Lymphedema ArmlymphedemaNCT07043140
Mobile Self-Management Training for Lymphedema Prevention
A study testing mobile application in people with Lymphedema Arm, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema Arm
- What is being tested?
- mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2025to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Metastatic breast cancer or a history of other cancers
- Cancer recurrence detected during the study
- Those diagnosed with lymphodema
- Patients with bilateral lymph node dissection
- Pregnant or breastfeeding patients
- Previously participated in a similar training program
Show all 9Show fewer
- Those with a medical condition that prevents them from performing the exercises designed to prevent lymphedema
- Patients who refused to participate in the study
- Reluctance to continue with the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Effectiveness of Mobile Technology-Assisted Self-Management Training for the Prevention of Lymphedema in Breast Cancer Patients
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.
Read the detailed description
Breast cancer is a disease in which abnormal breast cells grow out of control and form tumors which, if left uncontrolled, spread throughout the body and can even be fatal. Breast cancer is the most common cancer among women in the world and in our country and affects women physically, psychologically and socially. Local (surgical treatment, radiotherapy) and systemic (chemotherapy, hormone therapy, targeted drug therapy, immunotherapy) methods are used in the treatment of breast cancer. It is usually treated surgically, followed by chemotherapy or radiotherapy or a combination of the two. Patients receiving breast cancer treatment experience serious physical, psychological and social problems depending on the treatment. Especially in patients with sentinel lymph node biopsy and axillary lymph node dissection, lymphedema frequently occurs in the postoperative period.
Lymphedema occurs as a result of primary or secondary lymphatic dysfunction. Primary lymphedema is associated with developmental anomalies of the lymphatic system. Secondary lymphedema, on the other hand, is the type that is frequently encountered and usually seen in the upper extremities after breast cancer treatment approaches. Breast cancer-related lymphedema is a pathologic condition in which protein-rich fluid accumulates in soft tissues due to interruption of lymphatic fluid flow and an increase of 2 cm or more in arm circumference . Breast cancer-related lymphedema is a common complication after treatment. Lymphedema may occur in the arm, trunk or preserved breast . The incidence of lymphedema varies according to the treatment administered, lymphedema diagnostic criteria and follow-up period . In the literature, it is reported that the incidence of lymphedema after breast cancer treatment varies between 24.8% and 90.4% . In long-term prospective studies, it was found that the incidence of lymphedema ranged between 42% in five-year follow-up and 15-54% in three-year follow-up. In the early postoperative period after mastectomy, transient arm edema may occur due to local edema in the surgical field, which does not increase the arm circumference by more than 3 cm. The frequency of transient arm edema is not more than 5%. This is not of much clinical importance and does not require treatment. However, lymphedema may develop months or even years after surgery .Breast cancer-related lymphedema may occur immediately after treatment or may occur years later. Lymphedema formation is related with the degree of axillary dissection. The more lymph nodes are removed, the higher the risk of lymphedema. In the literature, it has been reported that breast cancer-related lymphedema is observed at a higher rate in mastectomy compared to breast conserving surgery.
Breast cancer-related lymphedema, a chronic complication, may develop at any time after breast cancer surgery and is difficult to treat once it occurs. The first stage of treatment consists of decongestive treatment methods such as skin care, manual lymph drainage, compression therapy, and exercises. In the second stage, lifelong self-management is essential for breast cancer patients to prevent lymphedema and control or delay its progression . Self-management is a positive and dynamic process in which a person manages his/her own chronic condition, such as lifestyle changes, symptom control, and treatment adherence. It is used to promote physical and mental health and improve quality of life.
In the literature, it has been reported that breast cancer patients at risk of lymphedema do not have sufficient information about lymphedema and are not aware that they may have lymphedema in the future. However, they also reported that they were not adequately informed about lymphedema before or after surgery. Oncology nurses play a key role in identifying patients with breast cancer at risk of lymphedema, providing comprehensive evaluation and early intervention, coordinating appropriate referrals to interdisciplinary team members for lymphedema management, and supporting patient self-management of lymphedema. However, reasons such as inadequate knowledge of nurses about lymphedema, not considering patient education as their role, lack of specialized nurses in this field, and high workload of nurses may negatively affect lymphedema self-management in breast cancer patients.
Considering all these factors, other opportunities should be offered to patients for lymphedema self-management. Especially in recent years, mobile health-based self-management interventions have become popular with the increase in smartphone use. Mobile health-based self-management interventions have been shown to improve self-management behaviors, functional exercise compliance, self-efficacy, disease-related quality of life, and reduce the incidence of lymphedema and anxiety levels in breast cancer patients. Compared to traditional care, it is emphasized that self-management interventions based on mobile health applications may be more useful in terms of eliminating time and space limitations and may facilitate health care by reaching more people.
Based on this literature, this study aims to determine the effectiveness of mobile technology supported self-management training for the prevention of lymphedema in patients with breast cancer.
- Conditions
- Lymphedema Arm
- Being tested
- mobile application
- Keywords
- Breast Cancer, Mobile Technology, Lymphedema, Self-Management Training
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile applicationOther
mobile application for lymphedema information and exercise
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | control group |
| Experimental group | Experimental | Mobile application Receives: Other: mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphedema Self-Management Support Scale For Breast Cancer Survivors
The Lymphedema Self-Management Support Scale for Breast Cancer Patients was developed by Fu et al. in 2024 to assess and understand the lymphedema self-management support received by breast cancer survivors. The scale consists of 21 items and 4 sub-dimensions. The 5-point Likert-type scale is scored as 0-not at all, 1-slightly, 2-moderately, 3-much, and 4-more. The total score of the scale is between 0 and 84. The higher the score, the higher the degree of support for lymphedema self-management. The total Cronbach's alpha value of the scale is 0.94 and the sub-dimensions are 0.88 for Basic Management Support, 0.95 for Treatment Management Support, 0.73 for Role Management Support and 0.79 for Emotional Management Support.
Measured: up to six months
Rosenberg Self-Esteem Scale
This scale was developed by Rosenberg in 1963 to assess self-esteem and its Turkish validity and reliability study was conducted by Çuhadaroğlu in 1986. Consisting of 63 items, the scale has 12 sub-dimensions and it is stated that the sub-dimensions can be used separately. In this study, the first "10" items of the scale will be used to measure self-esteem for the purpose of the research. Guttman scaling technique is used in scale scoring. Questions 1, 2, 4, 6, 7 of the 4-point Likert-type scale are positive and scored from 3 to 0, while questions 3, 5, 8, 9, 10 are negative and scored from 0 to 3. The total score range is between 0-30, with a score below 15 indicating low self-esteem. In Çuhadaroğlu's validity and reliability study, Cronbach's alpha value was found to be 0.71.
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start2 Feb 2025
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema ArmStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research will be carried out in two phases: methodological research and single-center randomized controlled experimental research. The population of the study will consist of patients diagnosed with breast cancer who have undergone breast surgery at least one (1) month 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 patients who meet the study criteria at the specified time and place, volunteer to participate in the study, and will be selected by randomized controlled method using a table of numbers in line with the simple random sampling method. The power analysis for the sample size was performed using Gpower version 3.1.9.2 and the minimum number of subjects required in the experimental and control groups was calculated as 50 people in each group (Type I Error = 0.05; Power of Test = 0.80; Effect Value = 0.5; Safety = 0.95). Considering the possible losses that may occ
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Dolu, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043140
- Sponsor's protocol ID
- Nursing Faculty
- Acronym
- lymphedema
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To preserve the originality of the work
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effectiveness of Mobile Technology-Assisted Self-Management Training for the Prevention of Lymphedema in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07043140
- Acronym / sponsor ID
- lymphedema / Nursing Faculty
- Conditions
- Lymphedema Arm
- Keywords
- Breast Cancer, Mobile Technology, Lymphedema, Self-Management Training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 29 Jun 2025 (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.
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.
Detailed description
Breast cancer is a disease in which abnormal breast cells grow out of control and form tumors which, if left uncontrolled, spread throughout the body and can even be fatal. Breast cancer is the most common cancer among women in the world and in our country and affects women physically, psychologically and socially. Local (surgical treatment, radiotherapy) and systemic (chemotherapy, hormone therapy, targeted drug therapy, immunotherapy) methods are used in the treatment of breast cancer. It is usually treated surgically, followed by chemotherapy or radiotherapy or a combination of the two. Patients receiving breast cancer treatment experience serious physical, psychological and social problems depending on the treatment. Especially in patients with sentinel lymph node biopsy and axillary lymph node dissection, lymphedema frequently occurs in the postoperative period.
Lymphedema occurs as a result of primary or secondary lymphatic dysfunction. Primary lymphedema is associated with developmental anomalies of the lymphatic system. Secondary lymphedema, on the other hand, is the type that is frequently encountered and usually seen in the upper extremities after breast cancer treatment approaches. Breast cancer-related lymphedema is a pathologic condition in which protein-rich fluid accumulates in soft tissues due to interruption of lymphatic fluid flow and an increase of 2 cm or more in arm circumference . Breast cancer-related lymphedema is a common complication after treatment. Lymphedema may occur in the arm, trunk or preserved breast . The incidence of lymphedema varies according to the treatment administered, lymphedema diagnostic criteria and follow-up period . In the literature, it is reported that the incidence of lymphedema after breast cancer treatment varies between 24.8% and 90.4% . In long-term prospective studies, it was found that the incidence of lymphedema ranged between 42% in five-year follow-up and 15-54% in three-year follow-up. In the early postoperative period after mastectomy, transient arm edema may occur due to local edema in the surgical field, which does not increase the arm circumference by more than 3 cm. The frequency of transient arm edema is not more than 5%. This is not of much clinical importance and does not require treatment. However, lymphedema may develop months or even years after surgery .Breast cancer-related lymphedema may occur immediately after treatment or may occur years later. Lymphedema formation is related with the degree of axillary dissection. The more lymph nodes are removed, the higher the risk of lymphedema. In the literature, it has been reported that breast cancer-related lymphedema is observed at a higher rate in mastectomy compared to breast conserving surgery.
