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

Sponsor
Dokuz Eylul University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05058495
Collaborator
(none)
60
1
2
3
20.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mobile Lymphedema Self-Care Support Program
  • Other: standart lymphedema education
N/A

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
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
a prospective, randomized controlled studya prospective, randomized controlled study
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.
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: mobile programme users

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
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:
  • standart lymphedema education
  • Other: standart lymphedema education
    The control group will be received standart lymphedema education. The standart lymphedema education is an oral education that composed of informations about lymphedema and lymphedema self-care.

    Active Comparator: control group

    Patients who will receive standart lymphedema education

    Other: standart lymphedema education
    The control group will be received standart lymphedema education. The standart lymphedema education is an oral education that composed of informations about lymphedema and lymphedema self-care.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Breast Cancer Related Lymphedema Self-Care Scale Score [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 [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 [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 Outcome Measures

    1. Change in Arm circumferences [baseline, 1 month, 3 month]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 55 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ege Universitesi, Lymphedema unit of Physical therapy and rehabilitation department İzmir Bornova Turkey 35030

    Sponsors and Collaborators

    • Dokuz Eylul University

    Investigators

    • Study Chair: Özgül Karayurt, PhD, Izmir University of Economics
    • Study Chair: Sibel Eyigör, MD, Ege University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zeynep Deveci, Principal Investigator, Dokuz Eylul University
    ClinicalTrials.gov Identifier:
    NCT05058495
    Other Study ID Numbers:
    • 2020.KB.SAG.069
    First Posted:
    Sep 27, 2021
    Last Update Posted:
    Sep 27, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zeynep Deveci, Principal Investigator, Dokuz Eylul University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 27, 2021