ProvoxLife Adoption Trends for Heat-Moisture Exchanger

Study Overview
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Brief Summary
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This study examines factors that affect how often patients who have a total laryngectomy use a ProvoxLife heat-moisture exchanger (HME) system to help improve their lung function. ProvoxLife HMEs are single use heat- and moisture exchangers for patients breathing through a tracheostoma. Information from this study may help doctors learn more about factors associated with patterns of use and how often patients use the ProvoxLife HME system.

Detailed Description
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PRIMARY OBJECTIVE: I. To determine clinical and patient factors associated with patterns of use of the ProvoxLife HME system for pulmonary rehabilitation after total laryngectomy. SECONDARY OBJECTIVES: I. To explore outcomes associated with patterns of ProvoxLife HME system. II. To explore factors associated with post-laryngectomy outcomes. OUTLINE: Patients undergo speech and swallow evaluation by speech pathologist or study staff member and examination of tracheoesophageal puncture (TEP) and laryngectomy stoma. Patients also complete questionnaires over 30 minutes about use the ProvoxLife HME system, symptoms, ability to communicate, exercise and physical activity levels, and quality of life at baseline and 3 months post-ProvoxLife.

Official Title
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ProvoxLife® Adoption Trends for Heat-Moisture Exchanger (HME): The PATH Registry

Conditions
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Malignant Head and Neck Neoplasm

Intervention / Treatment
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* Other: Clinical Evaluation
* Procedure: Physical Examination
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults >= 18 years of age planned for or status post total laryngectomy Using or ready for fit of HME system Exclusion Criteria: Active malignancy if post-total laryngectomy (TL) at the time of enrollment Unable to complete questionnaires in English language The primary endpoint derives from a study specific questionnaire, due to limited resources, is only available in English language Cognitive or other limitations that preclude independent self-care or completion of questionnaires Cognitive or other limitations that preclude independent self-care or completion of questionnaires will be assessed in the screening interview by the clinical or research team

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (evaluation, examination, questionnaire)<br>Patients undergo speech and swallow evaluation by speech pathologist or study staff member and examination of TEP and laryngectomy stoma. Patients also complete questionnaires over 30 minutes about use the ProvoxLife HME system, symptoms, ability to communicate, exercise and physical activity levels, and quality of life at baseline and 3 months post-ProvoxLife. | Other: Clinical Evaluation<br>* Undergo speech and swallow evaluation<br>* Other names: Clinical Assessment;Procedure: Physical Examination<br>* Undergo examination of TEP and laryngectomy stoma<br>* Other names: General Examination;Other: Quality-of-Life Assessment<br>* Complete questionnaires<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Complete questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine clinical and patient factors associated with patterns of use of the ProvoxLife HME system for pulmonary rehabilitation after total laryngectomy. |  | Up to 3 months post-ProvoxLife HME |