Clinical trial NCT06766708: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Survivor
Lymphedema
Keywords: Breast cancer-related lymphedema
daily life activities
patient activation
patient adaptation
patient education
self-management of lymphedema
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Hacettepe University Hospital
First posted: 2025-01-09
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: this pre-test post-test in one group quasi-experimental study
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Impact of a Lymphedema Management Education Program on Symptoms in Breast Cancer-Related Lymphedema Patients Using Circumferential Measurements and Bioimpedance Spectroscopy (BIS)
timeFrame: By the end of the program (after 12 months).
measure: The Impact of a Lymphedema Management Education Program on Patient Compliance Using the Patient Activation Measure (PAM)
timeFrame: By the end of the program (after 12 months)
measure: The Impact of a Lymphedema Management Education Program on Activity Levels Using the Patient Activation Measure (PAM)
timeFrame: By the end of the program (after 12 months).
measure: The Impact of a Lymphedema Management Education Program on Activity Levels Using the Daily Living (Katz ADL) Index
timeFrame: By the end of the program (after 12 months).
measure: The Impact of a Lymphedema Management Education Program on Independence in Daily Living Activities Using the Katz Activities of Daily Living (Katz ADL) Index
timeFrame: By the end of the program (after 12 months).
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Çankaya
Study officials:
References:
citation: 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.