Division of Cancer Prevention NH-DCP-001: Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
All Ages, Male and Female
DCP-001 (primary)
NH-DCP-001
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.
Objectives
1) Implement a screening tool in NCORP to collect broader demographic and clinical data to generate hypothesis and research questions in the following areas of research: cancer screening, cancer prevention, symptom science, cancer care disparities, comparative effectiveness and cancer care delivery research.
2) Collect expanded demographic and clinical data (e.g., SES, co-morbidities, method of diagnosis) across the NCORP network to help identify and best characterize patients that are screened but not enrolled and for patients that participate in NCI trials, to understand how these variables may impact outcomes.
3) Enhance an understanding of site- specific and trial-specific accrual barriers that will inform the development of effective strategies to improve accrual, particularly for minority and underserved populations.
4) Provide data for internal and external evaluation of NCORP s first RFA cycle and reissuance.
Eligibility
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.
Treatment Sites in Georgia
NGMC-Gainesville
Wisteria Building Suite 420
200 South Enota
Gainesville, GA 30501
770-219-8822
www.nghs.com
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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