and Human Services (HHS)
EXPIRED
REDUCING BARRIERS TO SYMPTOM MANAGEMENT AND PALLIATIVE CARE RELEASE DATE: May 26, 2004 RFA Number: RFA-CA-05-013 EXPIRATION DATE: September 27, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENTS OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/) Office of Research on Women’s Health (ORWH) (http://www4.od.nih.gov/orwh/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.399 (NCI); 93.361 (NINR) LETTER OF INTENT RECEIPT DATE: August 24, 2004 APPLICATION RECEIPT DATE: September 24, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The purpose of this RFA is to solicit grant applications for research directed at developing and testing interventions to reduce or overcome barriers to the delivery of appropriate symptom management and palliative care to patients suffering from disease and/or treatment- related sequelae. Historically, the cancer symptom management research community has focused largely on describing symptom prevalence and testing new interventions to ameliorate one or more symptoms. Many of these studies have shown efficacy, yet, because of a number of patient, clinician, and health system-related barriers, the larger cancer community is not adopting these findings. Research is needed to discover new or innovative way to implement evidenced based practices into routine clinical care. We must expand and accelerate our potential to address the problems of inadequate symptom management and palliative care among diverse populations in the United States. Given NCI’s challenge goal of eliminating the suffering and death due to cancer by 2015, efforts must be directed to improving the delivery of treatments to prevent or ameliorate the adverse physical and psychosocial consequences associated with the diagnosis and treatment of cancer. RESEARCH OBJECTIVES Background As a result of advances in the early detection, prevention, and treatment of cancer, the population of individuals living with, through, and beyond a cancer diagnosis in this country is growing. Currently, an estimated 9.6 million Americans are living with a history of malignancy. At one time almost uniformly fatal for most, cancer has now become a chronic condition for many. Success in achieving this goal, however, has not been without cost. None of our current cancer therapies is symptom-free. Side effects may range from mild and transient (e.g., alopecia, nausea, neutropenia), to chronic (e.g fatigue, sexual dysfunction, lymphedema), to late and potentially life- threatening (e.g., second cancers, cardiomyopathy). While prevalence estimates vary widely, a substantial number of patients and survivors experience cancer- and treatment-related physical and psychosocial impairments. Pain, depression, and fatigue, alone or in combination, are the most frequently cited symptoms that occur along the trajectory of the cancer experience. Cancer patients may also suffer from anorexia, cachexia, gastrointestinal problems, cognitive impairments, dyspnea, and anxiety at various stages of their illness. Although the chronicity of cancer-associated conditions mandates symptom management and palliative care throughout the course of the disease, many cancer patients fail to receive such care and continue to suffer needlessly. The prevalence of a number of cancer-related symptoms, most notably pain, depression, and fatigue, has been unacceptably high for more than two decades and there is little indication that it is decreasing. Of the 29 epidemiological studies reporting on the prevalence and/or incidence of cancer-related pain between 1982 and 2001, no single survey identified a pain prevalence rate below 14 percent of the patients surveyed. One recent study reported a pain prevalence rate of 52 percent among 240 Veterans diagnosed with both solid tumors and hematological cancers. For both the clinician and the cancer patient, depression is often viewed as a natural symptom or outcome of the disease. To the contrary, cancer patients are three times more likely than the general population and almost two times more likely than other medically hospitalized patients to develop depression. A number of studies have shown that depressed cancer patients are more likely to request euthanasia or physician-assisted suicide and are more likely to commit suicide. The prevalence of depression is higher in cancer patients with the greatest disability and distressing physical symptoms, such as pain. Similar to cancer-related pain and depression, the prevalence of cancer-related fatigue is high and often variable. Three studies, conducted on a total of 1,796 cancer patients diagnosed with a variety of cancer types and stages, reported prevalence rates ranging from 26 percent to as high as 58 percent. The variability in the prevalence of specific cancer related symptoms could be attributed to a variety of factors, which include: disease characteristics, patient demographics, clinician and health system characteristics, and methodological issues, such as lack of consensus on the best measures of symptoms. For example, stage of disease is frequently cited as an important predictor of symptom incidence and severity. Cleeland and colleagues, surveying 54 treatment locations affiliated with the Eastern Cooperative Oncology Group (ECOG), estimated that 67 percent of metastatic cancer patients (871 of 1308) had pain. Vuorinen, on the other hand, found a much lower prevalence of pain, 28 percent, in 240 newly diagnosed cancer patients. We believe that a number of advances have been made in the understanding and treatment of cancer-related symptoms, but these advances have not translated into standard-of-care practices in the cancer setting. Many cancer patients report that they are not routinely asked about their symptoms, are reluctant or afraid to report symptoms, are unaware of available symptom management treatments, do not adhere to symptom treatments when provided, and at times are not offered any treatment even when they do report problematic symptoms. In the same study conducted by Cleeland and colleagues, 42 percent of those with pain were inadequately managed. Clearly, the prevalence of one or more symptoms would be much lower and overall quality of life improved if patients were asked about their symptoms, were offered treatments, and were assisted in adhering to the treatment plan. Special populations, such as children, the elderly, minority, and individuals of lower socio-economic status are at higher risk for receiving inadequate or no treatment for their cancer-related symptoms. Barriers unique to vulnerable and medically underserved populations include pharmacies that do not stock opiods or have inadequate supplies of these drugs and individuals lacking knowledge of federal, state, and local benefits that may assist them in accessing hospice and end of life care. Pain management has been well-studied, resulting in the publication and wide dissemination of clinical practice guidelines through multiple channels and organizations, including requirements through the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Despite the long publication history of these guidelines, cancer patients continue to suffer from inadequate relief of their pain. The identification and treatment of psychiatric disorders and psychosocial distress have also greatly improved, but in patients with cancer, they continue to be under diagnosed and under treated, especially in those with advanced cancer. The American Society of Clinical Oncology conducted a survey in 1998 of more than 3,200 oncologists and found that one of their top educational needs was to improve their ability to diagnose and treat depression and psychosocial distress in cancer patients, especially those nearing the end-of-life (Ezekial Emmanuel, personal communication, 2003). Interventions must be developed that reduce the barriers to patients receiving optimal relief of their symptoms, not only to eliminate suffering, but also to ensure adherence to cancer treatment when cancer can be cured or controlled. Physician-related barriers to delivering symptom management are most often related to inadequate skills and knowledge in the areas of communication, assessment, and treatment. The physician, for example, may not remember or think to ask a patient about symptoms, while the patient may not feel comfortable raising issues beyond immediate cancer care. There are often difficulties in communication, notably in children, the elderly, and across cultures. The physician may hesitate to prescribe narcotics for pain control for fear of potential addiction or side effects. In treating patients who are on multiple medications for co-morbidities, which are common to many older cancer patients, the physician may be unsure how best to manage additional medications. Lack of adequate time and staff may also compromise a physician’s ability to treat symptoms appropriately. Further exacerbating the problem is the fragmentation of follow-up care of cancer survivors. Oncologists, which can include medical, surgical, and radiation oncologists, as well as primary care providers, mental health specialists, and other subspecialties may all be involved in the care of cancer patients and survivors, yet there may not be a point person coordinating the logistics of these many specialties. Communication between and among all the health care providers caring for a cancer patient can be difficult, particularly if they are in different locations, without a common database for medical records. A number of health system factors can potentially hinder the delivery of symptom management. They can range from environmental, legal and regulatory restrictions to the macro (hospital policies and pharmacies, information systems) and micro (shared practice cultures and processes) within health care systems. The legal and regulatory restrictions compound the problem because they often vary from state to state and reimbursement policies can vary among private health insurance and public programs. All such factors can affect safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity. For example, problems related to the larger healthcare system include inadequate reimbursement, restrictive regulation of controlled substances, and problems of availability of opioids in the patient’s pharmacy. Effective delivery of palliative care within a health care environment depends on the timely coordinated response to patient needs. Examples of problems include inadequate information systems to learn about patient symptoms and to provide resources both to clinicians and patients to address them. Examples of challenges at the level of the office or clinic include organizing care processes to anticipate need, to respond to individual patient preferences and to problems when they are most needed, to address capacity and patient flow, to gather information about patterns of care for use in designing processes and improving care, and to develop effective multidisciplinary teams that use the skills and knowledge of all members. Addressing these challenges might go beyond a focus on the patient visit to include other forms of communicating with patients and providing care using a variety of telecommunication platforms. Any proposal, however, needs to be evaluated in relation to its effect on patient care and outcomes. In addition to system and provider barriers, patients and their family members or caregivers may also contribute to problems in the delivery of optimal symptom management. Among the most common recipient barriers is lack of awareness of need. For example, many patients, like their providers, may simply assume that symptoms of depression or anxiety are expected when the diagnosis is cancer. The adverse impact on patients functioning of insomnia and fatigue, among the more common symptoms experienced in those in active treatment, is often underappreciated. The frequently parallel belief that there is nothing to be done when a symptom occurs is a further barrier to receipt of appropriate help. Reluctance to appear weak or foolish or unable to cope additionally can contribute to failure to report symptoms when they do occur, even when these are troublesome to patients. For example, a woman undergoing chemotherapy may be very upset by her hair loss but fail to mention this to her treating team because she feels her preoccupation is a vain concern in the context of the seriousness of her illness. The perceived stigma associated with needing or having to ask for help itself can be a potent barrier to accessing care. This may be particularly true among different ethnocultural groups where a premium is placed on stoicism. In other cases, concern about taking up limited clinic time or physician visits to discuss what may seem to be unrelated or seemingly non-medical issues (e.g., anxiety, social isolation) may cause patients to avoid these important topics in discussions with their doctors or clinic staff. Patients may also wait for a physician to introduce a topic before expressing their concerns. At times, embarrassment can keep a patient from discussing a bothersome symptom. This is especially true when the symptom affects bowel, bladder, or sexual functioning domains. Finally, even when effective help is offered, patients may be resistant to use the interventions that are recommended. This may be due to fear of an intervention’s consequences. A classic example is the often expressed concern that narcotic use for pain will lead to subsequent addiction. Alternatively, they may be overwhelmed with the challenge of self-medicating and adjusting dosage to maximize benefits. Reluctance to seek help (e.g., counseling or rehabilitation services) may also be driven by lack of insurance or financial resources to pay for these services. Cancer and treatment-related symptoms among survivors may pose an additional set of problems. These post-treatment symptoms may be interpreted as potential disease recurrence and result in fear and a reluctance to acknowledge them. Alternatively survivors may believe that chronic symptoms (e.g., pain, fatigue, lymphedema) are simply something with which they must learn to live. Because research documenting the types and frequency of long-term and late effects of cancer is only now beginning to appear, it is difficult to know how common some symptoms are in the growing population of both young and older Americans living with a history of cancer. For their part, both family and non-family caregivers often share concerns and reservations similar to those experienced by patients themselves. They may fail to recognize that the patient’s symptom warrants further workup or care, may want to believe the individual for whom they are caring is coping well, may think there is little to be done for a given problem, may worry about addicting a patient or inducing undesirable side effects by providing medication, or may believe they or others in the home or external care setting can provide all the support or intervention required to meet a patient’s symptom needs. In summary, there is compelling evidence that cancer patients do not receive adequate symptom management or palliative care throughout the course of their disease. We need to be able to identify who is at risk for cancer-related symptoms and test methods that will ensure the routine delivery of interventions across the continuum of cancer care. Results of research related to this RFA should (1) generate knowledge about how to reduce barriers to the delivery of symptom management and palliative care, (2) address barriers for vulnerable, medically underserved, and special populations to access and receive palliative care, and (3) encourage research collaborations across disciplines and cancer care delivery systems (i.e., academic centers, community hospitals, HMOs, doctor practices, hospices) and public-private partnerships. Objectives and Scope The goals of this research initiative are to develop and test interventions to overcome barriers to the