HRQoL in Patients With Solid Tumors Treated With Hadrontherapy

NCT05947149 · tracked via the Priya Life Science Italy tracker

Sponsor

CNAO National Center of Oncological Hadrontherapy

Phase

Observational

Started

2023-03-27

Last updated

2025-08-06

Condition(s) studied

Head and Neck CancerSkull Base--CancerBrain Cancer

Investigational drug(s) / intervention(s)

questionnaires administration

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

investigate relation between quality of life and several socio- psycho- variables — 5 years follow uo after hadrontherapy
quality of life in subjects treated with curative hadrontherapy investigated by global score according to Short-form-12-health-survey-questionnaire (SF-12) and compared to healthy population

Trial sites (1)

Facility	City	Region	Status
CNAO	Pavia	Pv	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05947149 on ClinicalTrials.gov ↗ ← All trials in Italy