Clinical trial NCT06166953: The Effect of Digital Technology-Supported Education on Patients Undergoing Breast Reconstruction After Mastectomy: A Randomized Controlled Study
Official title: The Effect of Digital Technology-Supported Education and Monitoring on Anxiety, Pain, Sleep and Quality of Life in Patients Undergoing Immediate Breast Reconstruction After Mastectomy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
mobile application
nursing care
technology
surgery
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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

Detailed description: 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.

Eligibility criteria: 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

Exclusion Criteria:

* Patients planned to undergo total abdominal hysterectomy and bilateral salpingo oophorectomy with immediate reconstruction after mastectomy

Primary outcomes:
measure: Anxiety
timeFrame: Baseline and 30th days
measure: Surgical pain
timeFrame: (Change from baseline to 5th, 15th and 30th days will be assessed).
measure: Sleep quality
timeFrame: (Change from baseline to 5th, 15th and 30th days will be assessed).
measure: Quality of life after surgery
timeFrame: (Change from baseline to 5th, 15th and 30th days will be assessed).
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Başkent University Hospital
state: Çankaya
Study officials:
References: