Spots Global Cancer Trial Database for ProvoxLife Adoption Trends for Heat-Moisture Exchanger

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Trial Identification

Brief Title: ProvoxLife Adoption Trends for Heat-Moisture Exchanger

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

Study ID: NCT05036330

Conditions

Malignant Head and Neck Neoplasm

Interventions

Clinical Evaluation

Physical Examination

Quality-of-Life Assessment

Questionnaire Administration

Study Description

Brief Summary: 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: 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.