Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07712120 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Brief Clinical Psychological Intervention With Biofeedback in Head and Neck Cancer

Study acronym: INTEGRATE-HNC
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07712120
Lead Sponsor University of Turin, Italy
Collaborators: ASL Città di Torino, Italy
Conditions
(from sponsor)
Head and Neck Cancer, Surgery for Head and Neck Cancer Patients, Demolitive Surgical Procedures on the Oral Cavity or Oropharynx, With or Without Simultaneous Reconstruction Using Flaps
Related terms Head and Neck Neoplasms
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov