- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05583981
Stakeholder Assessment of Implementing the Commission on Cancer Operative Standards for Cancer Surgery
February 28, 2023 updated by: Ko Un Park, Ohio State University Comprehensive Cancer Center
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
31
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational (interview)
Participants participate in interview over 30-60 minutes.
|
Participate in interview
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Barriers to implementing breast Synoptic Operative Reports
Time Frame: Up to 2 years
|
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
Time Frame: Up to 2 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2021
Primary Completion (Actual)
June 15, 2022
Study Completion (Actual)
June 15, 2022
Study Registration Dates
First Submitted
October 12, 2022
First Submitted That Met QC Criteria
October 13, 2022
First Posted (Actual)
October 18, 2022
Study Record Updates
Last Update Posted (Actual)
March 2, 2023
Last Update Submitted That Met QC Criteria
February 28, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-21198
- NCI-2021-08725 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 1K08CA263488-01A1 (U.S. NIH Grant/Contract)
- 202010121 (Other Grant/Funding Number: Alliance NCTN Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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