MastectomyNCT04872803
Emotional Security and Quality of Life Among Breast Cancer Patient Who Have Undergo Mastectomy
An observational study of Mastectomy, run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mastectomy
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 31 Dec 2021
- Phase
- Observational
- 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: female patient between 18y and 55y with first-time breast cancer diagnosis and post-operative mastectomized patients
Who may be able to join
- female patient between 18y and 55y
- a first-time breast cancer diagnosis
- post-operative mastectomized patients
- clear consent to participate in study
Who cannot join
- male gender
- females patient with concurrent comorbid psychiatric or neurological disorders
- age younger than 18y
- patients with disease recurrence, patients presenting with other malignancies
Trial locations and contacts
No sites are listed yet.
About this study
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 .
Read the 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
- Conditions
- Mastectomy
- Keywords
- Mastectomy, breast cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life post mastectomy
To evaluate the impact of breast cancer on the quality of life
Measured: 6 months
Secondary outcomes (1)
Stages of breast cancer and emotional security
Studying the effect of different stages of breast cancer and its duration on the emotional security
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Omar, Assiut University
- Investigators
- Asmaa Omar, Master, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872803
- Sponsor's protocol ID
- Emotional security&mastectomy
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Security and Quality of Life Among Breast Cancer Patient Who Have Undergo Mastectomy
- ClinicalTrials.gov ID
- NCT04872803
- Acronym / sponsor ID
- Emotional security&mastectomy
- Conditions
- Mastectomy
- Keywords
- Mastectomy, breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 May 2021 (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.
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 .
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- female patient between 18y and 55y with first-time breast cancer diagnosis and post-operative mastectomized patients
Key inclusion criteria (4 listed)
- female patient between 18y and 55y
- a first-time breast cancer diagnosis
- post-operative mastectomized patients
- clear consent to participate in study
Key exclusion criteria (4 listed)
- male gender
- females patient with concurrent comorbid psychiatric or neurological disorders
- age younger than 18y
- patients with disease recurrence, patients presenting with other malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life post mastectomy
Time frame: 6 months
To evaluate the impact of breast cancer on the quality of life
1 secondary outcome
Stages of breast cancer and emotional security
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
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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.
Asmaa Omar, Master principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Mastectomy, run by Assiut University.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Omar (+201281272808, asmaa93omar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life post mastectomy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2021.