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

NCT06166953 | Recruiting DMC

• 1 other identifier: KA22/498
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; mobile application; nursing care; technology; surgery

Outcome Measures

Primary Outcomes (4)

• 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

• 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).

• 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).

• 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).

Study Arms (2)

mobile application

EXPERIMENTAL

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.

Other: digital technology-supported education

Control

NO INTERVENTION

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.

Interventions

digital technology-supported education OTHER

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

mobile application

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Başkent University Hospital

Ankara, Çankaya, 06490, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Aylin Günay, MSc,RN

CONTACT

+905330888921; aylingunay@baskent.edu.tr

Azize Karahan, Prof

CONTACT

+905324319456; kazize@baskent.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: September 27, 2024
• Primary Completion: May 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)