Factor Influencing Breast Surgery Type Decision-Making | NCT05604677

Studies
Factor Influencing Breast Surgery Type Decision-Making

NCT05604677

Sponsor

Etienne El Helou

Status

Completed

Last Update Posted

Nov 7, 2022Actual

Enrollment

380Actual

Phase

Not provided

Conditions

Breast Neoplasm

Interventions

Breast Surgery

Countries

Lebanon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2022Actual

Primary Completion Date

Jul 31, 2022Actual

Completion Date

Aug 19, 2022Actual

First Submitted Date

Oct 30, 2022

First Submission Date that Met QC Criteria

Oct 30, 2022

First Posted Date

Nov 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2022

Last Update Posted Date

Nov 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this observational study is to determine the factors influencing the decision-making process for breast surgery type, in Lebanese women likely to face breast cancer.

The main questions it aims to answer are the presence or not of a correlation between the type of choice and the following data:

Demographic
Health Status
Several factors that may influence the decision

Participants will complete a well-structured and organized online survey

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

380Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breast Surgery	Procedure	Breast-conserving Surgery or modified radical mastectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Influencing Factors	Factors influencing breast surgery type decision making process	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lebanese Females

Exclusion Criteria:

None

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Lebanese Females

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Etienne El-Helou, MD	Dr Etienne El Helou	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HelouEl		Baabda	Mount Lebanon	1003	Lebanon

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015412	Mastectomy, Segmental

Ancestor Terms

ID	Term
D008408	Mastectomy
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided