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NCT Number: NCT07467083

Development and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Undergoing Radiation Therapy

The aim of this study is to investigate whether a nurse-led preemptive symptom management protocol can reduce the radiation therapy interruption rate in patients with head and neck cancer compared to conventional care models.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location status: Recruiting

Location contact

Xingchen Peng

CONTACT

[email protected]

18980606753

About this study

The aim of this study is to investigate whether a nurse-led preemptive symptom management protocol can reduce the radiation therapy interruption rate in patients with head and neck cancer compared to conventional care models. The secondary objective is to evaluate whether the nurse-led preemptive symptom management protocol improves symptoms, quality of life, and psychological well-being in head and neck cancer patients undergoing radiation therapy compared to conventional care models.

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

Nurse-led preemptive symptom management

Behavioral

The intervention encompasses four key components: symptom monitoring and management guided by a standardized manual, emotional and psychological support integrating family involvement and traditional cultural values, family-unit-based education and skills training, and care coordination ensuring multidisciplinary communication.

Concentional care

Behavioral

Conventional care encompasses basic nursing care and routine health education, including instruction related to radiotherapy.

Primary outcomes

  1. Radiotherapy interruption rate

    Time frame: The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks.

    The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy.

Secondary outcomes

  1. Rehospitalization rate

    Time frame: The time frame spans from the commencement of radiotherapy to three months post-radiotherapy, with an approximate total evaluation period of five months.

    Rehospitalization was defined as any unplanned hospital admission within 3 months after completing radiotherapy for reasons unrelated to antitumor treatment.

Other outcomes

  1. Quality of life as sssessed by the EORTC QLQ-C30 Questionnaires

    Time frame: 1 week before radiotherapy ; at the middle of radiotherapy (usually 3 weeks after the start of radiotherapy) ; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks) ; and 1, 2, 3 months after the end of radiotherapy.

    European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30). This is a 30-item questionnaire assessing quality of life in cancer patients through functional scales, symptom scales, and a global health status scale. Scores are transformed to a 0-100 scale. For functional scales and global health status, higher scores indicate better quality of life; for symptom scales, higher scores indicate worse symptoms.

  2. Quality of life as sssessed by the EORTC QLQ-H&N35 Questionnaires

    Time frame: 1 week before radiotherapy ; at the middle of radiotherapy (usually 3 weeks after the start of radiotherapy) ; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks) ; and 1, 2, 3 months after the end of radiotherapy.

    European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Head and Neck Cancer Module (EORTC QLQ-H&N35). This is a 35-item module specifically designed for patients with head and neck cancer, assessing symptoms and side effects related to the disease and treatment. All items are scored on a 0-100 scale, where higher scores represent worse symptoms or more problems.

  3. Symptom burden

    Time frame: Weekly during radiotherapy and 1, 2, and 3 months post-radiotherapy.The evaluation period is approximately 5 months.

    The symptom burden of the patients was evaluated using the M.D. Anderson Symptom Inventory (MDASI). This is a brief, multi-symptom assessment tool comprising 13 core symptom items and 6 interference items. Each item is rated on an 11-point numeric scale ranging from 0 to 10. For all items, higher scores indicate greater symptom severity or greater interference with daily functioning.

  4. Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale

    Time frame: Weekly during radiotherapy and 1, 2, and 3 months post-radiotherapy.The evaluation period is approximately 5 months.

    This 7-item subscale assesses anxiety symptoms. Each item is rated on a 4-point scale (0 to 3), and scores are summed to yield a total score ranging from 0 to 21. Higher scores indicate greater anxiety severity (worse outcome).

  5. Hospital Anxiety and Depression Scale (HADS) - Depression Subscale

    Time frame: Weekly during radiotherapy and 1, 2, and 3 months post-radiotherapy.The evaluation period is approximately 5 months.

    This 7-item subscale assesses depressive symptoms. Each item is rated on a 4-point scale (0 to 3), and scores are summed to yield a total score ranging from 0 to 21. Higher scores indicate greater depression severity (worse outcome).

  6. Adverse events

    Time frame: From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks.

    Adverse events were assessed and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0. Each adverse event is assigned a grade from 1 to 5, where Grade 1 indicates mild symptoms, Grade 2 moderate, Grade 3 severe or medically significant, Grade 4 life-threatening consequences, and Grade 5 death related to the adverse event. Higher grades represent greater severity (worse outcome).

  7. Tumor response

    Time frame: From the initiation of radiotherapy until three months after its completion.The evaluation period is approximately 5 months.

    Tumor response was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Based on this criteria, tumor response is categorized into one of four ordinal categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). CR and PR represent objective tumor response (better outcome), while PD represents disease progression (worse outcome).

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Apr 1, 2026

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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