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

NCT07305766 | Completed DMC

• 1 other identifier: No. PUMCSON-2023-26
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy

Keywords

Evidence-Based Nursing Protocol; Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• Incidence of oral mucositis

  WHO Oral Mucositis Assessment Scale

  One treatment cycle (21days)

Secondary Outcomes (2)

• Oral Condition Assessment

  One treatment cycle (21days)

• Salivary pH

  One treatment cycle (21days)

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Behavioral: Conventional nursing measures

Intervention group

EXPERIMENTAL

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.

Behavioral: Intervention group

Interventions

Intervention group BEHAVIORAL

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.

Intervention group

Conventional nursing measures BEHAVIORAL

Conventional nursing measures were provided, entailing patient education on oral care (brushing twice daily and rinsing with plain water postprandially), as well as symptom management according to established protocols.

Also known as: Control group

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100144, China

Location

Related Publications (1)

• Xu Y, Wang J, Zhang Y, Guo Z, Zhang W, Zhang S, Shi W, Ma W. Occurrence and Influencing Factors of Oral Mucositis in Patients With Cancer: A Cross-Sectional Study in China. Oncol Nurs Forum. 2025 Oct 20;52(6):460-472. doi: 10.1188/25.ONF.460-472.

  PMID: 41123400 RESULT

MeSH Terms

Conditions

Stomatitis; Ulcer

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: October 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Publication date: January 30, 2028

Locations

CN (1)