The following are the funded research projects underway at Carolina Nursing to advance health for all.
Principal Investigator: Hudson Santos, PhD, RN
Funded by: National Institutes of Nursing Research (2018-2019)
Abstract: The overall goal of this application is to establish relationships among DNA methylation, maternal hardship and neurodevelopmental impairment in extremely preterm children. The central hypothesis is that maternal hardship clusters are associated with neurodevelopmental outcomes, especially cognitive and affective impairment, in extremely preterm children and that this relationship is mediated by DNA methylation in the placenta. The study will examine a diverse sample of extremely preterm children (N = 889) drawn from the Extremely Low Gestational Age Newborns Study (ELGAN, #1UG3OD023348-01). ELGAN is a multi-center longitudinal study of the risk of neurologic disorders in extremely preterm children. I will combine existing data on (1) prenatal maternal hardship; (2) DNA methylation from placental specimens; and (3) neurodevelopmental impairment, specifically cognitive and affective outcomes at ages 2 and 10. Furthermore, I will be involved in the third phase of ELGAN follow-up to collect neurodevelopmental impairment data on participants at age 15.
The Specific Aims are to (1) Establish maternal hardship clusters using prenatal socioeconomic and stressful life events factors; (2) Identify associations between maternal hardship clusters and child cognitive and affective outcomes at ages 2, 10 and 15 years; and (3) Determine the extent to which DNA methylation mediates the relationship between maternal hardship and cognitive and affective outcomes. This research aligns closely with NINR?s Innovative Question 2.6 on etiological pathways to prevent chronic illnesses with known risk factors in childhood. My research background is in nursing, with specific foci of maternal hardship, perinatal affective symptoms in minority and/or other vulnerable mothers, and related child outcomes. My short-term career goal is to expand my research to link maternal hardship to epigenetic mechanisms and neurodevelopmental outcomes among at-risk children. The proposed training activities will include formal didactic, hands-on instruction and research immersion in epigenetics, the biological bases of child neurodevelopment; experience in large interdisciplinary teams; responsible conduct in research; and publications and attendance at conferences. I have assembled an interdisciplinary mentoring team of internationally recognized experts. This award will move me to independence as a researcher, support my next steps in securing funding, and help me achieve my long-term goal of becoming a nurse leader in longitudinal research to prevent or minimize neurodevelopmental impairment related to maternal hardship among at-risk children. My subsequent R01 will explore additional epigenetic pathways related to hardship. I plan to use the 35 cohorts of the NIH Environment influences on Child Health Outcomes (ECHO Program; ~ 40,000 children by 2019), which includes ELGAN, to identify modifiable factors that could be potential targets for interventions.
Public Health Relevance
This research is relevant in its investigation of placental DNA methylation as a mediator of the association between maternal hardship and neurodevelopmental impairments in extremely preterm children. This study will provide the groundwork to inform interventions to reduce mothers? stress responses and children?s neurodevelopmental impairment, thereby improving quality of life for the 16,500 families with a child surviving extremely premature birth annually in the US.
