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Development and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Undergoing Radiation Therapy

Development and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Undergoing Radiation Therapy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07467083
Enrollment
170
Registered
2026-03-12
Start date
2026-03-15
Completion date
2027-03-01
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

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.

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.

Interventions

BEHAVIORALNurse-led preemptive symptom management

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.

BEHAVIORALConcentional care

Conventional care encompasses basic nursing care and routine health education, including instruction related to radiotherapy.

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Radiotherapy interruption rateThe 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.

Secondary

MeasureTime frameDescription
Rehospitalization rateThe time frame spans from the commencement of radiotherapy to three months post-radiotherapy, with an approximate total evaluation period of five months.Rehospitalization was defined as any unplanned hospital admission within 3 months after completing radiotherapy for reasons unrelated to antitumor treatment.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026