Breast CarcinomaNCT05583981
Stakeholder Assessment of Implementing the Commission on Cancer Operative Standards for Cancer Surgery
An observational study of Breast Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Interview
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 15 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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
Who may be able to join
- Adults >= 18 years
- Available phone or device for contact
- English speaking
- Works at Commission on Cancer (CoC) - accredited cancer program
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Breast Carcinoma
- Being tested
- Interview
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Participate in interview
| Study group | Role | What they receive |
|---|---|---|
| Observational (interview) | Participants participate in interview over 30-60 minutes. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Dec 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ko Un Park, Ohio State University Comprehensive Cancer Center
- Investigators
- Ko Un Park, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583981
- Sponsor's protocol ID
- OSU-21198
- Other IDs
- NCI-2021-08725, 1K08CA263488-01A1, 202010121
- Status last verified
- Feb 2023
- First submitted
- 12 Oct 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stakeholder Assessment of Implementing the Commission on Cancer Operative Standards for Cancer Surgery
- ClinicalTrials.gov ID
- NCT05583981
- Acronym / sponsor ID
- OSU-21198
- Conditions
- Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (interview) | – | Other: InterviewParticipants participate in interview over 30-60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (4 listed)
- Adults >= 18 years
- Available phone or device for contact
- English speaking
- Works at Commission on Cancer (CoC) - accredited cancer program
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewParticipate in interview | Other | Observational (interview) |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ko Un Park, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barriers to implementing breast Synoptic Operative Reports (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.