FREQUENTLY ASKED QUESTIONS

NCORP community-based research examines strategies to reduce cancer risk and incidence; improve cancer care outcomes; expand access to cancer care; increase quality and value of care; and reduce cancer disparities. This includes:

• Cancer prevention studies to identify and evaluate interventions to reduce cancer risk and incidence;
• Cancer control studies to reduce incidence and co-morbidity of cancer and its treatment, and enhance quality of life;
• Cancer screening studies to evaluate early diagnosis interventions and cancer recurrence; and
• Health-related quality of life or patient-reported outcomes research nested in National Clinical Trials Network (NCTN) treatment trials.

Other research areas include:

• Natural history and mechanisms of cancer and its treatment-related symptoms and toxicities;
• Post-treatment surveillance (such as tumor markers of recurrence, and optimal screening modalities);
• Issues with the appropriate use of proven early detection interventions, such as over-diagnosis of cancer; and
• Management of pre-cancerous lesions.

In addition, NCORP’s cancer care delivery research (CCDR) agenda encompasses a multidisciplinary field of scientific investigation including:

• Examination of how social factors, financing systems, organizational structures/processes, health technologies, and healthcare provider and individual behaviors affect cancer outcomes, access to and quality of care, cancer care costs, and health and well-being of cancer patients and survivors.
• Focus may be on individuals, families, organizations, institutions, providers, communities, populations, and their interactions.

NCORP consists of three major components: Research Bases, Community Sites, and Minority/Underserved Community Sites.

Research Bases – Seven Research Bases serve as hubs to design and conduct multi-center cancer prevention, control and screening/post-treatment surveillance clinical trials, and cancer care delivery research (CCDR) studies. Research Bases consist of researchers with expertise in cancer clinical trials and CCDR. They provide the established infrastructure including: administration, data management, scientific and statistical leadership, study operational processes and personnel, and regulatory compliance for clinical trials and cancer care delivery research.

Community Sites – Thirty-four Community Sites accrue participants to clinical trials conducted by NCORP Research Bases and to NCI NCTN treatment, imaging, and quality-of-life trials; and participate in CCDR involving patients, practitioners and/or healthcare organizations. Community Sites also engage community partners and support CCDR studies.

Minority/Underserved Community Sites - Twelve Minority/Underserved Community Sites accrue participants to trials conducted by NCORP Research Bases and to NCI NCTN treatment, imaging, and quality-of-life trials; and participate in CCDR. Minority/Underserved Community Sites have a patient population comprising at least 30% racial/ethnic minorities or rural residents. Also, they engage community partners and support CCDR studies.

No. NCI has been collaborating with community investigators and bringing research to communities for more than 30 years. Cancer clinical research traditionally was conducted at academic medical centers, but most cancer care actually takes place in the community setting.

NCORP builds on the scope and activities of two previously supported networks that were consolidated to preserve and enhance cancer research in the community: the NCI Community Clinical Oncology Program (Community Clinical Oncology Programs, Minority-Based Clinical Oncology Programs, and Research Bases) and the NCI Community Cancer Centers Program (NCCCP).

During the consolidation, NCI’s Division of Cancer Prevention, the group that leads NCORP, reached out to organizations that were not funded in the new program to address their specific organizational needs to ensure that patients in active trials and follow up had the opportunity to continue to receive care on their studies. Ongoing trials from the CCOP program will be seamlessly incorporated into the NCORP mechanism and continue to completion.

Approximately $12 million of NCI funds are being provided for a responsible transition to ensure patient care and support of existing studies.

NCORP has been in development at the NCI for over a year. The program concept was approved by the NCI Board of Scientific Advisors on June 24, 2013, and the Funding Opportunity Announcements for NCORP Sites and Research Bases were released in November 2013. Applications were reviewed by non-NCI expert panels assembled by the NCI and then evaluated by NCI program staff in order to make a final funding plan. This plan was reviewed and approved by the NCI Scientific Program Leaders committee, chaired by the NCI director.

The program will receive $93 million a year for 5 years. NCI announced the final list of NCORP Sites on August 1, 2014. The listing of sites is available at http://ncorp.cancer.gov.