delivery of symptom management and palliative care, thereby decreasing the suffering and improving the health and quality of life of persons living with cancer. Program staff at the NCI and other NIH Institutes and Centers that are participating in this RFA conceptualize symptom management as one component of the care delivered to cancer patients at risk for or experiencing disease-and treatment-related symptoms. Other components, as defined by the World Health Organization, include communication, decision-making, management of complications of treatment, psychosocial care of patient and family, and care of the dying. To address the complex and interdependent physical, social, psychological, and existential needs of patients and their families requires a multidisciplinary team approach. Ideally, palliative care begins at the diagnosis of cancer or other illness and is given in conjunction with disease directed therapies, such as chemotherapy or radiation therapy. Accordingly, the focus of this initiative is broad and includes cancer patients across the disease trajectory. Settings where interventions could be tested include, but are not limited to, acute care facilities, the home, skilled nursing facilities, outpatient clinics, and hospices. Given the significant number of cancer patients being treated in community settings, we are particularly interested in applications that would access this type of setting or would develop interventions that are generalizable to the broader community setting. For example, the unique research infrastructures of the Community Clinical Oncology Program (http://www3.cancer.gov/prevention/ccop/aboutccop.html) and the HMO Cancer Research Network (http://hmoresearchnetwork.org/) make them particularly suitable for implementing these types of interventional research projects. Common strategies to disseminate evidenced based practice guidelines, e.g., scientific publications, direct mailings, electronic dissemination, etc., have been found to be insufficient to change or improve clinical practice. New methods are needed to implement (sometimes referred to as translate) what is known to be effective or appropriate symptom management into routine cancer care. The focus of this RFA is to solicit applications in this emerging field of translational research. The proposed interventions should build on current knowledge and research findings in the area of patient, family/informal caregiver, clinician, and/or health care system barriers. We anticipate that most projects will meet the following NIH operational definition of a clinical trial, a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions. Please note, clinical trials that are testing agents or drug delivery systems to improve one or more symptoms will not be considered responsive to this RFA. In addition, projects that are primarily descriptive or observational will not be considered responsive to this RFA. Appropriate Topics The following list of research topics are for illustrative purposes. Applications on topics not explicitly listed below, but which fall within the objective described above, are also welcome. A) Research Related to Patient, Family, or Informal Caregiver Barriers: o Examine the effects of patient concerns, patient choices, decision- making strategies, and caregiver values on adhering to symptom management or palliative care strategies. o Test interventions that will promote patients and caregivers understanding and use of medications for symptom relief. o Test whether interventions to improve patient’s and caregiver’s ability to report onset, severity, and duration of symptoms at any point along the cancer continuum will improve patient reported symptoms. o Test interventions targeted to specific age groups that experience challenges to optimal symptom management due to developmental stage, such as young children, adolescents and young adults, or the elderly. Include both patients and caregivers wherever appropriate. B) Research Related to Health Care Providers: o Determine if systematic use of clinical practice guidelines improves patient outcomes. o Examine the effect of knowledge of ethical and legal codes on the quality of symptom management. o Test whether interventions that incorporate the routine use of a brief, validated symptom assessment tool would improve symptoms. o Test whether interventions to increase clinician referral to and/or recommendation for the use of support groups would improve patient outcomes. o Test interventions to improve clinician’s communication, assessment and management of symptoms or problems that are under reported or difficult to discuss, i.e., end of life issues, sexual dysfunction. o Test interventions to reduce communication barriers between provider and patients and/or caregivers that impede symptom relief and HRQOL throughout the cancer trajectory. C) Health Care System o Assess the efficacy of and cost effectiveness of new ways for patients and families to report distressing symptoms to their health care providers. o Examine the impact of novel technologies to enhance patients and their families abilities to report distressing symptoms. o Examine the impact of a feedback mechanism that would routinely describe practice patterns for assessing and managing symptoms. o Test novel strategies that improve delivery of symptom