphagia Rehabilitation in Head and Neck Cancer Patients: Results from a Multi-center Clinical Trial

Gintas P Krisciunas, Kerlly Castellano, Timothy M McCulloch, Cathy L Lazarus, Barbara R Pauloski, Tanya K Meyer, Darlene Graner, Douglas J Van Daele, Alice K Silbergleit, Lisa R Crujido, …

Dysphagia, Vol.32(2), pp.327-336

04/2017

DOI: 10.1007/s00455-016-9760-4

PMCID: PMC5382097

PMID: 27848021

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https://www.ncbi.nlm.nih.gov/pmc/articles/5382097View

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Abstract

A 5-year, 16-site, randomized controlled trial enrolled 170 HNC survivors into active (estim + swallow exercise) or control (sham estim + swallowing exercise) arms. Primary analyses showed that estim did not enhance swallowing exercises. This secondary analysis determined if/how patient compliance impacted outcomes. A home program, performed 2 times/day, 6 days/week, for 12 weeks included stretches and 60 swallows paired with real or sham estim. Regular clinic visits ensured proper exercise execution, and detailed therapy checklists tracked patient compliance which was defined by mean number of sessions performed per week (0-12 times) over the 12-week intervention period. "Compliant" was defined as performing 10-12 sessions/week. Outcomes were changes in PAS, HNCI, PSS, OPSE, and hyoid excursion. ANCOVA analyses determined if outcomes differed between real/sham and compliant/noncompliant groups after 12 weeks of therapy. Of the 170 patients enrolled, 153 patients had compliance data. The mean number of sessions performed was 8.57/week (median = 10.25). Fifty-four percent of patients (n = 83) were considered "compliant." After 12 weeks of therapy, compliant patients in the sham estim group realized significantly better PAS scores than compliant patients in the active estim group (p = 0.0074). When pooling all patients together, there were no significant differences in outcomes between compliant and non-compliant patients. The addition of estim to swallowing exercises resulted in worse swallowing outcomes than exercises alone, which was more pronounced in compliant patients. Since neither compliant nor non-compliant patients benefitted from swallowing exercises, the proper dose and/or efficacy of swallowing exercises must also be questioned in this patient population.

Adult

Aged

Combined Modality Therapy

Deglutition Disorders - etiology

Deglutition Disorders - rehabilitation

Electric Stimulation Therapy

Exercise Therapy

Female

Head and Neck Neoplasms - complications

Humans

Male

Middle Aged

Patient Compliance

Treatment Outcome

Details

Title: Subtitle: Impact of Compliance on Dysphagia Rehabilitation in Head and Neck Cancer Patients: Results from a Multi-center Clinical Trial
Creators: Gintas P Krisciunas - Boston Medical Center
Kerlly Castellano - Boston Medical Center
Timothy M McCulloch - Cellulose Sciences International
Cathy L Lazarus - Mount Sinai Beth Israel
Barbara R Pauloski - University of Wisconsin
Tanya K Meyer - University of Washington Medical Center
Darlene Graner - Mayo Clinic
Douglas J Van Daele - University of Iowa
Alice K Silbergleit - Henry Ford Hospital
Lisa R Crujido - Mayo Clinic Hospital
Denis Rybin - Boston University
Gheorghe Doros - Boston University
Tamar Kotz - Mount Sinai Hospital.
Susan E Langmore - Boston Medical Center
Resource Type: Journal article
Publication Details: Dysphagia, Vol.32(2), pp.327-336
DOI: 10.1007/s00455-016-9760-4
PMID: 27848021
PMCID: PMC5382097
NLM abbreviation: Dysphagia
ISSN: 0179-051X
eISSN: 1432-0460
Grant note: R01 CA120950 / NCI NIH HHS
Language: English
Date published: 04/2017
Academic Unit: Radiation Oncology; Medicine Administration; Otolaryngology
Record Identifier: 9984311443102771

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