Assessment of the New Provox Life System for Pulmonary Health and Quality of Life After Total Laryngectomy

Study Overview
=================
Brief Summary
-----------------
Background: The benefits of using Heat and Moisture Exchangers (HMEs) for pulmonary rehabilitation after total laryngectomy are widely known. However, current available HMEs do not reach the level of humidification capacity of the nose, and patients adherence to using an HME 24/7 is not always possible. Provox Life HMEs and attachments are a new range of HMEs and attachments, with improved humidification/breathability performance, and designed to suit different situations. Purpose and aim: In this clinical trial, the new Provox Life System was assessed for pulmonary rehabilitation and QoL after total laryngectomy, and compared with currently available HMEs and attachments. Methods: Forty laryngectomized patients, who were previous users of HMEs, were randomized to Usual Care or Provox Life for 6 weeks, after which a cross-over occurred. Data was collected at baseline, and after the end of each study period. Additionally, patients filled in a diary and tally sheet to record their forced expectorations and coughing.

Official Title
-----------------
A Randomized Cross Over Clinical Trial Assessing the New Provox Life System for Pulmonary Rehabilitation and Quality of Life After Total Laryngectomy

Conditions
-----------------
Laryngectomy

Intervention / Treatment
-----------------
* Device: Provox Life
* Device: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total laryngectomy, irrespective of pharynx reconstruction method 18 years or older Provox XtraHME user Provox Adhesive user Longer than 3 months after total laryngectomy Longer than 6 weeks after postoperative radiotherapy Exclusion Criteria: Medical problems prohibiting the use of HME or adhesive Active recurrent or metastatic disease (medical deterioration) Recent pulmonary infections/unstable pulmonary condition Reduced mobility of arms and/or hands, unable to remove an HME Unable to understand the Patient Information and/or unable to give Informed Consent Insufficient cognitive ability to handle the HME or adhesive LaryButton users

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Single center, randomized, prospective crossover study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Provox Life HMEs followed by Usual Care HMEs<br>Use of Provox Life devices during a period of six weeks followed by use of Usual Care devices during a period of six weeks. | Device: Provox Life<br>* Use of Provox Life range of HMEs for different situations and their attachments (adhesives and laryngectomy tubes)<br>Device: Usual Care<br>* Continued Usual Care routines.<br>|
| Other: Usual Care HMEs followed by Provox Life HMEs<br>Use of Usual Care devices during a period of six weeks followed by use of Provox Life devices during a period of six weeks. | Device: Provox Life<br>* Use of Provox Life range of HMEs for different situations and their attachments (adhesives and laryngectomy tubes)<br>Device: Usual Care<br>* Continued Usual Care routines.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of forced mucus expectorations per 24 hours | Patient reported, recorded by Tally sheeting on 3 days | during week 6 of period 1 and period 2 (each period is 6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of (involuntary) dry coughs per 24 hours | Patient reported, recorded by Tally sheeting on 3 days | during week 6 of period 1 and period 2 (each period is 6 weeks) | 
| Coughing Symptoms (COUS) domain score of CASA-Q | Cough Symptoms (COUS), assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q) questionnaire. CASA-Q score between 0-100, with higher scores meaning less symptoms and less impact. | Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks) | 
| Coughing Impact (COUI) domain score of CASA-Q | Cough Impact (COUI), assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q) questionnaire. CASA-Q score between 0-100, with higher scores meaning less symptoms and less impact. | Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks) | 
| Sputum Symptoms (SPUS) domain score of CASA-Q | Sputum Symptoms (SPUS), assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q) questionnaire. CASA-Q score between 0-100, with higher scores meaning less symptoms and less impact. | Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks) | 
| Sputum Impact (SPUI) domain score of CASA-Q | Sputum Impact (SPUI), assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q) questionnaire. CASA-Q score between 0-100, with higher scores meaning less symptoms and less impact. | Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks) | 
| Peristomal skin irritation | Recorded by study specific questionnaire on frequency of Skin irritation. | Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks) | 
| Average number of days with skin irritation | Patient reported, recorded by daily diary keeping the last two weeks of each study period | during week 5 and week 6 of period 1 and period 2 (each period is 6 weeks) | 
| Quality of Life by EQ-5D-5L | Patient reported, the descriptive system assesses health in five dimensions, from which a health state index score is calculated, range from 0 to 1, with higher scores indicating higher health utility | Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks) | 
| Frequency of using sleeping medication | Study-specific questionnaire on use of sleeping medications | Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks) | 
| Average number of hours of HME use per 24 hours | Patient reported, recorded by daily diary keeping the last two weeks of each study period | during week 5 and week 6 of period 1 and period 2 (each period is 6 weeks) | 
| Situational usage pattern of Provox Life HMEs | Study-specific questionnaire about the situational use of devices | Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks) | 
| Patient satisfaction with the Provox Life devices | Patient satisfaction with devices through study specific questionnaires. | At the end of Period 1 (Group A), at the end of Period 2 (Group B) (each period is 6 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary rehabilitation, Quality of Life, Heat and Moisture Exchangers