Quality of Life in Head and Neck Patients

Quality of Life Assessment Study in Patients With Metastatic Head and Neck Neoplasia Submitted to Immunotherapy in Brazil

Sponsors

Lead Sponsor: University of Brasilia

Source University of Brasilia
Brief Summary

Evaluation of health-related quality of life of head and neck cancer patients undergoing immunotherapy

Detailed Description

Introduction: The treatment of head and neck neoplasms, as well as the evolution of the disease, can affect a variety of body functions, including breathing, swallowing and speech, with great potential to cause various physical, emotional, and social problems to the patient, leading to considerable impairment of their quality of life. Several instruments were developed to measure this variable. Such evaluation is currently considered fundamental to report therapeutic results, but there is no consensus regarding the instrument to be employed. The University of Washington questionnaire has been the most widely used so far. EORTC (European Organization for Cancer Research and Treatment) recently published a new questionnaire specifically for patients treated for head and neck cancer (EORTC QLQ-H & N43), already validated in Portuguese for Brazil. Objectives: The aim of this prospective and multi-institutional study is to evaluate the quality of life of patients with metastatic head and neck cancer undergoing immunotherapy in different regions of Brazil. Other endpoints will also be evaluated such as disease-free survival and overall survival. Procedures: EORTC QLQ-30 and EORTC QLQ-H & N43 questionnaires, validated in Portuguese for Brazil, will be applied to all patients with metastatic head and neck neoplasms undergoing immunotherapy at participating institutions. These will be evaluated before the beginning of the treatment and then every 2 months, for an estimated period of 2 years or until death or on demand, in case of symptomatology that justifies it.

Overall Status Not yet recruiting
Start Date 2021-05-01
Completion Date 2023-06-30
Primary Completion Date 2023-03-30
Study Type Observational
Primary Outcome
Measure Time Frame
Quality of life 2 years
Overall survival 2 years
Enrollment 100
Condition
Intervention

Intervention Type: Other

Intervention Name: questionnaire

Description: Questionnaire for health-related quality of life evaluation

Other Name: EORTC H&N-43

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: 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. Exclusion Criteria: - 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: Marcos Santos, MD PhD

Phone: +55 62 992970666

Email: [email protected]

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Brasilia

Investigator Full Name: Marcos Santos

Investigator Title: MD PhD

Keywords
Has Expanded Access No
Acronym QLiHN
Patient Data Yes
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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