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

Breast Cancer Related Lymphedema Clinical Trial

Official title:

Investigation of the Effect of Mobile Lymphedema Self-Care Support Program on Self-Care, Quality of Life and Lymphedema-Related Symptoms in Women With Breast Cancer-related Lymphedema: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05058495
• Other study ID #: 2020.KB.SAG.069
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: February 2024
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Cancer Related Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Ege Universitesi, Lymphedema unit of Physical therapy and rehabilitation department	Izmir	Bornova

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Breast Cancer Related Lymphedema Self-Care Scale Score	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.	baseline, 1 month, 3 month
Primary	Change in Quality of Life Measure for Limb Lymphedema-Arm Scale Score	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.	baseline, 1 month, 3 month
Primary	Change in Lymphedema Symptom Intensity and Distress Survey Score	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.	baseline, 1 month, 3 month
Secondary	Change in Arm circumferences	Circumferential measurements are taken at the metacarpal joint, wrist, elbow, 10 cm below and 10 cm above the elbow.	baseline, 1 month, 3 month