LONG TERM CANCER SURVIVORS: RESEARCH INITIATIVES RELEASE DATE: April 7, 2003 RFA: CA-04-003 National Cancer Institute (NCI) (http://www.nci.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANT NUMBER (S): 93.399 LETTER OF INTENT RECEIPT DATE: May 12, 2003 APPLICATION RECEIPT DATE: June 16, 2003 This RFA is a reissuance of RFA CA-97-018, which was published in the NIH Guide on September 5, 1997. THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism 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 The Long Term Cancer Survivors RFA re-issuance is a major initiative of the National Cancer Institute's FY 2004 Extraordinary Opportunity in Cancer Survivorship, and reflects the NCI's recognition of the critical importance and need for research that addresses the impact of cancer and its treatment on individuals living years beyond a cancer diagnosis. The population of long- term cancer survivors continues to grow: 62% of adult and 77% of pediatric cancer survivors survive beyond 5 yrs, and cancer can be for most a chronic disease. However, limited research has addressed outcomes of cancer and its treatment among long-term cancer survivors (those who are 5 years or more beyond cancer diagnosis). The request for re-issuance of this RFA is a clear signal to the research community regarding the critical need for more information about long-term cancer survivorship, especially among cancer survivors diagnosed as adults, and is intended to catalyze efforts to address the many unanswered questions in this challenging spectrum of the cancer control continuum. To be effective, applications are expected to cover the full range of domains affected by long-term survival from cancer (physiologic, psychologic, social, behavioral, economic) and emphasize understudied areas and gaps in current research. It is expected that interdisciplinary efforts will result in new and/or improved syntheses, theories, methods, and interventions. The purpose of this RFA re-issuance is to build upon the established research base and to provide a critical additional stimulus to the research community to undertake studies on cancer survivors who are 5 years or more post- diagnosis, focusing especially on research areas that remain understudied. It is critical that we expand and accelerate our potential to address the impact of long-term survival in particular with respect to: a) specific survivor groups: such as those treated for previously understudied cancer sites (e.g. colorectal, gynecologic, hematologic, head and neck), and those belonging to underserved populations (elderly, rural, low education/income, diverse racial and ethnic groups); and b) questions addressing specific gaps in our knowledge: such as the incidence of and risk factors for late and long-term (chronic or persistent) effects of cancer and its treatment, the role of socio-cultural and behavioral factors in modulating treatment outcomes, the impact of survivorship on health care utilization, the role of co-morbidity in outcomes, appropriate follow up care and surveillance for survivors, and the effect on families of living with a cancer history in a loved one. Results from the original RFA demonstrate that: (1) there are long latencies for potentially life-threatening late effects (e.g., heart failure secondary to the cardiotoxic effects of cancer treatment) emphasizing the need for extended follow up; (2) many disease and treatment related toxicities (e.g., fatigue, sexual dysfunction, cognitive impairment, neuropathies) can be persistent, worsen over time, and carry significant potential to adversely affect the health and well being of survivors; (3) the adverse sequelae of cancer and its treatment contribute to the ongoing burden of illness, costs, and decreased length/quality of survival; and (4) early identification of, and interventions among, those at increased risk for problems hold the promise of reducing adverse outcomes. RESEARCH OBJECTIVES Background The goal of survivorship research is to focus on the health and life of a person with a history of cancer beyond the acute diagnosis and treatment phase. Survivorship research seeks to examine the causes of, and to prevent and control the adverse effects associated with cancer and its treatment, and to optimize the physiologic, psychosocial, and functional outcomes for cancer survivors and their families. A hallmark of survivorship research is its emphasis on understanding the integration/interaction of multi-disciplinary domains. As children and adults with a history of cancer are living longer and data from research studies mature, the challenges of survivorship have become a growing focus of attention. What is clear is that most of our current treatments, although benefiting the patient overall, will produce some measure of adversity such as: cardiotoxicity, neurocognitive problems, premature menopause, sexual impairment, infertility, chronic fatigue, pain syndromes, and second malignancies. Research also shows that many survivors and their families experience significant adverse psychosocial outcomes long after treatment ends including: poor quality of life, fear of recurrence, poor self- esteem, anxiety and depression, job lock or loss, employment and insurance discrimination, body-image disturbances, relationship difficulties, and financial hardship. Despite the increasing number of cancer survivors living 5 years or more after a cancer diagnosis, a review of the literature, and of the NIH funded grant portfolio, indicates that most of what we know about survivorship today focuses largely on the period between diagnosis and 2 years after treatment. Most potentially life-threatening late effects of cancer treatment have much longer latency periods, and tend to occur during the extended survivorship years. The fact that the number of cancer survivors is growing annually, and is expected to continue to do so in the future, makes the commitment to understanding the unique needs of this population, and identifying those at increased risk for complications of treatment, and/or interventions to reduce that risk (e.g., use of cardio-protective agents during chemotherapy), not merely a timely but a compelling investment. Consonant with the overall mission of the NCI, knowledge about the latent human costs of cancer is critical if we are to reduce the burden of cancer nationally. Knowledge about the chronic or delayed complications of cancer and its treatment or care can be used to inform our understanding of the biology of the disease; lead to the design of novel, less toxic treatments; test the effectiveness of interventions – medical, pharmacologic, and behavioral – to reduce adverse physiological and quality of life outcomes; guide follow-up care practices; and inform patient and provider treatment-related decision making. While cancer survivors are living longer, we have limited knowledge and many questions about the health status, functioning, and quality of life for most of those who are post-treatment: What are the most common late effects of treatment? Who is at risk and can they be protected? Can treatment-related injury to normal tissue be prevented or reversed? What proportion of survivors will experience recurrent or second malignancies? Who should be following these survivors for disease recurrence? What constitutes "optimal surveillance" and what is the cost of such follow-up care? Do medical, psychosocial, or behavioral interventions reduce morbidity in these populations? The long-term effects of cancer and its treatment remain poorly documented and understood. Few current cancer therapies are benign. In the future, debilitating side effects may diminish as more molecularly targeted therapies are developed and used. Until then, however, the oncologic community must work with drug and treatment modalities that carry the risk of producing mild to severe adverse chronic or late effects. To date, the prevalence, incidence, relative risk, and genetic basis of late and long-term effects remain to be elucidated for the majority of cancer sites. There is growing appreciation of the role that sociocultural and behavioral factors play in patient outcomes, decision-making, adherence to treatments, and willingness to adopt appropriate surveillance and health maintenance behaviors post-treatment. While we know that human behavior can have a profound impact on how cancer is managed and may also affect disease-free or overall survival, we are not currently using this information in the systematic delivery of care. For example, it is estimated that 23-35% of head and neck cancer patients and 13-20% of lung cancer patients who smoked prior to illness continue to do so after treatment. Two published meta-analyses found that psychosocial or behavioral interventions can improve patients' health-related quality of life, functioning and even medical status. Despite this, we know little about how best or when to deliver these interventions and their resulting economic impact on individuals and society. More research is also needed to address survivorship outcomes among populations such as the elderly and those from diverse ethnocultural groups that have been under-represented in previous research. Although more than 60% of cancer survivors are age 65 and older, and the median age at diagnosis is 67-68, only a fraction of our funded research is looking at the effect of cancer on these older Americans, many of whom are also affected by co-morbid health conditions. Nor do we know what impact cancer has on the functioning and well-being of the millions of family members affected by this disease, many of whom may themselves be at increased risk for cancer due to shared cancer causing genes or environmental risk factors such as lifestyle or toxic exposures that are amenable to intervention. As cancer care is pushed into the outpatient setting, the economic, physical and emotional burden on family members is increasing. For example, 33-40% of parents of childhood cancer survivors continue to experience symptoms of post-traumatic stress disorder years after their child's treatment has ended. High levels of anxiety are reported among adult daughters who function as a caregiver for a parent with cancer. To date, we have failed to appreciate this additional at-risk population or taken advantage of the opportunity to provide these vital caregivers with supportive or health promoting interventions as part of standard care and follow-up. Finally, while high quality follow-up care is a necessary fact of life for all cancer survivors, both for the early detection of physiological and psychosocial sequelae, and for the timely introduction of optimal treatment strategies to prevent or control late effects, to-date, there is no standardized model of service delivery applied consistently across cancer centers. Nor has an attempt been made to examine the quality, content, and optimal frequency of follow-up care of cancer survivors delivered in the community setting by oncologists or by primary care providers. Cancer survivors and their family members face unique and uncharted consequences of illness and treatment. Information about survivors is critical if we are to: o Help patients make decisions now about treatment options that will affect their future; o Tailor therapies to maximize cure while minimizing adverse treatment related effects; o Develop and disseminate evidence-based interventions that reduce cancer morbidity as well as mortality and facilitate adaptation among cancer survivors; and o Improve quality of care, control costs, and equip the next generation of physicians, nurses, and other healthcare professionals to provide not just the science but also the art of comprehensive cancer medicine; Research Goals and Scope The scope of this RFA is limited to long-term cancer survivors, defined as those individuals who are least 5 years beyond a primary cancer diagnosis. The goal of this RFA is to promote and support research that will lead to the decrease in physiologic and psychosocial morbidity and mortality associated with long term (more than 5 years) survival from cancer. Grant applications are expected to propose innovative research that examines the impact of physiologic, psychologic, social, behavioral, or economic consequences of cancer and its treatment among long-term cancer survivors (individuals who have survived 5 years or more beyond a cancer diagnosis) and their family members. This RFA is designed to: 1) encourage researchers to address specific questions that may affect long-term cancer survivors to a greater extent than those less than 5 years beyond diagnosis or those with no cancer history; 2) ensure that applications cover the full range of domains affected by long-term survival from, and treatment for, cancer (physiologic, psychologic, behavioral, social, and economic), specifically examine the integration/interaction of these domains, and emphasize understudied areas and gaps in current cancer survivorship research; and, 3) stimulate the research community to pay particular attention to studies that focus on survivor groups belonging to understudied cancer sites (e.g., colorectal, hematologic, head & neck, gynecologic) or underserved populations (e.g., low education/income, ethnically diverse, rural, older and adult cancer survivors). While the most critical need is for additional data on long-term adult cancer survivors, the RFA will not be limited to persons who were diagnosed and treated as adults. Innovative studies addressing gaps in research among long- term survivors of childhood cancer are also to be encouraged. Attention must be paid to the use of appropriately valid and reliable measures of both physiologic and psychosocial variables. A short period of time at the start of the award can be dedicated to additional validation studies if needed. It is suggested that the proposals will encompass multidisciplinary and/or interdisciplinary approaches and multiple end-points where appropriate. Potential Areas of Research Emphasis This initiative focuses on expanding our understanding of the physiologic, psychologic, social, behavioral, and economic effects of cancer and its treatment among long-term survivors of cancer (those who are 5 years or more beyond a diagnosis of cancer), and especially seeks to emphasize understudied questions, populations, and gaps in cancer survivorship research. Note that these are examples only and are not intended to be inclusive. A) Research Related to Specific Groups: such as those treated for previously understudied cancer sites (e.g. colorectal, gynecologic, hematologic, head and neck), and those belonging to underserved populations (older, adult, rural, low education/income, diverse racial and ethnic populations). o What are the late or persistent effects of cancer and its treatment in older adult (65 years or older) long term cancer survivors? o What are the characteristics of long-term survivors from rural communities and those from low income and educational backgrounds? o What are the similarities and differences in the survivorship experience among ethnocultural minority or underserved cancer survivors, compared to Caucasian survivors? o What is the health status, functioning, and quality of life of long term cancer survivors belonging to diverse cancer sites? Which are the most common chronic and late effects among survivors across diverse cancer sites and which may be unique to subsets of different cancer survivor groups? B) Research Addressing Specific Gaps In Our Knowledge: in particular as related to: 1) Physiologic Late or Long Term Effects o Who is at risk for late and long-term effects and can they be protected? Are there specific, modifiable risk factors (other than exposure to treatment) for the development of late effects? o Which sub-groups of adult cancer survivors are at elevated risk for declines in functional status? o What are the most common late physiological sequelae of cancer and its treatment among adults, and their effect on physical and psychosocial health? o To what extent does cancer treatment accelerate age-related changes? o Do co-morbidities affect risk for, development of, severity and timing of late effects of cancer treatment among adult cancer survivors? o What proportion of survivors will experience recurrent or second malignancies? o Which subsets of survivors of pediatric or adult cancer are at elevated risk for cardiotoxic or neuro-cognitive sequelae of chemotherapy? 2) Psychosocial Effects o What are the psychosocial and behavioral consequences of late and/or long- term physiological sequelae for survivors' health and well-being? o To what extent do education and income mediate longer-term outcomes? o Do the differences observed in the psychological impact of cancer between younger and older cancer patients dissipate with longer term survival? o Which factors promote resilience and optimal well-being in survivors and their families? Does resilience and growth positively affect length and/or quality of survival? Which coping styles (e.g., active engagement, religion/spirituality, positive reframing) are associated with growth and the capacity to derive a positive meaning from the cancer experience? 3) Interventions o Which interventions (medical, educational, psychosocial or behavioral) are most effective in preventing or controlling late or long-term physiologic or psychosocial effects? When in the course of illness or recovery should they be delivered and by whom? o Can interventions delivered years after treatment control, reduce, or treat chronic or late cancer related morbidity? o What are the most cost-effective delivery routes (e.g., phone, internet, tailored print material) for reaching survivors with information about late effects and follow-up care needs years after treatment has ended? o To what extent can models for self-management of chronic illness be used to improve care for long-term cancer survivors? 4) Health Behaviors o Which sociocultural and behavioral factors play an important part in patient outcomes, decision-making, adherence to medical recommendations, and willingness to adopt appropriate surveillance and health maintenance behaviors post-treatment? o Can dietary factors such as high intake of protein after breast cancer increase survival from the disease? o Does regular physical activity after cancer increase length and quality of survival? o Does avoidance of weight gain after male or female hormonally dependent cancers increase length and quality of survival? o Does having a cancer history alter cancer risk behaviors among long term survivors (e.g., smoking, alcohol consumption, sunscreen use)? 5) Impact of Cancer on Family Members: o What long-term impact does cancer have on the functioning and well-being of family members of survivors? o Does developmental stage of the family at diagnosis affect adaptation long- term? o Does cancer in a family member alter the health behaviors and cancer screening practices of individual family members, and if so how? 6) Post Treatment Follow-Up Care, Surveillance, and Health Care Utilization o Who is currently following cancer survivors for disease recurrence, and cancer treatment-related late and long-term effects? o What is the optimal frequency, content, and setting of post-treatment medical surveillance of cancer survivors, especially for those who are adults, and by whom should it be delivered? o How does cancer history affect subsequent health care utilization, both cancer-related and that associated with co-morbidities? C) Research That Promotes the Development