ProvoxLife Adoption Trends for Heat-Moisture Exchanger

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Head and Neck Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Clinical Evaluation; Procedure: Physical Examination

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 Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients using or planning to use HME as part of standard care

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational (evaluation, examination, questionnaire); 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: Questionnaire Administration; Complete questionnaires; Other: Quality-of-Life Assessment; Complete questionnaires; Other Names: Quality of Life Assessment; Other: Clinical Evaluation; Undergo speech and swallow evaluation; Other Names: Clinical Assessment; Procedure: Physical Examination; Undergo examination of TEP and laryngectomy stoma; Other Names: Assessment; General Examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Katherine A Hutcheson, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 2020-1114 (Other Identifier: M D Anderson Cancer Center); NCI-2021-08784 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No