The SHINE-MDT Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Head and Neck Carcinoma; Radiotherapy Side Effects

• Registration Number: NCT05828004
• Lead Sponsor: West China Hospital

Brief Summary

Radiotherapy is one of the main treatments for head and neck Carcinoma. The incidence of radiotherapy-related adverse events is greater than 90%, and severe adverse events may lead to the interruption of radiotherapy.

The management of nutritional, psychological, and rehabilitative issues in patients undergoing radiotherapy for head and neck cancer presents unique clinical challenges. We aimed to evaluate the efficacy of the SHINE-MDT (Supportive Holistic Interventions by Nurses and Experts via Multidisciplinary Team) in reducing radiotherapy interruptions and improving patients' quality of life (QoL) compared with usual care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-04-25
• Study Start: 2023-04-27
• Primary Completion: 2023-12-01
• Study Completion: 2024-06-01
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-27
• Last Update Posted: 2025-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

1. Patients had pathologically confirmed malignant head and neck tumors without distant metastasis.
2. Patient age ≥18 years;
3. Patients were scheduled to undergo either postoperative adjuvant radiotherapy or radical radiotherapy, with or without concurrent chemotherapy.
4. Baseline ECOG (Eastern Cooperative Oncology Group) score 0-2;
5. Good cognitive and reading skills, able to complete the questionnaire survey.

Exclusion Criteria

1. Presence of other malignant tumors aside from head and neck malignancies;
2. A history of prior head and neck radiotherapy;
3. Mental illness or cognitive impairments;
4. Uncontrolled systemic diseases that could significantly affect their QoL

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Radiotherapy interruption rate	5 days	Interruption of radiotherapy was defined as the actual end date of radiotherapy minus the expected end date at least 5 days

Secondary Outcome Measures

Name	Time	Method
Quality of life score (EORTC QLQ C30)	Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment	Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ C30)
Quality of life score QLQ-HN35	Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment	Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire QLQ-HN35
Nutritional status (NRS 2002, PG-SGA)	Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment	Nutritional status was calculated according to Nutrition Risk Screening 2002 and Patient-Generated Subjective Global Assessment。
Psychological status (DT, PHQ-9, HADS)	Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment	Psychological status was calculated according to Distress Thermometer (DT), Hospital Anxiety and Depression Scale (HADS), and Patient Health Questionnaire-9 (PHQ-9)

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China