NCT07712120 Brief Clinical Psychological Intervention With Biofeedback in Head and Neck Cancer
| NCT ID | NCT07712120 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Turin, Italy |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2025-11-20 |
| Primary Completion | 2026-02-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 58 participants in total. It began in 2025-11-20 with a primary completion date of 2026-02-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Head and neck cancer and its surgical treatment may significantly affect patients' psychological well-being, body image, somatic experience, and quality of life. This pilot randomized controlled non-pharmacological study aims to evaluate the short-term efficacy of a brief clinical psychological intervention including biofeedback techniques in reducing post-traumatic stress symptoms in patients undergoing demolitive surgery of the oral cavity or oropharynx, with or without simultaneous flap reconstruction. Secondary objectives are to evaluate the effects of the intervention on somatopsychic distress and quality of life, assess the persistence of intervention effects over time, and examine the impact of flap reconstruction on patients' psychological outcomes and quality of life. Eligible participants will be randomly assigned to either an experimental group receiving two 60-minute clinical psychological sessions integrating biofeedback techniques or a control group receiving standard care without the study intervention. Psychological and clinical assessments will be performed at baseline (before surgery), at hospital admission for surgery, and at the post-discharge follow-up visit.
Eligibility Criteria
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.
Contact & Investigator
Monica Agnesone, Director, Psychology Unit
PRINCIPAL INVESTIGATOR
ASL Città di Torino
Frequently Asked Questions
Who can join the NCT07712120 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07712120 currently recruiting?
Yes, NCT07712120 is actively recruiting participants. Contact the research team at antonella.granieri@unito.it for enrollment information.
Where is the NCT07712120 trial being conducted?
This trial is being conducted at Turin, Italy.
Who is sponsoring the NCT07712120 clinical trial?
NCT07712120 is sponsored by University of Turin, Italy. The principal investigator is Monica Agnesone, Director, Psychology Unit at ASL Città di Torino. The trial plans to enroll 58 participants.
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