Active — Not RecruitingNot Applicable

Mobile Self-Management Training for Lymphedema Prevention

Turkey (Türkiye)120 participantsStarted 2025-02-02

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria:Female patients with primary breast cancer * Patients with unilateral breast cancer * Those who had breast cancer surgery at least 1 month ago * Unilateral mastectomy with axillary lymph node dissection (removal of at least 2 lymph nodes) * 18 years of age or older * Patients with a body mass index (BMI) ≤ 30 (pretreatment BMI may be a risk factor for lymphedema) * Those who have a smartphone and know how to use it * Those without a defined severe mental disorder * Those who can speak Turkish and have the ability to read, understand and demonstrate awareness of the work * Those without vision and hearing problems * Those without communication problems * Those who volunteered to participate in the study Exclusion Criteria: * 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 * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lymphedema Self-Management Support Scale For Breast Cancer Survivors

Timeframe: up to six months

Rosenberg Self-Esteem Scale

Timeframe: up to six months

Trial details

NCT IDNCT07043140

SponsorInonu University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-30

View on ClinicalTrials.gov More Lymphedema Arm trials