P30 Center of Excellence for Biobehavioral Approaches to Symptom Management

(P30 NR011403)

Virginia Commonwealth University, Mary Jo Grap, PhD, FAAN, Center PI

Final Report (2014)

Purpose / Center Aims: The P30 Center of Excellence for Biobehavioral Approaches to Symptom Management builds on the synergy developed, resources garnered, and systems developed during our successful P20 Exploratory Center for Biobehavioral Clinical Research (P20 NR008988, N. McCain, PI, 2004- 2009). The specific aims of the P30 Center are to: (1) expand research capacity for scientists by centralizing research resources/infrastructure for biobehavioral clinical research focused on symptom management; (2) advance biobehavioral approaches for symptom management, including fatigue; (3) facilitate the development/expansion of investigator-initiated biobehavioral research that have a common theme of fatigue; and (4) establish a mature environment of sustainable biobehavioral research in symptom management that is clinically focused and interdisciplinary in nature.

Description & Progress on Aims: The Center enacts its aims through 3 cores: Administrative Core (M.J. Grap), Biobehavioral Science (N. McCain, D. Lyon), Data Services and Analysis (R.K. Elswick) with the following outcomes for each specific aim.

1.We have successfully centralized resources to support a wide range biobehavioral scientist and have refined these processes over the last 5years.

2.All 5 projects have been completed, 4 with published results, one in data analysis. We have assisted more than54additionalscientistsfrommultipledisciplinestodevelopandimplementbiobehavioralprojects.

3.We have assisted faculty and their collaborators to apply for 43 grants with 21funded.

4.The 5 project directors have all developed sustainable programs of research which includes work with interdisciplinary teams. All have been successful in submitting for and/or obtaining additionalfunding.

Description of Pilot Projects and their Outcomes:

1.Self-efficacy, Stress, Immunity, and Symptoms of Fibromyalgia (V. Menzies). RCT to test a 10-week guided imagery intervention on self-efficacy, perceived stress, and selected biobehavioral factors in women (N=72) diagnosed with fibromyalgia. Results: Decreases in fatigue (p<0.01), pain severity (p<0.01), depression (p=0.02), and perceived stress (p=0.05) and increase in self-efficacy for managing symptoms (p=0.02) from baselinetoweek10ininterventioncomparedtocontrols.NodifferencesbetweeninlevelsofTh1/Th2cytokines orCRP.

2.Biobehavioral Factors and Fatigue in Adolescents and Young Adults (AYA) with Sickle Cell Disease (S. Ameringer).Wedescribedfatigueandexaminedbiobehavioralcorrelatesoffatigue(inflammation,oxygenation, pain, anxiety, and depressive symptoms, and sleep quality) in 60 AYA (ages 15-30) with SCD; and qualitatively explored AYAs’ representations of fatigue. Fatigue levels were mild to moderate. Fatigue was significantly correlated with stress, anxiety, sleep, depressive symptoms, pain, hemoglobin, and quality oflife.

3.Guided Imagery (GI) Effects on Pregnancy Symptoms and Outcomes (N. Jallo). Aims of this 12-weekRCT are: (1) to test the effects of a GI intervention on maternal stress and related symptoms, neuroendocrine and immunological mediators and birth outcomes in 72 pregnant African American women between 14-17 weeks gestation; and (2) to test the proposed theoretical model by examining predicted relationships among stress, fatigue, anxiety, depression, unhappiness, patterns of neuroendocrine and immunologic factors, and birth outcomes.

4.Exploring the Effects of Tai Chi on Cardiometabolic Risk in Women (J. Robins). 4. A randomized study examined the feasibility and biobehavioral effects of a tailored tai chi intervention in 63 women with increased cardiometabolic risk. The intervention was deemed feasible and acceptable. Tai chi was associated with significant increased mindfulness, self-compassion and spirituality and decreased depressive symptoms as well as decreases in TNF and IFN, cytokines associated with inflammation and insulinresistance.

5.Neurocognitive Impairment (NI) in Women with Early Stage Breast Cancer (A. Starkweather, J. Walter). This prospective, longitudinal project examines the relationships of fatigue, perceived stress, depressive symptoms and NI and explores the relationships among key behavioral and biological markers that may explain mechanisms for NI. Up to 60 women with Stage I or II BC with surgical treatment (biopsy, lumpectomy or mastectomy) half receiving adjuvant chemotherapy and 30 healthy controls are included, subject enrollment is complete, data analysis isunderway.

Overall Center Outcomes (2009-2014):

Number of years the center has been funded: 5

Number of Publications: 25 (Publication list is attached)

Number of Grants funded and submitted: 27 funded; 49 submitted

Pilots completed and pilots that were funded in the Aims: 5 pilots completed, 5 pilots funded

Number of supplements: 0

Is there cost sharing or fee for service structures in place? Yes

Number of outside investigators who use the Center resources: More than 54

Resources leveraged: CTSA (mock review, I2B2, Clinical Research Support, Mentors, Incubator), VCUHS pathology labs & clinics, Human Performance Lab, Mid-Atlantic Twin Registry, Cytogenics Lab, Massey Cancer Center, Community Hospitals, Kliewer Prevention Research Lab, Virginia Department of Health, Boys/Girls club

Publications Reported for this Reporting Period

NIH Public Access (completed)

MontpetitAJ,AlhareeriAA,MontpetitM,StarkweatherAR,Elmore LW,FillerK,MohanrajL,BurtonCW,MenziesVS,LyonDE,Jackson- CookCK.Telomerelength:areviewofmethodsformeasurement. Nurs Res. 2014 Jul-Aug; 63(4):289-99. PubMed PMID: 24977726; NIHMSID:592942.

WilliamsonS,MunroC,PicklerR,GrapMJ,ElswickRKJr.Comparison ofbiomarkersinbloodandsalivainhealthyadults.NursResPract. 2012;2012:246178. PubMed PMID: 22619709; PubMed Central PMCID:PMC3350846.

RobinsJL,ElswickRK,McCainNL.Thestoryoftheevolutionofa uniquetaichiform:origins,philosophy,andresearch.JHolistNurs. 2012Sep;30(3):134-46.PubMedPMID:22228833;PubMedCentralPMCID:PMC3762493.

Robins JL, McCain NL, Elswick RK. Exploring the complexity of cardiometabolicriskinwomen.BiolResNurs.2012Apr;14(2):160-70. PubMedPMID:21406504;PubMedCentralPMCID:PMC3762497.

LyonD,WalterJ,MunroCL,SchubertCM,McCainNL.Challengesin interpretingcytokinebiomarkersinbiobehavioralresearch:abreast cancerexemplar.BiolResNurs.2011Jan;13(1):25-31.PubMedPMID: 21199813;PubMedCentralPMCID:PMC3966622.

MenziesV,LyonDE,ElswickRKJr,McCainNL,GrayDP.Effectsof guidedimageryonbiobehavioralfactors inwomenwithfibromyalgia. JBehavMed.2014Feb; 37(1):70-80.PubMed PMID:23124538;

PubMed Central PMCID: PMC3610859.

LyonD, Elmore L, Aboalela N, Merrill-Schools J, McCain N, StarkweatherA,ElswickRKJr,Jackson-CookC.Potentialepigeneticmechanism(s)associatedwith the persistenceofpsychoneurological symptoms in women receiving chemotherapyfor breast cancer: a hypothesis. Biol Res Nurs. 2014 Apr;16(2):160-74. PubMed PMID: 23585573;PubMedCentralPMCID:PMC3872254.

MenziesV,JalloN.Guidedimageryasatreatmentoptionforfatigue: a literature review. J Holist Nurs. 2011 Dec; 29(4):279-86. PubMed PMID:21772047;PubMedCentralPMCID:PMC3709599.

StarkweatherAR,SherwoodP,LyonDE,McCainNL,BovbjergDH, BroaddusWC. Abiobehavioralperspective ondepressivesymptomsin patientswith cerebral astrocytoma. J Neurosci Nurs. 2011 Feb; 43(1):17-28.PubMedPMID:21338041;PubMedCentralPMCID: PMC3732744.

StarkweatherAR, Lyon DE, Schubert CM. Pain and inflammation inwomen with early-stage breast cancer prior to induction of chemotherapy.BiolResNurs.2013Apr;15(2):234-41.PubMedPMID: 22084403;PubMedCentralPMCID:PMC3729026.

StarkweatherA.Improvingpatient-centeredmedical-surgicalnursing practice with quality-of-life assessment, Medsurg Nurs. 2010 Jul- Aug; 19(4):224-32.PubMedPMID:20860248;PubMedCentralPMCID: PMC3732743.

Arango-LasprillaJC,KetchumJM,StarkweatherA,NichollsE,Wilk AR. Factorspredictingdepressionamongpersonswith spinalcord injury1to 5 yearspostinjury.NeuroRehabilitation.2011; 29(1):9-21. PubMedPMID:21876291;PubMedCentralPMCID:PMC3729031.

StarkweatherA.Psychologicandbiologicfactorsassociatedwithfatigueinpatientswith persistent radiculopathy.PainManagNurs. 2013 Mar; 14(1):41-9. PubMed PMID: 23452526; PubMed Cent ral PMCID:PMC3734854.

Starkweather AR, Witek-Janusek L, Nockels RP, PetersonJ, Mat hews HL. The multiple benefits of minimally invasive spinal surgery:resultscomparingtransforaminallumbarinterbodyfusion andposteriorlumbarfusion.JNeurosciNurs.2008Feb; 40(1):32-9. PubMedPMID:18330408;PubMedCentralPMCID:PMC3714401.

Driscoll CJ, Lyon D, McCain NL. Integrating genomics into biobehavioralresearch:atransplantationexemplar. BiolResNurs. 2011Oct; 13(4):340-5.PubMedPMID:21196421;PubMedCentral PMCID:PMC3966624.

LyonDE,McCainNL,PicklerRH,MunroC,ElswickRKJr.Advancing thebiobehavioralresearchoffatigue with geneticsandgenomics.J NursScholarsh.2011Sep; 43(3):274-81.PubMedPMID:21884373; PubMedCentralPMCID:PMC3934428.

MontpetitAJ.Akangarooandyourresearchtoolbox.BiolResNurs. 2011Oct; 13(4):337-9.PubMedPMID:22058074;PubMedCentral PMCID:PMC3907194.

JalloN,LyonDE,KinserPA,KellyDL,MenziesV,Jackson-CookC. Recruitingforepigeneticresearch:facilitating theinformedconsent process. Nurs Res Pract . 2013; 2013:935740. PubMed PMID: 23840949;PubMedCentralPMCID:PMC3690242.

StarkweatherAR,LyonDE,ElswickRKJr,MontpetitA,ConleyY, McCain NL. Symptom Cluster Research in Women with Breast Cancer: A Comparison of Three Subgrouping Techniques. Adv Breast Cancer Res. 2013 Oct; 2(4):107-113. PubMed PMID: 24498579;PubMedCentralPMCID:PMC3909650.

StarkweatherAR,LyonDE,ElswickRKJr,MontpetitAJ,ConleyY, McCain NL. A Conceptual Model of Psychoneurological Symptom Cluster Variation in Women with Breast Cancer: Bringing Nursing ResearchtoPersonalizedMedicine.CurrPharmacogenomicsPerson Med. 2013 Sep; 11(3):224-230. PubMed PMID: 24497894; PubMed CentralPMCID:PMC3909649.

Ameringer S, Elswick RK Jr, Smith W. Fatigue in adolescents andyoung adults with sickle cell disease: biological and behavioral correlates and health-related quality of life. J Pediatr Oncol Nurs. 2014Jan-Feb; 31(1):6-17.PubMedPMID:24378816;PubMedCentral PMCID:PMC3982311.

Robins JL, Kiken L, Holt M, McCain NL. Mindfulness: An effective coachingtoolforimprovingphysicalandmentalhealth.JAmAssoc NursePract.. 2013Nov21; PubMedPMID:24259186;PubMedCentral PMCID:PMC4029868.[Epubaheadofprint]

SturgillJ,McGeeE,MenziesV.Uniquecytokinesignatureintheplasmaofpatientswithfibromyalgia.JImmunolRes.2014;2014:938576.PubMedPMID:24741634;PubMedCentral PMCID:PMC3987983.

AmeringerS,MunroC,ElswickRKJr.Assessingagreementbetween salivary alpha amylase levels collected by passive drool and eluted filter paper in adolescents with cancer. Oncol Nurs Forum. 2012 Jul; 39(4):E317-23.PubMedPMID:22750901;PubMedCentralPMCID: PMC4049331.