The Effect of Interactive Nurse Support Program Developed by Mobile Application on Patient Outcomes in Breast Cancer Patients Receiving Chemotherapy During the Coronavirus Pandemic.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of Multidimensional Scale of Perceived Social Support score at baseline and one week later after first, second, third and fourth chemotherapy.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being 18 years or older,
- •Volunteering to participate in the research,
- •Having been diagnosed with breast cancer (Stage 0,1,2),
- •Being able to understand and speak Turkish,
- •ECOG performance scale score of 0, 1 and 2
- •Being literate
- •Owning a mobile phone with Android or iphone operating system processor and using the phone effectively
- •Receiving chemotherapy treatment for the first time
排除标准
- •Refusal to participate in the research,
- •Diagnosing metastatic breast cancer (Stage 3,4),
- •Receiving simultaneous radiotherapy or biotherapy with chemotherapy,
- •Having visual, auditory or mental problems,
- •Having a psychiatric diagnosis,
- •Those who have received chemotherapy before
- •ECOG performance scale score of 3 and 4,
- •Taking part in another research that will affect the research results
研究组 & 干预措施
Intervention group receiving interactive nurse support based on mobile application
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.
干预措施: Mobile Application with Interactive Nurse Support (Device)
Control group receiving standard care and 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.
结局指标
主要结局
Change of Multidimensional Scale of Perceived Social Support score at baseline and one week later after first, second, third and fourth chemotherapy.
时间窗: 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.
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
Change of Memorial Symptom Assesment Scale score at baseline and one week later after first, second, third and fourth chemotherapy.
时间窗: 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.
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.
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.
时间窗: 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.
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.
Change of Beck Anxiety Inventory scale score at baseline and one week later after first, second, third and fourth chemotherapy.
时间窗: 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.
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.
次要结局
未报告次要终点
研究者
handan özdemir
Phd Candidate
Ankara University