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| ID | Type | Description | Link |
|---|---|---|---|
| U34CA297499 | U.S. NIH Grant/Contract | View source | |
| UG1CA189824 | U.S. NIH Grant/Contract | View source | |
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| NCI - 2025-07036 | Other Identifier | NCI Trial Identifier | |
| WF-2402CD | Other Identifier | Lead Organization Identifier | |
| WF-2402CD | Other Identifier | DCP Identifier | |
| WF-2402CD | Other Identifier | CTEP Identifier |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial tests a new way to share radiation therapy plans using the Collaborative Oncology between Radiologists and Radiation oncologists for the Evaluation of Contoured Targets (CORRECT) workflow to improve communication and collaboration between radiation oncologists (ROs) and radiologists when determining cancer targets for radiation treatment. Systemic barriers limit critical communication between radiation oncologists and radiologists and can lead to both under and overdosing of radiation therapy (RT) tumor targets and failures to properly interpret post-treatment imaging. The limited formal diagnostic radiology training of many providers can make differentiating normal from disease imaging findings during target determination difficult, especially in complex disease sites like the lung, head, and neck. Inaccurate target determination may result in cancer return, excess toxicity, or both. Likewise, radiologists who cannot access prior RT plans may mistake expected RT changes for recurrent cancer or overlook true progression. The CORRECT workflow was developed by ROs and radiologists to address RO-radiology communication barriers by facilitating sharing of comprehensive RT target contours during RT planning. The CORRECT workflow begins with the normal process of RO target contouring. Computed tomography (CT) images are then fused with RT targets and pushed to a pre-designated Picture Archiving and Communications System (PACS) software folder accessible by the radiology department. The radiologist can then review the fused images at their chosen time and annotate images to indicate potential deviations (e.g., not avoiding normal tissue or not including all tumor). The RO reviews the annotated images and decides if any changes to treatment targets are needed for the final treatment plan. Through this independent, asynchronous review of high-quality images, CORRECT overcomes many of the limitations of existing communication methods between RO-radiologist, fostering a more collaborative, efficient, and precise approach to cancer treatment planning.
PRIMARY OBJECTIVE:
To determine the feasibility of the CORRECT workflow, defined as the return of radiology feedback via CORRECT within 2 business days from receipt of initial RT targets.
SECONDARY OBJECTIVES:
I. To further assess the feasibility of the CORRECT workflow as measured by 1) time (in business days) required to install the information technology (IT) application at each practice, 2) the number and proportion of cases per practice with reports of technical issues requiring centralized IT or CORRECT study team assistance, 3) percentage of approached patients who declined consent.
II. To assess ROs and radiologists' perceptions of acceptability, appropriateness and feasibility of the CORRECT workflow using the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM), along with the acceptability of CORRECT workflow training.
III. To identify facilitators and barriers to radiation oncology-radiology standard of care collaboration, CORRECT workflow implementation, and participation in the future trial using a qualitative interview.
OUTLINE:
ROs and radiologists receive training on the use of the CORRECT workflow and practice with test cases. ROs and radiologists then use the CORRECT workflow with patient cases for 12 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Services Research (CORRECT workflow) | Experimental | ROs and radiologists receive training on the use of the CORRECT workflow and practice with test cases. ROs and radiologists then use the CORRECT workflow with patient cases for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training and Education | Behavioral | Receive training and practice cases on CORRECT workflow |
|
| Measure | Description | Time Frame |
|---|---|---|
| The return of radiology feedback via Collaborative Oncology between Radiologists and Radiation oncologists for the Evaluation of Contoured Targets (CORRECT) (feasibility) | If > 50% of patients have target feedback returned to the radiation oncologist within 2 business days, this workflow will be considered feasible in community practice. | Within 2 business days from receipt of initial radiation therapy (RT) targets |
| Measure | Description | Time Frame |
|---|---|---|
| Time (in business days) required to install the information technology (IT) application | Will be assessed at each practice as tracked on the CORRECT IT data form | During study start-up prior to the enrollment of first patient case; up to 60 days after CIRB approval at the practice. |
| The number and proportion of cases per practice with reports of technical issues requiring centralized IT or CORRECT study team assistance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Craver | Contact | 336-716-0891 | NCORP@wfusm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kathryn Weaver, PhD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest NCORP Research Base | Winston-Salem | North Carolina | 27157 | United States |
Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
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6 months after publication for a 2 year duration
upon request to NCORP@wfusm.edu
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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No Data Available
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| Communication Intervention | Other | Use CORRECT workflow |
|
| Survey Administration | Other | Ancillary studies |
|
| Interview | Other | Ancillary studies |
|
| Electronic Health Record Review | Other | Ancillary studies |
|
Will be assessed at each practice as tracked on the CORRECT IT data form. |
| During RT planning for each patient; over the 9 months of of patient accrual |
| Percentage of approached patients who declined consent | Will be assessed at each practice as tracked on the Patient Refusal form. | During screening and enrollment over the 9 months of patient accrual |
| Acceptability of the CORRECT workflow. | Will be assessed using the Acceptability of Intervention Measure. Will be collected on the post-study radiation oncologist/radiologist survey. Scale has four items measured on a Likert scale from 1 (completely disagree) to 5 (completely agree). The four items are averaged to obtain a final score. | Up to 2 months after patient enrollment has concluded |
| Appropriateness of the CORRECT workflow | Will be assessed using the Intervention Appropriateness Measure. Will be collected on the post-study radiation oncologist/radiologist survey. Scale has four items measured on a Likert scale from 1 (completely disagree) to 5 (completely agree). The four items are averaged to obtain a final score. | Up to 2 months after patient enrollment has concluded |
| Feasibility of the CORRECT workflow | Will be assessed using the Feasibility of Intervention Measure. Will be collected on the post-study radiation oncologist/radiologist survey. Scale has four items measured on a Likert scale from 1 (completely disagree) to 5 (completely agree). The four items are averaged to obtain a final score. | Up to 2 months after patient enrollment has concluded |
| Facilitators and barriers to radiation oncology-radiology standard of care collaboration, CORRECT workflow implementation, and participation in the future trial | Will be identified using qualitative interviews using the radiation oncologist/radiologist interview guide. | Up to 2 months after patient enrollment has concluded |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008919 |
| Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |