An interventional study of Self-management Interventions in Breast Cancer (Locally Advanced or Metastatic) and Lymphedema Arm, sponsored by Al-Zaytoonah University of Jordan. Completed at 1 site in Jordan. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Al-Zaytoonah University of Jordan · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
For patients assigned for intervention group (self-management interventions), they received education on self-management intervention and exercise training. The follow-up data collection performed at first month later in clinic, when the researcher returned to the same patient and evaluated the changes by takes upper extremity circumference measurement, LISD scale, and QOL questionnaires. Using self-administered technique, it is possible to assess any changes in the patient's risk of developing lymphedema over time. Then follow up at third month takes by telephone. For the Placebo group data were collected at baseline, follow-up one month, and 3-months without implementing the program.
Behavioral: Self-management Interventions
For the placebo group data were collected at baseline, follow-up one month, and 3-months without implementing the program.
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.
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
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.
Time frame: From enrollment to the end of treatment at 12 weeks (3 months)
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
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.
Time frame: From enrollment to the end of treatment at 12 weeks (3 months)
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.
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.
Time frame: From enrollment to the end of treatment at 12 weeks (3 months)
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Plan to share: Yes
Supporting information: Study protocol
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Al-Zaytoonah University of Jordan