The Effect of Mobile Application-based Information About Before and After Surgery

Study Overview
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Brief Summary
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Aim and hypothesis: This study was conducted to evaluate the effect of mobile information given to women before and after breast cancer surgery on anxiety, distress, and quality of life. E-mobile information given to women before and after breast cancer surgery reduces the level of anxiety (I) and the level of distress (II), and positively affects their quality of life (III). Methods: This randomized controlled study was conducted between April and August 2021 in the surgical oncology clinic-outpatient clinics of a university hospital. Patients in the intervention group (n=42) used the mobile information application for one month with routine care. Patients in the control group (n=40) received their routine care. Data were collected with data collection forms one week before and three weeks after surgery.

Official Title
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The Effect of Mobile Application-based Information About Before and After Surgery on Anxiety, Distress and Quality of Life of Women With Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Using mobile information application about before and after surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for elective surgery due to breast cancer, Over 18 years old, Read and understand Turkish, At least primary school graduates, Have internet access, Have a smartphone with an android operating system suitable for downloading the mobile application. Exclusion Criteria: Diagnosed with active psychiatric disease, Using antidepressant medication, Vision problems that prevented them from using the mobile application, Scheduled for reconstructive surgery using their own tissue

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>The mobile information application was downloaded from the Android market and installed on the patients' phones, and the patients were taught about how to use it. The patients were given a short information brochure on the use of the mobile application. One week after the surgery, the patients were called and reminded about the use of the application. Three weeks after the surgery, data were collected through telephone interviews using the Patient Follow-up Form, Anxiety, Distress and Quality of Life measurement tools, the Patient Information Satisfaction Questionnaire, and the Mobile Application Evaluation Form. | Other: Using mobile information application about before and after surgery<br>* The mobile application had three sections: Information forum (I), Personal forum (notebook and reminder) (II) and Ask the Researcher (messaging) (III). The information forum (Figure 2) is a section that enables patients to access related articles, pictures, and videos. The personal forum is a section that allows patients to create their notes and use the necessary reminders. Ask the researcher section allows patients to communicate with the researcher via messages. The participants could download the mobile application with the name Breast Cancer Surgery Information Guide from the Google Play Store and install it on their phones. Users who were authenticated by the researcher were able to access the content with an e-mail and password.<br>|
| No Intervention: Control Group<br>The patients received routine care and training in the clinic, and no additional intervention was applied. Three weeks after the surgery, data were collected through telephone interviews using the Patient Follow-up Form, Anxiety, Distress and Quality of Life measurement tools, and the Patient Information Satisfaction Questionnaire | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of NCCN Distress Thermometer score at baseline and one month later | This scale was developed by Roth et al. (1998) to measure psycho-social distress in cancer patients. It consists of the visual analog scale that individuals can apply on their own, consists of only one question, and is used to evaluate the stress situations patients have experienced in the last week and a list of problems. There is a thermometer with numbers from 0 to 10 on the scale. On the distress thermometer, a score of 0 indicates that the individual has never experienced distress, and a score of 10 indicates that he or she has experienced distress at the upper limit. | The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Hospital Anxiety and Depression Scale score at baseline and one month later | The HAD is a self-report scale used to diagnose anxiety and depression in a short time and to determine the risk group in patients with physical illness and/or applying to primary health care services. Only the Anxiety subscale (HAD-A) was used in this study. Anxiety subscale consists of 7 items (1st, 3rd, 5th, 7th, 9th, 11th and 13th questions). Items 1, 3, 5, 11, and 13 show gradually decreasing severity. The score that can be obtained from the HAD-A ranges between 0 and 21 (min.-max.). | The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery. | 
| Change of FACT-G Quality of Life Scale score at baseline and one month later | Functional Assessment of Cancer Therapy-General (version 4) Quality of Life Scale consists of 4 dimensions; physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), and functional well-being (7 items). There are a total of 27 questions on the scale. The scale has a 5-point Likert-type structure and is scored between 0-4. All questions are used to assess the patients' quality of life in the last 7 days. The total score of the scale is equal to the sum of the sub-dimensions, and a high score on the scale indicates a high quality of life. | The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, mobile application, mobile health, anxiety, distress, quality of life