The Effect of Mobile Lymphedema Self-Care Support Program on Self-Care in Women With Breast Cancer-related Lymphedema

Not Applicable

Completed

• Conditions: Breast Cancer Related Lymphedema
• Interventions: Other: Mobile Lymphedema Self-Care Support Program; Other: standart lymphedema education

• Registration Number: NCT05058495
• Lead Sponsor: Dokuz Eylul University

Brief Summary

The aim of this randomized controlled study is to evaluate the effect of the mobile lymphedema self-care support program on self-care, quality of life and symptoms related to lymphedema in women with breast cancer-related lymphedema.

H1: There is a difference between the Lymphedema Self-Care Scale mean score in women who develop lymphedema due to breast cancer, according to the use of the mobile lymphedema self-care support program.

H2: There is a difference between the Lymphedema Quality of Life Scale average score in women who develop lymphedema due to breast cancer according to the status of using the mobile lymphedema self-care support program.

H4: There is a difference between lymphedema arm circumference measurements according to the use of the mobile lymphedema self-care support program in women who develop lymphedema due to breast cancer.

H5: In women who develop lymphedema due to breast cancer, there is a difference in the situation of experiencing symptoms related to lymphedema according to the use of the mobile lymphedema self-care support program.

Detailed Description

The content of the mobile program was developed by the researchers. The mobile lymphedema self-care support program content was reviewed by an expert group consisting of doctors, physiotherapists and nurses working with patients with lymphedema. Patients will be contacted via telephone and will be informed about the study, and the experimental and control groups will be selected through the randomization program among the patients who agree to participate in the study and meet the sampling inclusion criteria. Patients were blinded, and blindness will be achieved in the data analysing stage. All measurements will be made to the experimental and control groups at the same time. The standard lymphedema self-care training will be given to the experimental and the control group. And the experimental group will be educated on how to use the mobile program. When the study is completed, the control group will also be allowed to use the mobile program.

Study Timeline

• Study First Submitted: 2021-02-15
• Study Start: 2021-09-01
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-27
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 98

Inclusion Criteria

• diagnosed as breast cancer-related lymphedema
• literate,
• having a smart phone,
• completed breast cancer treatment at least six months ago
• volunteering to participate in the study

Exclusion Criteria

• having morbid obesity
• having metastazis
• having dementia
• having other psychiatric conditions
• another health problem that could prevent to exercise
• not using smart phone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mobile programme users	standart lymphedema education	Patients will receive and use Mobile Lymphedema Self-Care Support Program application and will receive standart lymphedema education.
control group	standart lymphedema education	Patients who will receive standart lymphedema education
mobile programme users	Mobile Lymphedema Self-Care Support Program	Patients will receive and use Mobile Lymphedema Self-Care Support Program application and will receive standart lymphedema education.

Primary Outcome Measures

Name	Time	Method
Change in Lymphedema Symptom Intensity and Distress Survey Score	baseline, 1 month, 3 month	The Turkish version of Lymphedema Symptom Intensity and Distress Survey is valid and reliable. The highest score of the scale is 30 and the lowest score is zero. A high score means experiencing too many symptoms.
Change in Breast Cancer Related Lymphedema Self-Care Scale Score	baseline, 1 month, 3 month	The Breast Related Lymphedema Self-Care Scale is valid and reliable tool. The lowest score is 31, the highest score is 124. Higher scores indicate better self-care.
Change in Quality of Life Measure for Limb Lymphedema-Arm Scale Score	baseline, 1 month, 3 month	The Quality of Life Measure for Limb Lymphedema-Arm Scale was translated and cross-culturally adapted to Turkish. The highest score of the scale is 80 and the lowest score is 20. A high score indicates poor quality of life.

Secondary Outcome Measures

Name	Time	Method
Change in Arm circumferences	baseline, 1 month, 3 month	Circumferential measurements are taken at the metacarpal joint, wrist, elbow, 10 cm below and 10 cm above the elbow.

Trial Locations

Locations (1)

Ege Universitesi, Lymphedema unit of Physical therapy and rehabilitation department; 🇹🇷 İzmir, Bornova, Turkey