Expired PAR-14-067: Fundamental Mechanisms of Affective and Decisional Processes in Cancer Control (U01)

Part 1. Overview Information

Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI)
Funding Opportunity Title	Fundamental Mechanisms of Affective and Decisional Processes in Cancer Control (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. April 24, 2014 - See Notice NOT-CA-14-043. Notice of Correction to the Public Pre-application Webinar. April 16, 2014 - Public Pre-application Webinar for PAR-14-067. See Notice NOT-CA-14-042.
Funding Opportunity Announcement (FOA) Number	PAR-14-067
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.393
Funding Opportunity Purpose	The purpose of this Funding Opportunity Announcement (FOA) is to encourage projects to generate fundamental knowledge of affective processes. Basic affective science projects should have key downstream consequences for single (e.g., genetic testing consent) and multiple (e.g., adherence to oral chemotherapy regimen) event decisions and behaviors across the cancer prevention and control continuum. The FOA is expected to encourage scientific disciplines that have not traditionally conducted cancer research such as affective and cognitive neuroscience, decision science, and consumer science to elucidate perplexing and understudied problems in basic affective and decision sciences with promise of having downstream implications for cancer prevention and control science.

Key Dates

Posted Date	January 8, 2014
Open Date (Earliest Submission Date)	May 10, 2014
Letter of Intent Due Date(s)	30 days before the application due date
Application Due Date(s)	June 10, 2014; October 15, 2014; June 10, 2015; October 14, 2015; June 10, 2016; October 14, 2016, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	October/November 2014; February/March 2015; October/November 2015; February/March 2016; October/November 2016; February/March 2017
Advisory Council Review	January 2015; May 2015; January 2016; May 2016, January 2017; May 2017
Earliest Start Date	April 2015; July 2015; April 2016; July 2016; April 2017; July 2017
Expiration Date	October 15, 2016
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage projects to generate fundamental knowledge of affective processes. Basic affective science projects should have key downstream consequences for single (e.g., genetic testing consent) and multiple (e.g., adherence to oral chemotherapy regimen) event decisions and behaviors across the cancer prevention and control continuum. The FOA is expected to encourage scientific disciplines that have not traditionally conducted cancer research such as affective and cognitive neuroscience, decision science, and consumer science to elucidate perplexing and understudied problems in basic affective and decision sciences with promise of having downstream implications for cancer prevention and control science.

This FOA is expected to engage scientists with limited knowledge of cancer prevention and control science. Projects should leverage classic and contemporary experimental designs and methodological paradigms to expand our understanding of affective and decisional processes that may contribute to cancer risk and outcomes. Applications are encouraged to incorporate more than one operationalization of affect (e.g., fMRI, brain lesion, physiological assessment, self-report, induction).

Projects should generate basic fundamental knowledge that provides opportunities and approaches for future applied cancer prevention and control research and interventions. Results will provide information that can be leveraged in future efforts to address perplexing scientific questions related to the behavioral reduction of cancer burden. Applications are expected to consider cancer applications in the articulation and planning of basic projects. This will ensure that basic discoveries supported under this FOA have near-term potential for translation to interventions to improve cancer prevention and control.

Background and Rationale

Individuals navigate each day making a variety of decisions, and are often unable to articulate the reasoning behind the choices they make. Often, more cognitive or deliberative explanations fail to explain these decisions, and emotional stimuli (e.g., anecdotes, imagery) often overwhelm reason-based inputs. Researchers have long speculated about the role of emotions in decision making, but tools to begin to unpack the influence of emotion on decision making are only now available. With recent advances in affective science, paradigm-shifting discoveries have changed our fundamental understanding of human decision making. For example, it is now known that emotion, although sometimes deleterious, is necessary to produce decisions that are in an individual’s best interest.

Cancer Relevance: Decisions about health and health behaviors confer significant risks and benefits along the cancer control continuum. Informed by decades of basic and translational evidence, behavioral science efforts to reduce the cancer burden have historically targeted risk perception and social normative determinants. Those investments have yielded actionable findings. However, new knowledge is needed to optimize individual and group decision making relevant to cancer risk and outcomes. Recently converging evidence demonstrates affect is a key component of decision making. Affect has been demonstrated to systematically improve or degrade decisions, depending on context. Association studies implicate affective states in cancer-related information processing; decisions about cancer risk and prevention behaviors (e.g., smoking, overeating, cancer screening, HPV vaccination); and decisions about treatment and treatment adherence. However, our understanding of why affect matters and how emotions influence single and multiple event decisions relevant to cancer prevention and control is in its infancy. Scientific disciplines historically disconnected from cancer prevention and control efforts (e.g., social and affective neuroscience; marketing and consumer science; decision science) have developed sophisticated approaches and tools that could be leveraged to understand and change behaviors known to increase cancer risk or impede treatment outcomes.

