Importance: Guidelines recommend nutritional, psychological, and rehabilitation support for patients with head and neck cancer during radiotherapy, but many patients, particularly in China, lack efficient access to such services.
Objective: To assess the effectiveness of Supportive Holistic Interventions by Nurses and Experts via Multidisciplinary Team (SHINE-MDT), a framework to coordinate nutritional, psychological, and rehabilitation support, at reducing radiotherapy interruptions, improving nutritional status, alleviating psychological burdens, and enhancing the quality of life (QOL) among patients with head and neck cancer undergoing radiotherapy.
Design, setting, and participants: A randomized clinical trial (RCT) of SHINE-MDT vs usual care (UC) was conducted at West China Hospital from April 27 to December 1, 2023. Adult patients aged 18 years or older with head and neck cancer undergoing radiotherapy were enrolled.
Interventions: Eligible patients were randomly allocated (1:1) to either UC or SHINE-MDT. The SHINE-MDT group received nutritional, psychological, and rehabilitation support delivered by a team including oncology nurse specialists, radiation and medical oncologists, dietitians, psychotherapists, and rehabilitation physicians. The UC group received supportive measures aligned with standard practice.
Main outcomes and measures: The primary outcome was the radiotherapy interruption rate in the intent-to-treat population. Secondary outcomes included patient-reported QOL assessed using the European Organisation for Research and Treatment of Cancer QOL Questionnaire-Core 30 (QLQ-C30). Nutritional status was evaluated using Nutrition Risk Screening 2002 (NRS-2002) and the Patient-Generated Subjective Global Assessment (PG-SGA) and psychological status using a distress thermometer (DT), the Patient Health Questionnaire-9 (PHQ-9), and the Hospital Anxiety and Depression Scale (HADS). Assessments from baseline through 6 months posttreatment were analyzed using mixed-effects models for intergroup comparisons.
Results: A total of 233 patients were enrolled (mean [SD] age, 51.7 [13.9] years; mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 23.8 [3.3]; 158 males [67.8%]). The radiotherapy interruption rate in the SHINE-MDT group was 13.9 (95% CI, 4.2-23.6) percentage points lower than that in the UC group (11.1% [95% CI, 6.0%-18.2%] vs 25.0% [95% CI, 17.2%-34.2%]; P = .003). The SHINE-MDT group had superior outcomes compared with the UC group at the end of radiotherapy, with better global health status (mean QLQ-C30 score, 68.59 [95% CI, 65.83-71.35] vs 64.06 [95% CI, 61.48-66.64]; P = .009), improved mean psychological status scores (DT: 3.02 [95% CI, 2.68-3.35] vs 4.30 [95% CI, 4.00-4.59]; HADS-Anxiety: 4.96 [95% CI, 4.27-5.66] vs 7.27 [95% CI, 6.44-8.12]; HADS-Depression: 4.48 [95% CI, 4.00-4.98] vs 6.06 [95% CI, 5.42-6.70]; PHQ-9: 2.22 [95% CI, 1.73-2.72] vs 3.49 [95% CI, 2.94-4.03]; all P < .001), and better nutritional indicators reflected by lower mean NRS-2002 (2.19 [95% CI, 2.07-2.31] vs 2.80 [95% CI, 2.62-2.96]) and PG-SGA (6.89 [95% CI, 6.17-7.61] vs 10.19 [95% CI, 9.27-11.11]) (both P < .001) scores.
Conclusions and relevance: In this RCT, the SHINE-MDT intervention reduced radiotherapy interruptions, improved nutritional status, alleviated psychological burdens, and elevated QOL, indicating this framework may improve the holistic well-being of patients with head and neck cancer receiving radiotherapy.
Trial registration: ClinicalTrials.gov Identifier: NCT05828004.