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

NCT05058495 | Completed

• 1 other identifier: 2020.KB.SAG.069
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Related Lymphedema

Keywords

self-care; mobile application; quality of life; patient education; symptoms; Breast Cancer Related Lymphedema

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Change in Arm circumferences

  baseline, 1 month, 3 month

Study Arms (2)

mobile programme users

EXPERIMENTAL

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

Other: Mobile Lymphedema Self-Care Support Program; Other: standart lymphedema education

control group

ACTIVE COMPARATOR

Patients who will receive standart lymphedema education

Other: standart lymphedema education

Interventions

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.

Also known as: standard lymphedema education

mobile programme users

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.

control group; mobile programme users

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• having morbid obesity
• having metastazis
• having dementia
• having other psychiatric conditions
• another health problem that could prevent to exercise
• not using smart phone

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Ege Universitesi, Lymphedema unit of Physical therapy and rehabilitation department

Izmir, Bornova, 35030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Özgül Karayurt, PhD

  Izmir University of Economics

  STUDY CHAIR

• Sibel Eyigör, MD

  Ege University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients were blinded and the person responsible for the data analysis will be masked as to the patient grouping for analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: a prospective, randomized controlled study

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: September 27, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)