HRQoL in Patients With Solid Tumors Treated With Hadrontherapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCNAO National Center of Oncological Hadrontherapy
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Histological and/or radiological diagnosis of head and neck tumors
Trial population
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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
questionnaires administration
Other interventionEnrolled 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.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Cohort A Survivors1 intervention
Group B: Cohort B1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
5 years follow uo after hadrontherapySecondary outcomes
1
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
Time frame
before treatment and after 1 year from treatment completionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov