Head & Neck Cancer
Conditions
Brief summary
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
BEHAVIORALMultidisciplinary 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 to patients' nutritional status, pulmonary complication risk, swallowing function, voice function, oral health condition, and psychological status. Dynamic multidisciplinary communication and continuous monitoring are implemented during hospitalization to optimize perioperative recovery and nursing outcomes.
BEHAVIORALRoutine 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 tube and tracheostomy tube care.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative complication rates | 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. | Nurses will collect and record the occurrence of postoperative complications during hospitalization in both groups. Complications will be evaluated and confirmed by physicians and include pharyngocutaneous fistula, pulmonary infection, deep vein thrombosis of the lower extremities, and flap compromise. |
| Nutritional indicators (prealbumin, albumin) | At hospital admission and postoperative day 7 | Nutritional indicators will be assessed by serum prealbumin and albumin levels. Nurses will collect 5 mL of fasting venous blood samples in the morning at hospital admission and on postoperative day 7. Serum prealbumin and albumin levels will be measured and compared between groups. |
| Quality of life assessed by Functional Assessment of Cancer Therapy-General (FACT-G) | On the morning of hospital discharge | Quality of life will be assessed using the Functional Assessment of Cancer Therapy-General (FACT-G), which includes four domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The questionnaire contains 27 items scored on a 5-point Likert scale, with a total score ranging from 0 to 108. Higher scores indicate better quality of life. Only the general module will be used in this study because most patients remain on enteral tube feeding before discharge. |
| Nutritional indicators (BMI) | 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. | Body mass index (BMI) will be calculated using patients' height and weight measurements. Nurses will measure height and body weight at hospital admission and on the day of discharge, and BMI values will be calculated and compared between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative length of hospital stay | From postoperative day 1 to the day of hospital discharge (Up to 30 days). | Nurses will collect and record postoperative length of hospital stay in both groups. Postoperative length of hospital stay is defined as the number of days from postoperative day 1 to the day of hospital discharge, excluding the day of surgery. |
| Hospitalization costs | On the morning of hospital discharge,Nurses will collect and record total hospitalization costs incurred during the hospital stay for participants in both groups. | 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) | 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. | Nursing satisfaction will be assessed using the Newcastle Satisfaction with Nursing Scales (NSNS), a patient-reported instrument designed to evaluate satisfaction with nursing services from the patient's perspective. The scale contains 19 items scored using a 5-point Likert scale. Total scores range from 19 to 95, with higher scores indicating greater satisfaction with nursing care and lower scores indicating poorer satisfaction. The NSNS has demonstrated excellent reliability, with a reported Cronbach's alpha coefficient of 0.967. |
Countries
China
Contacts
CONTACTjiayan Cao
Outcome results
None listed