Clinical trial NCT05058495: The Effect of Mobile Lymphedema Self-Care Support Program on Self-Care in Women With Breast Cancer-related Lymphedema
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Related Lymphedema
Keywords: self-care
mobile application
quality of life
patient education
symptoms
Breast Cancer Related Lymphedema
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 98
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a prospective, randomized controlled study
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Breast Cancer Related Lymphedema Self-Care Scale Score
timeFrame: baseline, 1 month, 3 month
measure: Change in Quality of Life Measure for Limb Lymphedema-Arm Scale Score
timeFrame: baseline, 1 month, 3 month
measure: Change in Lymphedema Symptom Intensity and Distress Survey Score
timeFrame: baseline, 1 month, 3 month
Secondary outcomes:
measure: Change in Arm circumferences
timeFrame: baseline, 1 month, 3 month
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege Universitesi, Lymphedema unit of Physical therapy and rehabilitation department
state: Bornova
Study officials:
affiliation: Izmir University of Economics
name: Özgül Karayurt, PhD
role: STUDY_CHAIR
affiliation: Ege University
name: Sibel Eyigör, MD
role: STUDY_CHAIR
References: