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Clinical Trials in Turkey / NCT07043140
Active, not recruiting Not applicable

Mobile Self-Management Training for Lymphedema Prevention

NCT07043140 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-02-02
Last updated
2026-07-14

Condition(s) studied

Lymphedema Arm

Investigational drug(s) / intervention(s)

mobile application

mobile application: mobile application for lymphedema information and exercise

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Inonu University Malatya Battalgazi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07043140 on ClinicalTrials.gov ↗ ← All trials in Turkey