The impact of an artificial intelligence (AI)-assisted education program on mental health, social support and quality of life in older individuals with head and neck cancer: study protocol of a randomized controlled trial

BACKGROUND: Head and neck cancer (HNC) is a common malignant tumor, and its treatment often leads to functional impairments in speech, swallowing, and appearance, severely affecting patients' quality of life. Older individuals with HNC, due to the combined stress of aging and disease, face heightened mental health challenges. This study aims to evaluate the effect of AI-driven personalized health education on mental health, social support and quality of life in older patients after HNC surgery. METHODS: A single-center, two-group, randomized controlled trial will be conducted. One hundred of postoperative HNC patients aged ≥ 60 years will be randomly assigned to the intervention group (n = 50) or the control group (n = 50). The intervention group will receive 12 months of personalized and phased health education through the "Kangkang" AI assistant, including video/graphic and real-time AI Q&A. The control group received standardized SMS health education at the same frequency. The outcomes will include Perceived Stress Scale, Barthel Index, Patient Assessment of Constipation Quality of Life, Nutritional Risk Screening 2002, Numerical Rating Scale for Pain, Rosenberg Self-Esteem Scale, Pittsburgh Sleep Quality Index, UCLA Loneliness Scale (3rd edition), Fear of Cancer Progression Questionnaire-Short Form, World Health Organization Quality of Life Assessment for Older Adults, Generalized Anxiety Disorder-7, Patient Health Questionnaire-9, Morse Fall Scale. All assessments will be performed 5 times at baseline (preoperative) and 1, 3, 6, and 12 months postoperatively. Statistical analysis will be conducted using intention-to-treat analysis. Linear mixed models with maximum likelihood estimation will be used to analyze the continues variables and manage missing data. DISCUSSION: This will provide evidence on whether AI-driven, personalized health education can improve mental health, social support and quality of life in older patients after HNC surgery. The single-center design and reliance on self-reported outcomes may limit generalizability, and future multicenter studies are warranted. TRIAL REGISTRATION: The trial has been prospectively registered in the China Clinical Trials Registry on December 5, 2025, with registration number of ChiCTR2500114052.