Quality of Life in Head and Neck Patients
QLiHN
Quality of Life Assessment Study in Patients With Metastatic Head and Neck Neoplasia Submitted to Immunotherapy in Brazil
1 other identifier
observational
100
0 countries
N/A
Brief Summary
Evaluation of health-related quality of life of head and neck cancer patients undergoing immunotherapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2021
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2021
CompletedFirst Posted
Study publicly available on registry
April 21, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedApril 21, 2021
April 1, 2021
1.9 years
April 17, 2021
April 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Quality of life
Evaluation of quality of life based on validated questionnaire
2 years
Overall survival
Overall survival
2 years
Interventions
Questionnaire for health-related quality of life evaluation
Eligibility Criteria
Head and neck cancer patients undergoing systemic treatment with immunotherapy
You may qualify if:
- Patients with a diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck region, whose planned treatment is immunotherapy, will be included. We will consider, separately, patients that had been treated with platinum before (platinum-refractory) and patients that were not submitted to this treatment (platinum naïve).
- Primary site: patients with primary pharyngeal tumors (oro or hypopharynx), oral cavity and larynx will be included.
You may not qualify if:
- Patients with cognitive impairment that prevents the proper application of questionnaires
- Brain metastasis
- Autoimmune disease
- Systemic immunosuppressive treatment
- Hepatitis B, C or HIV infection
- Prior immunotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
April 17, 2021
First Posted
April 21, 2021
Study Start
May 1, 2021
Primary Completion
March 30, 2023
Study Completion
June 30, 2023
Last Updated
April 21, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- Data will be available from December 2023 to December 2028
- Access Criteria
- Request by email
Data base will be shared, if requested