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Recruiting NCT07467083

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

Phase III Interventional Head and Neck Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nurse-led preemptive symptom management, Concentional care.
Who it may be relevant to
Registry conditions: Head and Neck Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

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

Primary outcome measures

  • 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.]
Secondary outcome measures (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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

China · 1 center
  • West China Hospital of Sichuan University — Chengdu

Identifiers

NCT: NCT07467083 · 2026-18

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