Turkish Version of Breast Edema Questionnare: Validity and Reliability Study

Completed

• Conditions: Breast Edema

• Registration Number: NCT06593561
• Lead Sponsor: Aysima Barlak

Brief 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%. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-18
• Status Verified: 2023-02
• Primary Completion: 2023-06-30
• Study Completion: 2023-09-30
• Study First Submitted: 2024-09-08
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-12
• Last Update Posted: 2024-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Individuals with a diagnosis of breast cancer who have undergone breast-conserving surgery
• individuals who have signed the Informed Consent form

Exclusion Criteria

• illiterate individuals

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breast Edema Questionnare	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.

Secondary Outcome Measures

Name	Time	Method
Ultrasound	baseline	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.
Moisture Meter Compact	baseline	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.
Visual Analog Scale	baseline	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.

Trial Locations

Locations (1)

Faculty of Physical Therapy and Rehabilitation; 🇹🇷 Ankara, Sıhhiye, Turkey