Clinical trial NCT06591871: Educational Program on Self-Management for Women with Post-Mastectomy Lymphedema
Official title: Effect of Self-management Educational Program on Women's Self-care and Quality of Life Post Mastectomy Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Mastectomy Lymphedema
Keywords: Post mastectomy lymphedema
Quality of life
Self-care
Self-management educational program
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quasi-experimental research design was used for this study.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Effect of self-management educational program on self-care of post mastectomy lymphedema women
timeFrame: three months
Secondary outcomes:
measure: Effect of self-management educational program on quality of life of post mastectomy lymphedema women
timeFrame: three months
measure: Effect of self-management educational program on knowledge of post mastectomy lymphedema women
timeFrame: three months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: faculty of nursing - Assiut University Hospital
Study officials:
affiliation: Faculty of Nursing
name: Magda Ahmed, Dr
role: STUDY_DIRECTOR
References:
citation: 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.