Official Title

(DCP-001) Use of Clinical Trial Screening Tool to address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

Purpose

Despite a plethora of literature documenting barriers to clinical trial accrual, there are a scant number of well-designed studies testing interventions to overcome these barriers and a limited number of evidence-based strategies in the literature. Tehe rate of adult clinical trial participation remains stagnant at 3-5% and this rate is even lower for minority and underserved populations. Over the past 5 years, 14% of cancer control and prevention trials supported by the legacy NCI Community Clinical Oncology Program (CCOP) and Minority Based Community Clinical Oncology Program (MB-CCOP) closed due to poor accrual and furthermore, 40% did not meet accrual goals (unpublished data). In addition to low accrual, there is a lack of understanding of the patient population screened for clinical trials who do not enroll; and for those that do enroll, demographic data collected on trials sponsored by the National Cancer Institute (NCI) is limited to age, gender, race, ethnicity and method of payment/insurance status. It is well known that racial/ethnic minorities experience a larger cancer burden compared to that of Caucasians and are more likely to present at a later stage of cancer with a less favorable treatment outcome. Correlation of expanded patient demographics and clinical information to include socioeconomic status (SES) and method of diagnoses is one way to enhance our ability to evaluate potential differences in outcomes in clinical trials and factors influencing participation in clinical trials among minority and underserved populations. Inclusion of minority and underserved populations in cancer clinical trials not only is a mechanism to enhance our understanding of these disparities but also provides access to state-of-theart care. 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. The tool, based on a screening log successfully used within the NCI Community Cancer Centers Program (NCCCP), has been streamlined and integrated into the sites’ workflow by using OPEN. The NCORP Screening Tool In an effort to broaden our understanding of who is screened for NCI clinical trials and the barriers to clinical trial participation, NCORP has developed a clinical trials screening tool. 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. NCORP will expand the effort to study more directed demographic data along with specific diagnosis variables to improve overall understanding of patients who are screened and accrued to clinical trials as well as the barriers that prevent clinical trial participation. These data will be imbedded within familiar clinical trial data collection vehicles to diminish impact to the sites. Data analysis will focus on minority and underserved populations. Collection of broader demographic data will allow NCORP investigators to use this data to generate hypotheses and to develop concepts focusing on disparities research and cancer care delivery research, a new area of research in NCORP. Further, data from the tool will be used in evaluating aspects of the NCORP program such as the development of new concepts to move disparities and cancer care delivery research forward and participation of minority and underserved populations in clinical trials. The data from the tool will also be used as part of the sites’ progress report, providing data on screening efforts versus enrollment. 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.

Detailed Description

Eligibility Criteria

Inclusion Criteria

1.  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, late phase treatment trials and select phase II 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: a) Cancer diagnosis including stage and histology or pre-malignancy (not applicable to prevention, screening or post-treatment surveillance trials) b) Age range specified in the protocol for which the patient is being screened c) Indication for the study intervention (e.g., symptom, toxicity) 2.  A legally authorized representative may consent for a participant with impaired decision making.

Exclusion Criteria

N/A

Keywords and/or Specific Medical Conditions

Other

Cancer Health Disparities

NCI Community Oncology Research Program (NCORP)

Clinical Trial Screening

Sponsors

Division of Cancer Prevention, NCI