In brief
This clinical trial (NCT07043140) investigates whether a mobile app can help breast cancer patients prevent lymphedema by improving their self-management skills and self-esteem. Conducted at Inonu University Turgut Özal Medical Center in Malatya, Turkey, it uses a randomized controlled design with 120 participants...
What this article is about
Quick Answer
This clinical trial (NCT07043140) investigates whether a mobile app can help breast cancer patients prevent lymphedema by improving their self-management skills and self-esteem. Conducted at Inonu University Turgut Özal Medical Center in Malatya, Turkey, it uses a randomized controlled design with 120 participants (60 experimental, receiving the app; 60 control). Data will be collected using specific scales to assess knowledge, efficacy, and self-esteem related to lymphedema management. The study aims to determine if mobile technology can effectively support patients in preventing this challenging post-surgical complication.
Student takeaways
Key Takeaways
- The study aims to determine how a mobile application affects self-management abilities in breast cancer patients.
- It will assess changes in self-esteem among participants using the Rosenberg Self-Esteem Scale.
- Data collection involves scales like the Lymphedema Self-Management Support Scale and Breast Cancer Survivorship Self-Efficacy Scale.
- The research is designed to evaluate if mobile technology can improve patient understanding and control over lymphedema risks.
- The study's methodology includes a randomized controlled pretest-posttest design with 120 participants (60 experimental, 60 control) in the second stage.
Student summary
Why This Research Matters
This research study, titled 'Determining the Effectiveness of Mobile Technology-Assisted Self-Management Training for the Prevention of Lymphedema in Breast Cancer Patients,' aims to explore how mobile technology can help breast cancer patients manage their health and prevent lymphedema. Lymphedema is a condition where swelling occurs due to problems with the lymphatic system, often after surgery like sentinel lymph node biopsy or axillary lymph node dissection for breast cancer. This study recognizes that while lifelong self-management is crucial for preventing lymphedema in these patients, many do not receive enough information or support.
The research will be conducted at Inonu University Turgut Özal Medical Center Oncology Hospital in Malatya province, Turkey. It involves two main stages: a methodological stage and a randomized controlled pretest-posttest design. The study plans to recruit 147 participants for the first stage and then 120 people (60 in an experimental group receiving mobile technology support and 60 in a control group) for the second stage, with random assignment.
The researchers will collect data using several tools: a Personal Information Form, the Lymphedema Self-Management Support Scale for Breast Cancer Survivors, the Breast Cancer Survivorship Self-Efficacy Scale, and the Rosenberg Self-Esteem Scale. The primary goal is to determine how this mobile application affects patients' self-management abilities and their self-esteem.
The study's findings could be very important because they might show that using a mobile app can help breast cancer survivors better understand and manage lymphedema risks. If effective, such an app could become a valuable tool for nurses and healthcare providers to support these patients in preventing or delaying the onset of this challenging condition. This research highlights the potential role of technology in empowering patients through education and self-management strategies.
Source abstract
Study Overview
Breast cancer is the most common cancer among women in the world and in our country and affects women negatively in many ways. Depending on the treatment, patients experience serious problems. Especially in patients with sentinel lymph node biopsy and axillary lymph node dissection, lymphedema frequently occurs in the postoperative period. Lymphedema can develop at any time after breast cancer surgery and is difficult to treat once it occurs. Lifelong self-management is essential for breast cancer patients to prevent lymphedema and control or delay its progression. In the literature, it has been reported that patients do not have sufficient information about lymphedema, are not aware that they may have lymphedema in the future and do not receive the necessary support. This study aims to determine the effectiveness of mobile technology supported self-management training for the prevention of lymphedema in patients with breast cancer.
The research will be conducted in two stages, methodological and randomized controlled pretest-posttest design. The population of the study will consist of patients diagnosed with breast cancer who have undergone breast surgery at least three months ago at Inonu University Turgut Özal Medical Center Oncology Hospital in Malatya province and who agree to participate in the study. The sample will consist of 147 people in the first stage and 120 people in the second stage, 60 for each group (experimental and control) determined by power analysis. People will be randomly assigned to the experimental and control groups. The research data will be collected using Personal Information Form, Lymphedema Self-Management Support Scale for Breast Cancer Survivors, Breast Cancer Survivorship Self-Efficacy Scale, Rosenberg Self-Esteem Scale. As a result of the research, it will be determined how the mobile application affects the self-management and self-esteem of breast cancer patients. This mobile application developed in line with the results obtained can be recommended to patients with breast cancer.
Evidence appraisal
Main Findings
- The study aims to determine how a mobile application affects self-management abilities in breast cancer patients.
- It will assess changes in self-esteem among participants using the Rosenberg Self-Esteem Scale.
- Data collection involves scales like the Lymphedema Self-Management Support Scale and Breast Cancer Survivorship Self-Efficacy Scale.
- The research is designed to evaluate if mobile technology can improve patient understanding and control over lymphedema risks.
- The study's methodology includes a randomized controlled pretest-posttest design with 120 participants (60 experimental, 60 control) in the second stage.
Practice transfer
Clinical Relevance
- If effective, the mobile application could become a standard tool for nurses to educate breast cancer patients about lymphedema prevention and self-management.
- Improved patient knowledge and skills via such technology might lead to earlier detection of lymphedema symptoms or better adherence to preventive measures.
- Enhanced self-efficacy in managing their health could empower patients, potentially improving overall quality of life post-breast cancer treatment.
- The findings may support the development of other mobile health interventions for chronic disease management in oncology nursing practice.
- Successful implementation could reduce long-term healthcare costs associated with lymphedema complications by promoting proactive patient self-care.
Faculty notes
Educational Relevance
This clinical trial (NCT07043140) investigates the effectiveness of mobile technology-assisted self-management training for lymphedema prevention in breast cancer survivors, a significant public health concern given the high incidence of breast cancer globally. The study is conducted at Inonu University Turgut Özal Medical Center Oncology Hospital in Malatya province, Turkey.
The research employs a two-stage design: an initial methodological phase followed by a randomized controlled pretest-posttest trial. For the latter stage, 120 participants (60 experimental, 60 control) will be recruited from patients diagnosed with breast cancer who have undergone surgery at least three months prior and agree to participate. Random assignment ensures balanced group comparison.
Data collection instruments include: a Personal Information Form; the Lymphedema Self-Management Support Scale for Breast Cancer Survivors (assessing knowledge, skills, and confidence in managing lymphedema); the Breast Cancer Survivorship Self-Efficacy Scale (measuring belief in one's ability to manage cancer-related challenges); and the Rosenberg Self-Esteem Scale (evaluating overall self-worth). The primary outcome is to determine how a developed mobile application influences patients' self-management capabilities and self-esteem.
The study addresses a critical gap by focusing on patient education and empowerment through technology, which could lead to improved long-term outcomes for breast cancer survivors. If successful, the findings may support the integration of such mobile interventions into standard nursing care protocols, enhancing patient autonomy and reducing healthcare burdens associated with lymphedema management.
Critical appraisal
Limitations
- As a clinical trial (ACTIVE_NOT_RECRUITING), specific results or conclusions are not yet available to report as findings; the abstract only outlines the study's design and objectives.
- The generalizability of any future positive outcomes might be limited if the sample, though powered for its stage, is drawn from a single medical center in Malatya province, Turkey.
- The long-term effectiveness and sustainability of mobile technology-assisted self-management training beyond the study period are not addressed by this abstract.
Classroom use
Discussion Questions
- What specific features might make a mobile app effective for lymphedema prevention education?
- How can nurses best integrate technology-assisted tools into their patient care routines for breast cancer survivors?
- What are the potential challenges in ensuring consistent use of such an application by patients over time?
- Beyond knowledge, what other factors (e.g., motivation, social support) might influence a patient's ability to prevent lymphedema effectively?
- How could this type of intervention be adapted or scaled for different cultural contexts or healthcare systems?
- What ethical considerations arise when developing and deploying mobile health applications for vulnerable populations like cancer patients?
- If the app proves effective, how should its cost-effectiveness be evaluated compared to traditional educational methods?
- What role might family members or caregivers play in supporting a patient's use of such an application?
- How can healthcare providers ensure that information from these apps is accurate and evidence-based?
- What are the potential risks associated with relying on mobile technology for critical health management, especially if app access or functionality fails?
Search-ready answers
Frequently asked questions
What is the main goal of this clinical trial (NCT07043140)?
The primary goal is to determine how effective mobile technology-assisted self-management training is in helping breast cancer patients prevent lymphedema. Specifically, it aims to see if such a mobile application can improve their ability to manage their health and affect their self-esteem.
Who are the participants for this study?
The study involves patients diagnosed with breast cancer who have undergone breast surgery at least three months ago. They will be recruited from Inonu University Turgut Özal Medical Center Oncology Hospital in Malatya province, Turkey, and must agree to participate.
What kind of research design is being used?
The study uses a two-stage approach: an initial methodological stage followed by a randomized controlled pretest-posttest design. In the second stage, 120 participants will be randomly assigned to either an experimental group (receiving mobile technology support) or a control group.
What tools are used to collect data from participants?
Data collection involves several instruments: a Personal Information Form; the Lymphedema Self-Management Support Scale for Breast Cancer Survivors; the Breast Cancer Survivorship Self-Efficacy Scale; and the Rosenberg Self-Esteem Scale.
Why is this study important?
Lymphedema can develop after breast cancer surgery, especially following sentinel lymph node biopsy or axillary lymph node dissection. It's difficult to treat once it occurs, so prevention through effective self-management training is crucial. This study explores if mobile technology can provide better support and education than current methods.
What are the potential benefits of a successful mobile application for patients?
If successful, the mobile application could empower breast cancer survivors by improving their understanding of lymphedema risks, enhancing their confidence in managing their health (self-efficacy), potentially boosting self-esteem, and ultimately helping them prevent or delay the onset of this condition.
What is known about patient awareness regarding lymphedema before this study?
The abstract mentions that literature reports patients often do not have sufficient information about lymphedema, are unaware they may develop it in the future, and do not receive necessary support. This study aims to address these gaps using mobile technology.
What is the status of this clinical trial record on ClinicalTrials.gov?
The study type is listed as 'Clinical trial - ACTIVE_NOT_RECRUITING'. This means that while it's a registered clinical trial, recruitment for participants has not yet begun or may have concluded. Specific results are therefore not available from this abstract.
What specific outcomes related to the mobile application will be assessed?
The study aims to determine how the mobile application affects two main areas: 1) self-management abilities of breast cancer patients (assessed via scales like Lymphedema Self-Management Support Scale and Breast Cancer Survivorship Self-Efficacy Scale), and 2) their self-esteem (assessed via Rosenberg Self-Esteem Scale).
What is the significance of lifelong self-management for lymphedema prevention?
The abstract states that 'Lifelong self-management is essential for breast cancer patients to prevent lymphedema and control or delay its progression.' This highlights that ongoing patient effort in managing risk factors and symptoms is critical, which this study aims to support through technology.