Abstract
IMPORTANCE: Managing head and neck squamous cell carcinoma (HNSCC) involves complex decision-making, requiring a balance between optimizing prognosis and preserving quality of life. However, the role of individualized prognostic counseling in the decision-making process is not well known. OBJECTIVE: To assess the association of individualized prognostic counseling with the decision-making process in patients with primary HNSCC. DESIGN, SETTING, AND PARTICIPANTS: This prospective nonrandomized clinical trial with sequential cohorts was conducted at an academic tertiary referral center. Patients with newly diagnosed primary HNSCC who were eligible for curative treatment were enrolled between January 2014 and August 2018 (cohort 1; standard) and between October 2019 and January 2022 (cohort 2; intervention). Data were analyzed between January and August 2023. INTERVENTION: Cohort 1 received standard counseling from the treating physician, while cohort 2 received additional individualized prognostic counseling through an online prognostic model. Both cohorts were divided into small laryngeal squamous cell carcinoma (SLSCC) and other HNSCC groups. MAIN OUTCOMES AND MEASURES: The primary outcome was decisional conflict, measured using the Decisional Conflict Scale. Secondary outcomes included perceived role in decision-making (Control Preferences Scale), decisional regret, treatment choice, and quality of life. RESULTS: A total of 458 patients were enrolled (258 in cohort 1 and 200 in cohort 2; mean [SD] age, 66.1 [8.8] years; 79% [362 of 458] men). Decisional conflict was lower following individualized prognostic counseling for both SLSCC (Cohen d = 0.19; 95% CI, -0.10 to 0.49) and other HNSCC groups (Cohen d = 0.34; 95% CI, 0.10-0.58). Among patients with other HNSCC, the largest and most precise effect sizes were seen in the informed, values clarity, and support subscales of the Decisional Conflict Scale. Decisional regret was lower at 3 to 6 months after individualized counseling (cohort 2 median, 5 [IQR. 0-20] and cohort 1 median, 20 [IQR, 1-29]; rank-biserial r = 0.15 for SLSCC; cohort 2 median, 10 [IQR. 0-20] and cohort 1 median, 20 [IQR, 10-25]; rank-biserial r = 0.29 for other HNSCC), indicating small to moderate improvements. These differences were minimal at 12 months. An association between individualized counseling and more active or shared decision-making roles was observed in the other HNSCC group (Cramer V = 0.21). No relevant differences in quality-of-life outcomes were identified. CONCLUSIONS AND RELEVANCE: This nonrandomized clinical trial found that individualized prognostic counseling with an online prognostic model was associated with improvements in decisional conflict and decisional regret and promoted a more active and shared decision-making role among patients with head and neck cancer. The findings suggest integrating individualized prognostic information into routine consultations may enhance patient engagement, strengthen shared decision-making, and reduce uncertainty in complex treatment choices. TRIAL REGISTRATION: Dutch Trial Register: NTR4106.