ProvoxLife Adoption Trends for Heat-Moisture Exchanger

Active, not recruiting

• Conditions: Malignant Head and Neck Neoplasm
• Interventions: Other: Clinical Evaluation; Procedure: Physical Examination; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT05036330
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2021-05-21
• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15
• Primary Completion: 2027-02-02
• Study Completion: 2027-02-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Adults >= 18 years of age planned for or status post total laryngectomy
• Using or ready for fit of HME system

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (evaluation, examination, questionnaire)	Clinical Evaluation	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.
Observational (evaluation, examination, questionnaire)	Questionnaire Administration	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.
Observational (evaluation, examination, questionnaire)	Quality-of-Life Assessment	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.
Observational (evaluation, examination, questionnaire)	Physical Examination	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States