The SHINE-MDT Randomized Controlled Trial

Sichuan University

Status: Completed

Conditions: Head and Neck Carcinoma; Radiotherapy Side Effects

Treatments: Behavioral: Whole-Course Multidisciplinary Care Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05828004

2022-1831

Details and patient eligibility

About

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.

Enrollment: 233 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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233 participants in 2 patient groups

standard care group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Whole-Course Multidisciplinary Care Intervention