CompletedNot Applicable

The SHINE-MDT Randomized Controlled Trial

China233 participantsStarted 2023-04-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Radiotherapy interruption rate

Timeframe: 5 days

Trial details

NCT IDNCT05828004

SponsorWest China Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-01

View on ClinicalTrials.gov More Head and Neck Carcinoma trials