Integrating Clinical Psychology Into the Care of Patients With Head and Neck Cancer: A Pilot Randomized Controlled Trial

BACKGROUND Head and neck cancer encompasses oncological conditions that can develop in several anatomical sites, including the oral cavity, pharynx, larynx, nasal cavity, and salivary glands. In particular, oral cavity cancer, including cancers of the lips, tongue, floor of the mouth, cheeks, gums, and palate, is a major cause of cancer-related mortality worldwide and is characterized by facial disfigurement and functional impairment, with a five-year survival rate of approximately 50%. Approximately 35,310 new cases of oral cavity cancer are diagnosed annually in the United States, and approximately 67,000 new cases occur in the European Union. Treatment for head and neck cancer may include demolitive and/or reconstructive surgery, radiotherapy, chemotherapy, and immunotherapy. These treatments may result in difficulties with eating, swallowing, and speaking, as well as alterations in body image, with significant consequences for patients' psychological well-being and quality of life. The literature highlights the presence of anxiety, post-traumatic stress symptoms, and depressive symptoms among patients with head and neck cancer. Within an integrated care perspective, it is essential to consider how both the oncological disease and its treatments may affect patients' somatopsychic balance and their ability to perceive, communicate, work, and maintain meaningful relationships. In particular, integrating clinical psychological interventions that focus on the somatic and psychological aspects of illness experience and psychophysiological processes may represent a valuable approach.

However, the literature shows a lack of empirically validated psychological interventions specifically targeting patients with head and neck cancer.

PLANNED STUDY This study is a pilot randomized controlled clinical trial evaluating the efficacy and feasibility of a brief clinical psychological intervention including biofeedback techniques to reduce post-traumatic stress symptoms and somatopsychic distress in patients undergoing demolitive surgery of the oral cavity or oropharynx, with or without simultaneous flap reconstruction.

OBJECTIVES OF THE STUDY

• The primary objective of this study is 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 compare the effects of the psychological intervention on somatopsychic distress and quality of life in patients undergoing oral cavity or oropharyngeal surgery, with or without simultaneous flap reconstruction; to evaluate the persistence over time of the effects of the psychological intervention in patients with and without simultaneous flap reconstruction; to examine the impact of flap reconstruction on quality of life and somatopsychic distress after surgery, regardless of assignment to the psychological intervention.