NCT05415033

Brief Summary

To test validity and reliability of the translated Arabic version of breast questionnaire .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

1 month

First QC Date

June 7, 2022

Last Update Submit

May 14, 2023

Conditions

BREAST-Q

Outcome Measures

Primary Outcomes (1)

  • SATISFACTION WITH BREASTS

    With your breast area in mind, in the past week, how satisfied or dissatisfied have you been with

    3 monthes

Secondary Outcomes (1)

  • PSYCHOSOCIAL WELL-BEING

    3 monthes

Other Outcomes (7)

  • SEXUAL WELL-BEING

    3 monthes

  • PHYSICAL WELL-BEING: CHEST

    3 monthes

  • ADVERSE EFFECTS OF RADIATION

    3 monthes

  • +4 more other outcomes

Study Arms (1)

BREAST-Q

OTHER
Other: BREAST-Q

Interventions

BREAST-QOTHER

arabic version of breast questionnaire

BREAST-Q

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 7, 2022

First Posted

June 10, 2022

Study Start

June 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05