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

Effect of Self-management Educational Program on Women's Self-care and Quality of Life Post Mastectomy Lymphedema

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06591871
Enrollment
40
Registered
2024-09-19
Start date
2023-06-01
Completion date
2024-05-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Mastectomy Lymphedema

Keywords

Post mastectomy lymphedema, Quality of life, Self-care, Self-management educational program

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.

Interventions

OTHERSelf-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).

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Quasi-experimental research design was used for this study.

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of self-management educational program on self-care of post mastectomy lymphedema womenthree monthsEffect of self-management educational program on self-care of post mastectomy lymphedema women by using (The Breast Cancer Related Lymphedema (BCRL) Self-Care Scale). It comprised 31 items organized into four subdimensions called: Protection, activity and disease process management, pressure management, sustainability. Responses to these items were scored using a four-point likert scale: 4 for always, 3 for often, 2 for occasionally, and 1 for none. The scale yielded a minimum possible score of 31 and a maximum of 124.Higher scores reflect better self-care practices.

Secondary

MeasureTime frameDescription
Effect of self-management educational program on quality of life of post mastectomy lymphedema womenthree monthsEffect of self-management educational program on quality of life of post mastectomy lymphedema women by using (Lymphedema Quality of Life Questionnaire-Arm (LYMQOL-Arm)).It comprises four domains with 21 questions and the last one about overall QoL. The domains are symptoms, appearance, function, and mood. Responses are evaluated on a four-point Likert scale: 1 (not at all), 2 (a little), 3 (quite a bit), and 4 (a lot). with higher scores indicating a worse QoL. Unlike the other questions, in question 21 (Q21) the patients are requested to rate their general quality of life from 0(poor)-10 (excellent). Higher scores of (Q21) indicate a better overall quality of life.
Effect of self-management educational program on knowledge of post mastectomy lymphedema womenthree monthsEffect of self-management educational program on knowledge of post mastectomy lymphedema women by using Pre/Post Knowledge Assessment Questionnaire. It comprised two sections; first, an assessment of women's knowledge about post-mastectomy lymphedema, through nine multiple-choice questions (MCQs) .Second, knowledge regarding post mastectomy lymphedema self-care (10MCQs). Responses from these women were scored as one for each correct answer and zero for incorrect answers or unknown; the total score was calculated by summing the scores for all items and then transformed into a percentage. A percentage score of 60% or higher was considered satisfactory knowledge, while below 60% was considered unsatisfactory.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026