NCT05828004

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

April 27, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

February 2, 2023

Last Update Submit

August 27, 2025

Conditions

Head and Neck CarcinomaRadiotherapy Side Effects

Keywords

Head and Neck CarcinomaMultidisciplinary TeamRadiotherapy interruptionSupportive Care

Outcome Measures

Primary Outcomes (1)

  • Radiotherapy interruption rate

    Interruption of radiotherapy was defined as the actual end date of radiotherapy minus the expected end date at least 5 days

    5 days

Secondary Outcomes (4)

  • 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 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)

    Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment

  • Psychological status (DT, PHQ-9, HADS)

    Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment

Study Arms (2)

standard care group

NO INTERVENTION

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

MDT care group

EXPERIMENTAL

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

Interventions

Whole-Course Multidisciplinary Care InterventionBEHAVIORAL

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.

MDT care group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

  • Pei Y, Wang J, Li J, Chen Y, He J, Wei Z, Liu Z, Su Y, Dai T, Yin L, Deng Y, Zhou J, Tian H, Li Y, Chen X, Zhang S, Chen Y, Yan Q, Li R, Jiang Z, Hu X, Peng X. Multidisciplinary Team Support for Patients With Head and Neck Cancer Receiving Radiotherapy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2547590. doi: 10.1001/jamanetworkopen.2025.47590.

    PMID: 41396606DERIVED

Study Officials

  • Xingchen Peng, Ph.D

    West China Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Professor

Study Record Dates

First Submitted

February 2, 2023

First Posted

April 25, 2023

Study Start

April 27, 2023

Primary Completion

December 1, 2023

Study Completion

June 1, 2024

Last Updated

August 28, 2025

Record last verified: 2025-08

Locations

CN(1)