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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06166953
• Other study ID #: KA22/498
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 11, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: December 2023
• Source: Baskent University
• Contact: Aylin Günay, MSc,RN
• Phone: +905330888921
• Email: aylinn.gunay[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: December 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• digital technology-supported education
The education will include information about surgical process and care after surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety	The Hospital Anxiety and Depression Scale will be used. It is a valid and reliable scale in Turkish. The higher score the higher risk for depression or anxiety. (Change from baseline to 5th, 15th and 30th days will be assessed).	Baseline and 30th days
Primary	Surgical pain	Visual Analogue Scale (VAS): It is used to evaluate the subjective discomfort states of patients. It consists of a horizontal line 10 cm long. It is a ruler with the left side stating "no pain" and the right side stating "the worst pain" (unbearable pain). Values range from 0 to 10, with higher values indicating increased discomfort. It is easy to apply. It has been shown to be sensitive to pain and discomfort.	(Change from baseline to 5th, 15th and 30th days will be assessed).
Primary	Sleep quality	Pittsburg Sleep Quality Index: It is valid and reliable scale. in Turkish language.The scale consists of 24 questions, 19 of which are feedback questions and 5 of which are to be answered by the spouse or roommate. When calculating the index score, questions answered by the individual's spouse or roommate are not included in the calculation. Self-assessment questions include various items related to sleep quality. These are to determine sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems. The 18 items scored are grouped into 7 component scores. Some of the components consist of a single substance, while others are obtained by grouping several substances. Each item is evaluated with a score between 0-3. The sum of these seven component scores gives the total index score. Total score is between 0-21. A high total score indicates poor sleep quality.	(Change from baseline to 5th, 15th and 30th days will be assessed).
Primary	Quality of life after surgery	SF-12 Quality of Life Scale (SF-12), is a scale that evaluates the quality of life for the last four weeks without focusing on a specific age group or disease group. High scores indicate good health status.	(Change from baseline to 5th, 15th and 30th days will be assessed).