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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-08784 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-1114 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Evaluation | Other | Undergo speech and swallow evaluation |
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| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Active malignancy if post-total laryngectomy (TL) at the time of enrollment
Unable to complete questionnaires in English language
Cognitive or other limitations that preclude independent self-care or completion of questionnaires
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Patients using or planning to use HME as part of standard care
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| Name | Affiliation | Role |
|---|---|---|
| Katherine A Hutcheson | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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| Physical Examination | Procedure | Undergo examination of TEP and laryngectomy stoma |
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| Quality-of-Life Assessment | Other | Complete questionnaires |
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| Questionnaire Administration | Other | Complete questionnaires |
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