Lung CarcinomaCORRECTNCT07282444
A New Way to Share Radiation Therapy Plans Between Doctors, CORRECT Trial
A study testing Training and Education, Communication Intervention and Survey Administration in people with Lung Carcinoma and Head and Neck Carcinoma, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Carcinoma, Head and Neck Carcinoma
- What is being tested?
- Training and Education, Communication Intervention and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- PRACTICE: Participation by the Community Site or Academic 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest NCORP Research Base
Winston-Salem, North Carolina, 27157
Kathryn E Weaver, PhD, 336-716-0891, kathryn.weaver@wfusm.edu
Karen T Craver, MT, 3367160891, karen.craver@advocatehealth.org
About this study
Official title: Collaborative Oncology Between Radiologists and Radiation Oncologists for the Evaluation of Contoured Targets (CORRECT)
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.
Read the detailed description
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:
- 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
- Conditions
- Lung Carcinoma, Head and Neck Carcinoma
- Being tested
- Training and Education, Communication Intervention, Survey Administration, Interview, Electronic Health Record Review
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training and EducationBehavioural
Receive training and practice cases on CORRECT workflow
Communication InterventionOther
Use CORRECT workflow
Survey AdministrationOther
Ancillary studies
InterviewOther
Ancillary studies
Electronic Health Record ReviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Training and Education; Other: Communication Intervention; Other: Survey Administration; Other: Interview; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Will be assessed at each practice as tracked on the CORRECT IT data form
Measured: 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
Will be assessed at each practice as tracked on the CORRECT IT data form.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 months after patient enrollment has concluded
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- No Data Available
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathryn Weaver, PhD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282444
- Sponsor's protocol ID
- IRB00141160
- Other IDs
- U34CA297499, UG1CA189824, P30CA012197, NCI - 2025-07036, WF-2402CD, WF-2402CD, WF-2402CD
- Acronym
- CORRECT
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Oncology Between Radiologists and Radiation Oncologists for the Evaluation of Contoured Targets (CORRECT)
- ClinicalTrials.gov ID
- NCT07282444
- Acronym / sponsor ID
- CORRECT / IRB00141160
- Conditions
- Lung Carcinoma, Head and Neck Carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 15 Dec 2025 (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 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.
Detailed description
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:
- 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
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- No Data Available
| Arm | Type | Receives |
|---|---|---|
| Health Services Research (CORRECT workflow) | Experimental | Behavioral: Training and Education, Other: Communication Intervention, Other: Survey Administration, Other: Interview, Other: Electronic Health Record ReviewROs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (7 listed)
- PRACTICE: Participation by the Community Site or Academic 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)
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 |
|---|---|---|
| Training and EducationReceive training and practice cases on CORRECT workflow | Behavioural | Health Services Research (CORRECT workflow) |
| Communication InterventionUse CORRECT workflow | Other | Health Services Research (CORRECT workflow) |
| Survey AdministrationAncillary studies | Other | Health Services Research (CORRECT workflow) |
| InterviewAncillary studies | Other | Health Services Research (CORRECT workflow) |
| Electronic Health Record ReviewAncillary studies | Other | Health Services Research (CORRECT workflow) |
Primary outcome
The return of radiology feedback via Collaborative Oncology between Radiologists and Radiation oncologists for the Evaluation of Contoured Targets (CORRECT) (feasibility)
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.
7 secondary outcomes
Time (in business days) required to install the information technology (IT) application
Time frame: 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
Time frame: During RT planning for each patient; over the 9 months of of patient accrual
Percentage of approached patients who declined consent
Time frame: During screening and enrollment over the 9 months of patient accrual
Acceptability of the CORRECT workflow.
Time frame: Up to 2 months after patient enrollment has concluded
Appropriateness of the CORRECT workflow
Time frame: Up to 2 months after patient enrollment has concluded
Feasibility of the CORRECT workflow
Time frame: 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
Time frame: Up to 2 months after patient enrollment has concluded
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Yes. 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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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.
Kathryn Weaver, PhD study chair
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training and Education, Communication Intervention and Survey Administration in people with Lung Carcinoma and Head and Neck Carcinoma, run by Wake Forest University Health Sciences 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 14 inclusion and 7 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: opening soon, as of the sponsor's last update on 23 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Craver (336-716-0891, NCORP@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The return of radiology feedback via Collaborative Oncology between Radiologists and Radiation oncologists for the Evaluation of Contoured Targets (CORRECT) (feasibility) (time frame: Within 2 business days from receipt of initial radiation therapy (RT) targets). 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 23 Oct 2026.