The Effect of Education Given on Preventing Mouth Ulcers in Women With Breast Cancer

NCT07042568 | Completed

• 1 other identifier: TÜTF-GOBAEK 2022/382
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of nursing education provided to women diagnosed with breast cancer undergoing chemotherapy on their quality of life and the severity of oral mucositis (mouth sores). The main questions this study aims to answer are:

1. 1.Does nursing education aimed at preventing oral mucositis in women diagnosed with breast cancer have an effect on quality of life?
2. 2.Does nursing education aimed at preventing oral mucositis in women diagnosed with breast cancer have an effect on the severity of oral mucositis? The researchers will evaluate the effect of nursing education on quality of life and oral mucositis severity by randomly assigning one group to receive education and the other group to not receive education.

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3); Chemotherapy

Keywords

Education; Breast cancer; Chemotherapy; Oral mucositis; Quality of life; Nursing

Outcome Measures

Primary Outcomes (1)

• Comparison of general health, functional and symptom-related quality of life (QLQ-C30), WHO oral toxicity criteria and ADR measurement scores within and between the intervention and control groups

  The European Organisation for Research and Treatment of Cancer QLQ-C30 Version 3.0 Quality of Life Scale consists of a total of 30 questions divided into three subscales: general well-being, functional scale, and symptom scale. In this scale developed by the WHO, stage 0 represents normal oral mucosa, while stage 4 represents the highest severity of oral mucositis. The Oral Assessment Guide (OAG) covers eight areas: voice, swallowing, tongue, lips, oral mucosa, saliva, gums, and teeth/dentures. When calculating the final total oral mucosa score, the scores obtained from these eight areas are added together. The lowest score is 8, and the highest score is 24. An increase in the score indicates an increase in the severity of oral mucositis, while a decrease indicates a decrease in the severity of oral mucositis.

  First day and 21st day

Study Arms (2)

Intervention (Education + Telephone consultation)

EXPERIMENTAL

Behavioral: Nursing education aimed at preventing oral mucositis

Control group

NO INTERVENTION

They continued to receive routine nursing care.

Interventions

Nursing education aimed at preventing oral mucositis BEHAVIORAL

The intervention group was trained on the use of the Oral Mucositis Prevention Patient Education Handbook, which was prepared by the researchers based on literature information and expert opinions. Participants in the intervention group received telephone consultations on days 7 and 14. The control group continued to receive routine nursing care. The second interview was completed on day 21, when both the intervention and control group patients returned for their next treatment cycle, using the WHO Oral Toxicity Criteria, ADR, and EORTC QLQ-C30 Version 3.0 Quality of Life Scale.

Intervention (Education + Telephone consultation)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women diagnosed with breast cancer and undergoing chemotherapy,
• Aged 18 or older,
• Volunteering to participate in the study,
• Able to communicate, read and write in Turkish,
• With at least 3 weeks of chemotherapy treatment remaining

You may not qualify if:

• Having a known psychiatric illness that could interfere with the intervention and data collection process,
• Receiving chemo-radiotherapy,
• Having cognitive, perceptual, or communication issues that may affect their ability to understand the provided education.

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Balkan Oncology Hospital affiliated with Trakya University Hospital, Trakya University, Republic of Turkey

Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Stomatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

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

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 29, 2025
• Study Start: February 13, 2023
• Primary Completion: June 15, 2023
• Study Completion: August 15, 2023
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

TU (1)