Stakeholder Assessment of Implementing the Commission on... | NCT05583981

Studies
Stakeholder Assessment of Implementing the Commission on Cancer Operative Standards for Cancer Surgery

NCT05583981

Sponsor

Ohio State University Comprehensive Cancer Center

Status

Completed

Last Update Posted

Mar 2, 2023Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Breast Carcinoma

Interventions

Interview

Countries

United States

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2021-08725	Registry Identifier	CTRP (Clinical Trial Reporting Program)
1K08CA263488-01A1	U.S. NIH Grant/Contract		View source
202010121	Other Grant/Funding Number	Alliance NCTN Foundation

Status Module

Record Verification Date

Feb 2023

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

Dec 1, 2021Actual

Primary Completion Date

Jun 15, 2022Actual

Completion Date

Jun 15, 2022Actual

First Submitted Date

Oct 12, 2022

First Submission Date that Met QC Criteria

Oct 13, 2022

First Posted Date

Oct 18, 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

Feb 28, 2023

Last Update Posted Date

Mar 2, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ko Un Park, Principal Investigator, Ohio State University Comprehensive Cancer CenterPrincipal Investigator

Lead Sponsor

Ohio State University Comprehensive Cancer CenterOTHER

Collaborators

Name	Class
National Cancer Institute (NCI)	NIH

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

This study investigates the barriers to implementing breast Synoptic Operative Reports. Information from this study may help researchers identify performance objectives for the breast Synoptic Operative Reports to be adopted, implemented and continued.

Detailed Description

PRIMARY OBJECTIVES:

I. To identify and describe barriers to implementing breast Synoptic Operative Reports (SOR) from multiple constructs.

Ia. Identify performance objectives - who must do what - for the breast SOR to be adopted, implemented, and continued.

OUTLINE:

Participants participate in interview over 30-60 minutes.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational (interview)		Participants participate in interview over 30-60 minutes.	Other: Interview

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interview	Other	Participate in interview	Observational (interview)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Barriers to implementing breast Synoptic Operative Reports	This is a qualitative study in which we will conduct in-depth, semi-structured interviews with key stakeholders. A template analysis identifying priori themes will be used, then coding for impact and/or implementation strategy.	Up to 2 years
Performance objectives for the breast Synoptic Operative Reports to be adopted, implemented, and continued	This is a qualitative study in which we will conduct in-depth, semi-structured interviews with key stakeholders.A template analysis identifying priori themes will be used, then coding for impact and/or implementation strategy.	Up to 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults >= 18 years
Available phone or device for contact
English speaking
Works at Commission on Cancer (CoC) - accredited cancer program

Exclusion Criteria: none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Key stakeholders (e.g. electronic medical record [EMR] engineer, Cancer Liaison Physician [CLP], breast surgeon, and cancer registrar administrator) from Ohio State University and 3 other Commission on Cancer (CoC)-accredited cancer programs

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ko Un Park, MD	Ohio State University Comprehensive Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ohio State University Comprehensive Cancer Center		Columbus	Ohio	43210	United States

Label	URL
The Jamesline	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Nov 5, 2021	Jan 13, 2023	ICF_000.pdf

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
D007407	Interviews as Topic

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided