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

March 26, 2026 updated by: Xingchen Peng, West China Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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).
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
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).
Weekly during radiotherapy and 1, 2, and 3 months post-radiotherapy.The evaluation period is approximately 5 months.
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).
From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks.
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).
From the initiation of radiotherapy until three months after its completion.The evaluation period is approximately 5 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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