Educational Program on Self-Management for Women with Post-Mastectomy Lymphedema

NCT ID: NCT06591871

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-05-01

Brief Summary

Post mastectomy lymphedema is a chronic disease that negatively affect physical, social, psychological and emotional well-being, so Patient education regarding self-management is crucial to enhance women's self -care and quality of life.

Detailed Description

Improvement in screening and treatment modalities of breast cancer has translated into higher survival rates in these patients. Unfortunately, this gain in survival leading to high prevalence of serious consequences of cancer treatments. Among these, post mastectomy lymphedema. It was estimated that 10 million women had breast cancer- related lymphedema (BCRL) worldwide, with 3-5 million affected in the United States. Approximately one in five women undergoing breast cancer surgery at risk for developing lymphedema .

Post-mastectomy lymphedema is a chronic and progressive tissue swelling caused by the abnormal buildup of protein-rich fluids in the interstitial space due to disrupted lymphatic drainage. This swelling results in physical symptoms such as heaviness, pain, decreased flexibility or tightness, stiffness, fatigue and numbness in the affected extremity. Its long-term burden extends beyond these physical symptoms, to significantly impact social, psychological, emotional functioning .also pose financial burdens to patients, the healthcare system, and society which lead to poor quality of life .

Lymphedema self-management constitutes the standard lymphedema treatment that should be maintained throughout life. In this context, the nurse's role becomes magnified. Self-management is the ability of individual to manage one's own chronic condition, encompassing the management of symptoms

, physical and psychosocial impacts, treatment, and incorporating these management practices into daily activities to attain optimal quality of life.

Nurses contribute significantly in management of post mastectomy lymphedema through educating the patients about lymphedema self-care behaviors which are important to control lymphedema symptoms, decrease lymphedema stages and prevent further progression of the disease. Lymphedema self-care involves maintaining risk-reduction behaviors, exercising, weight control, good nutrition, healthy lifestyle behaviors, caring and proper fit of compression garments, self-lymph drainage, skin care, signs and symptoms, preventing and managing infections.

Conditions

Post Mastectomy Lymphedema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Forty women with post-mastectomy lymphedema participated in this study.

Forty women with post-mastectomy lymphedema participated in this study. All were free from other disabling conditions impeding self-care practices, hadn't previously received any educational programs about post-mastectomy lymphedema. The educational program was implemented through (5) sessions; (2 theoretical & 3 practical). Theoretical part included the following: a brief overview of anatomy and physiology of the lymphatic system, definition, causes, signs and symptoms, risk factors, stages, diagnosis and complications of post mastectomy lymphedema, also instructions about general practices for preventing and managing infection, hand and arm care, a healthy nutrition and when you call your physician. While, the practical part included the use of compression bandages, garments and their care, upper extremity lymphedema exercises and Manual Lymphatic Drainage (MLD) massage.

Each session lasted 45 to 60 minutes and was conducted individually or in small groups of 2-3 women.

Group Type: EXPERIMENTAL

Self-management educational program for post mastectomy lymphedema women

Intervention Type: OTHER

The researcher created this program in response to the identified needs of post mastectomy lymphedema women to provide them with essential knowledge and self-care practices concerning post-mastectomy lymphedema. It was designed as a straightforward Arabic booklet written in simple language and supplemented with colorful illustrations and images to accommodate women of varying educational levels. It was consisted of two sections:

Theoretical section included the following (A brief overview of anatomy and physiology of the lymphatic system, definition, causes, signs and symptoms, risk factors , stages, diagnosis and complications of post mastectomy lymphedema, also instructions about general practices for preventing and managing infection, hand and arm care ,a healthy nutrition and when you call your physician ).

Practical section included (use of compression bandages, garments and their care, upper extremity lymphedema exercises, Manual Lymphatic Drainage (MLD) massage).

Interventions

Self-management educational program for post mastectomy lymphedema women

The researcher created this program in response to the identified needs of post mastectomy lymphedema women to provide them with essential knowledge and self-care practices concerning post-mastectomy lymphedema. It was designed as a straightforward Arabic booklet written in simple language and supplemented with colorful illustrations and images to accommodate women of varying educational levels. It was consisted of two sections:

Theoretical section included the following (A brief overview of anatomy and physiology of the lymphatic system, definition, causes, signs and symptoms, risk factors , stages, diagnosis and complications of post mastectomy lymphedema, also instructions about general practices for preventing and managing infection, hand and arm care ,a healthy nutrition and when you call your physician ).

Practical section included (use of compression bandages, garments and their care, upper extremity lymphedema exercises, Manual Lymphatic Drainage (MLD) massage).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• women diagnosed with post-mastectomy lymphedema,free from other disabling conditions impeding self-care practices, No prior participation in lymphedema-related educational programs, and provided an agreement for participation in the study

Exclusion Criteria

• Women with mental problems
• Unable to communicate with health team

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Walaa Ali Abd El-Rahman

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magda Ahmed, Dr

Role: STUDY_DIRECTOR

Faculty of Nursing

Locations

faculty of nursing - Assiut University Hospital

Asyut, Egypt, Egypt

Countries

Egypt

References

Donahue PMC, MacKenzie A, Filipovic A, Koelmeyer L. Advances in the prevention and treatment of breast cancer-related lymphedema. Breast Cancer Res Treat. 2023 Jul;200(1):1-14. doi: 10.1007/s10549-023-06947-7. Epub 2023 Apr 27.

Reference Type: BACKGROUND

PMID: 37103598 (View on PubMed)

Other Identifiers

Lymphedema Post mastectomy

Identifier Type: -

Identifier Source: org_study_id