The SHINE-MDT Randomized Controlled Trial

August 27, 2025 updated by: Xingchen Peng, West China Hospital

Effect of Multidisciplinary Team Support on Head and Neck Cancer Patients Receiving Radiotherapy: The SHINE-MDT Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

233

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: standard care group
The standard care group is the routine care group, that is, under the current standard antitumor treatment and follow-up mode, the patients independently decided whether to carry out nutritional and psychological intervention after the advice from the medical care department of oncology
Experimental: MDT care group
The MDT care group is the whole-course multidisciplinary care intervention group, which is conducted by a multidisciplinary team composed of the oncology department, nutrition department, mental health center and rehabilitation department.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiotherapy interruption rate
Time Frame: 5 days
Interruption of radiotherapy was defined as the actual end date of radiotherapy minus the expected end date at least 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score (EORTC QLQ C30)
Time Frame: 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)
Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment
Quality of life score QLQ-HN35
Time Frame: 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
Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment
Nutritional status (NRS 2002, PG-SGA)
Time Frame: 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。
Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment
Psychological status (DT, PHQ-9, HADS)
Time Frame: 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)
Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Investigators

  • Principal Investigator: XingChen Peng, Ph.D, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1831

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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