A New Way to Share Radiation Therapy Plans Between Doctors, CORRECT Trial

NCT07282444 | Not Yet Recruiting DMC

• 6 other identifiers: IRB00141160U34CA297499UG1CA189824P30CA012197NCI - 2025-07036WF-2402CD
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Carcinoma; Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Time (in business days) required to install the information technology (IT) application

  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

  During RT planning for each patient; over the 9 months of of patient accrual

• Percentage of approached patients who declined consent

  During screening and enrollment over the 9 months of patient accrual

• Acceptability of the CORRECT workflow.

  Up to 2 months after patient enrollment has concluded

• Appropriateness of the CORRECT workflow

  Up to 2 months after patient enrollment has concluded

Study Arms (1)

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.

Behavioral: Training and Education; Other: Communication Intervention; Other: Survey Administration; Other: Interview; Other: Electronic Health Record Review

Interventions

Training and Education BEHAVIORAL

Receive training and practice cases on CORRECT workflow

Health Services Research (CORRECT workflow)

Communication Intervention OTHER

Use CORRECT workflow

Health Services Research (CORRECT workflow)

Survey Administration OTHER

Ancillary studies

Health Services Research (CORRECT workflow)

Interview OTHER

Ancillary studies

Health Services Research (CORRECT workflow)

Electronic Health Record Review OTHER

Ancillary studies

Health Services Research (CORRECT workflow)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PRACTICE: Must provide radiation therapy for ≥ 3 patients per month with lung cancer or head \& neck cancer
• PRACTICE: At least one radiation oncologist and one radiologist (in house, contracted, etc.) at the practice willing to participate, but may have multiple participants at the practice
• PRACTICE: Radiation oncologist/radiologist team must use Picture Archiving and Communication System (PACS) software at this practice
• RADIATION ONCOLOGIST (NON-PATIENT): Must have been in independent practice (i.e., performing duties without preceptor oversight) for a minimum of six months
• RADIATION ONCOLOGIST (NON-PATIENT): Must treat lung and/or head \& neck cancer patients with curative intent radiation therapy
• RADIATION ONCOLOGIST (NON-PATIENT): Willing and able to participate in 15 minutes of mandatory virtual CORRECT training
• RADIATION ONCOLOGIST (NON-PATIENT): Willing to participate in a 30-minute interview, if selected at the end of the study
• RADIOLOGIST (NON-PATIENT): Must have been in independent practice (i.e., performing duties without preceptor oversight) for a minimum of six months
• RADIOLOGIST (NON-PATIENT): Agree to review pre-treatment radiation therapy targets during the course of the study duration (approximately 12 months). Willing and able to participate in 15 minutes of mandatory virtual CORRECT training
• RADIOLOGIST (NON-PATIENT): Willing to participate in a 30-minute interview, if selected at the end of the study
• PATIENT: Must have any stage of clinically diagnosed lung or head \& neck (HN) cancer
• PATIENT: Planned treatment with curative intent definitive RT (with or without other treatments). Curative intent RT must be documented in the electronic medical record (EMR) by the treating radiation oncologist
• PATIENT: Must be expected to be treated by a radiation oncologist participating in this study
• PATIENT: Must be 18 years or older

You may not qualify if:

• PRACTICE: Participation by the Community Site or Minority/Underserved Community Site in another National Cancer Institute (NCI) Community Oncology Research Program (NCORP) Cancer Care Delivery Research (CCDR) U34-supported protocol funded in NCI fiscal year 2025 or later. (Note: WF- 2301CD CONNECT is exempt from this policy, as it was funded prior to NCI fiscal year 2025.)
• RADIATION ONCOLOGIST (NON-PATIENT): Planning to leave their position at this practice within the next 12 months
• RADIATION ONCOLOGIST (NON-PATIENT): Providing service on a temporary basis (i.e., locum tenens providers)
• RADIOLOGIST (NON-PATIENT): Planning to leave their position at this practice within the next 12 months
• RADIOLOGIST (NON-PATIENT): Providing service on a temporary basis (i.e., locum tenens providers)
• PATIENT: Unable to understand English or Spanish
• PATIENT: Early glottic larynx cancer planned for definitive RT alone

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest NCORP Research Base

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Educational Status; Interviews as Topic

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kathryn Weaver, PhD

  Wake Forest University Health Sciences

  STUDY CHAIR

Central Study Contacts

Karen Craver

CONTACT

336-716-0891; NCORP@wfusm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No Data Available
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: No Data Available

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 15, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: 6 months after publication for a 2 year duration
• Access Criteria: upon request to NCORP@wfusm.edu

Locations

US (1)