Head and Neck CancerPhase 3NCT07467083
Development and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Undergoing Radiation Therapy
A Phase 3 study testing Nurse-led preemptive symptom management and Concentional care in people with Head and Neck Cancer, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Nurse-led preemptive symptom management and Concentional care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2026to 1 Mar 2027
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Xingchen Peng, 18980606753, pxx2014@163.com
About this study
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.
Read the detailed description
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. The secondary objective is to evaluate whether the nurse-led preemptive symptom management protocol improves symptoms, quality of life, and psychological well-being in head and neck cancer patients undergoing radiation therapy compared to conventional care models.
- Conditions
- Head and Neck Cancer
- Being tested
- Nurse-led preemptive symptom management, Concentional 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.
Nurse-led preemptive symptom managementBehavioural
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.
Concentional careBehavioural
Conventional care encompasses basic nursing care and routine health education, including instruction related to radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients 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. Receives: Behavioral: Nurse-led preemptive symptom management |
| Control group | Active comparator | Patients in the control group will receive conventional care, which encompasses standardized nursing procedures, routine health education (including information related to radiotherapy) and so on. Receives: Behavioral: Concentional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiotherapy interruption rate
The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy.
Measured: 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
Rehospitalization was defined as any unplanned hospital admission within 3 months after completing radiotherapy for reasons unrelated to antitumor treatment.
Measured: The time frame spans from the commencement of radiotherapy to three months post-radiotherapy, with an approximate total evaluation period of five months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start15 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467083
- Sponsor's protocol ID
- 2026-18
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Undergoing Radiation Therapy
- ClinicalTrials.gov ID
- NCT07467083
- Acronym / sponsor ID
- 2026-18
- Conditions
- Head and Neck Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The secondary objective is to evaluate whether the nurse-led preemptive symptom management protocol improves symptoms, quality of life, and psychological well-being in head and neck cancer patients undergoing radiation therapy compared to conventional care models.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Nurse-led preemptive symptom managementPatients 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 comparator | Behavioral: Concentional carePatients in the control group will receive conventional care, which encompasses standardized nursing procedures, routine health education (including information related to radiotherapy) and so on. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led preemptive symptom managementThe 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. | Behavioural | Intervention group |
| Concentional careConventional care encompasses basic nursing care and routine health education, including instruction related to radiotherapy. | Behavioural | Control group |
Primary outcome
Radiotherapy interruption rate
Time frame: 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.
The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy.
1 secondary outcome
Rehospitalization rate
Time frame: The time frame spans from the commencement of radiotherapy to three months post-radiotherapy, with an approximate total evaluation period of five months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nurse-led preemptive symptom management and Concentional care in people with Head and Neck Cancer, run by West China 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 4 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 1 Apr 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiotherapy interruption rate (time frame: 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.). 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 1 Apr 2026.