CompletedNot Applicable

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

Turkey (Türkiye)85 participantsStarted 2023-02-13

Plain-language 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. Does nursing education aimed at preventing oral mucositis in women diagnosed with breast cancer have an effect on quality of life? 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. Participants: When they come to receive their chemotherapy treatment (on the first day of the evaluation), the researcher will fill out a scale measuring quality of life and scales checking the condition of the oral mucosa. Participants in the education group will receive education from the researchers using an education booklet prepared by the researchers, and the booklet will remain with the participants. On days 7 and 14, the researcher will provide telephone consultation. On the 21st day, when the final evaluation will be conducted, data will be collected from participants through the scales.

Who can participate

Age range

18 Years – 80 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: First day and 21st day

Trial details

NCT IDNCT07042568

SponsorTrakya University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-15

View on ClinicalTrials.gov More Breast Cancer Early Stage Breast Cancer (Stage 1-3) trials