Intervening with Caregivers to Improve Patient Health Outcomes and Optimize Health Care Utilization

Please stand by for real time captions.>>Welcome and thank you for joining us today
for the webinar, Intervening with Cancer Caregivers to Improve Patient Health Outcomes and Optimize
Health Care Utilization FOA Reissuance. My name is Stephanie Myers and I will be your
WebEx host. Before I move into introducing our speaker
for today, I would like to go over a few things before we get started.>>All lines have been muted upon entry and
will remain muted for the duration of the webinar. Please submit your questions throughout the
presentation in the Q&A or chat panel and select all panelists from the drop down. We will ask them on your behalf during the
Q&A portion of the webinar. Questions about specific aims will not be
addressed during this webinar.>>If you need live captioning, please refer
to the media viewer on the panel.>>Is webinar is going to be recorded and
will be posted online in the near future. And now I’d like to turn it over to Dr.
Michelle Mollica who will begin the presentation.>>Thank you very much Stephanie. As Stephanie mentioned my name is Michelle
Mollica, and I am a program director in the healthcare delivery research program at the
National Cancer Institute. Over the next hour we will present some background
on our division and program within the NCI. Information about informal cancer caregiving,
specifics regarding the FOA, and then we will take your questions regarding this FOA. And again, to reiterate a note that questions
about specific aims or grant application details will not be addressed in today’s webinar.>>We will start with the background of our
division and program within the NCI.>>This is an organizational chart of all
of the extramural divisions within NCI, the division of cancer control and population
sciences, where we are located. And this is a large division with a portfolio
of about 800 grants and contracts. Our program is the healthcare delivery research
program, which is 1 out of 4 research programs within the division, other research programs
include behavioral research program, the epidemiology and genomics research program, and the surveillance
research program.>>The healthcare delivery research program’s
main mission is to advance innovative research to improve the delivery of cancer related
care. We have three branches, including the healthcare
assessment research branch, which assesses utilization, access, diffusion and population
based outcomes.>>The health systems and interventions branch,
which supports research to observe and intervene on behavior and context. And the outcomes research branch, where I
sit, which has a focus on patients and their caregivers with a mission to support research
to evaluate and improve patient experiences and health outcomes
>>At this point, I will go into some background information on informal caregiving. Caregivers, and specifically caregiving in
the cancer context, which led into the development of this FOA.>>Informal caregivers are individuals who
assist family members or friends by providing care which is typically uncompensated, usually
occurs in the home setting, and involves significant efforts of care for an extended period of
time.>>Being a caregiver is really characterized
by the tasks that caregivers take on, which can be many and varied. Examples include monitoring for side effects,
managing symptom burden, helping the care recipient make treatment decisions, coordinating
care among cancer providers, as well as triage in care, which is making decisions about whether
an emergent health issue requires immediate medical attention, and administering medications. Finally, caregivers often manage a care recipients
financial and social obligations in concert with their own.>>Caregiving in the context of cancer presents
unique aspects that were worthy of mentioning here. Cancer in and of itself is many diseases and
patients often receive multi-modal therapies. Cancer patients can experience more variability
in symptoms and toxicity from the therapies, than do individuals with chronic illnesses. This can affect the chains of the caregivers
monitor health status frequently and use a variety of technical and psychosocial skills
to promote patient health. Cancer caregivers typically spend more hours
per day providing and provide and intense care over a shorter period of time as compared
to other care recipients with chronic illnesses.>>This presents a high burden for providing
care. In addition, the unique points specific to
the cancer care continuum, including diagnosis, treatment, transition off treatment, survivorship
as well as end-of-life, lead to variability in the level of care burden and ongoing adjustments
unique for cancer caregivers.>>Finally, a unique hallmark of cancer is
the possibility of recurrence, which is stressful for both the patient and the caregivers alike. So, it’s not surprising that many cancer
caregivers report cancer specific stress that has a measurable impact on cancer caregiver
health and well being. In addition to the stress on caregivers themselves,
