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

NCT ID: NCT06766708

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Survivor Lymphedema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

this pre-test post-test in one group quasi-experimental study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

In our study, single-blinded research was implemented by blinding the researcher. Bilateral upper extremity circumferences of the patients were measured at 10 different points, spaced 4 cm apart from the wrist to the axilla, by an expert nurse other than the researcher. The measurements were recorded with an accuracy of up to 0.1 cm.

During the initial interview with the patients, the researcher completed the scales and forms and then conducted the Lymphedema Management Education Program using an educational booklet developed by the researchers.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

self-management lymphedema (SML) education program

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hacettepe University Hospital

UNKNOWN

Sponsor Role collaborator

Gizem Cansiz Ucar

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gizem Cansiz Ucar

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hacettepe University

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Cansiz G, Arikan Donmez A, Kapucu S, Borman P. 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. Eur J Oncol Nurs. 2022 Feb;56:102081. doi: 10.1016/j.ejon.2021.102081. Epub 2021 Dec 1.

Reference Type RESULT
PMID: 34875398 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KA-19098

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.