About this trial
This preliminary study will examine the feasibility of a cough skill training treatment approach to rehabilitate voluntary cough function in people with head and neck cancer. Cough skill training focuses on practicing cough as a compensatory strategy for when food or liquid enters the airway. Primary outcomes will be feasibility and immediate treatment effects. The investigators hypothesize that the treatment will be feasible and will result in improvements to voluntary cough peak expiratory flow rate.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Prior diagnosis of head and neck cancer at least 6 months post-diagnosis
Completed treatment for head and neck cancer, including surgery, radiation, or chemotherapy
Medically stable and able to follow commands and produce a voluntary cough
English speaking
Disqualifiers
Unable to provide informed consent assessed by a Montreal Cognitive Assessment (MoCA) score of <20
Unable to follow study instructions
Unable to produce a voluntary cough
History of neurologic disease
Trial design
Single group
Treatments tested in this trial
Handheld cough device
DeviceDuring each treatment session with study personnel and during home practice, participants will complete 25 repetitions (5 sets of 5) of a voluntary coughs.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility of cough skill training
Feasibility of cough skill training will be defined as the percentage of trials completing during treatment sessions.
Secondary outcomes
Change in voluntary cough peak expiratory flow rate
Peak expiratory flow rate is a measure of cough strength. Changes in cough strength from pretraining to post training will be recorded.
Acceptability assessed by the System Usability Scale
The System Usability Scale (SUS) is a quick, 10-item questionnaire used to measure how people feel about the ease of use of a product, app, or website. Users reply using a 5-point scale from strongly disagree to strongly agree, resulting in an overall score from 0 to 100, with higher scores associated with greater acceptability.
Satisfaction assessed by the Beck Satisfaction Scale
The 5-item satisfaction and acceptability scale used by Beck et al. (2017) measures treatment experience across five domains on a 5-point scale from 1=very unsatisfied to 5=very satisfied. It evaluates technology/tools, treatment tasks, convenience, organization/clinician interaction, and overall treatment satisfaction. Scores can range from 5 to 25 with higher scores associated with greater satisfaction.
Sponsors and contacts
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