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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A Survivors | 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. |
| |
| Cohort B | 100 patients with histological and/or radiological diagnosis of head and neck tumors enrolled at baseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaires administration | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| investigate relation between quality of life and several socio- psycho- variables | 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 | 5 years follow uo after hadrontherapy |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life related also to psychological variables, socio-cognitive factors, 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 |
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Cohort A ("survivors"):
Inclusion Criteria
Exclusion Criteria:
Cohort B:
Inclusion Criteria:
Exclusion criteria:
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The patients from cohort A will be selected and invited to participate in the study when evaluated for standard of care follow-up which is taking place in telemedicine modality through a digital meeting organized by the staff.
Patients from Cohort B with indication of hadrontherapy in radical setting will be consecutively enrolled at baseline (during CT simulation procedure or at the first session of RT).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Maria Camarda | Contact | +390382078501 | camarda@cnao.it | |
| Cristina Bono | Contact | +390382078613 | bono@cnao.it |
| Name | Affiliation | Role |
|---|---|---|
| Anna Maria Camarda | CNAO National Center of Oncological Hadrontherapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CNAO | Recruiting | Pavia | Pv | 27100 | Italy |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
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|
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |