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NCT Number: NCT05058495

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

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.

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Key information

Conditions

Breast Cancer Related Lymphedema Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

20 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ege Universitesi, Lymphedema unit of Physical therapy and rehabilitation department

Izmir, Bornova, 35030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile Lymphedema Self-Care Support Program

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.

Other names: standard lymphedema education

standart lymphedema education

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Change in Arm circumferences

    Time frame: baseline, 1 month, 3 month

    Circumferential measurements are taken at the metacarpal joint, wrist, elbow, 10 cm below and 10 cm above the elbow.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 27, 2021
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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