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

NCT07803549 | Completed

• 2 other identifiers: MOH/REC/2024/412025-2024/174/03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer (Locally Advanced or Metastatic); Lymphedema Arm

Keywords

Self-Management Interventions

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (1)

• 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.

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

Study Arms (2)

self-management interventions

EXPERIMENTAL

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

Control group (placebo)

NO INTERVENTION

For the placebo group data were collected at baseline, follow-up one month, and 3-months without implementing the program.

Interventions

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.

self-management interventions

Eligibility Criteria

• Gender Eligibility Details: Women with breast cancer.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any patients with cognitive disability
• Patients diagnosed with metastasis

Sponsors & Collaborators

• Al-Zaytoonah University of Jordan: lead

Study Sites (1)

Ministry of Health

Amman, Amman Governorate, 11733, Jordan

Location

Related Publications (8)

• Natarajan MK 4th, S J N, Mohanraj J, Vishwanath U. The Effect of Education on Knowledge Regarding Breast Cancer Related Lymphedema Risk Reduction and Prevention Among Nursing Personnel. Cureus. 2023 Sep 15;15(9):e45331. doi: 10.7759/cureus.45331. eCollection 2023 Sep.

  PMID: 37849580 RESULT

• 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

• Demir, S.G., 2008. Self-management of lymphedema in patients undergoing surgery for breast cancer. Journal of Breast Health 4 (2), 62-69.

  RESULT

• Huang TW, Tseng SH, Lin CC, Bai CH, Chen CS, Hung CS, Wu CH, Tam KW. Effects of manual lymphatic drainage on breast cancer-related lymphedema: a systematic review and meta-analysis of randomized controlled trials. World J Surg Oncol. 2013 Jan 24;11:15. doi: 10.1186/1477-7819-11-15.

  PMID: 23347817 RESULT

• Imokhai, P. O., Hall, O., Cardone, T. A., Vinagolu-Baur, J., Tilghman, H., Dunmore, K., & Brooks, A. Novel Approach to Early Diagnosis and Management of Lymphedema Following Axillary Lymph Node Dissection in Breast Cancer Surgery. http://dx.doi.org/10.20431/2455-572X.1101003

  RESULT

• Lian Y, Sandhu S, Asefa Y, Gupta A. The Effect of Exercise on Reducing Lymphedema Severity in Breast Cancer Survivors. Cancers (Basel). 2024 Mar 30;16(7):1367. doi: 10.3390/cancers16071367.

  PMID: 38611045 RESULT

• Liu F, Li F, Fu MR, Zhao Q, Wang Y, Pang D, Yang P, Jin S, Lu Q. Self-management Strategies for Risk Reduction of Subclinical and Mild Stage of Breast Cancer-Related Lymphedema: A Longitudinal, Quasi-experimental Study. Cancer Nurs. 2021 Nov-Dec 01;44(6):E493-E502. doi: 10.1097/NCC.0000000000000919.

  PMID: 34694088 RESULT

• Omidi Z, Kheirkhah M, Abolghasemi J, Haghighat S. Effect of lymphedema self-management group-based education compared with social network-based education on quality of life and fear of cancer recurrence in women with breast cancer: a randomized controlled clinical trial. Qual Life Res. 2020 Jul;29(7):1789-1800. doi: 10.1007/s11136-020-02455-z. Epub 2020 Mar 9.

  PMID: 32152817 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anoud J. Alsouliman, MsN

  Al-Zaytoonah University of Jordan Faculty of Nursing

  PRINCIPAL INVESTIGATOR

• Mohammad M Alnaeem, Ph.D.

  Al-Zaytoonah University of Jordan Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistance Professor

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: September 3, 2026
• Study Start: January 28, 2025
• Primary Completion: July 30, 2025
• Study Completion: August 20, 2025
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting in January 2025

Locations

JO (1)