Assessment of long term effect of Provox Life HME use on pulmonary symptoms in laryngectomized patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Compliant use of Provox Life HMEs
Instituto de Cancer Dr. Arnaldo
São Paulo, Brazil
CASA-Q Score
assessed with validated Coughing and Sputum Assessment Questionnaire (CASA-Q). Score between 0 and 100, with higher scores meaning less symptoms and less impact.
Time frame: Baseline, 3 months, 6 months, 9 months
Number of involuntary coughs per 24 hours
Patient reported, recorded by tally sheeting
Time frame: Baseline, 3 months, 6 months, 9 months
Forced Expectoration
Patient reported, recorded by tally sheeting
Time frame: Baseline, 3 months, 6 months, 9 months
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
Time frame: Baseline, 3 months, 6 months, 9 months
Jenkins sleep evaluation questionnaire
Patient reported to assess sleep quality. Score between 0 and 20, with higher score the more sleep disturbances
Time frame: Baseline, 3 months, 6 months, 9 months
Questionnaire to assess Shortness of Breath
from Ackerstaff et al., 1993
Time frame: Baseline, 3 months, 6 months, 9 months
Voice handicap Index
patient reported outcome, score from 0-40, with higher scores indicating greater voice-related handicap.
Time frame: Baseline, 3 months, 6 months, 9 months
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Consumption of medical devices (Number of devices used)
Number of devices used, by use of patient diary recoding number of devices used
Time frame: Baseline, 3 months, 6 months, 9 months
Study-specific questionnaire to assess number of complications and medical treatments
Study specific questionnaire to record complications and consumption of medications, diagnostics, treatment, medical care, medical transportation, sick leave
Time frame: Baseline, 3 months, 6 months, 9 months