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NCT Number: NCT05828004

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.

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Key information

Conditions

Head and Neck Carcinoma Radiotherapy Side Effects

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole-Course Multidisciplinary Care Intervention

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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。

  4. 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)

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 25, 2023
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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