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

NCT ID: NCT05058495

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2021-12-01

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.

Conditions

Breast Cancer Related Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

mobile programme users

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

Group Type: EXPERIMENTAL

Mobile Lymphedema Self-Care Support Program

Intervention Type: OTHER

The Mobile Lymphedema Self-Care Support Program is composed of three section. First section includes the information about lymphedema and lymphedema self care. Second section includes the exercises videos which women can concurrently exercise with application and an alarm to remind to exercise. Last section is a social network form the women could chat and share anything with eachother. Patients will be told how to use the Mobile Lymphedema Self-Care Support Program and a contact number will be provided to ask questions about the program at any time.

standart lymphedema education

Intervention Type: OTHER

The control group will receive standard lymphedema education. The standard lymphedema education is an online education composed of information about lymphedema and lymphedema self-care.

control group

Patients who will receive standart lymphedema education

Group Type: ACTIVE_COMPARATOR

standart lymphedema education

Intervention Type: OTHER

The control group will receive standard lymphedema education. The standard lymphedema education is an online education composed of information about lymphedema and lymphedema self-care.

Interventions

Mobile Lymphedema Self-Care Support Program

The Mobile Lymphedema Self-Care Support Program is composed of three section. First section includes the information about lymphedema and lymphedema self care. Second section includes the exercises videos which women can concurrently exercise with application and an alarm to remind to exercise. Last section is a social network form the women could chat and share anything with eachother. Patients will be told how to use the Mobile Lymphedema Self-Care Support Program and a contact number will be provided to ask questions about the program at any time.

Intervention Type: OTHER

standart lymphedema education

The control group will receive standard lymphedema education. The standard lymphedema education is an online education composed of information about lymphedema and lymphedema self-care.

Intervention Type: OTHER

Other Intervention Names

standard lymphedema education

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Deveci

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Özgül Karayurt, PhD

Role: STUDY_CHAIR

Izmir University of Economics

Sibel Eyigör, MD

Role: STUDY_CHAIR

Ege University

Locations

Ege Universitesi, Lymphedema unit of Physical therapy and rehabilitation department

Izmir, Bornova, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2020.KB.SAG.069

Identifier Type: -

Identifier Source: org_study_id