Clinical trial NCT05947149: HRQoL in Patients with Solid Tumors Treated with Hadrontherapy
Official title: Health Related Quality of Life (HRQoL) in Patients with Solid Tumors Treated with Hadrontherapy (HadroQoL).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Skull Base--Cancer
Brain Cancer
Keywords: cancer free survisorship
hadrontherapy
quality of life
Lead sponsor: CNAO National Center of Oncological Hadrontherapy
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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).

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.

Eligibility 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

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 metastasis

Primary outcomes:
measure: investigate relation between quality of life and several socio- psycho- variables
timeFrame: 5 years follow uo after hadrontherapy
Secondary outcomes:
measure: quality of life related also to psychological variables, socio-cognitive factors, resilience
timeFrame: before treatment and after 1 year from treatment completion
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: CNAO
state: Pv
Study officials:
affiliation: CNAO National Center of Oncological Hadrontherapy
name: Anna Maria Camarda
role: PRINCIPAL_INVESTIGATOR
References: