The Effect of Self-Management Interventions Among Patients With Breast Cancer Related-Lymphedema

To manage lymphedema, it's important to be aware of symptoms and risk factors, evaluate the afflicted extremity, prevent infections, care for the skin, protect the extremity from trauma, maintain a healthy weight, and exercise regularly. Patients were informed face-face about the development and risk factors of lymphedema before and after surgery (first and second day). Educational themes: Symptoms and signs of lymphedema, Development mechanisms and risk factors of lymphedema, Evaluation of lymphedema, Prevention of possible infections, Skin care, Protecting the arm and the breast from traumas, having ideal weight, Exercising.

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Key information

Conditions

Breast Cancer (Locally Advanced or Metastatic) Breast Diseases Breast Neoplasms Lymphedema Arm Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ministry of Health

Amman, Amman Governorate, 11733, Jordan

About this study

The implemented protocol (self-management interventions) includes several parts. First part was informing in which patients were informed face-face about the development and risk factors of lymphedema before and after surgery (first and second day). Educational themes: symptoms and signs of lymphedema, development mechanisms and risk factors of lymphedema, evaluation of lymphedema, prevention of possible infections, skin care, protecting the arm and the breast from traumas, having ideal weight, and exercising. Second part include lymphedema evaluation, in which measuring for the upper extremity circumference was done in the hospital using the metric measuring tape. The measurement was taken at four locations; specifically, metacarpophalangeal joints, at the wrist, 10 cm above and below the elbow joint. Third part was exercising program in which the patients during the first 24 hours after surgery were instructed to perform hand squeezing exercises with a medium-level stress ball four times a day, squeezing 15 times each. The researcher estimated the appropriate amount of exercise and start time for the patient based on their physical state and general health all over the post-operative period. Patients were instructed to perform active and passive arm exercises three to six times per day at start, gradually increasing to ten, shifting from passive to active within 30-60 minutes. Patients were instructed to warm up before exercising to prevent muscular damage and divide activities into 10-15-minutes sessions in case of pain. Fourth part was about simple lymphatic drainage where during patient massage, the researcher showed and taught deep diaphragmatic breathing exercises, neck drainage, afflicted side axillary drainage, and upper extremity drainage. Before the massage began, the patients practiced breathing exercises. To activate the lymphatic system, breathing exercises were initially done 3 times a day for 3 minutes, then increased to 3 times a day for 5 minutes in the months following.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

All patients with BCRL are undergoing Mastectomy
Adult patients ≥ 18 years old
Women with breast cancer who could read and write
Those who had been diagnosed with lymphedema.

Exclusion criteria

Any patients with cognitive disability
Patients diagnosed with metastasis

Treatment and study plan

Self-management Interventions

Behavioral

During the first 24 hours after surgery, patients were instructed to perform hand squeezing exercises with a medium-level stress ball four times a day, squeezing 15 times each. Patients were instructed to perform active and passive arm exercises three to six times per day at start, gradually increasing to ten, shifting from passive to active within 30-60 minutes. Patients were instructed to warm up before exercising to prevent muscular damage and divide activities into 10-15 minute sessions in case of pain.

Simple lymphatic drainage:

During patient massage, the researcher showed and taught deep diaphragmatic breathing exercises, neck drainage, afflicted side axillary drainage, and upper extremity drainage. Before the massage began, the patients practiced breathing exercises. To activate the lymphatic system, breathing exercises were initially done 3 times a day for 3 minutes, then increased to 3 times a day for 5 minutes in the months following.

Primary outcomes

The Lymphedema Symptom and Intensity Distress-Arm (LSID-A) tool is reliable to assess symptoms and distress related to lymphedema in the upper extremities, especially for breast cancer survivors. LSID-A measure the percentage of patients with lymphedema

Time frame: From enrollment to the end of treatment at 12 weeks (3 months)

The Lymphedema Symptom and Intensity Distress-Arm (LSID-A) Questionnaire is a reliable tool for assessing symptoms and distress related to lymphedema in the upper extremities, especially for breast cancer survivors. It consists of 30 items grouped into seven symptom clusters: Soft Tissue Sensation (4 items), Neurologic Sensation (7 items), Function (2 items), Biobehavioral (9 items), Resource (2 items), Sexuality (3 items), and Activity (3 items). Each item evaluates symptom presence with a "Yes" or "No," intensity on a 5-point scale from 0 (not present) to 5 (extremely intense), and distress on a similar scale from 0 (not distressing) to 5 (extremely distressing). The total score ranges from 0 to 30, with higher scores indicating greater severity and distress.
The Lymphedema Quality of Life Questionnaire (LYMQOL) is valid instrument to evaluate the impact of lymphedema on various aspects of life, emphasizing physical, emotional, and social dimensions. LYMQOL assess the level of QoL for patient with lymphedema

Time frame: From enrollment to the end of treatment at 12 weeks (3 months)

The Lymphedema Quality of Life Questionnaire (LYMQOL) is a valid and reliable instrument designed to evaluate the impact of lymphedema on various aspects of life, emphasizing physical, emotional, and social dimensions. The questionnaire comprises 27 items organized into four domains: 1. Function domain (items 1a - 1h, 2, 3) that assesses mobility, daily activities, and pain levels; 2. Appearance and Body Image domain (items 4-8) that explores concerns related to anxiety, depression, and body image; 3. Symptoms (items 9-14) that examines physical manifestations such as swelling, heaviness, and discomfort; 4. Emotion domain (items 15-20) that reflects feelings of social exclusion and emotional distress. Overall quality of life (Q21) is rated on a scale from 0 to 10. Participants respond using a Likert scale ranging from 1 to 4. A total score for each domain was calculated by adding all scores together and dividing by the total number of questions answered. Higher scores mean poor QoL.

Secondary outcomes

Upper Extremities Circumference was used to examine the presence of lymphedema before and after the self-management intervention, using the metric measuring tape. Upper Extremities Circumference measuring the distance around the midpoint of the arm.

Time frame: From enrollment to the end of treatment at 12 weeks (3 months)

The upper extremities were measured to examine the presence of lymphedema before and after the self-management intervention, using the metric measuring tape. The measurement was taken at four locations; specifically, metacarpophalangeal joints, at the wrist, 10 cm above and below the elbow joint.

Sponsors and collaborators

Lead sponsor

Al-Zaytoonah University of Jordan

Other

Registry information

Official study title

The Effect of Self-Management Interventions on Symptoms Severity and Quality of Life Among Patients With Breast Cancer Related-Lymphedema

Acronym: (BCRL)

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Sep 3, 2026
Registry last updated: Sep 3, 2026

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

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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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