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

Официальное название

Collaborative Oncology Between Radiologists and Radiation Oncologists for the Evaluation of Contoured Targets (CORRECT)

Обзор

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.

Подробное описание

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

Вмешательства

• Поведенческое Training and Education
  Receive training and practice cases on CORRECT workflow
• Другое Communication Intervention
  Use CORRECT workflow
• Другое Survey Administration
  Ancillary studies
• Другое Interview
  Ancillary studies
• Другое Electronic Health Record Review
  Ancillary studies

Первичные конечные точки

• The return of radiology feedback via Collaborative Oncology between Radiologists and Radiation oncologists for the Evaluation of Contoured Targets (CORRECT) (feasibility) [Срок оценки: Within 2 business days from receipt of initial radiation therapy (RT) targets]

Вторичные конечные точки (7)

• Time (in business days) required to install the information technology (IT) application [Срок оценки: 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 [Срок оценки: During RT planning for each patient; over the 9 months of of patient accrual]
• Percentage of approached patients who declined consent [Срок оценки: During screening and enrollment over the 9 months of patient accrual]
• Acceptability of the CORRECT workflow. [Срок оценки: Up to 2 months after patient enrollment has concluded]
• Appropriateness of the CORRECT workflow [Срок оценки: Up to 2 months after patient enrollment has concluded]
• Feasibility of the CORRECT workflow [Срок оценки: 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 [Срок оценки: Up to 2 months after patient enrollment has concluded]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Wake Forest NCORP Research Base — Winston-Salem

Идентификаторы

NCT: NCT07282444 · IRB00141160 · U34CA297499 · UG1CA189824 · P30CA012197 · NCI - 2025-07036 · WF-2402CD · WF-2402CD · WF-2402CD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