ProvoxLife Adoption Trends for Heat-Moisture Exchanger

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Malignant Head and Neck Neoplasm

Treatments: Other: Quality-of-Life Assessment; Other: Clinical Evaluation; Other: Questionnaire Administration; Procedure: Physical Examination

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05036330

NCI-2021-08784 (Registry Identifier)

2020-1114 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

130 participants in 1 patient group

Observational (evaluation, examination, questionnaire)

Description:

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.

Treatment:

Procedure: Physical Examination

Other: Questionnaire Administration

Other: Clinical Evaluation

Other: Quality-of-Life Assessment