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Breast cancer remains the most common type of cancer in the world. Cancer itself and chemotherapy treatment, which is one of the most important treatment steps, may cause unwanted physical, social and psychological effects (symptoms) for the patient. These effects significantly affect the patient's quality of life. It is possible to manage the symptoms and reduce their destructive effects with professional care and treatment support that includes evidence-based practices. On the other hand, breast cancer patients receiving chemotherapy during the Coronavirus Pandemic form the risk group in terms of infection; On the one hand, the continued treatment and care support, on the other hand, required changes in the approach to the patient in order to reduce the risk of infection. In addition to reducing the risk of infection, mobile applications can create an alternative during the coronavirus Pandemic. process in order to maintain quality and uninterrupted care and treatment. This study is planned to be conducted analytically in a randomized controlled single-blind pattern in order to determine the effect of the interactive nurse support program developed with the mobile application on the patient outcomes (symptom management, quality of life, social support perception and anxiety) in breast cancer patients who received chemotherapy during the coronavirus pandemic. Within the scope of the study, interactive nurse support developed with mobile application will be applied to the research group from patients who apply to the polyclinic to receive chemotherapy treatment, and the control group will receive standard care. As a result of the analysis of the data collected systematically with forms and scales, the effect of the interactive nurse support program developed with the mobile application on patient outcomes (symptom management, quality of life, social support perception and anxiety) will be evaluated and recommendations will be made regarding the use of the application in patients with breast cancer.
Type of Research:
This research is planned to be carried out as randomized controlled analytical in order to determine the effect of the interactive nurse support program developed with the mobile application in breast cancer patients receiving chemotherapy during the Coronavirus pandemic process.
Hypotheses of the Research:
H0-1: The interactive nurse support program developed with a mobile application in breast cancer patients receiving chemotherapy during the coronavirus pandemic is not effective on patients' perception of social support.
H0-2: The interactive nurse support program developed with a mobile application in breast cancer patients receiving chemotherapy during the coronavirus pandemic. process is not effective on symptom management (symptom frequency, severity, level of distress).
H0-3: The interactive nurse support program developed with a mobile application in breast cancer patients receiving chemotherapy during the coronavirus pandemic. is not effective on the quality of life of the patients.
H0-4: The interactive nurse support program developed with a mobile application in breast cancer patients receiving chemotherapy during the coronavirus pandemic is not effective on patients' anxiety levels.
Population and Sample of the Research:
The population of the study consists of all breast cancer patients who applied to Ankara City Hospital Medical Oncology Department Outpatient Clinic to receive chemotherapy treatment.
In order to determine the sample size, a similar study (Zhu et al. 2018) was examined, and since the measurement tools were different, this study could not be used in calculating the sample number. However, when similar studies using mobile applications were examined in terms of sample size, it was seen that the number of patients in the intervention and control groups was 50 or less. For this reason, first of all, after the twelve-week follow-up of 50 patients in the control group is completed, the mobile application will be applied to 10 patients from the intervention group. When the twelve-week follow-up of 10 patients from the intervention group is completed, a power analysis will be made with the G. Power program using the data of 10 patients in each group, and the minimum number of people to be sampled will be calculated. The number of patients in the control group and intervention group will be increased according to the minimum number of people calculated. In order to prevent possible interaction between the patients, data will be collected from the intervention group patients after the follow-up of the control group patients is completed
Randomization Method:
During the preliminary implementation of the study, it was learned that based on the new working procedure of the Outpatient Chemotherapy Unit, all breast cancer patients who received anthracycline-based chemotherapy were given a treatment appointment at the same time in the afternoon. It was also found that the patients received chemotherapy in the same time interval in side-by-side seats and that the risk of mutual interaction was quite high. Contamination because of interaction between the intervention and control groups causes potential bias in the evaluation of the effect of the intervention in randomized controlled experimental studies. For this reason, patients who met the inclusion criteria were assigned to the intervention and control groups in a way that they would not come into contact with each other. To this end, the Simple Randomization Technique was used to determine which group the data would be collected from first (Random.org, 2021). Since the first group was determined as the control group in the randomization, the data were collected from this group first and then from the intervention group.
