Mental health and resilience in people with glioblastoma or head and neck cancer
GlobAl Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer paTients
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 |
|---|---|
| Enrollment | 207 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Roma) |
| Trial ID | NCT06385132 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma
- 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
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.