NCT06591871

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

September 5, 2024

Last Update Submit

September 9, 2024

Conditions

Keywords

Post mastectomy lymphedemaQuality of lifeSelf-careSelf-management educational program

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.

EXPERIMENTAL

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.

Other: Self-management educational program for post mastectomy lymphedema 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).

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

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale with post mastectomy lymphedema
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

LymphedemaLymphatic DiseasesHemic and Lymphatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Magda Ahmed, Dr

    Faculty of Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Quasi-experimental research design was used for this study.
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

Locations