HRQoL in Patients With Solid Tumors Treated With Hadrontherapy

Study Overview
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Brief Summary
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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
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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, we will be facilitated, in the future, in adding new cohorts pending a study protocol amendment and ethical approval.

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

Conditions
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Head and Neck Cancer, Skull Base--Cancer, Brain Cancer

Intervention / Treatment
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* Other: questionnaires administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A Survivors<br>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. | Other: questionnaires administration<br>* 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.<br>|
| Cohort B<br>100 patients with histological and/or radiological diagnosis of head and neck tumors enrolled at baseline | Other: questionnaires administration<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life assessment | quality of life in subjects treated with curative hadrontherapy investigated by global score according to SF12 and compared to healthy population | 5 years follow uo after hadrontherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life assessment related also to psychological variables, socio-cognitive facors, resilience | quality of life in subjects treated with curative hadrontherapy investigated by global score according to EORTC QLQ-C30 | before treatment and after 1 year from treatment completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer free survisorship, hadrontherapy, quality of life