Principle Investigator: Diane Berry, PhD, RN
Funded by: National Institute for Nursing Research (2018-2019)
Abstract: Hispanic women and children who become overweight or obese are at risk for developing prediabetes, type 2 diabetes, and cardiovascular disease later in life. To date, there have been no interdisciplinary interventions that have targeted Hispanic women and their 4-year old children to improve nutrition and physical activity behaviors to manage adiposity and weight in mothers and prevent excessive adiposity and weight gain trajectory in their children. Using a randomized two-group, repeated measures experimental design, the goal of the proposed study is to investigate the efficacy of a 12-week nutrition and exercise education, physical activity, coping skills training, and home-based physical activity intervention in Hispanic women and their 4-year old children and 6 months of continued monthly contact to help overweight and obese Hispanic mothers improve adiposity, weight, health behaviors (nutrition and physical activity), and self-efficacy and their 4-year old children improve their adiposity and weight gain trajectory and health behaviors (nutrition and physical activity). W e will partner with two federally qualified health departments in Durham and Chatham, North Carolina to enroll Hispanic women and their 4-year old children and we will partner with community centers to deliver the intervention. A total of 294 Hispanic women with a BMI 2 >25 kg/m and 294 Hispanic 4-year old children with a BMI percentile > 25 will be enrolled over 4 years and randomized to the experimental or equal attention control group. Data will be collected at Time 1 (0 months [baseline]) to Time 2 (9 months [completion of the intervention]) and Time 1 to Time 3 (15 months [after 6 months with no contact from the study staff]). Data collected will include adiposity (primary outcomes: waist circumference, triceps and subscapular skinfolds) in mothers and children and weight (primary outcomes: body mass index [BMI] in mothers and BMI percentile in the children). Secondary outcomes will include health behaviors and self-efficacy in the mothers (Adult Health Behavior Questionnaire, Lifestyle Health Promoting Profile II, 3 day 24-Hour Food Recall, and 7 day Accelerometer, Eating Self-Efficacy Scale and Exercise Self-Efficacy Scale) and in the children (7 day Accelerometer and 3 day 24-Hour Food Recall). We will also evaluate the cost of delivering the program for public health departments. Data analysis will use general linear mixed models to test the hypotheses. Decreasing overweight and obesity in Hispanic women and slowing adiposity and weight gain trajectory in young Hispanic children is urgently needed to decrease morbidity, mortality, and future health care costs. The knowledge to be gained from this study may provide a foundation for extending this intervention to other Hispanic mothers and children in other communities to assist mothers in managing their weight and preventing excessive adiposity and weight gain in their children. This approach is translatable, real-world, and could be replicated in other areas of the United States.
Public Health Relevance
The proposed research is relevant to public health because the prevalence of overweight and obesity is increasing in Hispanic women and young children. The goal of the proposed study is to investigate the efficacy of a nutrition and exercise education, exercise, coping skills training, home-based exercise in Hispanic women and the Color Me Healthy program in their 4-year old children. This project is relevant to NIH’s mission since it will test new strategies to prevent and manage chronic disease in minority mothers and their young children.
Principal Investigator: Lixin Song, PhD, RN, FAAN
Funded by: National Institutes of Nursing Research
Abstract: Over 180,000 men will be diagnosed with localized prostate cancer in 2016 and 92% of these men will have localized or regional disease. Fortunately, treatment with curative intent (surgery or radiation with/without hormone therapy) provides long-term cancer-free survival. However, survivors experience urinary, sexual, bowel and hormonal symptoms, general distress, pain, fatigue, and sleep disturbance. For men in an intimate relationship, these symptoms disrupt couple’s relationships and intimacy, and reduce quality of life (QOL) of both patients and their partners who are often their primary caregivers. Symptom effects may have as great or greater impact on their partners’ QOL than on patients’ own QOL. Management of the negative effects of cancer and its treatment is a significantly under-addressed supportive care need for these men and their intimate partners. Most existing online programs are not couple-focused or use generalized “one-size fits all” approaches that have fallen short of improving QOL. Existing in-person couple-focused programs are expensive and inconvenient because of the time and travel required. To address these unmet supportive care needs, Dr. Song led an interdisciplinary team to develop and pilot test the usability and feasibility of an evidence-based, couple-focused, tailored mobile health (mHealth) intervention, “Prostate Cancer Education & Resources for Couples” (PERC). Based on the adapted stress-coping theoretical framework and developed with stakeholder involvement, PERC aims to improve QOL for both patients and partners through enhancing positive appraisals, self-efficacy, social support, and healthy behaviors for symptom management. Using mHealth technologies, PERC provides comprehensive, user-friendly content, and uses tailoring and personalization features designed to increase personal relevance of, and couples’ accessibility to PERC modules. We propose to rigorously test the efficacy of PERC using a population-based, geographically and demographically diverse cohort in a randomized controlled trial. The specific aims are:
Primary Aim: Assess if patients and partners receiving PERC will report greater improvement in their cancer-related QOL scores than those in the control group (usual care plus the National Cancer Institute (NCI) prostate cancer website) at 4, 8, and 12 months post-baseline.
Secondary Aim: Test if patients and partners in PERC will report significantly more positive appraisals and higher levels of coping resources at follow-ups than those in the control group.
Exploratory Aim: Determine if patient race and ethnicity, education, type of treatment, or couples’ relationship quality moderate the effects of PERC on patient and partner QOL at follow-ups. This study will provide a novel model for self-managing chronic illness symptoms that impact couples’ relationships, intimacy, and QOL. It addresses the National Institute of Nursing Research’s (NINR) goal to develop and test new strategies for symptom self-management to help patients and caregivers better manage their illness and improve QOL. It also responds to calls for programs from the Institute of Medicine (IOM) and American Cancer Society (ACS) to address treatment-related effects and improve survivors’ QOL.
Principal Investigator: Linda Beeber, PhD, RN, FAAN
Funded by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (2016-2018)
Co-Investigators: George Knafl and Julee Waldrop, School of Nursing and Dore LaForett, Frank Porter Graham Child Development Institute
Abstract: This two-phase project will test the feasibility of integrating into Early Intervention (EI) services an intervention to enhance communication between infants and toddlers with diagnosed or suspected developmental disabilities and their depressed mothers. Federally-funded EI services are provided in all 50 states to infants and toddlers with developmental delays to improve long-term child cognitive and behavioral outcomes. EI services are optimized when the child receives consistent developmentally supportive activities as part of the family’s normal routines throughout the day, every day. EI services frequently include parent-implemented language enrichment interventions to increase child-centered speech and reciprocal (turn-taking) communication, which have been linked to positive child outcomes. Such interventions are dependent on consistent parent attentiveness, reciprocal interactions, and sensitivity to child cues. Depressive symptoms, prevalent in mothers of EI-enrolled children, can rob mothers of these capabilities. Fortunately, providing depressed mothers with concrete, attainable skills for improving interactions with their child can reduce the impact of depression on mother and child. EI is an ideal setting in which to integrate screening, support, and targeted communication skills for depressed mothers in order to improve EI child outcomes. First, we will use focus group and interview data to tailor a toolkit and training program for EI staff and determine whether it is feasible for staff to identify, screen and support mothers with depressive symptoms. Data on the toolkit will be collected from 4 EI staff on feasibility (ease of use, time required) and acceptability to mothers. Then, we will determine whether it is feasible for mothers to engage in an intervention to increase their child-centered speech and reciprocal communication using a technology-supported Language ENhancement Assessment/intervention system (LENA) embedded in EI services. The LENA uses an infant or toddler garment with an integrated audiotape device that records adult speech centered on the child, child vocalizations, and reciprocal turn-taking conversations between parent and child. The LENA software produces visual feedback that a mother can use to focus her language-based interactions with her child. The LENA-supported communication feedback intervention will be implemented with 10 mothers and 10 EI staff by using LENA one day a week for 16 consecutive hours for three consecutive weeks. Feasibility data, LENA communication data (adult word count, child vocalizations and conversational turn-taking), the Communication and Symbolic Behavior Scale, maternal depressive symptoms (PHQ-9) and child disability profiles (Mullen Scales of Early Learning) will be analyzed to determine the potential usefulness of the approach. The tailored intervention package will be designed for maximum scalability, with the ultimate goal of use by EI professionals across the country to enhance mother-child communication and maximize EI outcomes for children.
