DCP-001

In an effort to broaden the understanding of who is screened for NCI clinical trials and the barriers to clinical trial participation, NCORP has developed a clinical trials screening tool. Use and testing of screening tools has been encouraged by cancer care organizations nationally including: NCI, American Society of Clinical Oncology (ASCO); American College of Surgeons’ Commission on Cancer to address accrual to cancer trials; and by the NCI/ASCO/American Association of Clinical Research (AACR)/American Cancer Society (ACS) Cancer Disparities Research Think Tank: Charting the Future of Cancer Disparities Research. The overall objective of this protocol is to determine if such a screening tool within NCORP can further its’ research agenda focused on addressing health care disparities and increasing clinical trial accrual, especially among minority and underserved populations.

In summary, an important aspect of conducting clinical research is to enhance enrollment so that trial accrual more accurately reflects the broader population that will/may ultimately benefit from the trial results and to collect information from patients that will inform future research questions and better trial development/structure. Implementation of a patient clinical trials screening tool within NCORP will provide data to enhance patient enrollment to clinical trials, including minority and underrepresented populations. The NCORP Clinical Trials Screening Tool will also provide a unique opportunity to collect expanded demographic and clinical data to increase our understanding of who is or is not enrolled in NCI sponsored trials and address research questions related to disparities in cancer care and cancer care delivery. The NCORP Clinical Trials Screening Tool will add eight elements that are not currently being collected including marital status, rural status, education level, employment status, annual income, insurance status at time of clinical trial screening, method of diagnosis and comorbidities.

Patient Enrollment:

Potential study participants will be asked to participate in the screening tool study at the time they are screened for a NCORP or NCTN clinical trial or up to 4 weeks after screening is complete and eligibility is determined for the NCORP or NCTN trial. Patients can be registered to DCP-001 up to 4 weeks after eligibility for and enrollment status to the trial for which the patient is being screened for has been determined. Participants may be screened for more than one clinical trial. The DCP-001 informed consent document only needs to be signed once. Following informed consent, the participant will be asked several demographic questions and questions related to clinical trial participation. Clinical information requested by the tool will be obtained from the participant’s medical record by a member of the research team.

Patients may be informed about the study, consented and trial data may be collected over the phone when it is not feasible for the patient to return to the clinic for an unscheduled visit due to distance, lack of transportation, physical limitations or poor health.