Head and Neck Cancer, Skull Base--Cancer, Brain Cancer
Conditions
Keywords
cancer free survisorship, hadrontherapy, quality of life
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.
Interventions
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.
Sponsors
CNAO National Center of Oncological Hadrontherapy
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactAnna Maria Camarda
Backup ContactCristina Bono
Outcome results
None listed