management to medically underserved and vulnerable cancer populations. o Test innovative models of care coordination within health care systems that will improve communication and quality of care for patients transitioning between care delivery systems, i.e., acute care to hospice. o Examine the effect of standardizing elements of palliative care within clinical information systems. o Examine the impact of shared formularies when patients move to another site of care. The cultural, ethnic, and developmental aspects of the population targeted for study must be considered in designing interventions. Validation of established assessment guides in low literacy and non- English speaking populations should be considered as part of a broader intervention where appropriate. Biological and behavioral variables should be included as appropriate to the research question. Collaboration across disciplines and the inclusion of community and primary care givers on the research team are considered essential elements to the success of the project. MECHANISMS OF SUPPORT This RFA will use NIH R01 (research project grant) and R21 (exploratory/developmental grant) award mechanisms. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July, 2005. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. For R21 submissions, an applicant may request a project period of up to 2 years and submit budgets up to $100,000 direct cost (four budget modules) per year unless the application includes consortium costs, in which case the limit is $125,000 direct costs (five budget modules) per year. These grants are non-renewable and continuation of projects developed under this RFA will be through the traditional unsolicited investigator initiated grant program. For R01 submissions, an applicant may request a project period of up to 5 years and is strongly encouraged to submit budgets that do not exceed $500,000 in direct costs in any year of the project. (Please note that facilities and administrative [F&A] costs requested by any consortium participants are excluded from the direct cost limit per NIH Guide Notice NOT-OD-04-040.) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html ) This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. FUNDS AVAILABLE The participating ICs intend to commit $5,200,000 in FY 2005 to fund ten to fifteen new and/or competitive continuation grants in response to this RFA. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the ICs provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations; o Public or private institutions, such as universities, colleges, hospitals, and laboratories; o Units of state and local governments; o Eligible agencies of the Federal government; o Domestic or foreign institutions/organizations; and o Faith-based or community-based organizations. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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 programs. SPECIAL REQUIREMENTS Data Safety and Monitoring: applicants should describe the organizational structures and procedures they will employ to ensure the safety of participants and the validity and integrity of the data. Please see http://grants.nih.gov/grants/guide/notice-files/not98-084.html for additional guidance. Annual Meetings: Applicants funded under this RFA will be required to attend meetings in which study plans, findings, and issues of common interest and concern will be shared and discussed. All R01 applicants should include in their budgets funds for attending an initial kick- off meeting at or near the time of the award, and annual meetings thereafter through the end of the requested term of award. All R21 applicants should include in their budgets funds for 1 meeting in the second year of the grant. For budgeting purposes, applicants should assume that the meetings will be held in Bethesda, Maryland at the National Institutes of Health and require the attendance of at least the Principal Investigator (PI). Travel and lodging costs should be addressed. Reporting Requirments: Final Report: at the completion of the project, the Principal Investigator (PI) must provide a detailed report to the Program Director that addresses: o overall aims / goals of the proposal, o the extent to which the aims were accomplished, o the challenges encountered, o the detailed results of the study and of interim analyses, o detailed list of presentations, abstracts, and papers (accepted, in press, published), o hard copies of publications (accepted, in press, published), and o copies of any products developed as part of the research (e.g. measurement tools, educational materials, intervention manuals, etc). WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Ann O Mara, Ph.D., M.P.H., R.N. Program Director Community Oncology and Prevention Trials Research Group Division of Cancer Prevention National Cancer Institute 6130 Executive Blvd., EPN Room 2012 Bethesda, MD 20892-8329 Rockville, MD 20854 (for express/courier service) Telephone: (301) 496-8541 Email: [email protected] Martha L. Hare, Ph.D., R.N NIH/National Institute of Nursing Research 6701 Democracy Boulevard One Democracy Plaza, Room 710 Bethesda, MD 20892-4870 (Courier: 20817) Telephone: 301-451-3874 Fax: 301-480-8260 Email: [email protected] Lisa Begg, Ph.D. Director of Research Programs NIH/OD/ORWH, ORWH 1 Center Drive Bethesda, MD 