Turkish Version of Breast Edema Questionnare: Validity and Reliability Study

NCT06593561 | Completed

• 1 other identifier: GO22/879
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Edema

Keywords

radiotherapy; breast cancer; lymphedema

Outcome Measures

Primary Outcomes (1)

• 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.

  one week

Secondary Outcomes (3)

• Ultrasound

  baseline

• Moisture Meter Compact

  baseline

• Visual Analog Scale

  baseline

Interventions

Breast Edema Questionnare OTHER

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• illiterate individuals

Sponsors & Collaborators

• Aysima Barlak: lead

Study Sites (1)

Faculty of Physical Therapy and Rehabilitation

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PT

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: October 18, 2022
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: September 19, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)