Without improvements in our basic knowledge about relevant determinants of individual and collective behavior, efforts to develop, test, and disseminate cancer control and biomedical interventions to reduce cancer risk, incidence, morbidity and mortality are hampered.

The potential of this investment is highlighted in (but not limited to) the following examples:

Self regulation/ tobacco control: Cancer-related behavioral risk factors, like smoking, often involve self-regulation failure, triggered in part by negative emotions. Although smoking prevalence has decreased steadily over the last 30 years, the rate has plateaued and disparities in use and health-related outcomes remain. New insights are needed to reaccelerate gains in primary prevention of tobacco use. Scientists are beginning to appreciate brain circuitry underlying self-regulation. Interestingly, it seems that neural circuitry underlying self-regulatory ability is shared across different areas of the brain specialized for different functions, specifically emotion, cognition, and motor control. Emerging evidence suggests that efforts to train motor control can increase activity among other domains that share neural circuitry. This body of work has potentially important implications for primary prevention. If it could be demonstrated that similar changes in neural circuitry are maintained and associated with increased emotional regulatory ability, it might be possible to leverage motor control training or engineer neural plasticity to prevent behaviors associated with self-regulation failure. Implications of this basic research are not limited to tobacco use; similar processes have been implicated in other cancer-related behaviors, such as overeating. Advances in the understanding of the complexities of self-regulation and the contribution of emotion and other functional domains could improve primary prevention efforts.
HPV vaccination adherence: Population-level surveillance finds that 32% of girls and 1.4% of boys receive the recommended HPV vaccination as indicated. Sociodemographic, economic, and public policy factors contribute to vaccination uptake; yet parents also report that different emotions influence their decisions to vaccinate. Studies have cited prevalent fear of vaccinations purported medical side effects and the potential for increased promiscuity as a result of vaccination,19 as well as dread or anticipated regret over having a child vaccinated. Given this context, it might appear intuitive to counter these affectively laden perceptions by addressing misconceptions about risk or by facilitating fear about HPV and cervical cancer to counter fear of vaccination. However, data from MMR vaccination campaigns suggest that offering evidence to counter misconceptions about risks can backfire, as fears, suspicions, and non-adherence increase among targeted parents. Moreover, explicit attempts to motivate health behaviors by eliciting fear of consequences, an approach not grounded in evidence-based affective science, often fail to increase health behaviors uptake and can even incite defensive reactions that result in less health behaviors. This body of work suggests greater understanding of how emotions motivate or hinder primary prevention decisions is necessary. If seminal breakthroughs were advanced in the conceptualization of intricate emotions like fear, precise leverage of this emotion without increasing suspicion and anticipated regret might be possible. This knowledge could be synthesized with evidence of environmental and contextual factors to develop multi-level interventions to optimally facilitate parental vaccination decisions.
Cancer screening: Adherence to cancer screening recommendations in the U.S. is suboptimal: 59% for colorectal cancer, 72% for breast cancer, and 83% for cervical cancer. Among other factors, a decision to engage in cancer screening can be motivated by emotion and affective experiences, like worry and relief. Emotions can also hinder screening, such as when culturally driven, cancer-related shame leads to decisions to avoid cancer screening or treatment. Because biological and cultural contributions to emotion and downstream consequences depend on the specific emotion and domain, a lack of basic research on relief, regret, shame, and worry in cultures and racial/ ethnic groups with screening disparities limits efforts to intervene on those constructs. Gaining mechanistic knowledge about how affective and emotional states are constructed within different cultures, would contribute to future interventions to reduce disparities among segments of the population known to avoid cancer screening.
Over-screening: Although improving adherence to recommended screenings is an important goal, reducing inappropriate screening is also critical (i.e., when individuals are too young or old to benefit, when screening is undertaken at too frequent intervals, or when a particular screening’s efficacy is not supported by empirical evidence). In some instances, guidelines call for shared decision making, or a discussion about screening options that takes into account risks and benefits, as well as the patient’s preferences and values. Reactions to guidelines suggesting reduced screening are laced with suspicion. Moreover, because individuals have difficulty anticipating how they will feel when an emotional event happens, over-screening is likely caused in part by an inability to anticipate future emotional reactions to a false positive result or unnecessary biopsy. These emotional dynamics have the potential to influence the process of shared decision making. However, little mechanistic research has examined the interaction between the emotions of all individuals in an interpersonal encounter and the resultant communication and decision-making patterns at the individual and group levels. Clarifying the mechanistic perspective on the dynamics of emotions within clinical encounters and the ways in which errors in anticipating future emotions contribute to a decision to screen without adequate consideration of risks and benefits would allow future efforts to reduce overscreening to be more effective.
Cancer treatment: Negative emotions after cancer diagnosis can cause patients to delay treatment or have difficulty deciding between treatments. Cancer patients maladaptive emotion regulatory strategies also influence decisions regarding clinical trials, which contribute to low enrollment rates. Cancer treatment adherence, in particular, may be improved by a better understanding of affective factors. Oncologists are increasingly reliant on oral chemotherapy regimens, which present a unique set of adherence challenges. Oral agents are often just one facet of a complex combination of treatments, highlighting the need to understand individual differences in capacity to engage in effective self-management. Candidacy for oral chemotherapy is partly determined by an assessment of a patient’s ability to understand and follow complex instructions and manage side effects and adverse events. Evidence suggests that information processing is profoundly affected by emotions such as anger. Moreover, positive emotional responding may trigger broadened cognitive processing that can facilitate attention and creativity, as well as strengthen the link between intentions and behavior. Thus, individual differences in affective reactions to cancer diagnosis and emotional temperament could predict ability to adhere to oral chemotherapy regimens. Deficits in basic psychological research on affective processes that contribute to information processing, self-management, and responsibility and control hinder effective adherence interventions. Identifying fundamental neural and psychological mechanisms of the effect of emotions on information processing and self-management could allow future interventions to be constructed to facilitate self-efficacy for managing side effects and adverse events, improving adherence and treatment outcomes.

