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

NCT07622381 | Recruiting

• 1 other identifier: bc20255265
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Head & Neck Cancer

Outcome Measures

Primary Outcomes (4)

• 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.

  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)

  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.

  At hospital admission and postoperative day 7

• 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.

  On the morning of hospital discharge

• 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.

  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 (3)

• Postoperative length of hospital stay

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

• 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.

• 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.

Study Arms (2)

Multidisciplinary Specialist Nurse-Led Perioperative Nursing Management

EXPERIMENTAL

Participants in this group will receive a multidisciplinary specialist nurse-led perioperative nursing management program in addition to routine care. The intervention is based on collaborative care theory and includes comprehensive assessment, individualized multidisciplinary interventions, dynamic follow-up, and quality assurance. Specialist nurses collaborate with physicians, dietitians, and psychological counselors to provide personalized perioperative management.

Behavioral: Multidisciplinary Specialist Nurse-Led Perioperative Nursing Management

Routine Perioperative Nursing Care

PLACEBO COMPARATOR

Participants in this group will receive routine perioperative nursing care for head and neck cancer surgery. Routine care includes admission education, nutritional screening and intervention, disease-related education, basic and specialized nursing care, respiratory function training, and discharge health education.

Behavioral: Routine Perioperative Nursing Care

Interventions

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.

Multidisciplinary Specialist Nurse-Led Perioperative Nursing Management

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.

Routine Perioperative Nursing Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

jiayan Cao

CONTACT

86+23340123-3130; Caojiayan_1976@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Nurse

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: June 3, 2026
• Study Start: November 24, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)