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

Not Applicable

Completed

• Conditions: Breast Cancer Survivor; Lymphedema

• Registration Number: NCT06766708
• Lead Sponsor: Gizem Cansiz Ucar

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.

Study Timeline

• Study Start: 2019-12-01
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Study First Submitted: 2024-12-17
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The Impact of a Lymphedema Management Education Program on Symptoms in Breast Cancer-Related Lymphedema Patients Using Circumferential Measurements and Bioimpedance Spectroscopy (BIS)	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.
The Impact of a Lymphedema Management Education Program on Patient Compliance Using the Patient Activation Measure (PAM)	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).
The Impact of a Lymphedema Management Education Program on Activity Levels Using the Patient Activation Measure (PAM)	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)
The Impact of a Lymphedema Management Education Program on Activity Levels Using the Daily Living (Katz ADL) Index	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.
The Impact of a Lymphedema Management Education Program on Independence in Daily Living Activities Using the Katz Activities of Daily Living (Katz ADL) Index	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.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Çankaya, Turkey