The Effect of Digital Technology-Supported Education on Patients Undergoing Breast Reconstruction After Mastectomy: A Randomized Controlled Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-27

Study Completion Date

2025-12-30

Brief Summary

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The goal of this randomized, controlled study is to test the effectiveness of digital technology-supported education on patients undergoing breast reconstruction after mastectomy.

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Detailed Description

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Breast cancer is the most common type of cancer in our country and all over the world, and there are surgery, radiotherapy, chemotherapy, hormonal and targeted treatment options in the treatment of patients diagnosed with breast cancer. Surgery is an important option for the majority of patients diagnosed with breast cancer, and breast-conserving surgery and mastectomy are frequently performed. Patients who undergo mastectomy can also choose breast reconstruction surgeries, which enable the reconstruction of breast tissue through various methods, because they feel better both psychologically and physiologically.

Breast reconstruction can be performed in two periods: early and late. Patients who undergo breast reconstruction simultaneously with mastectomy may experience psychological problems such as anxiety, depression and fear in the preoperative period, and patients may experience surgery-related bleeding, hematoma, seroma, wound infection, tissue necrosis, fat necrosis, capsule contraction, implant loss and pain. Complications may develop and individuals' quality of life may be negatively affected. Patients need support care, treatment and preventive health interventions, and education on late effects/long-term physical and psychosocial problems in order to maintain their independence in daily activities and improve their quality of life.

In addition to written, visual and audio materials in patient education, mobile applications and wearable technologies come to the fore with developing and advancing technology. Mobile health service offered starting from the pre-operative period; In addition to heart rate, blood pressure, oxygen saturation, blood glucose level, daily drainage monitoring, spirometry results and medication compliance; Pain level, sleep quality, daily living activities and exercise level can be evaluated, and the quality of care is increased with nursing care practices and continuity of education.

This study aims to determine the effect of mobile technology-supported education and monitoring on care outcomes in patients who underwent breast reconstruction simultaneously with mastectomy due to breast cancer.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A mobile application will be developed by software engineer including informational needs of breast cancer patients starting prior to surgery lasting to discharge. Expert opinion will be obtained about contents of mobile application. The application will be downloaded smart phones of patients for use when needed. Patients who meet the inclusion criteria will be informed about the research by the researcher according to the randomization list, and their consent will be obtained from those who agree to participate in the research. Due to the study design, patients will not know which intervention is being applied to them, and it will be done single-blinded. The application will be carried out by the researcher knowing the patients in the intervention and control groups. The analysis of the data coded as A and B will be done by a statistician.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Those who accepted the study were asked to read the "Informed Volunteer Consent Form" indicating that they volunteered to participate in the study, and the control and intervention group patients were instructed not to share information about the application with each other in order to prevent them from being influenced by each other in the outpatient clinic environment/institution.

Study Groups

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mobile application

The mobile application will be downloaded on smart phones of participants. This group will be able to look up information related to surgical period when needed.

Group Type EXPERIMENTAL

digital technology-supported education

Intervention Type OTHER

The education will include information about surgical process and care after surgery.

Control

The control group will receive routine care. This group will wear smart band for pulse rate, sleep, blood pressure, and SpO2 record for data collection times.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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digital technology-supported education

The education will include information about surgical process and care after surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being diagnosed with stage 1, 2, or 3 breast cancer
* Planned to undergo immediate breast reconstruction after mastectomy for the first time
* Being between 18 to 75 years old
* Able to use smart phone
* Having smart phone with Android v5.0 or iOS v9.0 and above software, Bluetooth and internet connection
* Having no hearing or visual impairment
* Having no physical limitation
* Turkish speaking volunteers