Validity and Reliability of Arabic Version of Breast Questionnaire

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: BREAST-Q
• Intervention / Treatment: Other: BREAST-Q

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 Type: Interventional
• Enrollment (Anticipated): 87
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: BREAST-Q	Other: BREAST-Q; arabic version of breast questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SATISFACTION WITH BREASTS	With your breast area in mind, in the past week, how satisfied or dissatisfied have you been with	3 monthes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSYCHOSOCIAL WELL-BEING	With your breast area in mind, in the past week, how often have you felt	3 monthes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SEXUAL WELL-BEING	Thinking of your sexuality, how often do you generally feel	3 monthes
PHYSICAL WELL-BEING: CHEST	In the past week, how often have you experienced	3 monthes
ADVERSE EFFECTS OF RADIATION	If you have had radiation on both breasts, answer these questions thinking of the breast you are least satisfied with. With your radiated breast(s) in mind, in the past week, how much have you been bothered	3 monthes
CANCER WORRY	These statements ask about the WORRY you may be experiencing about breast cancer	3 monthes
FATIGUE	Does FATIGUE (feeling tired) from breast cancer or its treatment affect your quality of life?	3 monthes
IMPACT ON WORK	Does breast cancer or its treatment affect your WORK LIFE? Please answer thinking of when you were last working.	3 monthes
SATISFACTION WITH MEDICAL TEAM	These questions ask about your breast cancer surgeon , members of the medical team other than the surgeon, members of the office staf	3 monthes

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 14, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Arabic BREAST-Q

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No