Post Mastectomy LymphedemaNCT06591871
Educational Program on Self-Management for Women With Post-Mastectomy Lymphedema
A study testing Self-management educational program for post mastectomy lymphedema women in people with Post Mastectomy Lymphedema, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Post Mastectomy Lymphedema
- What is being tested?
- Self-management educational program for post mastectomy lymphedema women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Women with mental problems
- Unable to communicate with health team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Self-management Educational Program on Women's Self-care and Quality of Life Post Mastectomy Lymphedema
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.
Read the 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
- Being tested
- Self-management educational program for post mastectomy lymphedema women
- Keywords
- Post mastectomy lymphedema, Quality of life, Self-care, Self-management educational program
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management educational program for post mastectomy lymphedema womenOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Self-management educational program for post mastectomy lymphedema women |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three months
Secondary outcomes (2)
Effect of self-management educational program on quality of life of post mastectomy lymphedema women
Effect 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.
Measured: three months
Effect of self-management educational program on knowledge of post mastectomy lymphedema women
Effect 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.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jun 2023
- Primary completion1 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Mastectomy LymphedemaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-experimental research design was used for this study.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Ali Abd El-Rahman, Assiut University
- Investigators
- Magda Ahmed, Dr, Study director, Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591871
- Sponsor's protocol ID
- Lymphedema Post mastectomy
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37103598
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Self-management Educational Program on Women's Self-care and Quality of Life Post Mastectomy Lymphedema
- ClinicalTrials.gov ID
- NCT06591871
- Acronym / sponsor ID
- Lymphedema Post mastectomy
- Conditions
- Post Mastectomy Lymphedema
- Keywords
- Post mastectomy lymphedema, Quality of life, Self-care, Self-management educational program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-experimental research design was used for this study.
| Arm | Type | Receives |
|---|---|---|
| Forty women with post-mastectomy lymphedema participated in this study. | Experimental | Other: Self-management educational program for post mastectomy lymphedema womenForty 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Women with mental problems
- Unable to communicate with health team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management educational program for post mastectomy lymphedema womenThe 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). | Other | Forty women with post-mastectomy lymphedema participated in this study. |
Primary outcome
Effect of self-management educational program on self-care of post mastectomy lymphedema women
Time frame: three months
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.
2 secondary outcomes
Effect of self-management educational program on quality of life of post mastectomy lymphedema women
Time frame: three months
Effect of self-management educational program on knowledge of post mastectomy lymphedema women
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 37103598Donahue 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magda Ahmed, Dr study director
Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management educational program for post mastectomy lymphedema women in people with Post Mastectomy Lymphedema, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of self-management educational program on self-care of post mastectomy lymphedema women (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06591871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.