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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dokuz Eylul University
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Change in Lymphedema Symptom Intensity and Distress Survey Score
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The patients were blinded and the person responsible for the data analysis will be masked as to the patient grouping for analysis.
Eligibility Criteria
- Ages
- 20 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
mobile programme users
Patients will receive and use Mobile Lymphedema Self-Care Support Program application and will receive standart lymphedema education.
Intervention: standart lymphedema education (Other)
control group
Patients who will receive standart lymphedema education
Intervention: standart lymphedema education (Other)
mobile programme users
Patients will receive and use Mobile Lymphedema Self-Care Support Program application and will receive standart lymphedema education.
Intervention: Mobile Lymphedema Self-Care Support Program (Other)
Outcomes
Primary Outcomes
Change in Lymphedema Symptom Intensity and Distress Survey Score
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Change in Arm circumferences(baseline, 1 month, 3 month)
Investigators
Zeynep Deveci
Principal Investigator
Dokuz Eylul University