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

October 28, 2024 updated by: Aylin Günay, Baskent University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey, 06490
        • Recruiting
        • Baskent University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: digital technology-supported education
The education will include information about surgical process and care after surgery.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Baseline and 30th days
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
Time Frame: (Change from baseline to 5th, 15th and 30th days will be assessed).
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
Time Frame: (Change from baseline to 5th, 15th and 30th days will be assessed).
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
Time Frame: (Change from baseline to 5th, 15th and 30th days will be assessed).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2024

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA22/498

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to share IPD .

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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