Breast cancer-related lymphedema, a chronic complication, may develop at any time after breast cancer surgery and is difficult to treat once it occurs. The first stage of treatment consists of decongestive treatment methods such as skin care, manual lymph drainage, compression therapy, and exercises. In the second stage, lifelong self-management is essential for breast cancer patients to prevent lymphedema and control or delay its progression . Self-management is a positive and dynamic process in which a person manages his/her own chronic condition, such as lifestyle changes, symptom control, and treatment adherence. It is used to promote physical and mental health and improve quality of life.
In the literature, it has been reported that breast cancer patients at risk of lymphedema do not have sufficient information about lymphedema and are not aware that they may have lymphedema in the future. However, they also reported that they were not adequately informed about lymphedema before or after surgery. Oncology nurses play a key role in identifying patients with breast cancer at risk of lymphedema, providing comprehensive evaluation and early intervention, coordinating appropriate referrals to interdisciplinary team members for lymphedema management, and supporting patient self-management of lymphedema. However, reasons such as inadequate knowledge of nurses about lymphedema, not considering patient education as their role, lack of specialized nurses in this field, and high workload of nurses may negatively affect lymphedema self-management in breast cancer patients.
Considering all these factors, other opportunities should be offered to patients for lymphedema self-management. Especially in recent years, mobile health-based self-management interventions have become popular with the increase in smartphone use. Mobile health-based self-management interventions have been shown to improve self-management behaviors, functional exercise compliance, self-efficacy, disease-related quality of life, and reduce the incidence of lymphedema and anxiety levels in breast cancer patients. Compared to traditional care, it is emphasized that self-management interventions based on mobile health applications may be more useful in terms of eliminating time and space limitations and may facilitate health care by reaching more people.
Based on this literature, this study aims to determine the effectiveness of mobile technology supported self-management training for the prevention of lymphedema in patients with breast cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This research will be carried out in two phases: methodological research and single-center randomized controlled experimental research. The population of the study will consist of patients diagnosed with breast cancer who have undergone breast surgery at least one (1) month 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 patients who meet the study criteria at the specified time and place, volunteer to participate in the study, and will be selected by randomized controlled method using a table of numbers in line with the simple random sampling method. The power analysis for the sample size was performed using Gpower version 3.1.9.2 and the minimum number of subjects required in the experimental and control groups was calculated as 50 people in each group (Type I Error = 0.05; Power of Test = 0.80; Effect Value = 0.5; Safety = 0.95). Considering the possible losses that may occ
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –control group |
| Experimental group | Experimental | Other: mobile applicationMobile application |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Metastatic breast cancer or a history of other cancers
- Cancer recurrence detected during the study
- Those diagnosed with lymphodema
- Patients with bilateral lymph node dissection
- Pregnant or breastfeeding patients
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 |
|---|---|---|
| mobile applicationmobile application for lymphedema information and exercise | Other | Experimental group |
Primary outcome
Lymphedema Self-Management Support Scale For Breast Cancer Survivors
Time frame: up to six months
The Lymphedema Self-Management Support Scale for Breast Cancer Patients was developed by Fu et al. in 2024 to assess and understand the lymphedema self-management support received by breast cancer survivors. The scale consists of 21 items and 4 sub-dimensions. The 5-point Likert-type scale is scored as 0-not at all, 1-slightly, 2-moderately, 3-much, and 4-more. The total score of the scale is between 0 and 84. The higher the score, the higher the degree of support for lymphedema self-management. The total Cronbach's alpha value of the scale is 0.94 and the sub-dimensions are 0.88 for Basic Management Support, 0.95 for Treatment Management Support, 0.73 for Role Management Support and 0.79 for Emotional Management Support.
Rosenberg Self-Esteem Scale
Time frame: up to six months
This scale was developed by Rosenberg in 1963 to assess self-esteem and its Turkish validity and reliability study was conducted by Çuhadaroğlu in 1986. Consisting of 63 items, the scale has 12 sub-dimensions and it is stated that the sub-dimensions can be used separately. In this study, the first "10" items of the scale will be used to measure self-esteem for the purpose of the research. Guttman scaling technique is used in scale scoring. Questions 1, 2, 4, 6, 7 of the 4-point Likert-type scale are positive and scored from 3 to 0, while questions 3, 5, 8, 9, 10 are negative and scored from 0 to 3. The total score range is between 0-30, with a score below 15 indicating low self-esteem. In Çuhadaroğlu's validity and reliability study, Cronbach's alpha value was found to be 0.71.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No. To preserve the originality of the work
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile application in people with Lymphedema Arm, run by Inonu 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 0 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphedema Self-Management Support Scale For Breast Cancer Survivors (time frame: up to six months). The study lists 2 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 14 Jul 2026.