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

Phase 3RecruitingNCT07467083

West China Hospital170 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

170

Conditions

Head and Neck Cancer

Interventions

Nurse-led preemptive symptom managementBEHAVIORAL

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 careBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

Outcomes

Primary Outcomes

Radiotherapy interruption rate

The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy.

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.

Secondary Outcomes

Rehospitalization rate

Rehospitalization was defined as any unplanned hospital admission within 3 months after completing radiotherapy for reasons unrelated to antitumor treatment.

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.

Data from ClinicalTrials.gov

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