The purpose of this Notice is to inform potential applicants of the special interest of the National Cancer Institute (NCI) in promoting research on understanding and enhancing oral anticancer medication utilization, adherence, and health care delivery.

Background

There are currently more than 50 U.S. Food and Drug Administration (FDA)-approved oral anticancer agents and it is expected that the rate of development, approval, and use of these medications will continue to increase. Achieving maximal benefit of oral anticancer agents requires that they are prescribed, administered and monitored properly. To pursue and accomplish this goal, it is necessary to track, utilize, and identify factors that influence adherence and that enhance care delivery systems that improve appropriate and safe use of these agents by both clinicians and patients. Research projects should advance actionable knowledge regarding the utilization, adherence, and/or care delivery of oral anticancer agents

There is little information about the adoption of newly approved oral agents, particularly those approved through an accelerated pathway, and the provider factors influencing utilization of these new therapies. Despite the targeted nature of many of these agents, use of these drugs may be accompanied by adverse events that are often unknown until the drugs have been widely used. In addition, there is scant information about the effect of genomic testing on off-label use of oral anticancer agents, as well as patient and provider characteristics associated with off-label prescribing

Adherence to oral anticancer agents, particularly molecularly targeted therapy, is critical to achieving an optimal clinical outcome. Suboptimal adherence may not only lead to poor survival, but to side effects and toxicities, unnecessary treatment changes, increased use of health care resources, and decreased patient satisfaction. The complexity of many oral anticancer regimens and the difficulty managing side effects of these drugs in the home have been strongly associated with suboptimal adherence, which may result in therapeutic failure.

Traditional parenteral therapy is administered in controlled clinical settings with the oncologist, nurses, and pharmacists providing care according to national safety standards. However, oral anticancer agents are often administered and monitored by patients and caregivers in the home. There is an emerging need for health care systems to establish new roles and responsibilities, models of care, technology support, patient education strategies, and interventions for coordinating care of these patients.

Research Objectives

This Notice invites research applications that: characterize the patient and provider factors influencing utilization of oral anticancer agents; identify structural, systemic, and psychosocial barriers to adherence; and/or develop models and strategies to improve safe and effective delivery of oral anticancer agents. Research may be focused at the patient (pediatric, adolescent, young adult, and/or adult), patient-caregiver dyad, provider, health care team, and/or health care delivery system levels. Research that merges expertise from diverse areas of science and clinical disciplines (e.g., pharmacy, nursing, oncology, primary care) or is focused on molecularly targeted agents is not required, but strongly encouraged. Addressing the needs of groups subject to disparities, such as the elderly or medically underserved, is an NCI priority.

Areas of interest include, but are not limited to, research that falls in one or more of the following three categories.

Utilization:

• Identify current trends in utilization of newly approved molecularly targeted oral therapies.
• Describe patient, provider, and organizational characteristics associated with prescribing and use of molecularly targeted oral therapies.

Adherence:

• Describe patients’ perception of risks associated with oral anticancer agents, and how these risk perceptions influence adherence.
• Identify daily decision points that influence adherence to oral anticancer therapy.

Care Delivery:

• Develop and test innovative intervention(s) in the care delivery setting to optimize patient treatment regimen adherence.
• Develop and test interventions to enhance patient reporting of side effects and timely system response.

Application and Submission Information

This notice applies to due dates on or after June 5, 2020, and subsequent receipt dates through January 8, 2023.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcements through the expiration date of this notice

Activity Code	FOA Title	First Available Due Date
R01	PA-19-056 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)	June 5, 2020
R01	PA-18-722 Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health (R01 Clinical Trial Optional)	June 5, 2020
R01	PAR-18-869 Modular R01s in Cancer Control and Population Sciences (R01 Clinical Trial Optional)	November 6, 2020
R01	PAR-18-559 Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)	June 5, 2020
R21	PA-19-053 NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)	June 16, 2020
R21	PA-18-723 Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health (R21 Clinical Trial Optional)	June 16, 2020
R21	PAR-19-309 Stimulating Innovations in Behavioral Intervention Research for Cancer Prevention and Control (R21 Clinical Trial Optional)	June 16, 2020
R03	PAR-20-052 NCI Small Grants Program for Cancer Research for Years 2020, 2021, and 2022 (NCI Omnibus R03 Clinical Trial Optional)	June 16, 2020
P01	PAR-20-077 National Cancer Institute Program Project Applications (P01 Clinical Trial Optional)	May 25, 2020

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-CA-20-026” (without quotation marks) in the Agency Routing Identifier field (box 4b) of the SF424 R&R form. Applications without this information in box 4b will not be considered for this initiative.

Although NCI is not listed as a Participating Organization in all the FOAs listed above, applications for this initiative will be accepted.

Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.