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Head & Neck CancerNCT07622381

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

A study testing Multidisciplinary Specialist Nurse-Led Perioperative Nursing Management and Routine Perioperative Nursing Care in people with Head & Neck Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Head & Neck Cancer
What is being tested?
Multidisciplinary Specialist Nurse-Led Perioperative Nursing Management and Routine Perioperative Nursing Care
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteChina
Study dates
24 Nov 2025to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin

    Cao, 86+23340123-3130, Caojiayan_1976@126.com

    Recruiting

Other trials in China

About this study

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

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:

Read more

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

Read the 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
  1. 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.
  2. 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.
Being tested
Multidisciplinary Specialist Nurse-Led Perioperative Nursing Management, Routine Perioperative Nursing Care
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidisciplinary Specialist Nurse-Led Perioperative Nursing ManagementBehavioural

    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 CareBehavioural

    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.

Study groups in NCT07622381
Study groupRoleWhat they receive
Multidisciplinary Specialist Nurse-Led Perioperative Nursing ManagementExperimentalParticipants 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.
Receives: Behavioral: Multidisciplinary Specialist Nurse-Led Perioperative Nursing Management
Routine Perioperative Nursing CarePlacebo comparatorParticipants 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.
Receives: Behavioral: Routine Perioperative Nursing Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2026
  2. Study start24 Nov 2025
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07622381
Sponsor's protocol ID
bc20255265
Status last verified
Jun 2026
First submitted
9 May 2026
Last updated
3 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multidisciplinary Specialist Nurse-Led Perioperative Nursing Management and Routine Perioperative Nursing Care in people with Head & Neck Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact jiayan Cao (86+23340123-3130, Caojiayan_1976@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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