The Effect of a Self-Management Lymphedema Education Program on Lymphedema, Symptoms, Compliance, Daily Living Activities, and Patient Activation in Breast Cancer-Related Lymphedema: A Quasi-Experimental Study

January 8, 2025 updated by: Gizem Cansiz Ucar

The Effect of a Self-Management Lymphedema Education Program on Lymphedema, Lymphedema-Related Symptoms, Patient Compliance, Daily Living Activities and Patient Activation in Patients With Breast Cancer-Related Lymphedema: A Quasi-Experimental Study

The aim of this pre-test post-test quasi-experimental study is to evaluate the effects of a self-management lymphedema (SML) education program on patient adherence, daily life activities, and patient activation in individuals with breast cancer-related lymphedema (BCRL). This study involves 44 patients diagnosed with BCRL and is conducted at Hacettepe University Oncology Hospital Lymphedema Diagnosis and Treatment Application and Research Center. Upper extremity lymphedema assessments are performed at the beginning of the study, followed by the implementation of a structured SML education program. Participants are monitored for a total of 12 months. Data collection tools include the Personal Information Form, Upper Extremity Lymphedema Diagnosis Form, Adaptation to Chronic Illness Scale, KATZ Daily Living Activities Index, Disability of Arm, Shoulder, and Hand Questionnaire, and Patient Activation Measure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study focuses on evaluating the potential benefits of a structured self-management lymphedema education program in patients with breast cancer-related lymphedema. It aims to improve patient adherence, activation, and daily life activity levels through a comprehensive education-based intervention.The study was conducted as a master's thesis and has been completed.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being female,
  • Aged 18 years or older,
  • Having undergone axillary lymph node dissection,
  • Having undergone breast cancer surgery,
  • Diagnosed with lymphedema (stage 1-2),
  • Individuals with no surgical plans during the study period.

Exclusion Criteria:

  • Not diagnosed with lymphedema,
  • Having a medical condition that prevents exercise,
  • Having advanced-stage heart or kidney failure,
  • Patients who refused to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental grup
one group quasi-experimental study was to determine the effects of self-management lymphedema (SML) education program on the patient adherence, daily life activities and patient activation in patients with breast- cancer related lymphedema (BCRL).
Other: self-management lymphedema (SML) education program
The content of the booklet was prepared based on literature review.. In addition to the above intervention methods, the phone number of each patient was taken and the patients were followed up by phone for 12 months. For this purpose, the patient was asked to fill in the compliance chart prepared in order to monitor the patient's compliance and was checked by the researcher every two weeks by phone call. By phone call; compliance with skin care, SLD, compression garments and exercise practices included in the SMLEP were evaluated and recorded. Within the scope of the SMLEP, the patients were asked to do exercises and SLD at least 3 days a week and 2 times a day (morning and evening) for 12 months. It was recommended to wear compression garments, especially during exercises and throughout the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Impact of a Lymphedema Management Education Program on Symptoms in Breast Cancer-Related Lymphedema Patients Using Circumferential Measurements and Bioimpedance Spectroscopy (BIS)
Time Frame: By the end of the program (after 12 months).
The impact of the Lymphedema Management Education Program will be evaluated on symptoms in breast cancer-related lymphedema patients using circumferential measurements and bioimpedance spectroscopy (BIS). Measurements will involve taking circumferential readings at 4 cm intervals along the arm with a 1-inch retractable tape, and arm volumes will be calculated using the truncated cone formula. BIS will provide L-Dex ratios to identify subclinical (≥6.5) and clinical (≥7) lymphedema through the L-Dex U400® device. Lymphedema severity will be classified based on the Tracey-Volume and Stilwell systems by comparing volume differences between affected and unaffected limbs. Baseline and endpoint measurements will be conducted under standardized conditions by a specialist nurse to ensure accuracy and consistency.
By the end of the program (after 12 months).
The Impact of a Lymphedema Management Education Program on Patient Compliance Using the Patient Activation Measure (PAM)
Time Frame: By the end of the program (after 12 months)
The impact of the Lymphedema Management Education Program on patient compliance will be evaluated using the Patient Activation Measure (PAM).
By the end of the program (after 12 months)
The Impact of a Lymphedema Management Education Program on Activity Levels Using the Patient Activation Measure (PAM)
Time Frame: By the end of the program (after 12 months).
The impact of the Lymphedema Management Education Program on activity levels will be evaluated using the Patient Activation Measure (PAM)
By the end of the program (after 12 months).
The Impact of a Lymphedema Management Education Program on Activity Levels Using the Daily Living (Katz ADL) Index
Time Frame: By the end of the program (after 12 months).
The impact of the Lymphedema Management Education Program on activity levels will be evaluated using the Katz Activities of Daily Living (Katz ADL) Index.
By the end of the program (after 12 months).
The Impact of a Lymphedema Management Education Program on Independence in Daily Living Activities Using the Katz Activities of Daily Living (Katz ADL) Index
Time Frame: By the end of the program (after 12 months).
The measurement of independence in daily tasks (e.g., bathing, dressing) will be conducted using the Katz Activities of Daily Living (Katz ADL) Index.
By the end of the program (after 12 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gizem Cansiz Ucar

Collaborators

Hacettepe University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

December 15, 2020

Study Completion (Actual)

December 15, 2020

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA-19098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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