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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multidisciplinary Specialist Nurse-Led Perioperative Nursing Management

    Behavioral

    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.

  • Routine Perioperative Nursing Care

    Behavioral

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Multidisciplinary Specialist Nurse-Led Perioperative Nursing ManagementExperimental treatment 1 intervention
Group B: Routine Perioperative Nursing CarePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

postoperative complication rates

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.

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.
2

Nutritional indicators (prealbumin, albumin)

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.

Time frame
At hospital admission and postoperative day 7
3

Quality of life assessed by Functional Assessment of Cancer Therapy-General (FACT-G)

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.

Time frame
On the morning of hospital discharge
4

Nutritional indicators (BMI)

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.

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 outcomes

1

Postoperative length of hospital stay

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.

Time frame
From postoperative day 1 to the day of hospital discharge (Up to 30 days).
2

Hospitalization costs

Nurses will collect and record total hospitalization costs incurred during the hospital stay for participants in both groups.

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.
3

Nursing satisfaction assessed by the Newcastle Satisfaction with Nursing Scales (NSNS)

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.

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.

Other outcomes

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