Principal Investigator: Kim Boggess, School of Medicine, Obstetrics and Gynecology (Lead) and Diane Berry, School of Nursing
Funded by: NIH Eunice Kennedy Shriver National Institute of Child Health and Human Development (2016-2021)
Co-Investigators: Laura Young, School of Medicine, Endocrinology
Abstract: Over 100,000 pregnant women with overt type 2 diabetes (T2DM) give birth in the United States every year. Strict maternal glycemic control is the key to optimizing infant outcomes. Medical treatment of overt T2DM in pregnancy is generally restricted to insulin as data on the safety and efficacy of oral hypoglycemic agents for overt T2DM is limited. However, over one-third infants born to women with overt T2DM experience an adverse outcome such as premature delivery, large-for-gestational age (LGA), hypoglycemia, hyperbilirubinemia, or birth trauma, suggesting that current treatment regimens fall short of optimizing outcomes. We believe that further research is needed to identify better strategies to reduce neonatal complications of overt T2DM in pregnancy. Metformin is the pharmacologic treatment of choice for overt T2DM outside of pregnancy. Metformin is favored over insulin because it results in less weight gain, fewer hypoglycemic episodes, and is oral rather than injectable. Metformin’s mechanism of action directly counteracts the insulin resistance characteristic of T2DM. Metformin is not recommended for treatment of T2DM complicating pregnancy, mainly because there are no large clinical studies examining its use in this context. Research is needed to address this knowledge gap. Our long-range goal is to optimize maternal and infant outcomes in overt T2DM complicating pregnancy. The objective of this proposal is to study the efficacy and safety of adjuvant metformin for treatment of T2DM among pregnant women receiving insulin therapy. Our central hypothesis is that compared to insulin alone, insulin plus metformin will result in improved neonatal outcomes. We will test this hypothesis by prospectively randomizing 1334 pregnant women with overt T2DM to insulin plus placebo therapy versus insulin plus metformin to accomplish the following specific aims: 1: To measure the effect of insulin/metformin on composite adverse neonatal outcome (perinatal mortality-miscarriage; stillbirth or neonatal death; preterm delivery, neonatal hypoglycemia, hyperbilirubinemia, and/or birth trauma); infant birth weight and fat mass, among pregnant women with T2DM.; 2: To measure safety of insulin/metformin use among pregnant women with overt T2DM; and 3: To quantify gestational weight gain (GWG) and satisfaction with therapy among women treated with metformin. Successful completion of this proposal will result in high quality contemporary evidence for management of overt T2DM complicating pregnancy to improve neonatal outcomes.
Principal Investigator: Jada Brooks, PhD, MSPH, RN
Funded by: NIEHS (2016-2018)
Mentors: David Peden, Pediatrics and Barbara Fredrickson, Psychology and Neuroscience
Scientific Advisors: Linda Beeber, School of Nursing and Giselle Corbie-Smith, Social Medicine
Biostatistician: Josephine Asafu-Adjei
Abstract: American Indian women experience particularly high mortality and morbidity from cardiovascular disease (CVD). Reducing this burden requires addressing preventable factors in the physical and psychosocial environment that are known to be important for the inflammatory responses involved in CVD. However, there is little evidence about the roles of environmental pollutant exposures and psychosocial factors in shaping immunologic function in American Indian women. This Mentored Patient-Oriented Research Career Development (K23) Award, entitled Inflammatory Markers, Hazardous Air Pollutants, and Psychosocial Factors proposes to address inflammation as a potential biological pathway linking environmental pollutant exposure and psychosocial factors to CVD in American Indian women. The working hypothesis is that American Indian women with positive psychosocial states are less susceptible to the inflammatory effects of environmental pollutants. The study will examine a sample of American Indian women (N = 150) drawn from southeastern North Carolina. A variety of assessment methods will be used, including survey methods, exposure assessment, and serum biomarker. Three Specific aims are to: 1) examine the association between environmental pollutants and inflammation in American Indian women; 2) examine the association between psychosocial states and inflammation in American Indian women; and 3) determine whether psychosocial states moderate the association between environmental pollutants and inflammation in American Indian women. With a background in nursing and epidemiology I am focusing my research on using community-based approaches to investigate relationships among environmental pollutants, psychosocial states, biological outcomes, and health disparities, particularly among American Indian women. The proposed training activities will include formal didactics and hands-on instruction in measurement and interpretation of environmental data, positive psychosocial states, and serum bioscience methods; community-engagement methods; responsible conduct in research; and attendance at national conferences. I have assembled an interdisciplinary mentoring team of internationally recognized experts who will provide me guidance in building new skills in environmental epidemiological measurement, psychosocial research, and serum biomarker measurement and analysis. The K23 award will move me to independence as a researcher, support my steps in securing funding as an independent investigator, and help me to become a nurse leader in environmental health disparities.
Principal Investigator: Jada Brooks, PhD, MSPH, RN
Funded by: National Institute on Drug Abuse via Florida Atlantic University Subcontract (2014-2019)
Abstract: Not available
Principal Investigator: Eric Hodges, PhD, FNP-BC
Funded by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (2016-2018)
Co-Investigators: Cathi Proper, UNC Center for Developmental Science; and Todd Schwartz, UNC School of Nursing
Abstract: Once obese as an infant, the relative risk of remaining obese appears to rise with increasing age. Thus, the early years of life have been posited as an important target period for obesity prevention. Widely viewed as a response to genetic, interpersonal, and environmental factors, obesity fundamentally reflects an imbalance between energy intake and expenditure. Self-regulation of energy intake aligned with physiologic need is essential to this balance. The process(es) by which infants begin to disassociate eating behavior from physiologic need is unclear, thus it is crucial to better understand predictors of individual differences in self-regulation of energy intake. It is well established that autonomic regulation may support infant behavioral regulation, suggesting that autonomic function may be a critical area to consider here. Moreover, self-regulation is strongly influenced by dyadic interaction quality during infancy, and findings reveal that more responsive interactions are associated with more effective autonomic regulation. A chronic mismatch between a caregiver’s feeding behavior and the infant’s state (feeding in the absence of hunger and/or feeding beyond fullness), is thought to contribute to obesity by undermining the infant’s capacity to self-regulate intake; the current proposal will be the first to examine the effects on autonomic regulation.
We propose an intervention to enrich the capacity of mother-infant dyads to perform their respective interactive tasks. We plan to teach mothers American Sign Language (ASL) signs indicative of hunger, thirst, and satiety, which they will in turn teach their preverbal infant. This training in ASL will be augmented with targeted information for mothers about infants’ capacities to self-regulate energy intake in response to hunger and satiety and communicate those states with intention. Mothers also will be taught about expected development of infants’ eating behaviors and nutritional requirements to support healthy growth.
Using a two-group randomized repeated measures design, this study aims to 1) evaluate the feasibility and acceptability of the intervention and study methods, including recruitment, enrollment, and data collection (self-report, anthropometrics, video observations, and respiratory sinus arrhythmia [RSA]) for infants and their mothers; 2) evaluate the initial impact of the intervention on observed feeding interactions, reported infant feeding behaviors and maternal feeding behaviors/beliefs, and infant nutritional intake and growth; and, 3) explore preliminary data on concordance between dyadic feeding interactions and autonomic regulation in both mothers and infants (RSA). In addition to a variety of self-report and anthropometric measures, this study will use integrated behavioral (video) and physiologic (RSA) measures to better understand feeding dynamics and their relationship with obesity risk. Understanding these processes is essential for developing appropriate preventions, or interventions, that will help reduce the prevalence of early childhood obesity and its extension into later childhood and beyond.
Principal Investigator: Kathleen Knafl, PhD, FAAN
Funded by: National Institutes of Health via subcontract with Childrens National Health System, Children’s Research Institute
Abstract: Not available
Principal Investigator: Kathleen Knafl, PhD, FAAN
Funded by: National Cancer Institute via subcontract with University of Pennsylvania
Abstract: Not available
Principal Investigator(s): Core: Alice Ammerman, Jennifer Leeman, DrPH, MDIV, and Sam Cykert; Center: Alice Ammerman
Funded by: Centers for Disease Control and Prevention via UNC Center for Health Promotion and Disease Prevention (2014-2019)
Principal Investigator: Jennifer Leeman, PhD, MDiv
Funded by: Centers for Disease Control and Prevention/National Institutes of Health (2014-2019)
Co-Investigators: Noel Brewer and Kurt Ribisl, Health Behavior; Stephanie Wheeler, Health Policy and Management
Abstract: Cancer has overtaken heart disease as the leading cause of death in North Carolina (NC), and disparities in cancer care and outcomes persist across racial, ethnic, and economic groups. To reduce cancer incidence and mortality, we will promote the adoption and implementation of evidence-based approaches (EBA) to cancer prevention and control (CPC). The Comprehensive Cancer Control Collaborative of North Carolina (4CNC) proposes to continue to contribute to the Cancer Prevention and Control Research Network’s (CPCRN) mission to facilitate uptake of evidence-based CPC interventions through research, training, and technical assistance. 4CNC has developed robust community-academic partnerships with researchers, care providers, and communities across North Carolina to promote the use of EBA to prevent cancer, increase screening, and enhance access to cancer care for all North Carolinians. 4CNC proposes to further develop its established organizational infrastructure to collaborate with CPCRN and with its strong local partners to accelerate the adoption of evidence-based CPC in NC communities and across the nation. We plan to move further along the discovery to delivery continuum by also engaging in research on how to disseminate and implement EBA to improve cancer outcomes among individuals, in communities, and across health care systems. We propose continuing our work to prevent and control colorectal cancer, eliminate disparities in breast cancer screening, prevent cervical cancer through increased HPV vaccination and reduce the impact of tobacco use. In partnership with CPCRN and our 4CNC local partners, our aims are: (1) Maintain and enhance existing 4CNC infrastructure to (a) further develop local and CPCRN partnerships and activities, (b) identify and rapidly respond to priority areas and emerging issues, (c) initiate and support CPC, dissemination, and implementation research and evidence-informed practice, and (d) more rapidly and broadly disseminate 4CNC products and results to partners at the local, state, and national levels as well as to funding entities and CPCRN members; (2) Advance the science and practice of dissemination and implementation research across the cancer continuum with a focus on (a) preventing cervical cancer via HPV vaccine uptake, (b) eliminating disparities in breast cancer screening and treatment, and (c) preventing initiation and promoting cessation of tobacco use; and (3) Create a community and research-based infrastructure, including a cross-CPCRN project, to support and inform implementation of Community Guide recommendations to increase CRC screening in NC, with a special emphasis on increasing use among minority and uninsured individuals.
Principal Investigator: Mary R. Lynn, PhD
Funded by: National Council of State Boards of Nursing (2016-2018)
Co-Investigators: Cheryl Jones, UNC School of Nursing
Abstract: Within the last 15 years hundreds of transition programs for new graduate registered nurses (NGRNs) have been launched yet, to date, no study has been located that characterizes these programs or compares them on essential components such a length, content, structure or outcomes. Yet transition programs are in place in virtually every hospital in the U.S. This project has been designed to fill that gap. This study will be done in two phases, each done collaboratively with a 10-member Advisory Board. The Advisory Board members represent a diverse population all with interests in transition programs – four head staff development departments, three of which have transition programs in their department, one is a chief nursing officer whose hospital started its own program, one in a clinical researcher involved in a national transition program, another an academic research who studies new graduate registered nurses, and the remaining members are a national-expert in nursing education, a sociologist with research experience in nursing-related workforces, and the director of a large national transition program. In Phase I, 1,400 U.S. hospitals will be randomly sampled from the AHA list of hospitals and their nursing education director asked to complete an assessment of their program for transitioning nurses as well as to provide characteristic data about their hospital. The Advisory Board will work to develop a schema to classify the transition program in 2 to 3 major characteristics (e.g., length, content) which will then have sub-categories developed. These will, in turn, be used for the sampling for Phase II where a hospital within each “cross-category” will be contacted and asked for the opportunity to recruit up to 24 new graduate registered nurses (540 NGRNs is the desired final sample) to complete several outcome instruments at the beginning, middle and end of their first year of employment. All data collection will occur online. The questions to be addressed include identifying the characteristics of transition programs for new graduate registered nurses in the U.S., exploring the relationship between variable in the domains of the NGRN, the program and the hospital, comparing NGRN across time and classification categories, and attempting to predict the NGRN outcome measures from the program and/or hospital characteristics. This study has implications in terms of the knowledge to be gained about transition programs in nursing and to inform regulatory bodies about the characteristics to consider if these programs are to be required before a nurse is “fully licensed.”
Funded by: National Institute of Nursing Research (1996-2021)
Abstract: The purpose of this research training grant renewal application is to prepare nurse scientists with capacities to develop theory-based interventions for preventing and managing chronic illness with a new emphasis on accelerating translation into practice. The T32 has matured over the last 20 years of funding; its focus has expanded to address emergent priorities in research on theory-based interventions for preventing and managing chronic illness as well as to reflect the strength and diversity of our faculty research. In this application, we address the imperative to speed the translation of research findings to practice for the improvement of patient and population health outcomes. The program is conceptualized around a paradigm that posits two approaches to speeding translation: designing interventions with implementation in mind and applying rigorous approaches to disseminating and implementing research findings. Our continued focus on theory-based interventions will be enhanced by a new focus on translational science and training in five translation catalysts: dissemination and implementation science, stakeholder engagement, patient-centered outcomes, pragmatic and adaptive trial designs, and mixed methods. For predoctoral trainees, enhancements to the PhD program will include: courses structured to address the five translation catalysts; mentored research experiences; and participation in seminar series concentrated on development as a scientist and on promoting translation of intervention research to practice. For postdoctoral trainees, the training program also will include independent research experiences and active involvement in interdisciplinary seminar series. A total of 14 predoctoral trainees and 10 postdoctoral trainees will be supported over the 5 years of the training program. The emphasis on the five new areas will capitalize on our faculty strengths, strong research infrastructure, and well-established partnerships on The University of North Carolina at Chapel Hill campus and throughout the rural and racially diverse state of North Carolina.
Principal Investigator: Lixin Song, PhD, RN
Funded by: National Cancer Institute, National Institutes of Health (2016-2018)
Co-Investigators: Deborah Mayer and Josephine Asafu-Adjei, School of Nursing; Ronald Chen, School of Medicine; and Sarah Birken, School of Public Health
Consultant: Laurel Northouse, University of Michigan
Abstract: Supporting NIH’s mission, this project aims to explore a new model of care that enhances survivorship care planning and promotes health for patients with localized prostate cancer (PCa) transitioning to post-treatment self-management. Survivorship care planning for patients with PCa is important because of the high incidence rates of PCa in the U.S., the frequent occurrence of treatment-related side effects, and reduced quality of life (QOL) in both patients and their partners (for patients who are partnered). Emerging evidence suggests that use of regular survivorship care plans (SCPs) does not improve health service and patient outcomes because the content in mandated SCPs does not consider patients’ information and care needs. We plan to integrate an evidence-based, theory-driven symptom self-management program, Prostate Cancer Education & Resources for Couples (PERC), with standardized SCPs and build enhanced SCPs (ESCPs). ESCPs will engage both patients and partners during survivorship care planning and provide a one-stop, comprehensive PERC program to improve their QOL and decrease patient use of post-treatment care services. The couple-focused, web-based tailored PERC program includes 12 online modules with assignments, a moderated chat room and a resource center. Tailored to patients’ and partners’ characteristics and preferences to address their specific care needs, PERC helps couples reduce negative appraisals of symptoms, increase access to social support, and enhance self-efficacy and health behaviors for symptom self-management. In this study, we propose to test the feasibility of ESCPs (regular SCPs with the PERC web link) and to conduct an initial benefit assessment of ESCPs. We will use a two-group (ESCP=intervention and SCP only=negative control) randomized controlled pretest-posttest design and collect data at baseline (T1) and 4 months later (T2) among 50 patients completing initial treatment for localized PCa and their partners. The specific aims are: Aim 1: Examine the feasibility of delivering ESCPs (as assessed by recruitment, enrollment, and retention rates, satisfaction with ESCP, and perceived ease of use of PERC). We will use mixed methods to achieve this aim. Aim 2: Estimate the magnitude of benefit of ESCPs. We hypothesize that, compared with the SCP only users, the ESCP users will report (1) greater improvement in their primary outcomes of QOL (overall, physical, emotional, and social QOL); (2) greater improvement in secondary outcomes (reduction in negative appraisals and improvement in self-efficacy, social support, and health behaviors to manage symptoms); and (3) fewer visits to post-treatment care services from between T1 and T2. The results from this study will help design a definitive randomized trial to test the efficacy of ESCP. The innovative ESCPs will strengthen survivorship care planning and allow PERC to be disseminated broadly and systematically without the need for costly resources or personnel. This proposed project is in response to calls for programs from the Institute of Medicine and American Cancer Society to address treatment-related effects and help cancer survivors maintain their QOL.
Principal Investigator: SeonAe Yeo, PhD, RN, FAAN
Funded by: UNC Center for Diabetes Translation Research to Reduce Health Disparities