HRQoL in Patients With Solid Tumors Treated With Hadrontherapy (HadroQoL)

Health Related Quality of Life (HRQoL) in Patients With Solid Tumors Treated With Hadrontherapy (HadroQoL).

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Brain Cancer; Skull Base--Cancer
• Intervention / Treatment: Other: questionnaires administration

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.

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Anna Maria Camarda; Phone Number: +390382078501; Email: camarda@cnao.it
• Study Contact Backup: Name: Cristina Bono; Phone Number: +390382078613; Email: bono@cnao.it

Study Locations

• Italy
  • Pv
    • Pavia, Pv, Italy, 27100
      • Recruiting
      • CNAO
      • Contact: Cristina Bono, MSc; Phone Number: 0382078613; Email: cristina.bono@cnao.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A Survivors; 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.	Other: questionnaires administration; 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.
Cohort B; 100 patients with histological and/or radiological diagnosis of head and neck tumors enrolled at baseline	Other: questionnaires administration; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life assessment	quality of life in subjects treated with curative hadrontherapy investigated by global score according to SF12 and compared to healthy population	5 years follow uo after hadrontherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life assessment related also to psychological variables, socio-cognitive facors, resilience	quality of life in subjects treated with curative hadrontherapy investigated by global score according to EORTC QLQ-C30	before treatment and after 1 year from treatment completion

Collaborators and Investigators

• Sponsor: CNAO National Center of Oncological Hadrontherapy
• Investigators: Principal Investigator: Anna Maria Camarda, CNAO National Center of Oncological Hadrontherapy

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Estimated): March 26, 2025
• Study Completion (Estimated): March 26, 2025

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; hadrontherapy; cancer free survisorship
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: CNAO OSS 52 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No