20892 Telephone: 301-496-7853 FAX: (301)-402-1798 E-Mail: [email protected] o Direct your questions about peer review issues to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: [email protected] o Direct your questions about financial or grants management matters to: Brian Martin Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, EPS Room 243 Bethesda, MD 20892-7150 Rockville, MD 20852 (for express/courier service) Telephone: (301) 846-1014 FAX: (301) 846-5720 Email: [email protected] LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Ann O Mara, Ph.D., M.P.H., R.N. Program Director Community Oncology and Prevention Trials Research Group Division of Cancer Prevention National Cancer Institute 6130 Executive Blvd., EPN 2012 Bethesda, MD 20892-7150 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8541 Email: [email protected] Prospective applicants are strongly encouraged to contact the program director listed above at their earliest convenience. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance, contact GrantsInfo, Telephone: (301) 710-0267, Email: [email protected]. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all five copies of the appendices must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8041, MSC-8329 Rockville, MD 20852 (express courier) Bethesda MD 20892-8329 Appendices should be comprised of single-sided, unbound materials, with separators between documents. APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e., FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html) This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCI. Incomplete and/or non-responsive applications will not be reviewed. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by an appropriate national advisory council or board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem in barriers to delivering symptom management and palliative care? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Is there a well-designed evaluation plan of the effect of the intervention on patient outcomes? Does the applicant acknowledge potential problem areas and consider alternative tactics? Does this intervention carry the potential to be incorporated in routine cancer care? Is it likely to be sustainable after research funding has ended? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score. PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: August 24, 2004 Application Receipt Date: September 24, 2004 Peer Review Date: February 200 Council Review: June 2005 Earliest Anticipated Start Date: July 2005 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (See NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing (http://grants.nih.gov/grants/policy/data_sharing) or state why this is not possible. Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. For additional information, see NIH Guide Notice on Further Guidance on a Data and Safety Monitoring for Phase I and II Trials at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html . Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available at http://www.cancer.gov/clinical_trials/. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research is available online at: http://cme.nci.nih.gov/. HUMAN EMBRYONIC STEM CELLS (hESC): . Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. References: Anderson KO Richman SP, Hurley J, Palos G, Valero V, Mendoza TR, Gning I, Cleeland CS. (2002). Cancer pain management among underserved minority outpatients: perceived needs and barriers to optimal control. Cancer Apr 15:94:2295-2304 Arolt V, Fein A, Driessen M et al.(1998). Depression and social functioning in general hospital in-patients. J Psychosom Res, 45(2), 117-26. Brietbart W, Rosenfeld B, Pessin H, et al. (2000). Depression, hopelessness, and desire for hastened death in terminally ill patients with cancer. JAMA, 284, 2907-2911. Carr D, Goudas L, Lawrence D, et al. (2002). Management of cancer symptoms: Pain, depression, and fatigue. Evidence Report/Technology Assessment No. 61 (Prepared by the New England Medical Center Evidence- based Practice Center under contract No 290-97-0019). AHRQ Publication No. 02-E032. Rockville, MD: Agency for Healthcare Research and Quality. Cella D, Davis K, Breitbart W et al. (2001). Cancer-related fatigue: prevalence of proposed diagnostic criteria in a United States sample of cancer survivors. J Clin Oncol, 19(14), 3385-91. Chang VT, Hwang SS, Feuerman M et al. (2000). Symptom and quality of life survey of medical oncology patients at a Veterans Affairs Medical Center: a role for symptom assessment. Cancer, 88(5), 1175-83. Chochinov HM, Tataryn D, Clinch JJ et al. (1999). Will to live in the terminally ill. Lancet, 354(9181), 816-9. Cleeland CS, Gonin R, Hatfield AK et al. (1994). Pain and its treatment in outpatients with metastatic cancer. N Engl J Med, 330(9), 592-6. Department of Defense, Veterans Health Administration. (2002) Clinical practice guideline for the management of postoperative pain. Version 1.2. Washington (DC): Department of Defense, Veterans Health Administration, May. Detmar SB, Aaronson NK, Wever LD, Muller M, Schornagel JH. How are you feeling? Who wants to know? Patients and oncologists preferences for discussing health-related quality-of-life issues. J Clin Oncol 2000;18:3295-3301. Emmanual EJ, Fairclugh DL, Daniels ER et al. (1996). Euthanasia