Use of a clinical trial screening tool to address cancer health disparities in the NCI Community Oncology Research Program (NCORP)
A clinical trial screening tool protocol has been developed to facilitate the formulation of research questions; particularly those evaluating factors related to populations that are underrepresented in clinical trials, and address cancer care disparities. This protocol is designed to allow the collection, storage, and abstraction of clinical and demographic data obtained during the screening process, using the Oncology Patient Enrollment Network (OPEN), the same informatics system used by investigators participating in NCI-sponsored trials. The protocol is not a scientific study; rather, a method to implement the screening tool and allow the collection and analyses of expanded data with informed consent.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- All patients (pediatric and adults) screened for selected NCORP trials supported by the Division of Cancer Prevention (DCP) and treatment trials supported by CTEP within the NCTN. Only NCORP sites will participate in DCP-001. These trials include symptom and toxicity management, prevention, screening, post-treatment surveillance, comparative effectiveness and late phase treatment trials. Cancer care delivery clinical trials will be included if the primary aim focuses on a patient intervention. A screened patient will be defined as one meeting the following minimum eligibility criteria per the protocol being screened for:
- Cancer diagnosis including stage and histology or pre-malignancy
- Age range specified in the protocol for which the patient is being screened
- Indication for the study intervention (e.g., symptom, toxicity)
- A legally authorized representative may consent for a participant with impaired decision making.
National Cancer Institute (NCI)