Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
130 participants
OBSERVATIONAL
2021-05-21
2027-02-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Clinical Evaluation
Undergo speech and swallow evaluation
Physical Examination
Undergo examination of TEP and laryngectomy stoma
Quality-of-Life Assessment
Complete questionnaires
Questionnaire Administration
Complete questionnaires
Interventions
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Clinical Evaluation
Undergo speech and swallow evaluation
Physical Examination
Undergo examination of TEP and laryngectomy stoma
Quality-of-Life Assessment
Complete questionnaires
Questionnaire Administration
Complete questionnaires
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Using or ready for fit of HME system
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Katherine A Hutcheson
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2021-08784
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-1114
Identifier Type: OTHER
Identifier Source: secondary_id
2020-1114
Identifier Type: -
Identifier Source: org_study_id
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