Nurse-led preemptive symptom management for head and neck cancer patients during radiation therapy
Development and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Undergoing Radiation Therapy
This project will try a nurse-led preemptive symptom management protocol to see if it reduces radiation therapy interruptions and eases symptoms for adults receiving radiotherapy for head and neck cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT07467083 on ClinicalTrials.gov |
What this trial studies
Adults with confirmed non-metastatic head and neck cancer who are scheduled for postoperative adjuvant or radical radiotherapy (with or without concurrent chemotherapy) will be enrolled at West China Hospital. Participants will receive either a nurse-led preemptive symptom management protocol delivered throughout the radiotherapy course or conventional care, with procedures and contacts occurring in person at the treatment center. The primary outcome is the rate of radiation therapy interruptions; secondary outcomes include symptom severity, quality of life, and psychological well-being measured by validated questionnaires. Data will be compared between the two groups to determine whether the preemptive nursing protocol reduces interruptions and improves patient-reported outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with pathologically confirmed malignant head and neck tumors without distant metastasis, scheduled for postoperative adjuvant or radical radiotherapy (with or without chemotherapy), with baseline ECOG 0–2 and the ability to complete questionnaires.
Not a fit: Patients with prior head and neck radiotherapy, other active malignancies, significant uncontrolled systemic disease, or cognitive/mental impairments are unlikely to benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, the nurse-led preemptive protocol could lower radiation treatment interruptions and improve symptoms, quality of life, and psychological well-being during radiotherapy.
How similar studies have performed: Nurse-led and proactive symptom-management programs in oncology have shown benefits in reducing symptoms and care disruption, but preemptive protocols specifically tailored to head and neck radiotherapy are less common and still being tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients had pathologically confirmed malignant head and neck tumors without distant metastasis. 2. Patient age ≥18 years; Patients were scheduled to undergo either postoperative adjuvant radiotherapy or radical radiotherapy, with or without concurrent chemotherapy. 3. Baseline ECOG (Eastern Cooperative Oncology Group) score 0-2; 4. Good cognitive and reading skills, able to complete the questionnaire survey. Exclusion Criteria: 1. Presence of other malignant tumors aside from head and neck malignancies; 2. A history of prior head and neck radiotherapy; 3. Mental illness or cognitive impairments; 4. Uncontrolled systemic diseases that could significantly affect their QoL.
Where this trial is running
Chengdu, Sichuan
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.