CNAO
Pavia, Pv, 27100, Italy
Location status: Recruiting
NCT Number: NCT05947149
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Pavia, Pv, 27100, Italy
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Cohort A ("survivors"):
Inclusion criteria
Exclusion criteria
Cohort B:
Inclusion criteria
Exclusion criteria
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.
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
Anna Maria Camarda
CONTACT
Cristina Bono
CONTACT
CNAO National Center of Oncological Hadrontherapy
Other
Health Related Quality of Life (HRQoL) in Patients With Solid Tumors Treated With Hadrontherapy (HadroQoL).
Acronym: HadroQoL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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