HRQoL in Patients With Solid Tumors Treated With Hadrontherapy

NCT05947149 | Recruiting

• 1 other identifier: CNAO OSS 52 2022
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Skull Base--Cancer; Brain Cancer

Keywords

cancer free survisorship; hadrontherapy; quality of life

Outcome Measures

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

  5 years follow uo after hadrontherapy

Secondary Outcomes (1)

• quality of life related also to psychological variables, socio-cognitive factors, resilience

  before treatment and after 1 year from treatment completion

Study Arms (2)

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

Cohort B

100 patients with histological and/or radiological diagnosis of head and neck tumors enrolled at baseline

Other: questionnaires administration

Interventions

questionnaires administration OTHER

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 A Survivors; Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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

Sponsors & Collaborators

• CNAO National Center of Oncological Hadrontherapy: lead

Study Sites (1)

CNAO

Pavia, Pv, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Anna Maria Camarda

  CNAO National Center of Oncological Hadrontherapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Maria Camarda

CONTACT

+390382078501; camarda@cnao.it

Cristina Bono

CONTACT

+390382078613; bono@cnao.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 17, 2023
• Study Start: March 27, 2023
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

IT (1)