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The SHINE-MDT Randomized Controlled Trial

NCT05828004 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2025-08-28

No results posted yet for this study

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.

Conditions

  • Head and Neck Carcinoma
  • Radiotherapy Side Effects

Interventions

BEHAVIORAL

Whole-Course Multidisciplinary Care Intervention

On the basis of standard treatment, all patients were evaluated by senior practice nurses in the Department of Oncology in person at the time of enrollment (before radiotherapy) and once every week during radiotherapy, and once in person/over the phone at 1, 2, 3, and 6 months after radiotherapy.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Xingchen Peng, Ph.D · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-27
Primary Completion
2023-12-01
Completion
2024-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05828004 on ClinicalTrials.gov