USF Health physician-scientist Dr. Juan Carlos Cardet was co-first author for the New England Journal of Medicine article reporting results of the long-awaited PREPARE trial

TAMPA, Fla (Feb. 26, 2022) — Black and Latinx patients suffer disproportionately from asthma, a chronic inflammatory disease with symptoms including shortness of breath, tightness in the chest, coughing, and wheezing. They experience more severe asthma, higher rates of asthma-related emergency department visits and hospitalizations, and approximately double the asthma death rates compared to white patients.

A new approach for managing moderate-to-severe asthma, known as single maintenance and reliever therapy, combines two medications in one inhaler for control of underlying inflammation and quick relief of acute symptoms. While this strategy has gained interest and led to updated guidelines for patients, no studies to date have focused on Black and Latinx populations.

To help address the lack of comparable data for these underrepresented populations, the PREPARE (PeRson EmPowered Asthma RElief) trial enrolled 1,201 Black and Latinx adults (ages 18 to 75)  with moderate-to-severe asthma. The study was conducted November 2017 to April 2021 at 19 sites in the U.S., including the USF Health Morsani College of Medicine, and Puerto Rico. Participants were randomized to one of two groups. In addition to continuing their usual asthma medications, half of the participants (intervention group) received one-time instruction on how to use inhaled corticosteroids whenever they dispensed airway-opening reliever medications via a nebulizer or rescue inhaler. The other half (control group) also continued their usual care (UC) but did not dispense inhaled corticosteroids as needed to treat asthma attacks along with quick-relief medications. All patients had one instructional visit followed by 15 monthly questionnaires.

The PREPARE study demonstrated that this new intervention, called Patient-Activated Reliever-Triggered Inhaled Corticosteroids (PARTICS), substantially reduced severe asthma attacks, improved asthma control and quality of life, and decreased lost days from work or school.

The study results were presented by USF Health physician-scientist Juan Carlos Cardet, MD, MPH, Feb. 26 at the 2022 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) and simultaneously published in The New England Journal of Medicine.

“Despite decades spent trying to find effective solutions to address the health disparities in asthma care, we haven’t made a significant dent in the problem,” said Dr. Cardet, an assistant professor in the USF Health Division of Allergy and Immunology. “The patient-centered PARTICS intervention we investigated works in underrepresented populations with poorly controlled asthma. It’s feasible, low cost, and may be easy to implement and help reduce the burden of complications from asthma if we can bring it to the clinic.”

Dr. Juan Carlos Cardet of the USF Health Morsani College of Medicine’s Allergy and Immunology Division studies better ways to treat poorly controlled asthma, including in underserved populations.

Dr. Cardet was the PREPARE study’s co-first author along with Elliot Israel, MD, the Gloria M. and Anthony C. Simboli Distinguished Chair in Asthma Research and director of Clinical Research in the Pulmonary and Critical Care Division, Brigham and Women’s Hospital. Thomas Casale, MD, a professor of medicine and pediatrics in the USF Health Division of Allergy and Immunology, helped execute the study as the USF site principal investigator.

Among PREPARE’s key findings:

• The annualized rate of severe asthma exacerbations was 0.69 per patient for participants in the PARTICS+UC group; the rate was 0.82 for the control group.
• Participants in the PARTICS+UC group also showed improved scores for asthma control and quality of life compared to patients in the control group.
• Those in the PARTICS+UC group also missed fewer days of school, work or other usual activities compared to the control group (13.4 versus 16.8 days)

A distinctive aspect of the PREPARE trial was the degree of engagement by patients to help optimize the study. Researchers collaborated with Black and Latinx adults with asthma as well as asthma caregivers — called Patient Partners — who are among the NEJM paper’s coauthors.

Dr. Cardet, working with Dr. Israel worked with other collaborators, designed a symptom-driven treatment approach consistent with what patients wanted; that is, an intervention intended to help control the chronic inflammation of asthma (with an inhaled corticosteroid) at the same time an inhaled reliever medication is delivered to ease severe flare-ups of symptoms.

Many patients are prescribed complicated regimens of controller medications to be taken daily, even on days when they experience no need for a fast-acting medication to open their constricted airways,” Dr. Cardet said. “In real life, patients may or may not adhere to that regimen when they’re feeling OK, but they will use their medications when symptoms arise.”

