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Recruiting NCT05947149

HRQoL in Patients With Solid Tumors Treated With Hadrontherapy

— Observational Head and Neck Cancer Skull Base--Cancer Brain Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: questionnaires administration.
Who it may be relevant to
Registry conditions: Head and Neck Cancer, Skull Base--Cancer, Brain Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Health Related Quality of Life (HRQoL) in Patients With Solid Tumors Treated With Hadrontherapy (HadroQoL).

Overview

The Quality of Life of patients treated with hadrontherapy is still limited. Two cohorts are established, they will be receiving specific standardized questionnaires to be evalutaed in their results.

Detailed description

Since 2011, CNAO has been treating patients suffering from solid tumors with particle therapy (both protons and carbon ions). Hadrontherapy improves outcome of radioresistant tumors which normally do not benefit from conventional radiotherapy. The treated population is highly heterogenous in term of tumor site, histotype, treatment fields and doses however its common anatomical origin justifies a unified approach in evaluating a QoL in this setting. QoL of patients suffering from these tumors have been poorly investigated and there are still few studies on patient reported outcomes (PROs) and QoL following hadrontherapy. In this context, therefore, there is a need to generate data by designing distinct cohort studies, conceived within a single protocol, that will gather quality of life data by means of standardized questionnaires of patients along their oncological history. Thanks to this protocol design, the investigator will be facilitated, in the future, in adding new cohorts pending a study protocol amendment and ethical approval.

Interventions

  • Other questionnaires administration
    Enrolled people will be requested to fill in questionnaires. Cohort A affected by head and neck cancer: SF-12, EORTC QLQ-C30, EORTC QLQ-H\&N43, HADS, Brief COPE, BRCS. Cohort A affected by skull base/brain cancer: SF-12, EORTC QLQ-BN20, HADS, Brief COPE, BRCS. Cohort B will receive: EORTC QLQ-C30, BRCS, PROFFIT, SF-12, EORTC QLQ-H\&N43.

Primary outcome measures

  • investigate relation between quality of life and several socio- psycho- variables [Time frame: 5 years follow uo after hadrontherapy]
Secondary outcome measures (1)
  • quality of life related also to psychological variables, socio-cognitive factors, resilience [Time frame: before treatment and after 1 year from treatment completion]

Eligibility criteria

Cohort A ("survivors"):

Inclusion criteria

  • Patients with at least a follow up of 5 years with head and neck, skull base and brain tumors and no evidence of progressive disease.
  • The patient is able to give consent

Exclusion criteria

  • Re-irradiation.
  • Second tumor.
  • Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires or affect quality of life.

Cohort B:

Inclusion criteria

  • Histological and/or radiological diagnosis of head and neck tumors
  • Patients candidate for curative intent hadrontherapy
  • Patients ≥ 18 years of age
  • The patient is able to give consent

Exclusion criteria

  • Re-irradiation.
  • Second tumor
  • Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires or affect quality of life
  • Presence of diffused metastasis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • CNAO — Pavia

Identifiers

NCT: NCT05947149 · CNAO OSS 52 2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