Breast Cancer Early Stage Breast Cancer (Stage 1-3)NCT07042568
The Effect of Education Given on Preventing Mouth Ulcers in Women With Breast Cancer
A study testing Nursing education aimed at preventing oral mucositis in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Chemotherapy, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Chemotherapy
- What is being tested?
- Nursing education aimed at preventing oral mucositis
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Feb 2023to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balkan Oncology Hospital affiliated with Trakya University Hospital, Trakya University, Republic of Turkey
Edirne, 22030
About this study
Official title: The Effect of Education Given to Women Diagnosed With Breast Cancer to Prevent Oral Mucositis on Quality of Life
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:
Read more
- Does nursing education aimed at preventing oral mucositis in women diagnosed with breast cancer have an effect on quality of life?
- 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.
Read the detailed description
This study is a two-armed, single-blind, randomised controlled trial (RCT). Participants were selected from an oncology hospital affiliated with a university hospital in western Turkey between February and August 2023. Women who met the following criteria were included in the study: Women diagnosed with breast cancer who were undergoing chemotherapy, aged 18 years or older, voluntarily participating in the study, capable of communicating in Turkish, and able to read and write, with at least three weeks of chemotherapy treatment remaining.
Patients who met the following criteria were excluded from the study: having a known psychiatric disorder that could interfere with the intervention and data collection process, receiving chemoradiotherapy, or having cognitive, perceptual, or communication problems that could affect their ability to understand the training provided.
To determine the sample size, a pre-power analysis was performed using the G-Power 3.1.9.7 programme. For this analysis, the initial measurement total mean EORTC QLQ-C30 quality of life scale scores of the intervention and control groups in the study by Yüce and Yurtsever [24] were used. According to the analysis results, with an effect size of 0.65, a significance level of p<0.05 in each group, a 95% confidence interval, and 80% test power, a minimum of 78 participants (39 participants each for the intervention and control groups) was determined. A total of 91 patients were reached during the specified dates, but 6 patients did not wish to continue the study and were therefore not included in the analysis. The study was completed with a total of 85 participants, including 43 in the intervention group and 42 in the control group.
After obtaining the necessary ethical committee and institutional approvals for this study, it was conducted through face-to-face interviews in a suitable room in the outpatient chemotherapy unit on the first day and the 21st day of chemotherapy for female patients diagnosed with breast cancer who met the inclusion criteria. On the first day of the interview, all participants were informed about the purpose and method of the study, and it was emphasised that participation in the study was entirely voluntary. Written informed consent was obtained through an informed consent form.
Taking into account the order of the randomisation table, one participant was included in the study each day, and on the first day of the interview, the researchers administered the Patient Information Form, the World Health Organisation (WHO) Oral Toxicity Criteria, the Oral Assessment Guide (OAG), European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) Version 3.0 Quality of Life Scale, Eastern Cooperative Oncology Group (ECOG) Performance Scale. In addition, 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.
- Being tested
- Nursing education aimed at preventing oral mucositis
- Keywords
- Education, Breast cancer, Chemotherapy, Oral mucositis, Quality of life, Nursing
- Medical subject headings
- Breast Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing education aimed at preventing oral mucositisBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Education + Telephone consultation) | Experimental | Not described Receives: Behavioral: Nursing education aimed at preventing oral mucositis |
| Control group | No intervention | They continued to receive routine nursing care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First day and 21st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start13 Feb 2023
- Primary completion15 Jun 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YAREN ÖZBEK, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042568
- Sponsor's protocol ID
- TÜTF-GOBAEK 2022/382
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Women Diagnosed With Breast Cancer to Prevent Oral Mucositis on Quality of Life
- ClinicalTrials.gov ID
- NCT07042568
- Acronym / sponsor ID
- TÜTF-GOBAEK 2022/382
- Keywords
- Education, Breast cancer, Chemotherapy, Oral mucositis, Quality of life, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does nursing education aimed at preventing oral mucositis in women diagnosed with breast cancer have an effect on quality of life?
- 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.
Detailed description
This study is a two-armed, single-blind, randomised controlled trial (RCT). Participants were selected from an oncology hospital affiliated with a university hospital in western Turkey between February and August 2023. Women who met the following criteria were included in the study: Women diagnosed with breast cancer who were undergoing chemotherapy, aged 18 years or older, voluntarily participating in the study, capable of communicating in Turkish, and able to read and write, with at least three weeks of chemotherapy treatment remaining.
Patients who met the following criteria were excluded from the study: having a known psychiatric disorder that could interfere with the intervention and data collection process, receiving chemoradiotherapy, or having cognitive, perceptual, or communication problems that could affect their ability to understand the training provided.
To determine the sample size, a pre-power analysis was performed using the G-Power 3.1.9.7 programme. For this analysis, the initial measurement total mean EORTC QLQ-C30 quality of life scale scores of the intervention and control groups in the study by Yüce and Yurtsever [24] were used. According to the analysis results, with an effect size of 0.65, a significance level of p<0.05 in each group, a 95% confidence interval, and 80% test power, a minimum of 78 participants (39 participants each for the intervention and control groups) was determined. A total of 91 patients were reached during the specified dates, but 6 patients did not wish to continue the study and were therefore not included in the analysis. The study was completed with a total of 85 participants, including 43 in the intervention group and 42 in the control group.
After obtaining the necessary ethical committee and institutional approvals for this study, it was conducted through face-to-face interviews in a suitable room in the outpatient chemotherapy unit on the first day and the 21st day of chemotherapy for female patients diagnosed with breast cancer who met the inclusion criteria. On the first day of the interview, all participants were informed about the purpose and method of the study, and it was emphasised that participation in the study was entirely voluntary. Written informed consent was obtained through an informed consent form.
Taking into account the order of the randomisation table, one participant was included in the study each day, and on the first day of the interview, the researchers administered the Patient Information Form, the World Health Organisation (WHO) Oral Toxicity Criteria, the Oral Assessment Guide (OAG), European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) Version 3.0 Quality of Life Scale, Eastern Cooperative Oncology Group (ECOG) Performance Scale. In addition, 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Education + Telephone consultation) | Experimental | Behavioral: Nursing education aimed at preventing oral mucositis |
| Control group | No intervention | –They continued to receive routine nursing care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing education aimed at preventing oral mucositisThe 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. | Behavioural | Intervention (Education + Telephone consultation) |
Primary outcome
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
Time frame: First day and 21st day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing education aimed at preventing oral mucositis in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Chemotherapy, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: First day and 21st day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.