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NCT Number: NCT05947149

HRQoL in Patients With Solid Tumors Treated With Hadrontherapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. investigate relation between quality of life and several socio- psycho- variables

    Time frame: 5 years follow uo after hadrontherapy

    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

Secondary outcomes

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

    Time frame: before treatment and after 1 year from treatment completion

    quality of life in subjects treated with curative hadrontherapy investigated by global score according to EORTC QLQ-C30

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Maria Camarda

CONTACT

[email protected]

+390382078501

Cristina Bono

CONTACT

[email protected]

+390382078613

Sponsors and collaborators

Lead sponsor

CNAO National Center of Oncological Hadrontherapy

Other

Registry information

Official study title

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

Acronym: HadroQoL

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2023
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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