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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedFirst Submitted
Initial submission to the registry
September 5, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedSeptember 19, 2024
September 1, 2024
10 months
September 5, 2024
September 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of self-management educational program on self-care of post mastectomy lymphedema women
Effect 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.
three months
Secondary Outcomes (2)
Effect of self-management educational program on quality of life of post mastectomy lymphedema women
three months
Effect of self-management educational program on knowledge of post mastectomy lymphedema women
three months
Study Arms (1)
Forty women with post-mastectomy lymphedema participated in this study.
EXPERIMENTALForty 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Women with mental problems
- Unable to communicate with health team
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
faculty of nursing - Assiut University Hospital
Asyut, Egypt, Egypt
Related Publications (1)
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.
PMID: 37103598BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Magda Ahmed, Dr
Faculty of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
September 5, 2024
First Posted
September 19, 2024
Study Start
June 1, 2023
Primary Completion
April 1, 2024
Study Completion
May 1, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share