Specific Research Objectives

Research questions of interest include, but are not limited to the following:

How do specific emotions influence or respond to patterns of judgment and decision making? How do emotions function in the context of social and cognitive factors that contribute to cancer risk behavioral decisions (e.g., smoking, non-adherence to HPV vaccination, diet, inactivity)?
How are emotions and other affective states regulated in the short- and long-term, and what are the temporal dynamics of emotional responding? How do emotion regulatory strategies function in the context of behaviors known to increase the risk of cancer, such as smoking, being sedentary, and overeating?
What are the neuropsychological underpinnings of craving? Can patterns of stimuli that trigger affective craving responses be identified so that future communication efforts (e.g., warning labels) do not inadvertently elicit those responses?
How do emotions influence information processing? How do patients or clinical trial participants understand informed consent documents and make decisions about clinical trial participation when emotional?
What are the implications of blended emotional states (e.g., being happy about the ability to express sadness, experiencing both anger and fear in concert)? Do blended negative emotional reactions to a cancer diagnosis influence decisions about treatment adherence?
How can physical sensations, emotional experiences, and perceptions of the world be distinguished? Can individuals be trained to disentangle bodily sensations from affective reactions to improve accurate symptom perception and care-seeking decisions?
How do interactions among individual-level emotions constitute a group emotional environment, and in turn, how does that environment influence shared decision making? Do common practices, such as constructing a tranquil health care environment, create circumstances for advantageous or disadvantageous clinical decision making?
How can the science of subjective experience be furthered through advances in measurement and technology? What is the best way to measure affect in cancer decision contexts involving healthy individuals, and those at increased risk for cancer, diagnosed with cancer, in treatment for cancer, in palliative care, and/ or in cancer survivorship?

Data Harmonization and Sharing: Because of the likelihood that some funded applications will examine similar underlying affective processes, awardees of this FOA will be required to participate in post-award standardization and harmonization efforts, as scientifically appropriate. These harmonization efforts will include scientifically appropriate standardization of self-report and physiological (e.g., fMRI, cortisol, skin conductance) assessments and paradigms for experimental induction of affect and emotion regulation. Consistent with achieving the goals of the program, investigators will also be expected to share data among other investigators funded by the initiative and with the general research community as appropriate.

Annual Meetings and Regular Teleconferences: Awardees of this FOA are required to attend an annual scientific meeting and participate in regular teleconferences to better facilitate collaboration among funded investigators and between investigators and NCI scientists.

Section II. Award Information

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New Renewal Resubmission Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are expected to differ, reflecting the actual needs of the proposed projects. It is anticipated and encouraged, however, that most requests remain between $250,000 and $450,000 per year direct costs commensurate with the scope and complexity of the proposed projects. In exceptional and well-justified circumstances, larger budgets may be requested but all requests must not exceed $700,000 direct costs per year.
Award Project Period	The scope of the proposed project should determine the project period. The maximum period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)

Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession

Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed activity
Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
Names of other key personnel
Participating institution(s)
Number and title of this funding opportunity

The letter of intent should be sent to:

Rebecca Ferrer, PhD
Telephone: 240-276-6914
Email: [email protected]

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover