The Effect of Mobile Lymphedema Self-Care Support Program on Self-Care in Women With Breast Cancer-related Lymphedema
Primary Purpose
Breast Cancer Related Lymphedema
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mobile Lymphedema Self-Care Support Program
standart lymphedema education
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer Related Lymphedema focused on measuring self-care, mobile application, quality of life, patient education, symptoms, Breast Cancer Related Lymphedema
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
Sites / Locations
- Ege Universitesi, Lymphedema unit of Physical therapy and rehabilitation department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mobile programme users
control group
Arm Description
Patients will receive and use Mobile Lymphedema Self-Care Support Program application and will receive standart lymphedema education.
Patients who will receive standart lymphedema education
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Change in Arm circumferences
Circumferential measurements are taken at the metacarpal joint, wrist, elbow, 10 cm below and 10 cm above the elbow.
Full Information
NCT ID
NCT05058495
First Posted
February 15, 2021
Last Updated
September 6, 2023
Sponsor
Dokuz Eylul University
1. Study Identification
Unique Protocol Identification Number
NCT05058495
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Related Lymphedema
Keywords
self-care, mobile application, quality of life, patient education, symptoms, Breast Cancer Related Lymphedema
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a prospective, randomized controlled study
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mobile programme users
Arm Type
Experimental
Arm Description
Patients will receive and use Mobile Lymphedema Self-Care Support Program application and will receive standart lymphedema education.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Patients who will receive standart lymphedema education
Intervention Type
Other
Intervention Name(s)
Mobile Lymphedema Self-Care Support Program
Other Intervention Name(s)
standart lymphedema education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
standart lymphedema education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Breast Cancer Related Lymphedema Self-Care Scale Score
Description
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.
Time Frame
baseline, 1 month, 3 month
Title
Change in Quality of Life Measure for Limb Lymphedema-Arm Scale Score
Description
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.
Time Frame
baseline, 1 month, 3 month
Title
Change in Lymphedema Symptom Intensity and Distress Survey Score
Description
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.
Time Frame
baseline, 1 month, 3 month
Secondary Outcome Measure Information:
Title
Change in Arm circumferences
Description
Circumferential measurements are taken at the metacarpal joint, wrist, elbow, 10 cm below and 10 cm above the elbow.
Time Frame
baseline, 1 month, 3 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Özgül Karayurt, PhD
Organizational Affiliation
Izmir University of Economics
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sibel Eyigör, MD
Organizational Affiliation
Ege University
Official's Role
Study Chair
Facility Information:
Facility Name
Ege Universitesi, Lymphedema unit of Physical therapy and rehabilitation department
City
İzmir
State/Province
Bornova
ZIP/Postal Code
35030
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Mobile Lymphedema Self-Care Support Program on Self-Care in Women With Breast Cancer-related Lymphedema
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