Construction and Preliminary Application of Evidence-Based Nursing Protocol for Oral Mucositis Related to Tumor Therapy

Peking Union Medical College

Status: Completed

Conditions: Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy

Treatments: Behavioral: Conventional nursing measures; Behavioral: Intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT07305766

No. PUMCSON-2023-26

Details and patient eligibility

About

Describe the incidence and influencing factors of cancer therapy-related oral mucositis. Based on evidence-based practice, develop a standardized nursing protocol for cancer therapy-related oral mucositis that aligns with China's national context and demonstrates strong clinical feasibility, and establish a clinical management pathway for cancer therapy-related oral mucositis. Validate the implementability of the standardized nursing protocol, and evaluate its clinical effectiveness and cost-effectiveness.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a confirmed cancer diagnosis who are aware of their condition.
• Patients currently undergoing non-surgical treatments such as chemotherapy, radiotherapy, immunotherapy, or targeted therapy.
• Patients who voluntarily agree to participate in this study and provide informed consent.

Exclusion criteria

• Patients with autoimmune diseases;
• Patients with primary or metastatic oral or lip cancer.;
• Patients who are participating in other intervention studies.;
• Swallowing problems existed in patients with Kubota drinking test > level 3;
• Coma or inability to open mouth, difficulty cooperating with the researcher.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Control group

Active Comparator group

Description:

In addition to providing patients with oral hygiene education (brushing teeth twice daily and rinsing with water after meals) and administering symptomatic treatment as prescribed, during their outpatient infusion visits, nurses will deliver evidence-based nursing interventions for cancer therapy-related oral mucositis through face-to-face education and guidance. Following discharge, patients will receive weekly online follow-up visits to enhance adherence to the protocol. Additionally, patients will be monitored for any adverse reactions or intolerance symptoms-such as nausea and vomiting-during the implementation of the evidence-based oral mucositis care regimen.

Treatment:

Behavioral: Conventional nursing measures

Intervention group

Experimental group

Description:

In addition to providing patients with oral hygiene education (brushing teeth twice daily and rinsing with water after meals) and administering symptomatic treatment as prescribed, during their outpatient infusion visits, nurses will deliver evidence-based nursing interventions for cancer therapy-related oral mucositis through face-to-face education and guidance. Following discharge, patients will receive weekly online follow-up visits to enhance adherence to the protocol. Additionally, patients will be monitored for any adverse reactions or intolerance symptoms-such as nausea and vomiting-during the implementation of the evidence-based oral mucositis care regimen.

Treatment:

Behavioral: Intervention group