cancer patients also report concerns about how cancer may have a negative impact on the
family members and caregivers.>>There have been several recent efforts
to advance research and set priorities in cancer caregiving. In 2016, the National Alliance for Caregiving
and partnership with the National Cancer Institute and the cancer support community, published
a report called “Cancer Caregiving in the US”, which was based on data from the 2015
caregiving in the US study. The study was based on an online probability
sample of caregivers, and cancer caregiving in the US compared to those who care for individuals
with other health problems. This report found that about 2.8 million adults
were currently serving as a caregiver to an adult with cancer, caring an average of 32.9
hours a week. In addition, 43% of cancer caregivers reported
performing complex medical nursing tasks without any prior preparation, and 50% report high
emotional stress. Finally, 25% of caregivers report high levels
of financial strain. And these results underscore the impact of
the cancer experience on caregivers and the need for interventions that address their
unmet needs.>>In 2015, colleages from both the NCI and
the National Institute for Nursing Research led a two day meeting with over 75 attendees
to discuss the state of the science, research and clinical priorities for informal cancer
caregiving. The results were published in the journal,
“Cancer.”>>The key areas of focus and resulting recommendations
that were covered in that meeting and subsequent paper are as follows: expanding assessment
of prevalence and burden of cancer caregiving, maximizing the positive impact of technology
in the realm of cancer caregiving, facilitating further integration of caregivers into the
healthcare system, and improving interventions for cancer caregivers and patients.>>In this area of improving interventions,
it was noted that there was a need to prioritize health outcomes of interest, improve definitions
of construct, examine effects interventions of patient and caregiver outcome, and replicate
interventions that show benefit and attempt fidelity and dose consideration. This area of improving interventions led to
the original development of this funding announcement.>>To address the gap of improving intervention,
NCI developed a FOA that focused on cancer caregivers, with the purpose of focusing on
interventions that examine strategy to support cancer caregivers to improve patient and caregiver
outcomes. Through the original PAR we were able to fund
nine awards, which includes four R01s, one R37 and four R21s. The R37 is a merit award for early stage investigators. It is awarded to ESI’s who submit an R01
application and receive a score within the NCI p lines and are endorsed by NCI leadership
and the National Cancer Advisory Board.>>You can see that this initiative has stimulated
a lot of successful applications and has also stimulated several collaborations among multiple
disciplines to design interventions aimed to improve patient health, caregiver well-being,
and optimizing healthcare utilization.>>We analyze the applications for the previous
PAR, however; which demonstrated the continued need to find applications in the area. We are excited to say that the PAR has now
been reissued, and at this point I will cover the details of the current FOA.>>PAR 19-352/355 entitled “Intervening
with Cancer Caregivers to Improve Patient and Caregiver Health Outcomes and Optimize
Healthcare Utilization,” Is intended to support interventions that examine strategies
to provide caregivers with training, promote coping skills, and ultimately help them manage
their care. Outcomes of interventions should aim to improve
patient’s health, caregiver well-being, and optimize healthcare utilization.>>Applications in response the funding will
be 1 out of 2 mechanisms, the R01 and R21 grant mechanisms. Most of you may be familiar with these mechanisms,
but just to review, the R01 is one of the most commonly used grant mechanisms. It supports a discreet, specified and circumcised
research project. There is no specific dollar limit, but advanced
permission is needed for over $500,000 in direct costs in any one year, and the R01
supports 3-5 years of funding.>>The R21 grant mechanism supports newer,
exploratory and development research projects, and can be used for pilot and feasibility
studies. The combined budget typically cannot exceed
$275,000 over the total and supports up to two years of funding.>>So, at this point we will go through application
requirements.>>First, the interventions must be delivered
to at least the caregiver, though interventions can also be delivered to the patient and care
recipient and caregiver dyad. Applications should focus on the caregivers
of patients ages 21 and over at the time of diagnosis, and we encourage you to refer to
RFA-CA-19-033 which focuses on intervention of pediatric cancer populations and does include
a component for caregivers. In addition, patients must be at the point
of diagnosis forward on the cancer control continuum. Studies conducted with patients in active
treatment, transitioning into survivorship with advanced cancer or at the end-of-life
are acceptable.>>Research projects appropriate for this
FOA are expected to include outcomes in the following three areas. Cancer patient health outcomes, which includes
can include, behavioral, physical and/or psychosocial morbidity, at least one caregiver well-being
outcome, and at least one health utilization outcome.>>And this can include patient readmissions
to hospital, number of emergency room visits, caregiver use of services, and caregiver use
of cancer support services.>>Research projects should aim to identify
intervention components that make them effective including the conceptual framework, timing
of and content of the intervention as well as dosage. Investigators are encouraged to consider the
potential for sustainability and scalability in the development, design and testing of
interventions. Transdisciplinary approaches that bring together
clinical and scientific fields that interface most cancer caregiving including, nursing,
social sciences and health services research, are encouraged. In addition, collaboration of diverse stakeholders
such as clinicians, researchers and caregivers in the development of interventions is also
encouraged. Studies targeting or expanding inclusion of
medically or minority and underserved patient caregiver populations will be given special
consideration under this FOA.>>Use of randomized control files and/or
pragmatic trial designs is strongly encouraged. Applications may include mixed methods approaches
to determine the most effective components in the context of the intervention. And finally, applications may or may not include
development and testing of tools to evaluate caregiving, although the focus should be on
the development and testing of an intervention.>>Applications not considered appropriate
for the FOA include those focusing on caregivers of pediatric populations, applications proposing
observational research only, and those focused on cancer patients or survivors only; not
including a caregiver population.>>In addition to describing the proposed
project using the standard subsection, investigators applying for this FOA must address all of
the specific aspects listed here.>>First, a clear definition of the target
cancer patient/caregiver population, as well as indication of how the project addresses
persistent and salient problems for the specified population. Inclusion of a research team with appropriate
caregiving science and health services expertise. A description of how the intervention will
balance improvements targeted in all three outcome area of healthcare utilization, caregiver
well-being, and patient health, and a strategy for how the intervention, if successful, will
be appropriately disseminated.>>Review criteria specific to this FOA: In
the area of significance, does the project address persistent and salient challenges
that the targeted cancer patient or caregiver population faces? How Amenable is the proposed intervention
for dissemination/implementation?>>Under the investigator review criteria:
how strong is a research team including representation of appropriate caregiving and health services
expertise?>>Under the approach: does intervention appropriately
balance improvements targeted in all three outcome areas, as we previously stated.>>As this PAR requires intervention study,
please note the updated NIH requirements for clinical trials research applications
>>The link at the bottom of the page has very useful information about these requirements.>>In terms of budget as with any grant application,
the budget should reflect the actual needs of the proposed project. For the R01 mechanism, advanced permission
is required for over $500,000 in direct costs in any year.>>And for the R21 specific to this FOA, the
combined budget for direct costs for the two-year project may not exceed $275,000, with no more
than $200,000 requested in any single year.>>You will see key resources here. First, we suggest that you read the FOA carefully. In addition, the previous PAR had two receive
dates per year, but this reissued PAR is moving to standard due dates. The first due date is special, so we alert
you to see that PAR 19-352, the R01 mechanism, new renewal and re-submissions are due on
October 17 and thereafter standard due dates apply. And for the R21 mechanisms, new submissions
are due on October 16 with re-submissions due November 16 thereafter standard due dates
apply.>>The webinar and FAQ from today’s webinar
will be posted on our website and ee encourage you to connect with us early.>>In summary, today we presented on PAR 19-352
and 355, intervening with cancer caregivers to improve patient and caregiver health outcomes
and optimize healthcare utilization.>>The announcement is designed to fund interventions
that support the success of informal cancer caregivers for adult cancer patients and measured
by improved patient health, improved caregiver well-being, and optimize healthcare utilization. We encourage you to read the online announcement
carefully, contact us with any questions, and the specific aims of the project that
you may be considering applying.>>Thank you, Michelle. I would now like to jump into questions from
the audience. As a reminder, you can ask a question by typing
it into the Q&A or chat box and selecting all panelists.>>For clarification, is the FOA only for
pediatric patients, caregivers or for adults?>>Thank you for this question. So, this FOA refers to caregivers of care
recipient’s that were diagnosed with cancer at age is 21 and older, again as noted in
the webinar, we refer you to the current pediatric RFA which does include caregiver population
of pediatric care recipients, for those applications you must intervene with the caregiver and
care recipient dyad in the pediatric RFA.>>How broadly defined is caregiver in terms
of this FOA?>>We have not specified a definition of caregivers
within the FOA, we intend it to be broad, but it is up to the researcher to determine
their operational definition of cancer caregiver and to support that with the rationale in
their application.>>OK, the next question is, can you please
clarify the receipt date?>>Absolutely. We’re moving from previously having two receipt
dates in April and October to standard receipt dates. The first receipt date in October is a little
bit different, so I encourage you to look at the FOA for specific details on that.>>Next question is, are multiple PI submissions
possible and/or encouraged?>>So, multiple PI submissions are definitely
possible and acceptable, but they are not required.>>Next we have, are we allowed to use novel
technology in this?>>Sure, so this FOA was written very broadly,
so as long as it meets the acceptable consideration as we noted in the webinar and the FOA, that
novel technologies would be acceptable.>>Are applications welcome across all cancer
sites and basis of care?>>Yes, there is a requirement for the phase
of the cancer care continuum from the point of diagnosis forward, but otherwise all aspects
and phases of the cancer care continuum as well as the cancer sites are acceptable. We encourage the investigators to really provide
a strong rationale in their application for why they chose the phase on the cancer care
continuum and the cancer site that they chose.>>Are foreign institutions allowed to respond
to this FOA?>>Foreign institutions not allowed to respond
to this FOA.>>Does the application apply to cancer caregivers
in hospice and palliative care?>>Yes, it does.>>Do applications need to target all three
types of outcomes, patient caregiver and healthcare utilization?>>Yes, there is a requirement in the FOA
to target all three levels of outcomes. We leave it up to the investigator to balance
those outcomes, so not all need to be primary outcomes, some could be exploratory based
on their intervention and conceptual framework.>>What is the review process after the scientific
review panel, for example, to what extent does the percentile versus other considerations
impact this funding announcement?>>Applications reviewed by study sections
receive a percentile score, as do other applications. Early-stage investigators may receive special
consideration in funding decisions, but otherwise it is standard.>>Do R21s need to propose at least a two-arm
RCT?>>R21s may, but they are not required to
propose a two-arm randomized control trial. The R21 is more exploratory in this mechanism,
and as a result, applicants can propose and acceptability and feasibility study with the
intention of designing a larger study to test the intervention that they are developing.>>Do applications need to include a data
sharing plan?>>All applications, regardless of the amount
of cost in their budget need to include a data sharing plan per the FOA, and I would
refer them to the FOA for details on the requirements.>>Can you please clarify that a proposal
that was submitted to the previous PAR would be considered a new submission or a resubmission
for the new PAR?>>Applications that were submitted to the
previous PAR, so that’s 18-246/247, but also 16-31, the previous version of the PAR
would be considered a resubmission for this PAR.>>How do you balance the three outcomes of
caregiver well-being and patient health and healthcare utilization and can one be primary
over the other?>>You definitely can prioritize one over
the older, depending on the goal of the research, the overall aims of the intervention and the
the population. It is always best to consult with us if you
want to talk through some of those questions.>>How can I be sure if my study meets the
definition of a clinical trial?>>We have great resources on the NIH website
and on that resources page on the webinar today to determine whether or not your application
meets the definition of a clinical trial.>>Can the intervention or assessment improve
outcomes for the patient and caregiver?>>Yes they can, we encourage you to consider
the components of the intervention when deciding how to balance those outcomes.>>I would like to use the NCI committee oncology
research program to conduct my clinical trial in response to this funding announcement,
is there anything special I need to do if I’m going to use the NCORP network?>>There are additional steps that you need
to take if you’re proposing to use the NCORP network to conduct your study. This process does take additional time, so
you must speak with the NCI NCORP staff before submitting an application, or proposing to
conduct a study with NCORP. I suggest sending an email to me, Michelle
Mollica, first, as soon as possible to let me know that you are planning to conduct your
study with NCORP, and I will work with NCI/NCORP staff to set up a call and they can outline
the process for you.>>Given the interaction with caregivers often
occur outside of the healthcare system, is it appropriate to include the settings in
the application?>>Absolutely, community-based setting or
settings outside the healthcare system are certainly appropriate. It is up to investigator to present the rationale
for their chosen setting.>>Are there suggestions for having to specifically
measure healthcare utilization outcomes and applications to this FOA?>>This is a great question, and one that
we certainly had in the previous PAR from investigators. There are many possible ways to measure healthcare
utilization and measures, we suggest having expertise in health services research, represented
on the study team. In addition, you might consider seeking input
from the healthcare system administrator or the hospital administrator to discuss your
proposed intervention and measure that if collected and showed improvement might foster
and facilitate implementation of those caregiving interventions. An important consideration is that the FOA
states optimize healthcare utilization as opposed to reduce healthcare utilization. So, for example, in better supporting caregivers,
that might actually lead to increase in preventive healthcare visits which would increase healthcare
utilization but perhaps ultimately more optimally utilized.>>The PAR asks applicants to consider sustainability
and scalability in the development, design, and testing of interventions. Do we have to submit an implementation science
application?>>That is a great question. We do ask that investigators consider the
potential for sustainability and scalability. That does not mean that we’re requiring
applicants to submit implementation science-based application, though, applicants may propose
the potential for scalability and sustainability as they consider the development design and
testing of the proposed intervention.>>Is an Awaiting Receipt of Application (ARA)
required for budgets that exceed $500,000 direct costs in any of the grant years?>>An ARA is required for a budget that exceeds
$500,000 in direct costs in any of the years. In our division, the division of Cancer control
and population sciences, the ARA must be submitted at least 8 weeks prior to the submission date. So, that means we suggest that you speak with
us very early in the processes that we can work with you on that ARA.>>How much pilot or preliminary data is needed
for the R01 application?>>That is a great question. Reviewers will evaluate the application for
scientific merit. For the R01 application, that includes an
assessment of the rigor of the proposed research and the prior research, which is developed
either by the applicant or cited from the literature. So, that should support the scientific premise
for the proposed project. Additional preliminary data should be sufficient
to support any gaps and to demonstrate that the proposed approach is potentially promising,
feasible, sufficiently rigorous, and that the applicant and their team have the skills
and experience to conduct the research. Again, when there’s a question of preliminary
data I suggest contacting us early to talk about that.>>Outcomes need to focus on caregivers & patients. But is it required to recruit both patients
and caregivers as participants into the study?>>There’s a growing body of research that
says that intervening with the caregiver can improve outcomes and impact outcomes with
the patient. So, for this FOA you do not need to intervene
with the caregiver/cancer patient dyad, you must intervene with at least the caregiver.>>Are new applicants who have not had prior
NIH funding before, encouraged to apply?>>Absolutely, investigators who have not
had prior NIH funding are definitely encouraged to apply. We do have special consideration for early-stage
investigators. When you are a new investigator, we strongly
consider speaking to us early so we can talk about your ideas.>>OK, so our last question is, is a letter
of intent required, what should be included?>>So, a letter of intent is not required,
but it is strongly recommended for this PAR. LOI’s should be sent at least one month
prior to the receipt date and should include the title of the proposed activity, the names
and contact information of the PIs, participating institutions and the number and title of the
funding opportunity. It should be sent by email with the PAR number
in the subject line to me, Michelle Mollica.>>Perfect, thank you for joining us for today’s
webinar. As mentioned earlier, the presentation will
be posted online in the near future. Please feel free to continue the conversation
through email, if you have additional questions that were not answered during today’s presentation.>>Thank you for your participation and have
a good day.>>[ Event End]

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