Mobile Self-Management Training for Lymphedema Prevention

NCT07043140 | Active Not Recruiting DMC

• 1 other identifier: Nursing Faculty
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphedema Arm

Keywords

Breast Cancer; Mobile Technology; Lymphedema; Self-Management Training

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  up to six months

Study Arms (2)

Control Group

NO INTERVENTION

control group

Experimental group

EXPERIMENTAL

Mobile application

Other: mobile application

Interventions

mobile application OTHER

mobile application for lymphedema information and exercise

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University

Malatya, Battalgazi, 44000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asisstant

Model Details: 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

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 29, 2025
• Study Start: February 2, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)