Breast CancerNCT06166953
The Effect of Digital Technology-Supported Education on Patients Undergoing Breast Reconstruction After Mastectomy: A Randomized Controlled Study
A study testing digital technology-supported education in people with Breast Cancer, run by Baskent University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- digital technology-supported education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Sep 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients planned to undergo total abdominal hysterectomy and bilateral salpingo oophorectomy with immediate reconstruction after mastectomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Başkent University Hospital
Ankara, Çankaya, 06490
Aylin Günay, MSc, 90 312 246 6666/2138, aylingunay@baskent.edu.tr
About this 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
The goal of this randomized, controlled study is to test the effectiveness of digital technology-supported education on patients undergoing breast reconstruction after mastectomy.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- digital technology-supported education
- Keywords
- breast cancer, mobile application, nursing care, technology, surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital technology-supported educationOther
The education will include information about surgical process and care after surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: (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.
Measured: (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.
Measured: (Change from baseline to 5th, 15th and 30th days will be assessed).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start27 Sep 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Günay, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166953
- Sponsor's protocol ID
- KA22/498
- Status last verified
- Oct 2024
- First submitted
- 4 Dec 2023
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to share IPD .
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06166953
- Acronym / sponsor ID
- KA22/498
- Conditions
- Breast Cancer
- Keywords
- breast cancer, mobile application, nursing care, technology, surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| mobile application | Experimental | Other: digital technology-supported educationThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Patients planned to undergo total abdominal hysterectomy and bilateral salpingo oophorectomy with immediate reconstruction after mastectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital technology-supported educationThe education will include information about surgical process and care after surgery. | Other | mobile application |
Primary outcome
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).
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No. There is not a plan to share IPD .
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital technology-supported education in people with Breast Cancer, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aylin Günay, MSc,RN (+905330888921, aylingunay@baskent.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Baseline and 30th days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.