Wake Forest NCORP Research Base
Winston-Salem, North Carolina, 27157, United States
Location contact
Karen T Craver, MT
CONTACT
Kathryn E Weaver, PhD
CONTACT
NCT Number: NCT07282444
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Winston-Salem, North Carolina, 27157, United States
Karen T Craver, MT
CONTACT
Kathryn E Weaver, PhD
CONTACT
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive training and practice cases on CORRECT workflow
Use CORRECT workflow
Ancillary studies
Ancillary studies
Ancillary studies
Time frame: Within 2 business days from receipt of initial radiation therapy (RT) targets
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.
Time frame: During study start-up prior to the enrollment of first patient case; up to 60 days after CIRB approval at the practice.
Will be assessed at each practice as tracked on the CORRECT IT data form
Time frame: During RT planning for each patient; over the 9 months of of patient accrual
Will be assessed at each practice as tracked on the CORRECT IT data form.
Time frame: During screening and enrollment over the 9 months of patient accrual
Will be assessed at each practice as tracked on the Patient Refusal form.
Time frame: Up to 2 months after patient enrollment has concluded
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.
Time frame: Up to 2 months after patient enrollment has concluded
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.
Time frame: Up to 2 months after patient enrollment has concluded
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.
Time frame: Up to 2 months after patient enrollment has concluded
Will be identified using qualitative interviews using the radiation oncologist/radiologist interview guide.
Contact information is provided by the study sponsor or research team.
Wake Forest University Health Sciences
Other
Collaborative Oncology Between Radiologists and Radiation Oncologists for the Evaluation of Contoured Targets (CORRECT)
Acronym: CORRECT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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