Quality of Life in Patients After Pharyngolaryngectomy
LARYNG-QDV
1 other identifier
observational
60
1 country
1
Brief Summary
Laryngeal cancer is an indication for a laryngectomy (separation of the airways and digestive tract). Laryngectomy causes a permanent disruption of self-perception. Communication, social interactions, diet andaesthetic appearance are altered. Its modifications disrupt the quality of life of patients and must be taken into account as soon as possible in patient cares.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2021
CompletedFirst Posted
Study publicly available on registry
December 15, 2021
CompletedStudy Start
First participant enrolled
February 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedMarch 25, 2022
December 1, 2021
3 months
December 1, 2021
March 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
EORTC QLQ-C30
The QLQ-C30 is a generic questionnaire with 30 questions coded in 4 response modalities (not at all (1), a little (2), enough (3), a lot (4)) or in 7 response modalities (from very bad (1) to excellent ( 7)). Questions are summarized in five multiitem domains (physical, role, cognitive, emotional, and social functioning) and nine single item domains (fatigue, pain, nausea/vomiting, appetite loss, financial impact; diarrhea, constipation, sleep disturbance and quality of life). Each domain is scored between 0 and 100. For functional domains, a high score value represents a high level of quality of life. For symptom domains, a high score represents an important level of symptoms (a low level of quality of life).
Day 0
Study Arms (1)
"with laryngectomy" group
"with laryngectomy" group: patients with laryngectomy for any type of cancer
Interventions
Eligibility Criteria
patients with laryngectomy
You may qualify if:
- male or female
- with laryngectomy
- agreeing to participate in the study
You may not qualify if:
- \- less than 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 5 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2021
First Posted
December 15, 2021
Study Start
February 10, 2022
Primary Completion
May 1, 2022
Study Completion
July 1, 2022
Last Updated
March 25, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share