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

Dokuz Eylül University (DEU)

Status: Completed

Conditions: Breast Cancer Related Lymphedema

Treatments: Other: standart lymphedema education; Other: Mobile Lymphedema Self-Care Support Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05058495

2020.KB.SAG.069

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: Female

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 2 patient groups

mobile programme users

Experimental group

Description:

Patients will receive and use Mobile Lymphedema Self-Care Support Program application and will receive standart lymphedema education.

Treatment:

Other: standart lymphedema education

Other: Mobile Lymphedema Self-Care Support Program

control group

Active Comparator group

Description:

Patients who will receive standart lymphedema education

Treatment:

Other: standart lymphedema education