HRQoL in Patients with Solid Tumors Treated with Hadrontherapy

Recruiting

• Conditions: Head and Neck Cancer; Skull Base--Cancer; Brain Cancer
• Interventions: Other: questionnaires administration

• Registration Number: NCT05947149
• Lead Sponsor: CNAO National Center of Oncological Hadrontherapy

Brief 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.

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.

Study Timeline

• Study Start: 2023-03-27
• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-07
• Study First Posted: 2023-07-17
• Status Verified: 2024-08
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-03-26
• Study Completion: 2025-03-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort B	questionnaires administration	100 patients with histological and/or radiological diagnosis of head and neck tumors enrolled at baseline
Cohort A Survivors	questionnaires administration	about 80 patients with at least a 5 year follow up with head and neck, skull base and brain tumors and no evidence of progressive disease.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
quality of life related also to psychological variables, socio-cognitive factors, resilience	before treatment and after 1 year from treatment completion	quality of life in subjects treated with curative hadrontherapy investigated by global score according to EORTC QLQ-C30

Trial Locations

Locations (1)

CNAO; 🇮🇹 Pavia, Pv, Italy