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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Behavioral: Nurse-led preemptive symptom management; Behavioral: Concentional care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Xingchen Peng; Phone Number: 18980606753; Email: pxx2014@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients had pathologically confirmed malignant head and neck tumors without distant metastasis.
2. Patient age ≥18 years; Patients were scheduled to undergo either postoperative adjuvant radiotherapy or radical radiotherapy, with or without concurrent chemotherapy.
3. Baseline ECOG (Eastern Cooperative Oncology Group) score 0-2;
4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Patients in the intervention group will receive a structured nurse-led preemptive symptom management protocol. This protocol, centered around trained oncology specialist nurses, involves systematic visits conducted before, during, and after radiotherapy. 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. The core of the intervention is the nurse's sustained engagement to proactively prevent and manage symptoms while reinforcing the family's role within the support system.	Behavioral: Nurse-led preemptive symptom management; 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.
Active Comparator: Control group; Patients in the control group will receive conventional care, which encompasses standardized nursing procedures, routine health education (including information related to radiotherapy) and so on.	Behavioral: Concentional care; Conventional care encompasses basic nursing care and routine health education, including instruction related to radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiotherapy interruption rate	The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rehospitalization rate	Rehospitalization was defined as any unplanned hospital admission within 3 months after completing radiotherapy for reasons unrelated to antitumor treatment.	The time frame spans from the commencement of radiotherapy to three months post-radiotherapy, with an approximate total evaluation period of five months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life as sssessed by the EORTC QLQ-C30 Questionnaires	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.	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.
Quality of life as sssessed by the EORTC QLQ-H&N35 Questionnaires	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.	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.
Symptom burden	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.	Weekly during radiotherapy and 1, 2, and 3 months post-radiotherapy.The evaluation period is approximately 5 months.
Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale	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).	Weekly during radiotherapy and 1, 2, and 3 months post-radiotherapy.The evaluation period is approximately 5 months.
Hospital Anxiety and Depression Scale (HADS) - Depression Subscale	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).	Weekly during radiotherapy and 1, 2, and 3 months post-radiotherapy.The evaluation period is approximately 5 months.
Adverse events	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).	From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks.
Tumor response	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).	From the initiation of radiotherapy until three months after its completion.The evaluation period is approximately 5 months.

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: March 7, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 2026-18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No