Data Collection Tools:
Application of the Research:
Part 1: Development of Mobile Application 1.1.Developing the Content of the Mobile Application The content of the mobile application will be created by the researcher as a result of extensive literature research. The content created will be submitted to expert opinion, including 1 oncologist, 1 surgical oncology specialist, 4 nurse lecturers, 1 Turkish Linguist, 1 psychiatrist, 1 psychologist and 2 oncology nurses. At the same time, the content of the mobile application will be examined by 3 breast cancer patients and its intelligibility will be evaluated. As a result of expert opinions and patient evaluations, arrangements will be made in the content of the mobile application and the mobile application will be finalized.
The mobile application content will consist of 5 parts:
Part 2: Implementation of Mobile Application and Collection of Data
Practices for Patients in the Intervention Group
Interviewing the patients in the intervention group the day before chemotherapy starts (day 0); *Demographic and Clinical Information Form
The mobile application will be installed on the patient's phone by the researcher. The patient will be registered to the program by creating a changeable user name.
The patient will be given 15-20 minutes of training on the use of the mobile application.
The mobile application will be applied during 4 cycles of chemotherapy (1 cycle/3 weeks or 1 cycle/2 weeks) from the first day of chemotherapy treatment.
The patient will record the symptoms (symptom type and severity) on the mobile application since the first chemotherapy treatment, and watch the relevant video recording according to the symptom experienced from the symptom management videos. The patient will be informed that he can record more than one symptom and watch all the videos as many times as he wants. Information texts on patient breast cancer and coronavirus will also be accessible at all times. This section covers the "Learning Module" of the mobile application.
Patients will be able to enter the Discussion Module according to their preferences and share their experiences and opinions with other patients in the research group who have had the same experiences. This section covers the "Discussion Module" of the mobile application.
Applications for the Patients in the Control Group:
Dependent and Independent Variables of the Research; Dependent Variables of the Research; symptom management, quality of life, perception of social support, level of anxiety. The independent variables of the research; sociodemographic and clinical characteristics of the patient, interactive nurse support mobile application Evaluation of Data The data to be obtained from the research will be analyzed with the SPSS 22 Program. Descriptive statistics (number, percentage, mean) will be used in the evaluation of the data. The relationship between the measured variables will be evaluated with the t-test, Pearson Chi-square test and Fishher's exact test. In the analysis of multiple dependent variables, 2-way Analysis of Variance and Regression Analysis will be used. A value of p<0.05 will indicate that the difference is significant, and a value of p>0.05 will indicate that the difference is not significant.
Ethical Dimension of Research Necessary permissions will be obtained from Ankara City Hospital in order to carry out the research. Written consent will be obtained from the patients to be included in the study with Informed Consent Forms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group receiving interactive nurse support based on mobile application | Experimental | Experimental: Intervention Group The mobile application containing an interactive nurse support program will be uploaded to the telephone of the intervention group patients. Patients will be informed on how to use the mobile application. Data will be collected face-to-face before chemotherapy begins and by telephone one week after every four chemotherapy. Demographic/Clinical Information Form, Eastern Cooperative Oncology Group Performance Scale, Multidimensional scale of perceived social support, Memorial Symptom Rating Scale, European Organization for Research and Treatment of Cancer- Quality of Life, QLQ-BR23, Beck Anxiety Scale and Mobile Application evaluation form will be used to collect data. |
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| Control group receiving standard care and no intervention | No Intervention | No Intervention: Control Group The patients received routine care and training in the polyclinic, and no additional intervention was applied. Data will be collected face-to-face before chemotherapy begins and by telephone one week after every four chemotherapy.Demographic/Clinical Information Form, Eastern Cooperative Oncology Group Performance Scale, Multidimensional scale of perceived social support, Memorial Symptom Rating Scale, European Organization for Research and Treatment of Cancer- Quality of Life, QLQ-BR23,Beck Anxiety will be used to collect data. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Application with Interactive Nurse Support | Device | A mobile application containing an interactive nurse support program will be applied to the patients in the experimental group and its effect on patient outcomes will be evaluated through scales. The mobile application consists of three modules. The first part is a learning module with videos on Covid 19, breast cancer and chemotherapy related side effects management. Second part is ask the nurse/doctor. Third part is patient experiences module. After the participants download the mobile application to their phones, they can log in to the application with a valid e-mail address and password. