HRQoL in Patients with Solid Tumors Treated with Hadrontherapy (HadroQoL)

CNAO National Center of Oncological Hadrontherapy

Status

Enrolling

Conditions

Skull Base--Cancer

Head and Neck Cancer

Brain Cancer

Treatments

Other: questionnaires administration

Study type

Observational

Funder types

Other

Identifiers

NCT05947149

CNAO OSS 52 2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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