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

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ClinicalTrials.gov Identifier: NCT05058495
Recruitment Status : Recruiting
First Posted : September 27, 2021
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Zeynep Deveci, Dokuz Eylul University

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
Breast Cancer Related Lymphedema Other: Mobile Lymphedema Self-Care Support Program Other: standart lymphedema education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a 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 : September 1, 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05058495


Contacts
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Contact: Zeynep Deveci, MSc +902582964370 devecizeynepzd@gmail.com
Contact: Özlem Bilik, PhD ozlembilik71@gmail.com

Locations
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Turkey
Ege Universitesi, Lymphedema unit of Physical therapy and rehabilitation department Recruiting
İzmir, Bornova, Turkey, 35030
Contact: zeynep deveci, MSc, RN         
Sponsors and Collaborators
Dokuz Eylul University
Investigators
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Study Chair: Özgül Karayurt, PhD Izmir university of economics
Study Chair: Sibel Eyigör, MD Ege University
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Responsible Party: Zeynep Deveci, Principal Investigator, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT05058495    
Other Study ID Numbers: 2020.KB.SAG.069
First Posted: September 27, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zeynep Deveci, Dokuz Eylul University:
self-care
mobile application
quality of life
patient education
symptoms
Breast Cancer Related Lymphedema
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Postoperative Complications
Pathologic Processes