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NCT Number: 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

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.

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Key information

Conditions

Breast Cancer Survivor Behavior Breast Cancer Lymphedema Health Behavior Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Participation Postoperative Complications Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Çankaya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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).

  3. 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)

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Gizem Cansiz Ucar

Other

Collaborators

  • Hacettepe University

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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