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Recruiting NCT07622381

Specialist Nurse-Led Nursing Management for Patients Undergoing Head and Neck Cancer Surgery

No phase Interventional Head & 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: Multidisciplinary Specialist Nurse-Led Perioperative Nursing Management, Routine Perioperative Nursing Care.
Who it may be relevant to
Registry conditions: Head & Neck Cancer. Basic parameters: 18 years — 70 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 →
Official title

Development and Evaluation of a Multidisciplinary Specialist Nurse-Led Perioperative Nursing Management Model for Patients Undergoing Head and Neck Cancer Surgery: A Prospective Controlled Study

Overview

The goal of this clinical trial is to evaluate the effectiveness of a multidisciplinary specialist nurse-led perioperative nursing management model for patients undergoing head and neck cancer surgery. The study aims to improve perioperative recovery, reduce postoperative complications, and enhance the quality of nursing care for patients with head and neck cancer. The main questions it aims to answer are: Does the multidisciplinary specialist nurse-led nursing management model reduce the incidence of postoperative complications in patients undergoing head and neck cancer surgery? Does the intervention improve nutritional indicators, quality of life, and nursing satisfaction compared with routine perioperative nursing care? Does the intervention reduce length of hospital stay and hospitalization costs? Researchers will compare patients receiving the multidisciplinary specialist nurse-led perioperative nursing management model with patients receiving routine perioperative nursing care to evaluate the effectiveness of the intervention. Participants will: Receive either routine perioperative nursing care or the multidisciplinary specialist nurse-led nursing management intervention during hospitalization Undergo comprehensive perioperative assessments, including nutritional status, risk of pulmonary complications, swallowing function, voice function, oral health status, and psychological condition Receive individualized multidisciplinary rehabilitation and nursing interventions developed collaboratively by specialist nurses, physicians, dietitians, and psychological counselors Participate in perioperative rehabilitation, health education, and continuous follow-up management during hospitalization Complete assessments of quality of life and nursing satisfaction during the perioperative period

Detailed description

Patients in the control group will receive routine perioperative nursing care for head and neck cancer surgery. Routine care includes admission education, nutritional screening and intervention, disease- and examination-related education, basic nursing care, specialized nursing care, and respiratory function training. Prior to discharge, patients will receive standardized health education regarding daily life precautions, swallowing and voice rehabilitation exercises, wound care, and management of nasogastric and tracheostomy tubes.

Participants in the intervention group will receive a multidisciplinary specialist nurse-led perioperative nursing management program in addition to routine care. The intervention was developed through evidence-based literature review and expert panel discussions and is guided by collaborative care theory. The management model consists of four major components: comprehensive assessment, individualized intervention planning, dynamic follow-up and feedback, and quality assurance with interdisciplinary coordination.

1. Comprehensive preoperative assessment

Following admission, patients will undergo multidimensional assessment and early risk screening performed by specialist nurses from different disciplines, with corresponding interventions initiated when necessary.

Assessment components include:

①Nutritional risk assessment: Registered nurses will conduct screening using the Nutritional Risk Screening 2002 (NRS-2002). Patients identified as being at nutritional risk will undergo further assessment using the Patient-Generated Subjective Global Assessment (PG-SGA) by nutrition specialist nurses and dietitians.

②Pulmonary complication risk assessment: Respiratory specialist nurses will assess risk factors for postoperative pulmonary complications using a structured screening tool developed for patients with head and neck cancer.

③Swallowing and voice function assessment: Rehabilitation specialist nurses will assess swallowing function using the Eating Assessment Tool-10 (EAT-10) and the Kubota Water Swallow Test. Voice function will be evaluated using the Voice Handicap Index-10 (VHI-10).

④Oral health assessment: Oral and maxillofacial specialist nurses will evaluate oral health status using the Oral Health Assessment Tool (OHAT).