Cancer disparities are an important focus of all NCORP research. This area addresses clinical trial and cancer care delivery research (CCDR) questions related to the most serious, prevalent cancers and cancer-related problems that disproportionately affect racial/ethnic minorities and underserved populations. It will include studies to:

• Enhance the participation of racial/ethnic minorities and the underserved in clinical trials;
• Address determinants of disparities (for example, social and health care system factors, co-morbidities, and genomics); and
• Evaluate differential outcomes in minority/underserved populations, including people in rural settings.

The NCORP director is Worta McCaskill-Stevens, MD, MS. She is also the chief of the Community Oncology and Prevention Trials Research Group in the NCI Division of Cancer Prevention, the division that houses NCORP.

Rachel Ballard-Barbash, MD, MPH, NCORP associate director, is from the NCI Division of Cancer Control and Population Sciences. Her area of focus for NCORP will be in cancer care delivery research.

Being able to join research studies in a person’s own community allows the person to stay close to family, friends, support systems and their local physicians and health organizations, where high-quality clinical studies are investigating ways to improve care.

Expanding clinical research beyond the academic environment allows access to a larger and more diverse patient population in a variety of "real world" healthcare settings. This can accelerate accrual to clinical trials, enable feasibility testing of promising new interventions, and increase the generalizability of study findings. Engaging community oncologists in collaborative research can also facilitate the uptake of effective, evidence-based practices into routine care.

Individuals, organizations, group practices or others interested in accessing NCI clinical trials through NCORP can contact the Principal Investigator or Administrator of a Community NCORP Site or Minority/Underserved NCORP Site. The listing of sites is available at http://ncorp.cancer.gov.

NCI has developed guidelines and processes to assist investigators in accessing NCORP’s network. For more information about supportive care, contact Ann O’Mara, PhD, RN, program director, at omaraa@mail.nih.gov. For information about cancer care delivery research, contact Kate Castro, RN, MS, AOCN, nurse consultant, at castrok@mail.nih.gov.

NCORP and the National Clinical Trials Network (NCTN) are funded through separate budgets. However, NCORP funding includes support for a number of NCTN activities, including patient accrual and data management in treatment clinical trials. All five NCTN groups and statistical centers are funded as NCORP Research Bases for cancer prevention, control, and cancer care delivery research. NCORP was designed to work seamlessly in tandem with the NCTN, which is led by the NCI Division of Cancer Treatment and Diagnosis (DCTD). NCORP will align with NCTN to reduce operational redundancies, streamline reporting requirements, and leverage cross-institutional data systems in order to create a more efficient clinical trials network.

Options for the National Clinical Trials Network (NCTN) Membership are to:

• Become a member of a Community NCORP Site or Minority/Underserved NCORP Site.
• Become a Main Member of an NCTN Network Group by contacting the Membership Affairs office of the particular Group. See the NCI NCTN page http://www.cancer.gov/clinicaltrials/nctn.
• Become an affiliate of a Main Member of an NCTN Group by contacting the Membership Affairs office of the particular Group. See the NCI NCTN page http://www.cancer.gov/clinicaltrials/nctn.

The following links have additional information about NCORP:

• NCORP website: http://ncorp.cancer.gov
• NCI Approves Funding Plan for NCI Community Oncology Research Program (NCORP), posted June 25, 2014 http://prevention.cancer.gov/news-events/news/20140625
• NCI Community Oncology Research Program (NCORP), updated June 25, 2014 http://prevention.cancer.gov/ncorp
• An Overview of NCI’s National Clinical Trials Network, posted May 29, 2014 http://www.cancer.gov/clinicaltrials/nctn
• An Open Letter to the Cancer Community Regarding Community Clinical Trials, posted April 10, 2014 http://www.cancer.gov/aboutnci/director/messages/clinicaltrials
• Statement on Forthcoming Changes in NCI’s Clinical Trials Programs, posted April 4, 2014 http://www.cancer.gov/newscenter/newsfromnci/2014/NCTNstatement
• NCI Community Oncology Research Program Approved, posted June 24, 2013 http://ccop.cancer.gov/news-events/news/20130625