and Testing of Tools to Evaluate Long-Term Survival Outcomes: specifically, those that are sensitive to change, include domains of relevance to long-term survivorship and will permit comparison of survivors to groups of individuals without a cancer history and/or with other chronic diseases over time. o Are there unique psychological concerns that are relevant to long-term survivors of cancer not captured in existing measures? o What criteria or cut-off scores for a given measure should be used to qualify a change in function as clinically significant (for example improvement or impairment)? o Does the value or weight that survivors place upon different domains of physical, psychological or social functioning shift over time? What is the correspondence between the value placed by survivors on different long-term health related outcomes compared to that of their partners and healthcare providers? D) Research That Takes Advantage of Existing Survivor Cohorts or Study Populations: especially to permit comparison of survivors' functioning over time and/or with other non-cancer populations (e.g., cohort, nested case- control, or case-cohort studies), and analyses of long-term effects of specific treatments (e.g., clinical trials and cooperative group long-term followup studies). Requirements In order for the purposes of the RFA to be accomplished, several requirements must be addressed: 1) The focus must be on long-term survivors of cancer. This is not limited to persons who were diagnosed and treated as adults. Innovative studies of survivors of childhood cancer are also encouraged. 2) Attention must be paid to the use of appropriately valid and reliable measures of both physiologic and psychosocial variables. A short period of time at the beginning of the award may be devoted to additional validation studies if necessary. The R21 mechanism is also encouraged for this purpose. 3) The creation of a database of the study population that could be used to facilitate future studies and additional data analyses should be considered. Study Design It is expected that competitive applications will be responsive to the intent of the RFA. Studies are encouraged that: o utilize an interdisciplinary/multidisciplinary approach and incorporate a range of survivorship research domains; o address under-researched questions or understudied groups in cancer survivorship; o attempt to incorporate analytic designs that permit comparisons with adequate control populations, and/or baseline or pre-intervention data; o are capable of generating quantitative estimates of increased or decreased risk; o examine the effect/impact of an intervention (that carries the potential to be disseminated, if appropriate). Use of Existing Studies: applicants should consider taking advantage of other research projects (e.g. clinical trials, co-operative group studies, existing study populations or cohorts) that could be expanded to include questions relevant to this initiative. This may provide timely and cost-efficient access to study populations or research settings. Project Timetable The maximum duration of the research projects will be five years (four year projects are encouraged). A sample project timetable for an R01 type submission is provided below; however, variations in project length within this period and variations of program phases may occur due to differences in time needed for recruitment, intervention, and follow-up. Phase 1 (6 months): Protocol refinement, pre-tests of measures, staff training, study start-up activities. Phase 2 (3-4 years): Recruitment of study participants, administration of questionnaires, intervention (if relevant), follow-up activities, preliminary and interim data analyses. Phase 3 (6 months): Data analysis and reporting. All investigators funded under this RFA will convene for an investigators' meeting at or near the beginning of phase 1 to discuss proposed study design and aims, approach, and metrics for evaluating acceptable study progress, and annually thereafter until the end of the study. MECHANISM OF SUPPORT This RFA will use three different grant mechanisms: the National Institutes of Health (NIH) research project grant (R01) award mechanism, the exploratory grant (R21) mechanism, and the small grant (R03) mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an R01 application submitted in response to this RFA may not exceed 5 years. Project periods of 4 years for R01 grants are preferred. The R21 and the R03 mechanisms are limited to 2 years and are not renewable. For R01 type applications, 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. For R21 submissions, you may request up to $100,000 direct costs (four budget modules) per year unless your 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 R03 submissions, the total budget may not exceed $100,000 in direct costs for the entire project. The direct costs in any one-year must not exceed $50,000. For R01 submissions, applicants are strongly encouraged to submit budgets that do not exceed $500,000 in direct costs. 