Psychological assessment: Responsible nurses will conduct psychological screening using the Patient Health Questionnaire-2 (PHQ-2) and Generalized ⑤Anxiety Disorder-2 (GAD-2). Participants with scores ≥3 on either assessment will undergo further evaluation using PHQ-9 and GAD-7 by psychological counselors. 2. Individualized multidisciplinary intervention

Following comprehensive assessment, the multidisciplinary core team will identify and prioritize patient problems and develop individualized management plans. Standardized management checklists will be used and adjusted according to patient condition and clinical needs.

The intervention is implemented during two phases:

Admission-to-preoperative phase: * Nutritional management ②Respiratory function training

* Oral health management ④Swallowing function training

* Non-verbal communication intervention

* Psychological intervention

Postoperative phase: * Nutritional management

* Airway management

* Oral and skin care

* Swallowing rehabilitation ⑤Voice rehabilitation training ⑥Psychological intervention 3. Dynamic tracking and multidisciplinary follow-up The multidisciplinary team will monitor intervention implementation through daily morning handovers. Team meetings will be conducted at least once weekly to review patient progress, identify key clinical issues, discuss difficult cases, and optimize intervention strategies to ensure implementation throughout the perioperative period. 4. Quality assurance and interdisciplinary coordination Quality assurance measures include daily supervision by nurse managers, standardized departmental training, and structured feedback mechanisms. These approaches are intended to improve consistency of care delivery, maintain nursing quality, and enhance communication efficiency among multidisciplinary team members.

Interventions

  • Behavioral Multidisciplinary Specialist Nurse-Led Perioperative Nursing Management
    Participants in the intervention group will receive a multidisciplinary specialist nurse-led perioperative nursing management program based on collaborative care theory. The intervention includes comprehensive assessment, individualized multidimensional rehabilitation, follow-up feedback, and quality control coordination throughout the perioperative period. Specialist nurses collaborate with physicians, dietitians, and psychological counselors to provide personalized management plans according t
  • Behavioral Routine Perioperative Nursing Care
    Participants in the control group will receive routine perioperative nursing care for patients undergoing head and neck cancer surgery, including admission education, nutritional screening and intervention, education related to the disease and examinations, basic nursing care, specialized nursing care, and respiratory function training. Before discharge, patients will receive health education regarding daily life precautions, swallowing and voice training methods, wound care, and nasogastric tub

Primary outcome measures

  • postoperative complication rates [Time frame: the day of surgery until discharge (up to 30 days ), a nurse will monitor and record patients' clinical conditions daily,On the day of discharge, the nurse will summarize and finalize the total incidence of complications during the hospital stay.]
  • Nutritional indicators (prealbumin, albumin) [Time frame: At hospital admission and postoperative day 7]
  • Quality of life assessed by Functional Assessment of Cancer Therapy-General (FACT-G) [Time frame: On the morning of hospital discharge]
  • Nutritional indicators (BMI) [Time frame: On the mornings of both hospital admission and discharge, a designated nurse will measure the patient's height and weight using standardized medical scales, and then calculate and record the BMI value.]
Secondary outcome measures (3)
  • Postoperative length of hospital stay [Time frame: From postoperative day 1 to the day of hospital discharge (Up to 30 days).]
  • Hospitalization costs [Time frame: On the morning of hospital discharge,Nurses will collect and record total hospitalization costs incurred during the hospital stay for participants in both groups.]
  • Nursing satisfaction assessed by the Newcastle Satisfaction with Nursing Scales (NSNS) [Time frame: On the morning of hospital discharge.The NSNS questionnaire will be administered by nurses on the morning of hospital discharge, and participants will complete the questionnaire before completing discharge procedures.]

Eligibility criteria

Inclusion criteria

  • Patients diagnosed with head and neck cancer according to the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Head and Neck Tumors (2023)
  • Patients scheduled to undergo head and neck cancer surgery
  • Age >18 years
  • Patients who fully understand the study and voluntarily agree to participate

Exclusion criteria

  • Patients with severe cardiovascular diseases, uncontrolled infections, or other diseases or complications that could affect study participation
  • Patients with an estimated survival time of less than 6 months based on tumor stage and overall health status

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

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

China · 1 center
  • Tianjin Medical University Cancer Institute and Hospital — Tianjin

Identifiers

NCT: NCT07622381 · bc20255265

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