Evaluating quality of life in cancer patients treated with hadrontherapy
Health Related Quality of Life (HRQoL) in Patients With Solid Tumors Treated With Hadrontherapy (HadroQoL).
This study is trying to see how hadrontherapy affects the quality of life for cancer patients with head and neck, skull base, and brain tumors, comparing long-term survivors with those currently receiving treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CNAO National Center of Oncological Hadrontherapy Academic / other |
| Locations | 1 site (Pavia, Pv) |
| Trial ID | NCT05947149 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the quality of life (QoL) in patients with solid tumors, specifically head and neck, skull base, and brain cancers, who have undergone hadrontherapy. Two cohorts will be established: one consisting of long-term survivors and another of patients receiving curative intent treatment. Participants will complete standardized questionnaires to evaluate their QoL throughout their oncological journey. The study seeks to fill the gap in existing literature regarding patient-reported outcomes following hadrontherapy.
Who should consider this trial
Good fit: Ideal candidates include patients with head and neck, skull base, or brain tumors who are either long-term survivors or candidates for curative hadrontherapy.
Not a fit: Patients with re-irradiation, second tumors, or significant psychiatric and neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term quality of life for cancer survivors treated with hadrontherapy.
How similar studies have performed: While there is limited research on QoL in patients treated with hadrontherapy, this approach aims to generate new data in a relatively novel area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pavia, Pv
- Cnao — Pavia, Pv, Italy (Recruiting)
Study contacts
- Principal investigator: Anna Maria Camarda — CNAO National Center of Oncological Hadrontherapy
- Study coordinator: Anna Maria Camarda
- Email: camarda@cnao.it
- Phone: +390382078501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.