Development and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Undergoing Radiation Therapy
1 other identifier
interventional
170
1 country
1
Brief Summary
The aim of this study is to investigate whether a nurse-led preemptive symptom management protocol can reduce the radiation therapy interruption rate in patients with head and neck cancer compared to conventional care models.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 head-and-neck-cancer
Started Mar 2026
Shorter than P25 for phase_3 head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2026
CompletedFirst Posted
Study publicly available on registry
March 12, 2026
CompletedStudy Start
First participant enrolled
March 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 1, 2026
March 1, 2026
12 months
February 4, 2026
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Radiotherapy interruption rate
The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy.
The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks.
Secondary Outcomes (1)
Rehospitalization rate
The time frame spans from the commencement of radiotherapy to three months post-radiotherapy, with an approximate total evaluation period of five months.
Other Outcomes (7)
Quality of life as sssessed by the EORTC QLQ-C30 Questionnaires
1 week before radiotherapy ; at the middle of radiotherapy (usually 3 weeks after the start of radiotherapy) ; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks) ; and 1, 2, 3 months after the end of radiotherapy.
Quality of life as sssessed by the EORTC QLQ-H&N35 Questionnaires
1 week before radiotherapy ; at the middle of radiotherapy (usually 3 weeks after the start of radiotherapy) ; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks) ; and 1, 2, 3 months after the end of radiotherapy.
Symptom burden
Weekly during radiotherapy and 1, 2, and 3 months post-radiotherapy.The evaluation period is approximately 5 months.
- +4 more other outcomes
Study Arms (2)
Intervention group
EXPERIMENTALPatients in the intervention group will receive a structured nurse-led preemptive symptom management protocol. This protocol, centered around trained oncology specialist nurses, involves systematic visits conducted before, during, and after radiotherapy. The intervention encompasses four key components: symptom monitoring and management guided by a standardized manual, emotional and psychological support integrating family involvement and traditional cultural values, family-unit-based education and skills training, and care coordination ensuring multidisciplinary communication. The core of the intervention is the nurse's sustained engagement to proactively prevent and manage symptoms while reinforcing the family's role within the support system.
Control group
ACTIVE COMPARATORPatients in the control group will receive conventional care, which encompasses standardized nursing procedures, routine health education (including information related to radiotherapy) and so on.
Interventions
The intervention encompasses four key components: symptom monitoring and management guided by a standardized manual, emotional and psychological support integrating family involvement and traditional cultural values, family-unit-based education and skills training, and care coordination ensuring multidisciplinary communication.
Conventional care encompasses basic nursing care and routine health education, including instruction related to radiotherapy.
Eligibility Criteria
You may qualify if:
- Patients had pathologically confirmed malignant head and neck tumors without distant metastasis.
- Patient age ≥18 years; Patients were scheduled to undergo either postoperative adjuvant radiotherapy or radical radiotherapy, with or without concurrent chemotherapy.
- Baseline ECOG (Eastern Cooperative Oncology Group) score 0-2;
- Good cognitive and reading skills, able to complete the questionnaire survey.
You may not qualify if:
- Presence of other malignant tumors aside from head and neck malignancies;
- A history of prior head and neck radiotherapy;
- Mental illness or cognitive impairments;
- Uncontrolled systemic diseases that could significantly affect their QoL.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, Professor
Study Record Dates
First Submitted
February 4, 2026
First Posted
March 12, 2026
Study Start
March 15, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
April 1, 2026
Record last verified: 2026-03