Mental health and resilience in people with glioblastoma or head and neck cancer
Official title: GlobAl Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer paTients
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06385132 · Data updated 2026-11-12
We will see how common different psychological and psychiatric problems are, and whether resilience helps protect against them, in adults with glioblastoma or head-and-neck cancer who are receiving curative long-course radiotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 207 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | May 2, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | September 1, 2028 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT06385132 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 75 with glioblastoma or head and neck cancer undergoing adjuvant long-course radiotherapy or radiochemotherapy at the enrolling center who can provide informed consent and complete questionnaires.
✕Probably not a fit
Patients receiving palliative radiotherapy, those older than 75, unable to consent, or with severe language deficits may not be eligible and are less likely to gain from this study's results.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will enroll consecutive adult patients with glioblastoma or head and neck cancer receiving adjuvant long-course radiotherapy or radiochemotherapy at a single center. Participants who can give informed consent and complete questionnaires will complete standardized psychological and psychiatric tests covering mood, mixed depressive features, anxiety, suicidality, loneliness, demoralization, and resilience. Investigators will describe the prevalence of these symptoms and explore associations between resilience and psychiatric outcomes. Patients over 75, those receiving palliative radiotherapy, or with severe language deficits will be excluded.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify patients at high risk for depression, anxiety, or suicidal thoughts and guide earlier, targeted psychosocial support.
How similar studies have gone: Previous observational studies have documented high rates of mood and anxiety disorders and a protective role for resilience in cancer patients, but combined focused data on glioblastoma and head-and-neck cohorts are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consecutive glioblastoma and head and neck cancer patients undergoing a long course of radiotherapy * Patients in adjuvant RT * Patients in radiotherapy plus chemotherapy (RTCT) adjuvant regimen * Ability to understand and complete the questionnaires * Age \> 18 years * Informed consent signed Exclusion Criteria: * Age \> 75 years * Glioblastoma and head and neck cancer patients undergoing palliative radiotherapy * Patients with inability to express informed consent * Patients denying informed consent * Patients affected by severe language deficits
Where it's running
-
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy Recruiting
Study contacts
- Principal investigator: Loredana Dinapoli — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Loredana Dinapoli
- Email: loredana.dinapoli@policlinicogemelli.it
- Phone: +390630154428
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
MRI-guided radiotherapy for cancer treatment
This study is testing a new way of giving radiation therapy for cancer that uses MRI technology to better target tumors and improve treatment for patients with different types of cancer.
-
Testing if lab drug screening can predict cancer treatment responses
This study is testing if a new way of checking how tumors respond to different cancer treatments can help doctors choose the best options for patients with solid tumors like bladder or kidney cancer.
-
Evaluating progastrin levels in cancer patients
This study is testing if measuring progastrin levels in the blood can help predict how cancer will progress and respond to treatment in patients with different types of cancer.
-
YN003 injection in glioma patients
This phase 1 study tests whether YN003 injected IV is safe and tolerable for adults with recurrent or progressive glioma, and to explore how the drug behaves in the body and any early signs of activity.
-
Brain connectome project in adults with brain glioma undergoing surgery
This registry collects MRI data and clinical information from adults with glioma to see how brain networks relate to surgery and recovery.
-
Phenotype-based Pain Guidance for Head and Neck Cancer-Related Pain (pilot)
This pilot test sees if tailoring pain treatment to a patient’s pain type can reduce head and neck cancer pain in adults who haven’t started cancer treatment yet.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.