- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04872803
Emotional Security and Quality of Life Among Breast Cancer Patient Who Have Undergo Mastectomy
April 29, 2021 updated by: Asmaa Omar, Assiut University
Breast cancer is the most common cause of cancer death among women worldwide.
Incidence rates are high in more developed countries than rates in less developed countries In Egypt, standardized age of cancers are 166.6per
100.000 in both sexes cancer breast represent 32%in females and 15.4%in both sexes of all cancer Mastectomy is an important treatment method in Brest cancer.
But, mastectomy has a deep and stable negative impact on a woman because, mastectomy as a treatment option, can result in a sense of mutilation and diminished self-worth and may threaten perceptions of femininity Body image of a woman includes the symbolic meaning and importance of her breasts.
The more she values her breasts, more devastating effects of having a mastectomy can be.
it has been reported that cutting off/amputating one or both breasts was associated with several problems in women such as loss of fertility, charm and sexuality, fear of recurrence Social support plays an important role in reducing the pressure and improving health.
Cancer patients who lack social support may be more pessimistic and desperate as they are constantly looking for support from others Therefore, it is critical for health care professionals to become familiar with the impact of a breast cancer diagnosis and its treatment on patient's quality of life .
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Breast cancer is the most common cause of cancer death among women worldwide.
Incidence rates are high in more developed countries than rates in less developed countries In Egypt, standardized age of cancers are 166.6per
100.000 in both sexes cancer breast represent 32%in females and 15.4%in both sexes of all cancer Mastectomy is an important treatment method in Brest cancer.
But, mastectomy has a deep and stable negative impact on a woman because, mastectomy as a treatment option, can result in a sense of mutilation and diminished self-worth and may threaten perceptions of femininity Body image of a woman includes the symbolic meaning and importance of her breasts.
The more she values her breasts, more devastating effects of having a mastectomy can be.
it has been reported that cutting off/amputating one or both breasts was associated with several problems in women such as loss of fertility, charm and sexuality, fear of recurrence Social support plays an important role in reducing the pressure and improving health.
Cancer patients who lack social support may be more pessimistic and desperate as they are constantly looking for support from others Therefore, it is critical for health care professionals to become familiar with the impact of a breast cancer diagnosis and its treatment on patient's quality of life
Study Type
Observational
Enrollment (Anticipated)
143
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Asmaa Omar
- Phone Number: +201281272808
- Email: asmaa93omar@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
female patient between 18y and 55y with first-time breast cancer diagnosis and post-operative mastectomized patients
Description
Inclusion Criteria:
- female patient between 18y and 55y
- a first-time breast cancer diagnosis
- post-operative mastectomized patients
- clear consent to participate in study
Exclusion Criteria:
- male gender
- females patient with concurrent comorbid psychiatric or neurological disorders
- age younger than 18y
- patients with disease recurrence, patients presenting with other malignancies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life post mastectomy
Time Frame: 6 months
|
To evaluate the impact of breast cancer on the quality of life
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stages of breast cancer and emotional security
Time Frame: 6 months
|
Studying the effect of different stages of breast cancer and its duration on the emotional security
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Asmaa Omar, Master, Assiut University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2021
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
April 27, 2021
First Submitted That Met QC Criteria
April 29, 2021
First Posted (Actual)
May 5, 2021
Study Record Updates
Last Update Posted (Actual)
May 5, 2021
Last Update Submitted That Met QC Criteria
April 29, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Emotional security&mastectomy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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