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

NCT06766708 | Completed

• 1 other identifier: KA-19098
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Survivor; Lymphedema

Keywords

Breast cancer-related lymphedema; daily life activities; patient activation; patient adaptation; patient education; self-management of lymphedema

Outcome Measures

Primary Outcomes (5)

• The Impact of a Lymphedema Management Education Program on Symptoms in Breast Cancer-Related Lymphedema Patients Using Circumferential Measurements and Bioimpedance Spectroscopy (BIS)

  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)

  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)

  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

  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

  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).

Study Arms (1)

Experimental grup

EXPERIMENTAL

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

Interventions

self-management lymphedema (SML) education program 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.

Experimental grup

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Since individuals diagnosed with breast cancer are predominantly women, the sample consisted of female participants.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gizem Cansiz Ucar: lead
• Hacettepe University: collaborator

Study Sites (1)

Hacettepe University

Ankara, Çankaya, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34875398 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Lymphedema; Breast Cancer Lymphedema; Patient Participation

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: this pre-test post-test in one group quasi-experimental study

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 9, 2025
• Study Start: December 1, 2019
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)