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of EORTC QLQ-C30 Quality of Life Scale and QLQ-BR23 Module score at baseline and one week later after first, second, third and fourth chemotherapy. | EORTC QLQ-C30 Quality of Life Scale was developed by Aronson in 1993.Turkish validity and reliability of the scale made by Beşer and Öz in 2003.The scale consists of three subgroups as general well-being, functional area and symptoms and includes 30 questions for the past week. The first 28 of the 30 items in the scale are a four-point Likert scale. In the 29th question of the scale, the patient is asked to evaluate his health on a scale of 1 to 7 (1: very poor and 7: excellent), and in the 30th question, the general quality of life.High functional area and general well-being subgroup scores and low symptom subgroup scores indicate a high quality of life. EORTC QLQ-BR23 Breast Cancer Module was developed by Srangers at al. in 1996.It consists of 23 items.High functional dimension scores indicate high quality of life. A high score on the symptoms dimension indicates a low quality of life. | The first measurement will be made before chemotherapy. The second, third, fourth, and fifth measurement will be made one week after the first, second, third, and fourth chemotherapy, respectively. |
| Change of Memorial Symptom Assesment Scale score at baseline and one week later after first, second, third and fourth chemotherapy. | Memorial Symptom Assesment Scale was developed by Portenoy et al. in 1994. Turkish validity and reliability of the scale made by Yıldırım et al. in 2011. The scale is used to evaluate the frequency and severity of symptoms experienced by cancer patients during the past seven days. It consists of 32 symptoms. While the 'frequency' and 'intensity' levels of the symptoms are answered as a 4-point likert, the 'distress' levels are answered as a 5-point likert. Total score is obtained by averaging thirty-two symptom scores. Each symptom score is calculated by averaging the frequency, severity, and degree of distress. | The first measurement will be made before chemotherapy. The second, third, fourth, and fifth measurement will be made one week after the first, second, third, and fourth chemotherapy, respectively. |
| Change of Multidimensional Scale of Perceived Social Support score at baseline and one week later after first, second, third and fourth chemotherapy. |
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Inclusion Criteria:
Exclusion Criteria:
Woman
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| Name | Affiliation | Role |
|---|---|---|
| Doğan Uncu, professor | Ankara Bilkent Central Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Ankara | Çankaya | 06800 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40185060 | Derived | Ozdemir H, Demir A, Bardakci M, Uncu D. The effect of an interactive nurse support program developed with a mobile application on patient outcomes in breast cancer patients who received outpatient chemotherapy: A randomized controlled trial. Eur J Oncol Nurs. 2025 Jun;76:102882. doi: 10.1016/j.ejon.2025.102882. Epub 2025 Mar 25. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Multidimensional Scale of Perceived Social Support was developed by Zimet et al. in 1988. Turkish validity and reliability of MSPSS was performed by Eker et al. MSPSS consists of 12 items and 3 sub-dimensions that subjectively evaluate the adequacy of social support from three different sources. These sub-dimensions are family, friends, and a special person. Each item was rated using a 7-point scale. The person to whom the scale was applied can give at least 1 point to the sentence that he disagreed with, and maximum 7 points to the sentence that he agrees with. As the score given to each item increases, the perceived social support also increases. Any score between 12 and 84 (min.-max.) can be obtained from the scale. The Cronbach Alpha coefficient of the scale is 0.89 |
| The first measurement will be made before chemotherapy. The second, third, fourth, and fifth measurement will be made one week after the first, second, third, and fourth chemotherapy, respectively. |
| Change of Beck Anxiety Inventory scale score at baseline and one week later after first, second, third and fourth chemotherapy. | Beck Anxiety Scale was developed by Aeron T. Beck in 1988 to measure anxiety in cancer It was translated into Turkish by Ulusoy et al in 1998 and validated. İtems in the scale describe the subjective, somatic and panic symptoms of anxiety. The scores obtained from all items are summed as "0=none, 1=mild, 2=moderate, 3=severe" for each item. The score range is between 0-63 (min.-max.) 8-15 points indicates mild anxiety, 16-25 points indicates moderate anxiety, 26-63 points indicates severe anxiety. A high total scale score indicates high anxiety. The Cronbach Alpha coefficient of the scale is 0.93. | The first measurement will be made before chemotherapy. The second, third, fourth, and fifth measurement will be made one week after the first, second, third, and fourth chemotherapy, respectively. |
| D017437 |
| Skin and Connective Tissue Diseases |