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.

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General
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Greendale GA, Petersen L, Zibecchi L, Ganz PA.  Factors related to sexual 
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