This work was supported by a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (PCS-1504-30283), the Gloria M. and Anthony Simboli Distinguished Chair in Asthma Research Award, grant #K23AI125785 from the National Institute of Allergy and Infectious Diseases (NIAID) and grant #AI-835475 from the American Lung Association (ALA)/American Academy of Allergy, Asthma & Immunology (AAAAI).

Dr. Cardet is a co-investigator for the Precision Interventions for Severe and/or Exacerbation-Prone Asthma Network (PrecISE) sponsored by the National Heart, Lung, and Blood Institute (NHLBI). This multisite clinical study, which aims to identify biomarkers to guide development of targeted treatments for severe asthma, is also seeking participants from underrepresented populations.

USF Health clinical and molecular geneticist Rebecca Sutphen, MD, has survived breast cancer and melanoma.

Genetic testing has been available since the mid-1990s to determine if a woman is likely to face one of her gender’s greatest fears: inherited breast and ovarian cancer. Yet, questions remain about whether common tests for the genes BRCA1 and BRCA2, which identify mutations that significantly increase a woman’s risk of breast and ovarian cancers, are reaching those who can most benefit and how the information learned from the testing is put to use.

USF Health medical and molecular geneticist Rebecca Sutphen, MD, a breast cancer and melanoma survivor, has broad expertise in genetic conditions affecting both adults and children. She has devoted much of her recent career working with Facing Our Risk of Cancer Empowered (FORCE), the leading national nonprofit advocacy organization for hereditary breast and ovarian cancer, to seek answers that will improve health outcomes of women at high risk for these cancers.

Dr. Sutphen’s research is guided in part by her own experiences as a patient, as well as Big Data’s emerging power to integrate electronic medical information and help build evidence about the effectiveness of clinical care. She emphasizes the need to ensure that patients help shape the investigative process.  In addition to her academic work, she is the chief medical officer of InformedDNA, a national genetic services organization.

The National Cancer Institute estimates only 3 percent of adults with cancer participate in clinical trials, with members of racial and ethnic minorities and low-income individuals particularly underrepresented.

“If research started with the questions that patients want answered, it seems likely there would be more participation in clinical studies, and it would be more obvious to patients how the research is relevant to them,” said Dr. Sutphen, professor of genetics at the USF Health Morsani College of Medicine’s Health Informatics Institute.

Cancer studies still largely focus on determining what treatments contribute to longer life, she said.

“Obviously survival is very important, but patients with cancer often have several options for treatment. What we learn from patients is that they also care about maintaining quality of life – things like the ability to get in their cars and continue to go to the grocery store, or to sleep at night… So, how can we better tailor the treatment options available to match each individual’s preferences?”

 Dr. Sutphen discusses the powerful potential of Big Data.

Dr. Sutphen works out of the Morsani College of Medicine’s Health Informatics Institute led by Jeffrey Krischer, PhD. She is pictured here with clinical research associate Beth Ann Clark, right.

USF helps lead way in BRCA testing and counseling

Dr. Sutphen, proficient in sign language, has a brother and sister who were both born deaf. She says her interest in genetics was sparked as a medical student when she accompanied her sister and her sister’s husband to Johns Hopkins medical genetics clinic for an evaluation of her 2-month-old nephew, also born deaf.

What the family learned about genetics and the probabilities of inheriting certain conditions was informative and fascinating, Dr. Sutphen said. “I saw genetics emerging as a new, growing area of science with the opportunity to impact the lives of people who really need information and can use it in a proactive way to make better decisions for themselves and their families.”

After earning an MD degree from Temple University School of Medicine, she completed a pediatrics residency at All Children’s Hospital in St. Petersburg and a fellowship in human genetics at USF. She is certified by the American Board of Medical Genetics in both clinical and molecular genetics.

In 1995 Dr. Sutphen joined the USF College of Medicine as a faculty member and shortly thereafter became the director of clinical genetics at All Children’s Hospital and at Moffitt Cancer Center.   As BRCA testing became commercially available, she helped USF establish one of the first programs in the state to offer clinical genetic testing and counseling for cancer.

For the first time, a test could identify if a person had inherited a defect in BRCA1 or BRCA2, and therefore tell who was at greater susceptibility for developing breast and ovarian cancer. Also, even if a woman with the inherited mutation never developed cancer herself, she would know she had a 50 percent chance of passing down the mutation, and increased risk, to any offspring.

But many more questions could not be answered. Was the risk the same for everyone who inherited a mutation? Was there a certain age the cancer would be likely to emerge? Could anything modify the risk? Will intensive screening (mammograms, MRIs, ultrasounds) catch a cancer early enough? Should a woman have her breasts or ovaries removed?

“While there was great excitement about the clinical availability of this new testing, there was a huge gap in what we could tell people about their own particular situation and what to do about it,” Dr. Sutphen said.

 Dr. Sutphen comments on engaging patients in the research process.

In the 1990s, Dr. Sutphen helped USF establish one of the first programs in the state to offer clinical genetic testing and counseling for hereditary breast and ovarian cancer.

Meeting begins enduring research collaboration, friendship

Dr. Sutphen began working with Distinguished University Health Professor Jeffrey Krischer, PhD, now director of the Health Informatics Institute, to develop NIH project proposals that would meaningfully address some of these unanswered questions. And in 2004, Dr. Sutphen invited Dr. Sue Friedman, founder and executive director of FORCE, to meet with the USF team to discuss how to best integrate “the patient voice and community” into the group’s hereditary cancer research.

After that initial meeting and learning about USF’s advanced health informatics capabilities, Dr. Friedman said, she quickly drafted a proposal to move her fledging nonprofit organization and family from South Florida to Tampa to work more closely with the USF team.

“When we first started looking at what a collaboration for hereditary breast and ovarian cancer research would look like, we included things like a yearly conference, a patient registry, research grants, writing a book. And, while there have been challenges along the way, in the last 12 years we’ve accomplished a lot of what we dreamed about and continue to build upon it,” Dr. Friedman said. “Aligning with USF has enhanced our organization’s ability to deliver meaningful research to the community, not just in terms of recruiting patients and reporting study results, but to actually help drive the research at every level.”

Along the way, Dr. Friedman, also a breast cancer survivor, and Dr. Sutphen became best friends as well research partners. “Rebecca has been visionary in recognizing the value of including health plan data in the research, and extraordinarily open to bringing in patients as equal stakeholders.”

Sue Friedman (left), founder and executive director of Facing Our Risk of Cancer Empowered, or FORCE, and USF’s Dr. Sutphen have worked together for the last 12 years. They have become friends who share a commitment to making patients equal stakeholders in driving hereditary cancer research.

 Inherited breast and ovarian cancer community’s influence on personalized medicine.

Research and advocacy join forces

Combining their complementary expertise in research and advocacy, USF Health and FORCE have attracted several highly competitive grants. Currently, Dr. Sutphen is the lead investigator for two national research awards focused on hereditary breast and ovarian cancer research.

• Impact of BRCA Testing on Newly Diagnosed U.S. Breast Cancer Patients. This landmark study, supported by a $2.8-million NIH RO1 award, is conducted in collaboration with the commercial health insurance plan Aetna. Researchers previously examined de-identified data on thousands of Aetna members across the country who received BRCA testing and surveyed them about factors associated with the use of this testing including genetic counseling services. Now, analyzing de-identified health claims information, Dr. Sutphen and colleagues will track the outcomes of consenting patients with increased risk for breast and ovarian cancer syndrome — including what types of health care professionals the women saw and how the positive genetic test results affected their decisions about managing cancer risk (including preventive treatment options), which patients subsequently were diagnosed with cancer and their medical treatment choices.

“To date,” Dr. Sutphen said, “there has been no similar study evaluating the health outcomes of a national sample of women undergoing BRCA testing in community settings.”

• Patient-Powered Research Networks, American BRCA Outcomes and Utilization of Testing Network (ABOUT Network). The project, totaling $2.4-million in support from the Patient Centered Outcomes Research Institute (PCORI) for Phases I and II, continues the work led by USF and FORCE to advance a national patient-centered research network of individuals with hereditary breast and ovarian cancer. The ABOUT Network was created to identify this patient community’s unmet needs, promote their governance in research and focus on the questions and outcomes that matter most to patients and their caregivers. USF’s ABOUT patient-powered research network is one of 20 nationwide participating in PCORI’s initiative to help individuals access their electronic health records data through existing patient portals and share it for research that could improve care for their conditions.

“We are establishing mechanisms to allow any patient in the U.S. who has hereditary breast and ovarian cancer to participate in studies relevant to them,” Dr. Sutphen said. “Harnessing the power of Big Data with guidance from patients enables a scale of research never before possible.”

Some early findings have begun to be disseminated. In a study published last year in JAMA Oncology, which attracted national media attention, Dr. Sutphen and co-authors found that most women who underwent BRCA testing did not receive genetic counseling by trained genetics professionals — and lack of physician recommendation was the most commonly reported reason. Yet, those who did get this clinical service before testing were more knowledgeable about BRCA and reported more understanding and satisfaction than women who did not.

This demonstrates gaps in services to be addressed, Dr. Sutphen said, because consultation with a trained genetics clinician is widely available (by phone or in person) and now covered as a preventive health service by most insurers with no out-of-pocket costs to patients.

 Dr. Sutphen talks about her breast cancer diagnosis.

Researcher confronts breast cancer as patient

Dr. Sutphen was diagnosed with breast cancer in 2008, following a routine mammogram. She was premenopausal and had no family history of cancer.   The radiologist who read her mammogram, a colleague, pulled her out of clinic at the Moffitt Lifetime Cancer Screening Center to alert her to the abnormality on her X-ray. The biopsy confirmed early-stage breast cancer.

“I was shocked,” she said. “I remember the part of the conversation ‘you have cancer,” seeing the doctor’s mouth moving and then not hearing any words after that.”

She called her best friend Sue Friedman, herself a breast cancer survivor, for support and after careful consideration of her treatment options decided to undergo a bilateral mastectomy with reconstruction.   The choice worked well for her, Dr. Sutphen said, but another friend with the same type of breast cancer chose lumpectomy instead.

“The first thing to look at is whether the likelihood for a recurrence of the cancer is the same if you have a lumpectomy or a mastectomy – and if the answer is yes, then beyond that it’s a matter of personal preference,” Dr. Sutphen said. “So, two people can make very different choices, but the right choice for each of them.”

In 2013, after having a “mole that looked different” on her arm checked out, Dr. Sutphen was diagnosed and treated for melanoma.

Her own experiences as a two-time cancer survivor have added perspective to her research, Dr. Sutphen said. “It really emphasized to me just what it’s like to be a patient, how difficult the decisions are to make, and how challenging your emotional state becomes.”

To make the often confusing and complex journey a little easier for patients and their families, Dr. Friedman and Dr. Sutphen collaborated with freelance writer Kathy Steligo on a book titled Confronting Hereditary Breast and Ovarian Cancer: Identify Your Risk, Understand Your Options, Change Your Destiny. They wanted to integrate into one book the latest evidence-based information to help women with cancer-susceptibility genes maximize their long-term survival and quality of life.

“The book was published in 2012, but it’s still 95 percent relevant today,” she said.

Dr. Sutphen with her daughter Serenity, 11.

Something you may not know about Dr. Sutphen

Dr. Sutphen was named one of the top 10 cancer medical geneticists in the United States in Newsweek’s “Top Cancer Doctors 2015” list. In 2012, she was selected by TEDMED to be the advocate leading its “Shaping the Future of Personalized Medicine” program, part of the Top 20 Great Challenges annual conference.

For many years she enjoyed the scenic adventure of flying paraplanes, or powered parachutes, ultralight aircraft with a motor, wheels and a parachute. But these days Dr. Sutphen prefers remaining on the ground to cheer on daughter Serenity, 11, a horseback rider who competes in barrel racing.

Photos by Eric Younghans, and audioclips by Sandra C. Roa, USF Health Communications

PCORnet will focus on questions and outcomes that matters most to patients and their caregivers to help shape the future of hereditary cancer research

Tampa, FL (Aug. 12, 2015) – A team led by the University of South Florida (USF Health) Morsani College of Medicine and the leading national hereditary breast and ovarian cancer advocacy organization, FORCE (Facing Our Risk of Cancer Empowered) received a $1.45-million funding award for a three-year project from the Patient-Centered Outcomes Research Institute (PCORI) to continue to advance and expand the ABOUT Network as part of the second phase of PCORnet: the National Patient-Centered Clinical Research Network.

The ABOUT Network (American BRCA Outcomes and Utilization of Testing Patient-Powered Research Network) focuses on hereditary cancer and is one of 34 health data networks recently approved for a total of $142.5 million from PCORI to support PCORnet.  PCORnet is a large, collaborative research initiative designed to link researchers, patient communities, clinicians, and health systems in productive research partnerships to leverage the power of large volumes of health data maintained by the partner networks. PCORnet will enable the nation to conduct clinical research more quickly and less expensively than is now possible and will ensure that research focuses on the questions and outcomes that matter most to patients and those who care for them.

The team is led by co-principal investigators Rebecca Sutphen, MD, professor of genetics at the USF Health Morsani College of Medicine, and Dr. Sue Friedman, founder and executive director of FORCE.  The Michigan Department of Health and Human Services Genomics and Genetic Disorders Section and advocacy organizations Black Women’s Health Imperative, Ovarian Cancer National Alliance, Sharsheret and Young Survival Coalition are also partners in the next phase of the network.

 USF’s Dr. Rebecca Sutphen, and FORCE’s Dr. Sue Friedman

“Our USF and FORCE teams bring highly complementary expertise in research and advocacy to this effort, and we anticipate that together we will play an important role in shaping the future of hereditary cancer research to improve health for the high-risk community,” said USF’s Dr. Sutphen. “We were honored to be selected as an inaugural member in Phase I of the PCORnet National Clinical Research Network and are excited to continue this important work in Phase II.”

“FORCE’s continued involvement in this collaboration will further advance our mission to improve the lives of people and families affected by hereditary breast and ovarian cancer,” said FORCE’s Dr. Friedman. “Our participation in PCORnet will provide members of our community with an unprecedented opportunity to establish goals, identify unmet needs, and shape the priorities for comparative effective research.”

“We’re pleased that the ABOUT Network has been approved for this funding support to continue our productive mutual efforts to build what we intend to be a premier national resource for conducting high-quality, patient-centered clinical research,” said PCORI Executive Director Joe Selby, MD, MPH. “I greatly appreciate the contributions of all the PCORnet partners during Phase I, which readied PCORnet for a robust start on an exciting second phase of expansion and the launch of several research studies.”

The funding award to the ABOUT Network has been approved by PCORI’s Board pending completion of a business and programmatic review by PCORI staff and negotiation of a formal award contract. PCORI is an independent, non-profit organization authorized by Congress in 2010 to fund research that will provide patients, their caregivers and clinicians with the evidence-based information they need to make better-informed health care decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

About USF Health
USF Health’s mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the College of Pharmacy, the School of Biomedical Sciences and the School of Physical Therapy and Rehabilitation Sciences; and the USF Physician’s Group. The University of South Florida is a Top 50 research university in total research expenditures among both public and private institutions nationwide, according to the National Science Foundation. For more information, visit www.health.usf.edu

About FORCE
No one should have to face hereditary breast and ovarian cancer alone.  For more than 15 years, FORCE has been the voice of the hereditary breast and ovarian cancer community. FORCE provides support, education and programs to help those facing hereditary breast and ovarian cancer know their healthcare options and make informed decisions. The organization is the de facto leader in guiding critical research and policy issues that impact the hereditary breast cancer and ovarian cancer community.  For more information about FORCE and hereditary breast and ovarian cancer, please visit www.facingourrisk.org

About PCORI
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available atwww.pcori.org.

Media contacts:
Anne DeLotto Baier, USF Health Communications, (813) 974-3303, or abaier@health.usf.edu
Karen Kramer, Vice President Marketing, FORCE, (866) 288-7475 x707, or karenk@facingourrisk.org

Tampa, FL (Jan. 23, 2014) – A team led by the University of South Florida (USF Health) Morsani College of Medicine and the leading national hereditary breast and ovarian cancer advocacy organization, FORCE (Facing Our Risk of Cancer Empowered), was awarded $960,026  from the Patient-Centered Outcomes Research Institute (PCORI) to develop and expand a health data network that will be part of PCORnet: the National Patient-Centered National Clinical Research Network.

The ABOUT Network (American BRCA Outcomes and Utilization of Testing Patient-Powered Research Network) is one of 29 that were recently approved for a total of $93.5 million from PCORI to form this new national resource that aims to boost the efficiency of health research.

PCORI envisions PCORnet to be a secure, national data network that improves the speed, efficiency, and use of patient-centered comparative effectiveness research (CER). By integrating data available in the 29 individual networks, PCORnet aims to provide access to a large amount of diverse, nationally representative health information that can support a range of study designs. It will reduce the time and effort needed to launch new studies and focus research on questions and outcomes especially useful to patients and those who care for them.

Moreover, PCORnet will join networks operated by both patient communities and health systems and will require patients’ and other stakeholders’ involvement in all aspects of the collection and use of the data. By enabling researchers and patients, clinicians, and other end-users of study results to interact directly and jointly determine research priorities, such as the selection of specific studies to support, PCORnet will advance the shift in clinical research from investigator-driven to patient-centered studies.

USF Health geneticist Dr. Rebecca Sutphen is the project’s principal investigator.

During the next 18 months, the USF Health and FORCE-led ABOUT Network team will use the PCORI funds to expand and improve its systems, work to standardize its data, and be part of the process to develop policies governing data sharing and security and protection of patient privacy. It also will refine its network’s capacity to engage and recruit patients and other stakeholders interested in participating in research.

The team is led by principal investigator Rebecca Sutphen, M.D., professor of genetics at the USF Health Morsani College of Medicine. The team also includes patient advocates focused on advancing hereditary cancer research led by Dr. Sue Friedman, founder and executive director of FORCE.  The Michigan Department of Community Health (MDCH) Genomics and Genetic Disorders Section is also partnering in the network.

“Our USF and FORCE teams bring highly complementary expertise in research and advocacy to this effort and we anticipate that together we will play an important role in shaping the future of hereditary cancer research to improve health for the high-risk community,” said USF’s Dr. Sutphen. “We’re honored to be selected as an inaugural member of the PCORnet National Clinical Research Network.”

“FORCE’s involvement in this collaboration will advance our mission to improve the lives of people and families affected by hereditary breast and ovarian cancer,” said FORCE’s Dr. Friedman. “Our participation in PCORnet will provide members of our community with unprecedented input to establish goals, identify unmet needs, and shape the priorities for comparative effective research.”

“We are pleased that the ABOUT Network will be part of this exciting initiative to build the data structures needed to significantly enhance the speed and efficiency of patient-centered comparative effectiveness research,” said PCORI Executive Director Joe Selby. “The process to select the awardees was very competitive and the ABOUT Network demonstrated it has the expertise, resources, and commitment to engaging patients and other stakeholders to be an excellent fit in PCORnet.”

The ABOUT Network was selected through a review process in which patients, caregivers, and other stakeholders joined scientists to evaluate the proposals. Applications were assessed for the capacity of their networks to collect comprehensive clinical data, how well they will engage patients and other stakeholders, and their ability to maintain data security and patient privacy, among other criteria.

All awards are approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

PCORI has awarded a total of $464.4 million since it began funding CER in 2012. For more information about PCORI funding, visit http://pcori.org/funding-opportunities.

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 About PCORI
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

About USF Health
USF Health’s mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the College of Pharmacy, the School of Biomedical Sciences and the School of Physical Therapy and Rehabilitation Sciences; and the USF Physician’s Group. The University of South Florida is a Top 50 research university in total research expenditures among both public and private institutions nationwide, according to the National Science Foundation. For more information, visit www.health.usf.edu

About FORCE
No one should have to face hereditary breast and ovarian cancer alone.  For more than 15 years, FORCE has been the voice of the hereditary breast and ovarian cancer community. FORCE provides support, education and programs to help those facing hereditary breast and ovarian cancer know their healthcare options and make informed decisions. The organization is the de facto leader in guiding critical research and policy issues that impact the hereditary breast cancer and ovarian cancer community.  For more information about FORCE and hereditary breast and ovarian cancer, please visit www.facingourrisk.org

Media contacts:
Anne DeLotto Baier, USF Health Communications, (813) 974-3303, or abaier@health.usf.edu
Karen Kramer, Vice President Marketing, FORCE, (866) 288-7475 x707, or karenk@facingourrisk.org

Tampa, FL (May 23, 2013) – The Patient-Centered Outcomes Research Institute (PCORI) has approved a $2.1-million award to the University of South Florida College of Nursing to study “Patient Outcomes of a Self-care Management Approach to Cancer Symptoms: A Clinical Trial.” USF Distinguished Professor and Thompson Professor of Oncology Nursing Susan C. McMillan, PhD, ARNP, FAAN, will lead the research project.

The USF College of Nursing project will test a brief intervention, known as COPE, which aims to teach cancer patients management skills for improving symptoms they identify as the highest priority.

“Improving cancer patients’ ability to self-manage difficult symptoms may diminish patient suffering, improve quality of life, and decrease emergency room visits and associated healthcare costs,” Dr. McMillan said. “We hope that this intervention will be as successful for patient self-care as it has been when implemented with caregivers of hospice patients with cancer.”

The USF College of Nursing study is one of 51 new awards by PCORI, totaling $88.6-million over three years, to fund patient-centered comparative clinical research effectiveness projects.  It is part of a portfolio of projects that address PCORI’s national research priorities and will provide patients with information to help them make better informed decisions about their care.

The only other new PCORI award in Florida went to the college’s clinical collaboration partner Moffitt Cancer Center to study a navigator-guided psychoeducational intervention for prostate cancer patients and caregivers.  Richard Roetzheim, MD, professor of family medicine at the USF Health Morsani College of Medicine, is one of the investigators for the Moffitt study.

Susan McMillan, PhD, is lead investigator for the USF Collge of Nursing’s newly awarded PCORI project.

The randomized clinical trial led by Dr. McMillan will evaluate the effectiveness of COPE in alleviating moderate to high-intensity cancer symptoms causing distress, frequency or interference with patients’ lives. To conduct the study, the researchers will recruit 300 cancer center outpatients with breast, colorectal, lung and prostate cancers

 “At the University of South Florida, the College of Nursing is conducting groundbreaking research to improve the health of patients, families and our community,” said Dianne Morrison-Beedy, PhD, RN, WHNP-BC, FNAP, FAANP, FAAN, senior associate vice president of USF Health, and dean of the College of Nursing. “At Nursing we are transforming healthcare and transforming lives – working with our healthcare partners locally, regionally and nationally to make life better.”

All the PCORI projects were selected through a highly competitive review process in which scientists, patients, caregivers, and other stakeholders helped to evaluate more than 400 applications for funding. Proposals were evaluated on the basis of scientific merit, how well they engage patients and other stakeholders, their methodological rigor, and how well they fit within PCORI’s national research priorities.

 “This project reflects PCORI’s commitment to support patient-centered comparative effectiveness research, a new approach to health research that emphasizes the inclusion of patients and caregivers at all stages of the study process,” said PCORI Executive Director Joe Selby, MD, MPH. “The research will provide patients and those who care for them better information about the healthcare decisions they face.”

“The vision of PCORI — that “patients and the public have the information they need to make decisions that reflect their desired health outcomes” — is highly aligned with the College of Nursing, where we focus on research that improves health,” said Cindy L. Munro, PhD, RN, ANP-BC, FAAN, USF College of Nursing professor and associate dean for research and innovation at the USF College of Public Health. “We are very proud that Dr. McMillan’s research has been selected for funding by PCORI.  Her work will not only benefit patients, but also serves as a model for research excellence in the College and beyond.”

Through the Center for Living with Chronic Illness, the USF College of Nursing focuses the research expertise of its nurse scientists, faculty and students as they collaborate on unique solutions to the nation’s leading health care problems, such as heart disease, Alzheimer’s disease and cancer.

The latest awards were part of PCORI’s second cycle of primary research funding. All were approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.  This new round of funding follows PCORI’s initial approval of $40.7 million in support for 25 projects under the institute’s national research priorities

For more information about PCORI’s funding announcements, visit www.pcori.org/funding-opportunities.

-USF Health-

USF Health’s mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the College of Pharmacy, the School of Biomedical Sciences and the School of Physical Therapy and Rehabilitation Sciences; and the USF Physician’s Group. The University of South Florida is a global research university ranked 50^th in the nation by the National Science Foundation for both federal and total research expenditures among all U.S. universities. For more information, visit www.health.usf.edu.

 -About PCORI-

The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

Media contact:
Ashlea Bailey, USF College of Nursing Communications
(813) 396-9642, or ahudak@health.usf.edu