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Completed

NCT Number: NCT06593561

Turkish Version of Breast Edema Questionnare: Validity and Reliability 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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of Physical Therapy and Rehabilitation

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breast Edema Questionnare

Other

The Breast Edema Questionnaire, developed to evaluate breast edema in women undergoing breast cancer surgery, will be applied.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Ultrasound

    Time frame: 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.

  2. Moisture Meter Compact

    Time frame: 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.

  3. Visual Analog Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aysima Barlak

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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