ProvoxLife Adoption Trends for Heat-Moisture Exchanger

N/AActive Not RecruitingNCT05036330

M.D. Anderson Cancer Center130 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

130

Conditions

Malignant Head and Neck Neoplasm

Interventions

Clinical EvaluationOTHER

Undergo speech and swallow evaluation

Physical ExaminationPROCEDURE

Undergo examination of TEP and laryngectomy stoma

Quality-of-Life AssessmentOTHER

Complete questionnaires

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

To determine clinical and patient factors associated with patterns of use of the ProvoxLife HME system for pulmonary rehabilitation after total laryngectomy.

Time frame: Up to 3 months post-ProvoxLife HME

Data from ClinicalTrials.gov

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