Brief psychological sessions with biofeedback for head and neck cancer surgery patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants are adults with head and neck cancer scheduled for demolitive oral/oropharyngeal surgery, with or without flap reconstruction. They are randomly assigned to receive two 60-minute sessions of a brief clinical psychological intervention that includes biofeedback, or standard care. The study looks at short-term effects on post-traumatic stress symptoms, somatopsychic distress, and quality of life, with additional assessment of how flap reconstruction might influence outcomes. Secondary analyses explore the persistence of effects over time. The trial is conducted across affiliated Italian centers led by the University of Turin.

Why it matters

Who can join: the full rules

Inclusion Criteria

Participants must meet all of the following criteria:

* Patients with a diagnosis of head and neck cancer scheduled to undergo demolitive surgery of the oral cavity or oropharynx, with or without simultaneous flap reconstruction.
* Age ≥18 years at the time of signing the informed consent form.
* Ability to understand and communicate in Italian.

Exclusion Criteria

Participants will be excluded if they:

* Are unable to provide written informed consent.
* Have a diagnosed psychiatric disorder.
* Have a diagnosed neurocognitive impairment.
* Are currently undergoing psychological or psychotherapeutic treatment.

Where it's running

• Head and Neck Cancer Unit, Asl Città di Torino
  Turin, Italy Recruiting

Study contacts

• Principal investigator: Monica Agnesone, Director, Psychology Unit — ASL Città di Torino
• Study coordinator: Antonella Granieri, Full Professor
• Email: antonella.granieri@unito.it
• Phone: 3204361389

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.