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. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the term/size of an award for R01 applications will vary also. Grants utilizing the NIH R21 or R03 grant mechanisms must adhere to their specified budget and term of award guidelines. The anticipated award date for grants funded under this RFA is April 2004. FUNDS AVAILABLE The estimated funds available for the first year of support for awards made under this RFA will be approximately $4M in FY 2004. Pending receipt of a sufficient number of applications of high scientific merit, the NCI intends to fund a total of approximately 10 to 15 new and/or competitive continuation grants in response to this RFA. Usual PHS policies governing grants administration and management related to the three mechanisms (R01, R21, R03) will apply. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is contingent upon the continuing availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding year(s) and the availability of funds. 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 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 and R03 applicants should include in their budgets funds for 1 meeting in the second year of the grant (the National Cancer Institute may be able to underwrite the costs for the initial kick-off meeting for R03 and R21 funded grantees). 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. 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: Direct your questions about scientific /research issues to: Noreen M. Aziz M.D., Ph.D., M.P.H Program Director Office of Cancer Survivorship Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Boulevard North, Room 4090 Bethesda, MD 20892 (For express / courier service only: Rockville, MD 20852) Telephone: (301) 496-0598 FAX: (301) 594-5070 Email: na45f@nih.gov Direct your questions about peer review issues 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 Telephone (301) 496-3428 FAX: (301) 402-0275 Email: ncirefof@dea.nci.nih.gov Direct your questions about financial or grants management matters to: Ms. Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Plaza South, Suite 243 Bethesda, MD 20892 (For express / courier service only: Rockville, MD 20852) Telephone: (301) 496-8634 FAX: (301) 496-8601 Email: crystal.wolfrey@nih.gov 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: Noreen M. Aziz M.D., Ph.D., M.P.H Program Director Office of Cancer Survivorship Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Boulevard North, Room 4090 Bethesda, MD 20892 (For express / courier service only: Rockville, MD 20852) Telephone: (301) 496-0598 FAX: (301) 594-5070 Email: na45f@nih.gov 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). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. 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/label-bk.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 (CSR) 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 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 must be sent to both to the CSR and the Referral Officer 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 change in practice is effective immediately. This policy is similar to and consistent with the policy for applications addressed to the Center 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 by 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. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NCI program staff. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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 (DEA) at NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique 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 second level review by the National Cancer Advisory 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 discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does your study address an important problem in long term cancer survivorship research? If the aims of your application are achieved, how do they advance scientific knowledge in this field? 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? Do you acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? Does your study address identified gaps in long-term cancer survivorship research? INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? ENVIRONMENT: Does the scientific environment in which your 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? Does the proposal demonstrate adequate access to the study population? 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). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. OTHER REVIEW CRITERIA: Are applications responsive to the intent of the RFA and propose research that (i) incorporates an interdisciplinary / multidisciplinary approach; (ii) addresses under-researched questions or understudied groups in survivorship research; (iii) utilizes analytic designs that permit comparison with cancer-free or other appropriate control populations or baseline data or pre-intervention data; (iv) permits the generation of quantitative estimates of risk such as odds ratio or relative risk; (v) examines the effect / impact of an intervention; and (vi) carries the potential to be disseminated (if the study proposed is an intervention). ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. 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: May 12, 2003 Application Receipt Date: June 16, 2003 Peer Review Date: October 2003 Council Review: February 18,2004 Earliest Anticipated Start Date: April 2004 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. MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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. See NIH Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II Trials" for additional information: 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: 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 AMENDMENT "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. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. 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 in now 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://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Guidance for investigators and institutional review boards regarding research involving human embryonic stem cells, germ cells, and stem cell-derived test articles can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02- 044.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 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). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). 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 No. 93.399 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 authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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 General Cancer Facts and Figures – 2002. Atlanta, GA: American Cancer Society, 2002. The Nation's Investment in Cancer Research. A plan and budget proposal for fiscal year 2004. Pages 88-93. National Institutes of Health, U.S. Department of Health and Human Services (http://plan.cancer.gov). Aziz NM. Cancer survivorship research: challenge and opportunity. J Nutr, 132(11): 3494S-503S; 2002. Aziz NM, Rowland JH. Cancer survivorship research among ethnic minority and medically-underserved groups. Oncol Nurs Forum, 2002;29:789-801. Ganz PA. Cancer Survivors: physiological and psychosocial outcomes, American Society of Clinical Oncology Education Book, 1998; 118-123. Rowland JH, Aziz NM, Tesauro G, Feuer EJ. The changing face of cancer survivorship. Seminars in Oncol Nurs, 2001;17:236-240. Yancik R, Ganz PA, Varricchio CG, Conley B. Perspectives on comorbidity and cancer in older patients: approaches to expand the knowledge base. J Clin Oncol, 2001;19:1147-51. Physiologic Late and Long Term Effects, Second Cancers Aziz NM. Long-term survivorship: Late Effects. In: Principles and Practice of Palliative Care and Supportive Oncology, 2nd ed. (Berger AM, Portenoy RK, and Weissman DE, eds), pp1019-1033. Lippincott Williams & Wilkins, Philadelphia, PA. Bhatia S, Robison LL, Oberlin O et al. Breast cancer and other second neoplasms after childhood Hodgkin's disease. N Engl J Med, 1996;334:745-751. Blatt J, Copeland DR, Bleyer WA. Late effects of childhood cancer and its treatment. In: P.A. Pizzo and D.G. Poplack (eds). Principles and practice of Pediatric Oncology, Revised edition. Philadelphia: J.B. Lippincott Co., 1997;1091-1114. Constine LS, Rubin P, Woolf PD et al. Hyperprolactinemia and hypothyroidism following cytotoxic therapy for central nervous system malignancies. J Clin Oncol, 1987;5:1841-1851. Ganz PA. Late effects of cancer and its treatment. Semin Oncol Nurs. 2001 Nov;17(4):241-8. Review Herold AH, Roetzheim RG: Cancer Survivors. Primary Care, 1992;19:779-791. Schwartz CL. Long-term survivors of childhood cancer: the late effects of therapy. Oncologist, 1999;4:45-54. Marina N: Long-term Survivors of Childhood Cancer. The Medical Consequences of Cure. Pediatric Clinics of North America, 1997;44:1021-1041. Meadows AT, Krejmas NL, Belasco JB. The medical cost of cure: sequelae in survivors of childhood cancer. In: Van Eys J, Sullivan MP, (eds). Status of the curability of childhood cancers. New York: Raven Press, 1980;263-276. Loescher LJ, Welch-McCaffrey D, Leigh SA, et al.: Surviving Adult Cancers. Part 1: Physiologic Effects. Annals of Internal Medicine, 1989;111:411-432. Psychosocial Outcomes Andersen BL. Surviving Cancer. Cancer, 1994;74:1484-95. Devine EC and Westlake SK. The effects of psychoeducational care provided to adults with cancer: meta-analysis of 116 studies. Oncol Nurs Forum,1995;22:1369-1381. Ganz PA, Desmond KA, Leedham B, Rowland JH, Meyerowitz BE, Belin TR. Quality of Life in Long-term, disease-free survivors of breast cancer: a follow-up study. J Natl Cancer Inst, 2002; 94:39-49. Gotay CC, Muraoka MY. Quality of life in ling-term survivors of adult-onset cancers. J Natl Cancer Inst, 1998; 90:656-67. Kornblith AB. Psychosocial adaptation of cancer survivors. In: Holland JC et al (eds). Psycho-Oncology. New York, Oxford University Press, 1998. Schnoll RA, Malstrom M, James C, Rothman RL, Miller SM, Ridge JA, Movsas B, Unger M, Langer C, and Goldberg M. correlates of Tobacco use among smokers and recent quitters diagnosed with cancer. Patient Education Counseling, 2001;1517:1-12. Meyer TA and Mark MM. Effects of psychosocial interventions with adult cancer patients: A meta-analysis of randomized experiments. Health Psychology, 14:101-108. Welch-McCaffrey D, Hoffman B, Leigh SA, et al.: Surviving Adult Cancers. Part 2: Psychosocial Implications. Annals of Internal Medicine, 1989;111:517-524. Cardiac Sequelae Lipshultz SE, Colan SD, Gelber RD et al. Late cardiac effects of doxorubicin therapy for acute lymphoblastic leukemia in childhood. N Engl J Med, 1991;324:808 -814. Steinherz LJ, Steinherz PG. Cardiac failure and dysrhythmias 6-19 years after anthracycline therapy: a series of 15 patients. Med Pediatr Oncol, 1995;24:352 -361. Neurocognitive Sequelae Brezden CB, Phillips KA, Abdolell M, et al. Cognitive function in breast cancer patients receiving adjuvant chemotherapy. J Clin Oncol, 2000;l8:2695-701. van Dam FS, Schagen SB, Muller MJ, et al. Impairment of cognitive function in women receiving adjuvant treatment for high-risk breast cancer: high-dose versus standard-dose chemotherapy. JNCI, 1998;90:210-8. Ochs J, Mulhern RK, Faircough D et al. Comparison of neuropsychologic function and clinical indicators of neurotoxicity in long-term survivors of childhood leukemia given cranial irradiation or parenteral methotrexate: a prospective study. J Clin Oncol, 1991;9:145 -151. Meyers CA, Weitzner MA: Neurobehavioral functioning and quality of life in patients treated for cancer of the central nervous system. Current Opinion in Oncology, 1995;7:197-200. Menopause Ganz PA, Greendale GA, Petersen L, Zibecchi L, Kahn B, Belin TR. Managing menopausal symptoms in breast cancer survivors: results of a randomized controlled trial. J Natl Cancer Inst, 2000;5:1054-64. Goodwin PJ, Ennis M, Pritchard KI et al. Risk of menopause during the first year after breast cancer diagnosis. J Clin Oncol, 1999;17:2365-2370. Sexuality Schiffman M (ed.), Cancer and sexuality. J Sex Educ Ther 26(3): entire issue, 2001. Syrjala KL, Schroeder TC, Abrams JR, et al. Sexual function measurement and outcomes in cancer survivors and matched controls. J Sex Res 37(3): 213-225, 2000. Greendale GA, Petersen L, Zibecchi L, Ganz PA. Factors related to sexual function in postmenopausal women with a history of breast cancer. Menopause, 2001;8:111-9. Lamb MA. Effects of Cancer on the Sexuality and Fertility of Women. Seminars in Oncology Nursing, 1995;11:120-127. McKee AL, Jr, Schover LR. Sexuality rehabilitation. Cancer 92: 1008-1012, 2001. Fatigue Andrykowski MA, Curran SL, Lightner R. Off-treatment fatigue in breast cancer survivors: a controlled comparison. J of Behav Med, 1998;21:1-18. Loge JH, Abrahamsen AF, Ekeberg O, Kaasa S. Hodgkin's disease survivors more fatigued than the general population. J Clin Oncol, 1999;17:253-261. Family Kupst MJ, Natta MB, Richardson CC, et al. Family coping with pediatric leukemia: Ten years after treatment. J Ped Psychol 20: 601-617, 1995. Welch, A.S, Wadsworth, M.E., & Compas, B.E. (1996). Adjustment of children and adolescents to parental cancer. Cancer, 77(7), 1409-1418. Faulkner, R. (2002). Children and adolescents of cancer patients: The impact of cancer on the family. The American Journal of Family Therapy, 30, 63-72. Lewis, F.M. (1993). Psychosocial transitions and the family's work in adjusting to cancer. Seminars in Oncology Nursing, 9 (2), 127-129. Carlson LE, Bultz BD, Speca M, Pierre MS. Partners of cancer patients: Part 1. Impact, adjustment, and coping across the illness trajectory. J Psychosoc Oncol 18(2): 39-63, 2000. Stuber ML, Christakis DM, Houskamp B, Kazak AE. Post trauma symptoms in childhood leukemia survivors and their parents. Psychosomatics, 1996;37:254- 261. Raveis VH, Karus D, Pretter S. Correlates of anxiety among adult daughter caregivers to a parent with cancer. J Psychosoc Oncol, 1999;17:1-26. Follow Up Care Burstein HJ, Winer EP. Primary care for survivors of breast cancer. N Engl J Med 343: 1086-1094, 2000. Richert-Boe KE. Heterogeneity of cancer surveillance practices among medical oncolgists in Washington and Oregon. Cancer 75: 2605-2612, 1995. Winn RJ. The NCCN Guidelines development process and infrastructure. Oncology 14: 26-30, 2000.


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