Breast EdemaNCT06593561
Turkish Version of Breast Edema Questionnare: Validity and Reliability Study
An observational study of Breast Edema, run by Aysima Barlak at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to investigate the complaint of breast edema after breast conserving surgery and radiotherapy, which are considered as the main treatment modalities for breast cancer. The incidence of breast edema after these treatments ranges from 0% to 90.4%. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Edema
- What is being tested?
- Breast Edema Questionnare
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2022to 30 Sep 2023
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female individuals diagnosed with breast cancer, undergoing breast conserving surgery, literate, and signed the informed consent form will be included in the study.
Who may be able to join
- Individuals with a diagnosis of breast cancer who have undergone breast-conserving surgery
- individuals who have signed the Informed Consent form
Who cannot join
- illiterate individuals
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Physical Therapy and Rehabilitation
Ankara, Sıhhiye, 06100
About this study
This study was planned to investigate the complaint of breast edema after breast conserving surgery and radiotherapy, which are considered as the main treatment modalities for breast cancer. The incidence of breast edema after these treatments ranges from 0% to 90.4%. In contrast to arm lymphedema, which has been described in detail in the literature, only a few studies have investigated breast edema. There is no survey study that comprehensively examines the presence of lymphedema and its clinical features (duration, severity, location). Studies to assess breast edema after breast cancer treatment have revealed the need for a condition-specific scale. Therefore, the "Breast Edema Questionnaire" was developed to assess breast edema in women who have undergone breast cancer surgery. The original language of this questionnaire is German and its reliability and validity has not been studied in another language. In this study, the validity and reliability of this questionnaire, which specifically assesses breast edema, will be tested in Turkish women.
- Conditions
- Breast Edema
- Being tested
- Breast Edema Questionnare
- Keywords
- radiotherapy, breast cancer, lymphedema
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Edema QuestionnareOther
The Breast Edema Questionnaire, developed to evaluate breast edema in women undergoing breast cancer surgery, will be applied.
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Edema Questionnare
Unlike arm lymphedema, which is described in detail in the literature, there are only a few studies investigating breast lymphedema after breast cancer treatment. Breast ultrasound (US) is considered to be a more reliable and quantitative measure of breast edema. However, there is no survey study that comprehensively examines these outcome measures according to the presence and clinical features of lymphedema (duration, severity, location of lymphedema). In studies conducted to evaluate breast edema after breast cancer treatment, the necessity of a situation-specific scale has emerged. For this reason, the "Breast Edema Questionnaire" was developed to evaluate breast edema in women undergoing breast cancer surgery.
Measured: one week
Secondary outcomes (3)
Ultrasound
Ultrasonography is routinely used in the evaluation of skin and soft tissue complaints.Generally, ultrasound is used to evaluate abscesses, cellulitis and foreign bodies in the skin and soft tissue. The deterioration of the skin by bacterial invasion causes infection in the dermis and subcutaneous fat. These findings are due to subcutaneous edema accumulation. Ultrasound will be used to determine the localization, severity and amount of edema.
Measured: baseline
Moisture Meter Compact
Fluid percentage will be evaluated using the Moisture Meter Compact instrument (Delphin technologies). The tissue dielectric constant (TDC) technique gives information about the emergence of lymphedema in the early stages and the change in the amount of water under the skin. The reflected wave contains information about the energy attraction, that is, the amount of water molecules in the skin. The resulting values are automatically converted to PWC values by the device software. The probe of the device showing the tissue dielectric constant will be placed on the skin. Tissue edema will be measured at different depths by making three different measurements. The reference point will be used.
Measured: baseline
Visual Analog Scale
The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For example, for pain, I have no pain at one end and very severe pain at the other end and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient\'s pain.
Measured: baseline
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 start18 Oct 2022
- Primary completion30 Jun 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast EdemaStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aysima Barlak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aysima Barlak, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593561
- Sponsor's protocol ID
- GO22/879
- Status last verified
- Feb 2023
- First submitted
- 8 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
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
- Turkish Version of Breast Edema Questionnare: Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT06593561
- Acronym / sponsor ID
- GO22/879
- Conditions
- Breast Edema
- Keywords
- radiotherapy, breast cancer, lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aysima BarlakUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (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.
This study was planned to investigate the complaint of breast edema after breast conserving surgery and radiotherapy, which are considered as the main treatment modalities for breast cancer. The incidence of breast edema after these treatments ranges from 0% to 90.4%. In contrast to arm lymphedema, which has been described in detail in the literature, only a few studies have investigated breast edema. There is no survey study that comprehensively examines the presence of lymphedema and its clinical features (duration, severity, location). Studies to assess breast edema after breast cancer treatment have revealed the need for a condition-specific scale. Therefore, the "Breast Edema Questionnaire" was developed to assess breast edema in women who have undergone breast cancer surgery. The original language of this questionnaire is German and its reliability and validity has not been studied in another language. In this study, the validity and reliability of this questionnaire, which specifically assesses breast edema, will be tested in Turkish women.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female individuals diagnosed with breast cancer, undergoing breast conserving surgery, literate, and signed the informed consent form will be included in the study.
Key inclusion criteria (2 listed)
- Individuals with a diagnosis of breast cancer who have undergone breast-conserving surgery
- individuals who have signed the Informed Consent form
Key exclusion criteria (1 listed)
- illiterate individuals
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 Edema QuestionnareThe Breast Edema Questionnaire, developed to evaluate breast edema in women undergoing breast cancer surgery, will be applied. | Other | – |
Primary outcome
Breast Edema Questionnare
Time frame: one week
Unlike arm lymphedema, which is described in detail in the literature, there are only a few studies investigating breast lymphedema after breast cancer treatment. Breast ultrasound (US) is considered to be a more reliable and quantitative measure of breast edema. However, there is no survey study that comprehensively examines these outcome measures according to the presence and clinical features of lymphedema (duration, severity, location of lymphedema). In studies conducted to evaluate breast edema after breast cancer treatment, the necessity of a situation-specific scale has emerged. For this reason, the "Breast Edema Questionnaire" was developed to evaluate breast edema in women undergoing breast cancer surgery.
3 secondary outcomes
Ultrasound
Time frame: baseline
Moisture Meter Compact
Time frame: baseline
Visual Analog Scale
Time frame: baseline
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.
- Individual participant dataSharing planned: No
Related trials for Breast Edema
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Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Edema, run by Aysima Barlak at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 Turkey (Türkiye). 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?
Breast Edema Questionnare (time frame: one week). 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 19 Sep 2024.