Enhancing quality of life in locally advanced laryngeal and hypopharyngeal cancer treatment through cognitive behavioural therapy implementation: a multicentre, single-blinded, randomized clinical trial

Abstract

BACKGROUND: Laryngeal cancer is the most prevalent among all the head and neck cancers. Typically, both laryngeal and hypopharyngeal cancers are diagnosed in a locally advanced stage, requiring aggressive and potentially mutilating treatments. This may result in significant comorbidities such as depression or chronic and severe pain, having a great impact in patients’ quality of life. Despite cognitive behavioural therapy has demonstrated remarkable benefits in enhancing quality of life and emotional wellbeing for patients with other cancers, its effectivity in patients with locally advanced laryngeal and hypopharyngeal cancer remains unexplored. This absence of literature in this particular population emphasizes the necessity of exploring the potential impact that cognitive behavioural therapy may have in improving quality of life, reducing comorbidities and potentially increasing survival rates of these patients. OBJECTIVE: The main objective is to study the efficacy of incorporating cognitive behavioural therapy to the standard treatment for improving quality of life among patients diagnosed with locally advanced laryngeal or hypopharyngeal cancer, in comparison with the standard treatment alone. Secondary objectives of this trial are to evaluate if incorporating cognitive behavioural therapy in the treatment plans results in an improvement of 1-year survival rates and a reduction on the amount of comorbidities in this population, compared to those only receiving the standard treatment. DESIGN AND SETTING: This study is designed as a multicentre, prospective, single-blinded, randomized clinical trial. It will be conducted in 8 different hospitals from Catalunya. PARTICIPANTS AND METHODS: 246 individuals newly diagnosed with locally advanced laryngeal or hypopharyngeal squamous cell carcinoma will be enrolled over a 20-months period through a non-probabilistic consecutive sampling. Patients will be randomly divided in two groups: an intervention group, receiving cognitive behavioural therapy sessions, and a control group, with control psychological sessions without a therapeutic goal. The amount and time of sessions will be the same in both groups: 15 sessions in 6 months. Throughout this period, 2 questionnaires will be answered 6 times in order to assess quality of life and potential comorbidities. Survival rates will be evaluated 1 year after diagnosis