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.
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.
Are unable to provide written informed consent.
Have a diagnosed psychiatric disorder.
Have a diagnosed neurocognitive impairment.
Are currently undergoing psychological or psychotherapeutic treatment.
Parallel
Brief clinical psychological intervention using biofeedback techniques
Other interventionIntervention type: Clinical psychological intervention using biofeedback tecniques. The intervention consists of two 60-minute clinical psychological sessions with a psychoanalytic framework. A biofeedback device with physiological sensors is used during the sessions to monitor physiological responses and provide real-time feedback during patients' diaphragmatic breathing. The biofeedback device does not constitute a separate intervention. During the first session, the clinician explores the patient's illness history, emotions, relationships, and experience of diagnosis and surgery. A biofeedback baseline is recorded, followed by diaphragmatic breathing training to support emotional regulation. In the second session, the clinician discusses the patient's experience after training, changes in emotions, and expectations about surgery and recovery. Biofeedback and breathing exercises are repeated.
Changes in post traumatic symptoms after the surgery
Changes in post traumatic symptoms * Total score. Range: 0-88. Higher scores mean a worse outcome. * Hyperarousal subscale. Range: 0-4. Higher scores mean a worse outcome. * Avoidance subscale. Range: 0-4. Higher scores mean a worse outcome. * Intrusion subscale. Range: 0-4. Higher scores mean a worse outcome
Changes in Body Image after a specific brief clinical-psychological intervention, including biofeedback technique
Changes in Body Image Scale (BIS) scores after a specific brief clinical-psychological intervention, including biofeedback technique BIS is a self-report questionnaire using a 4-point Likert scale with 10 items designed to assess body image from affective, behavioral, and cognitive perspectives. * Total score ranges from 0 to 30. * Higher scores indicate greater body image distress. * The total score is calculated by summing all item responses.
Changes in Quality of life after a specific brief clinical-psychological intervention, including biofeedback technique
Changes in Quality of Life ( EORTC QLQ-C30) scores after a specific brief clinical-psychological intervention, including biofeedback technique. The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30) is a standardized questionnaire used to assess quality of life in cancer patients. The questionnaire contains 30 items grouped into: Global Health Status / Quality of Life * Overall health * Overall quality of life Functional Scales * Physical functioning * Role functioning * Emotional functioning * Cognitive functioning * Social functioning Symptom Scales * Fatigue * Nausea and vomiting * Pain Single Symptom Items * Dyspnea * Insomnia * Appetite loss * Constipation * Diarrhea * Financial difficulties Raw scores are transformed to a 0-100 scale. Functional scales \& Global QoL: \- Higher score = better functioning / better QoL Symptom scales: \- Higher score = worse symptoms
Changes in Quality of life of head and neck cancer patients after a specific brief clinical-psychological intervention, including biofeedback technique
Changes in Quality of Life of head and neck cancer patients (EORTC QLQ-H\&N35) scores after a specific brief clinical-psychological intervention, including biofeedback technique. The EORTC QLQ-H\&N35 is a disease-specific module designed to be used together with the EORTC QLQ-C30 for patients with head and neck cancers. The QLQ-H\&N35 contains 35 items, covering symptoms and problems common in head and neck cancer. Multi-item Symptom Scales * Pain * Swallowing * Senses problems (taste/smell) * Speech problems * Social eating * Social contact * Sexuality Single-item Symptoms * Teeth problems * Opening mouth * Dry mouth * Sticky saliva * Coughing * Feeling ill * Use of painkillers * Nutritional supplements * Feeding tube * Weight loss * Weight gain Items use a 4-point Likert scale. For the scoring items are transformed to a 0-100 scale. Higher score = more severe symptoms / more problems
Changes in psychological distress and therapy outcomes after a specific brief clinical-psychological intervention, including biofeedback technique
Changes in psychological distress and therapy outcomes (CORE-OM) after a specific brief clinical-psychological intervention, including biofeedback technique. The CORE-OM is a widely used self-report questionnaire designed to measure psychological distress and therapy outcomes. It is commonly used in counseling services, clinical psychology, psychotherapy research, and mental health settings. CORE-OM assesses global psychological distress across four main domains: * Well-being (subjective emotional state) * Problems/Symptoms (anxiety, depression, trauma, physical symptoms) * Functioning (daily life, relationships, work/social functioning) * Risk (risk to self or others) Items are averaged to produce: * A total score and a Domain-specific scores * Higher scores = greater psychological distress
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University of Turin, Italy
Lead sponsor
ASL Città di Torino, Italy
Collaborator
