Quality of Life in Head and Neck Patients (QLiHN)

April 17, 2021 updated by: Marcos Santos, University of Brasilia

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Head and neck cancer patients undergoing systemic treatment with immunotherapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years
Overall survival
2 years
Quality of life
Time Frame: 2 years
Evaluation of quality of life based on validated questionnaire
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brasilia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2021

Primary Completion (ANTICIPATED)

March 30, 2023

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

April 17, 2021

First Submitted That Met QC Criteria

April 17, 2021

First Posted (ACTUAL)

April 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2021

Last Update Submitted That Met QC Criteria

April 17, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CONFIAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data base will be shared, if requested

IPD Sharing Time Frame

Data will be available from December 2023 to December 2028

IPD Sharing Access Criteria

Request by email

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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