Feasibility of Cough Skill Training in Individuals With Head and Neck Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston University Charles River Campus

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Handheld cough device

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Cough skill trainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of cough skill training

Feasibility of cough skill training will be defined as the percentage of trials completing during treatment sessions.

Time frame
6 weeks

Secondary outcomes

1

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.

Time frame
baseline, 6 weeks
2

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.

Time frame
6 weeks
3

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.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: