HRQoL in Patients With Solid Tumors Treated With Hadrontherapy

Trial Title: HRQoL in Patients With Solid Tumors Treated With Hadrontherapy

NCT ID: NCT05947149

Condition: Head and Neck Cancer
Skull Base--Cancer
Brain Cancer

Conditions: Official terms:
Brain Neoplasms

Conditions: Keywords:
cancer free survisorship
hadrontherapy
quality of life

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: questionnaires administration
Description: 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.
Arm group label: Cohort A Survivors
Arm group label: Cohort B

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.

Criteria for eligibility:

Study pop:
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).

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: CNAO

Address:
City: Pavia
Zip: 27100
Country: Italy

Status: Recruiting

Contact:
Last name: Cristina Bono, MSc

Phone: 0382078613
Email: cristina.bono@cnao.it

Start date: March 27, 2023

Completion date: March 26, 2025

Lead sponsor:
Agency: CNAO National Center of Oncological Hadrontherapy
Agency class: Other

Source: CNAO National Center of Oncological Hadrontherapy

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05947149