Head and Neck Cancers
Conditions
Keywords
cough skill training
Brief summary
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.
Detailed description
Participants will complete an initial in-person baseline evaluation of voluntary cough function, followed by five weekly telehealth treatment sessions for five weeks with home practice, before completing a post-treatment in-person evaluation. During each treatment session with study personnel and during home practice, they will complete 25 repetitions (5 sets of 5) of voluntary coughs.
Interventions
DEVICEHandheld cough device
During each treatment session with study personnel and during home practice, participants will complete 25 repetitions (5 sets of 5) of a voluntary coughs.
Sponsors
Boston University Charles River Campus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Recent laryngeal surgery or vocal fold injury * Active respiratory infection or febrile illness within the past 14 days * Chronic, severe, or unstable respiratory disease * Asthma or bronchitis * Smoking within the past five years * Uncontrolled hypertension * Recent myocardial infarction, unstable angina, stroke, or hospitalization for heart failure within the past 6 months * Significant uncontrolled arrhythmia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of cough skill training | 6 weeks | Feasibility of cough skill training will be defined as the percentage of trials completing during treatment sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in voluntary cough peak expiratory flow rate | baseline, 6 weeks | 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 | 6 weeks | 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 | 6 weeks | 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. |
Countries
United States
Contacts
CONTACTJames Borders, PhD CCC-SLP
PRINCIPAL_INVESTIGATORJames Borders, PhD CCC-SLP
Boston University Charles River Campus
Outcome results
None listed