Clinical trial · Observational
HRQoL in Patients With Solid Tumors Treated With Hadrontherapy
Health Related Quality of Life (HRQoL) in Patients With Solid Tumors Treated With Hadrontherapy (HadroQoL).
NCT05947149CI-TRIAL-00093194HadroQoLrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Skull Base--Cancer | Malignant Skull Base Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| questionnaires administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort A Survivors
- description
- 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.
- interventionNames
- Other: questionnaires administration
- label
- Cohort B
- description
- 100 patients with histological and/or radiological diagnosis of head and neck tumors enrolled at baseline
- interventionNames
- Other: questionnaires administration
Primary outcomes (1)
- measure
- investigate relation between quality of life and several socio- psycho- variables
- timeFrame
- 5 years follow uo after hadrontherapy
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 metastasisReferences
Publications (0)
Data not yet available
No reference posted for this study.