and physician-assisted suicide: attitudes and experiences of oncology patients, oncologists, and the public. Lancet, 29347(9018), 1805-10. Foley KM, Gelband H. (2001). Improving Palliative Care for Cancer.. Washington, D.C.: National Academy Press. Given CW, Given B, Azzouz F et al. (2001). Predictors of pain and fatigue in the year following diagnosis among elderly cancr patients. J Pain Symptom Manage, 21(6), 56-66. Green CR, Anderson KO, Baker TA, Campbell LC, Decker S, Fillingim RB, Kaloukalani DA, Lasch KE, Myers, C, Tait RC, Todd KH, Varrerand AH. The unequal burden of pain: confronting racial and ethnic disparities in pain. Pain Med 2003 Sep; 4:277-294 (review) Henderson JM, Ord RA. (1997). Suicide in head and neck cancer patients. J Oral Maxillofac Surg , 55(11), 1217-21. Hewitt M, Rowland JH. Mental health service use among adult cancer survivors: analyses of the National Health Interview Survey. J Clin Oncol 2002;23:4581-4590. Holland JC. (1999). NCCN practice guidelines for the management of psychosocial distress. Oncology, 13(5A), 113-147. Holland JS, Chertkov L. (2001). Clinical practice guidelines for the management of psychosocial and physical symptoms of cancer. In Foley KM and Gelband H (Eds). Improving Palliative Care for Cancer. Washington, DC: National Academy Press. Jacox A, Carr DB, Payne R, et al. (1994). Management of Cancer Pain. Clinical Practice Guideline No. 9. Agency for Health Care Policy and Research Publications No. 94-0592. Joint Commission on Accreditation of Healthcare Oranizations. Expert Resources on Health Care Issues. Pain Management Monographs. http://www.jcaho.org/news+room/health+care+issues/pm+monographs.htm Institute for Clinical Systems Improvement (ICSI). (2002). Assessment and management of acute pain. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI). Institute of Medicine. Crossing the Quality Chasm. (2001). A New Health System for the 21st Century. Washington, D.C.: National Academy Press. Lyne ME, Coyne PJ, Watson AC. Pain management issues for cancer survivors. Cancer Practice May/June 2002; 10:S27-32. Maguire P. Improving the detection of psychiatric problems in cancer patients. Soc Sci Med 1985;20:819-823. Moore KN, Estey A. The early post-operative concerns of men after radical prostatectomy. J Adv Nurs 1999;29:1121-1129. Morrison RS, Wallenstein S, Natale DK et al. (2000) We don t carry that ---failure of pharmacies in predominantly nonwhite neighborhoods to stock opiod analgesics. N Engl J Med, 342, 1023-6. Morrow GR, Andrews PL, Hickok JT, Roscoe JA, Matteson S. Fatigue associated with cancer and its treatment. Support Care Cancer 2002;10:389-398 National Cancer Policy Board, Institute of Medicine, National Research Council. (1999) Ensuring Quality Cancer Care. Maria Hewitt and Joseph V. Simone (Eds). Washington, D.C. National Academy Press. National Comprehensive Cancer Network. Practice Guidelines in Oncology. Guidelines for Supportive care. http://www.nccn.org/physician_gls/f_guidelines.html National Institutes of Health State of the Science Statement, Cancer Symptom Management: Pain, Fatigue, and Depression. Final Statement, October 26, 2002, online at http://consensus.nih.gov/ta/022/022_statement.htm Pargeon P, Haley B. Barriers to effective cancer pain management. J Pain Symptom Manage 1999;18:358-368. Payne R. (2001). Palliative care for African Americans and other vulnerable populations: access and quality issues. In National Cancer Policy Board, Institute of Medicine, National Research Council. Improving Palliative care for cancer. Kathleen M. Foley and Hellen Gelband (Eds.). Washington, D.C.: National Academy Press. PDQ Cancer Information Summaries: Supportive Care. http://www.cancer.gov/cancerinfo/pdq/supportivecare Savard J, Morin CM. Insomnia in the context of cancer: a review of a neglected problem. J Clin Oncol 2001;19:895-908. Schumacher KL, West C, Dodd M, Paul SM, Tripathy D, Koo P, Miaskowski CA. Pain management autobiographies and reluctance to use opioids for cancer pain management. Cancer Nursing 2002 Apr; 25:125-133. Schumacher KL, Koresawa S, West C, Hawkins C, Johnson C, Wais E, Dodd M, Paul SM, Tripathy D, Koo P, Miaskowski C. Putting pain management regimens into practice at home. J Pain Symptom Manage 2002 May; 23:369- 382. Sensky T, Dennehy M, Gilbert A, et al. Physicians’s perception of anxiety and depression among their outpatients: relationships with patients and doctors satisfaction with their interviews. JR Coll Phys Lond 1989;23:33-38. Steginga SK, Occhipinti S, Dunn J, Gardiner RA, Heathcote P, Yaxley J. The supportive care needs of men with prostate cancer (2000). Psycho- Oncology 2001;10:66-75. Stone P, Richardson A, Ream E et al. (2000) Cancer-related fatigue: inevitable, unimportant and untreatable? Results of a multi-centre patient survey. Cancer Fatigue Forum. Ann Oncol, 11(8), 971-5. Vogelzang NJ, Breitbart W, Cella D, Curt GA, Groopman JE, Horning, SJ, et al. Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. The Fatigue Coalition. Semin Hematol 1997(3 suppl 2):4-12. Vourinen E. (1993). Pain as an early symptom in cancer. Clin J Pain, 9(4). 272-8. World Health Organization (2002). WHO definition of palliative care. Retrieved July 30, 2003. Online at http://www.who.int/cancer/palliative/definition/en/
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