BREAST-QNCT05415033
Validity and Reliability of Arabic Version of Breast Questionnaire
A study testing BREAST-Q in people with BREAST-Q, run by Cairo University.
Trial summary
To test validity and reliability of the translated Arabic version of breast questionnaire . Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- BREAST-Q
- What is being tested?
- BREAST-Q
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Jul 2023
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients underwent to a mastectomy operation.
- Patients ages between 30 to 60 years.
- All participants able to read and write in Arabic.
- All participants can understand items of the questionnaire.
Who cannot join
- Patients with mental problems.
- Patient with communication, vision, hearing disorders.
- Patient who doesn't fill the questionnaire till the end.
- Patient who isn't cooperative in filling the questionnaire.
About this study
Official title: Validity and Reliability of Arabic Version of Breast Questionnaire for Post Mastectomy Patients
To test validity and reliability of the translated Arabic version of breast questionnaire .
Read the detailed description
Breast cancer is the second most common cancer among women in the United States, with an estimated 246,660 .
Breast cancer patients and survivors now have many surgical options, which emphasizes the importance of understanding the long-term quality of life (QOL) outcomes Women undergoing surgery for primary breast cancer are increasingly making their own surgical decisions, and are often choosing between breast conserving therapy and mastectomy with or without breast reconstruction Although recent studies suggest breast conserving therapy has a survival benefit patients often turn to satisfaction and QOL outcomes data to help guide the decision - making process .
In the treatment of the special type of breast cancer (STBC), the choice of chemotherapeutic agents is often based on the characteristic features of the histological type .
On the other hand, the surgical strategy is usually determined by the tumor size and presence of lymph node metastasis, and the indication for immediate reconstruction is rarely discussed based on the histological type .
A mastectomy is used to remove all breast tissue if you have breast cancer or are at very high risk of developing it. You may have a mastectomy to remove one breast (unilateral mastectomy) or both breasts (bilateral mastectomy) For those with early-stage breast cancer, there are two optiones a mastectomy and Breast-conserving surgery (lumpectomy), in which only the tumor is removed from the breast, may be another option .
Choosing between a mastectomy and lumpectomy can be difficult. Both procedures are equally effective for preventing a recurrence of breast cancer. But a lumpectomy isn't an option for everyone with breast cancer .
Newer mastectomy techniques can preserve breast skin and allow for a more natural breast appearance following the procedure. This is also known as skin- sparing mastectomy Surgery to restore shape to your breast - called breast reconstruction - may be done at the same time as your mastectomy or during a second operation at a later date .
The BREAST-Q can provide meaningful data that can be used to support quality metrics and evidence-guided surgical practices in oncologic breast and plastic surgery It has been widely used by clinicians and researchers to help patients and surgeons better understand outcomes .
Since BREAST-Q was developed in 2009, it has been widely used by clinicians and researchers to capture information regarding health-related quality of life (HRQoL) and patient satisfaction related to breast surgery .
- Conditions
- BREAST-Q
- Being tested
- BREAST-Q
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREAST-QOther
arabic version of breast questionnaire
| Study group | Role | What they receive |
|---|---|---|
| BREAST-Q | Other | Not described Receives: Other: BREAST-Q |
What is being measured
The primary outcome is the main question the study is designed to answer.
SATISFACTION WITH BREASTS
With your breast area in mind, in the past week, how satisfied or dissatisfied have you been with
Measured: 3 monthes
Secondary outcomes (1)
PSYCHOSOCIAL WELL-BEING
With your breast area in mind, in the past week, how often have you felt
Measured: 3 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BREAST-QStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gehad emad el din abd elaziz dandash, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415033
- Sponsor's protocol ID
- Arabic BREAST-Q
- Status last verified
- May 2023
- First submitted
- 7 Jun 2022
- Last updated
- 16 May 2023
- 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 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Arabic Version of Breast Questionnaire for Post Mastectomy Patients
- ClinicalTrials.gov ID
- NCT05415033
- Acronym / sponsor ID
- Arabic BREAST-Q
- Conditions
- BREAST-Q
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 10 Jun 2022 (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.
To test validity and reliability of the translated Arabic version of breast questionnaire .
Detailed description
Breast cancer is the second most common cancer among women in the United States, with an estimated 246,660 .
Breast cancer patients and survivors now have many surgical options, which emphasizes the importance of understanding the long-term quality of life (QOL) outcomes Women undergoing surgery for primary breast cancer are increasingly making their own surgical decisions, and are often choosing between breast conserving therapy and mastectomy with or without breast reconstruction Although recent studies suggest breast conserving therapy has a survival benefit patients often turn to satisfaction and QOL outcomes data to help guide the decision - making process .
In the treatment of the special type of breast cancer (STBC), the choice of chemotherapeutic agents is often based on the characteristic features of the histological type .
On the other hand, the surgical strategy is usually determined by the tumor size and presence of lymph node metastasis, and the indication for immediate reconstruction is rarely discussed based on the histological type .
A mastectomy is used to remove all breast tissue if you have breast cancer or are at very high risk of developing it. You may have a mastectomy to remove one breast (unilateral mastectomy) or both breasts (bilateral mastectomy) For those with early-stage breast cancer, there are two optiones a mastectomy and Breast-conserving surgery (lumpectomy), in which only the tumor is removed from the breast, may be another option .
Choosing between a mastectomy and lumpectomy can be difficult. Both procedures are equally effective for preventing a recurrence of breast cancer. But a lumpectomy isn't an option for everyone with breast cancer .
Newer mastectomy techniques can preserve breast skin and allow for a more natural breast appearance following the procedure. This is also known as skin- sparing mastectomy Surgery to restore shape to your breast - called breast reconstruction - may be done at the same time as your mastectomy or during a second operation at a later date .
The BREAST-Q can provide meaningful data that can be used to support quality metrics and evidence-guided surgical practices in oncologic breast and plastic surgery It has been widely used by clinicians and researchers to help patients and surgeons better understand outcomes .
Since BREAST-Q was developed in 2009, it has been widely used by clinicians and researchers to capture information regarding health-related quality of life (HRQoL) and patient satisfaction related to breast surgery .
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BREAST-Q | Other | Other: BREAST-Q |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients underwent to a mastectomy operation.
- Patients ages between 30 to 60 years.
- All participants able to read and write in Arabic.
- All participants can understand items of the questionnaire.
Key exclusion criteria (4 listed)
- Patients with mental problems.
- Patient with communication, vision, hearing disorders.
- Patient who doesn't fill the questionnaire till the end.
- Patient who isn't cooperative in filling the questionnaire.
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 |
|---|---|---|
| BREAST-Qarabic version of breast questionnaire | Other | BREAST-Q |
Primary outcome
SATISFACTION WITH BREASTS
Time frame: 3 monthes
With your breast area in mind, in the past week, how satisfied or dissatisfied have you been with
1 secondary outcome
PSYCHOSOCIAL WELL-BEING
Time frame: 3 monthes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing BREAST-Q in people with BREAST-Q, run by Cairo 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 16 May 2023. 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?
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?
SATISFACTION WITH BREASTS (time frame: 3 monthes). 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 16 May 2023.