Teresa Knoop, MSN, RN, AOCN®, CCRP

Per­son­al­ized med­i­cine is a rel­a­tively new approach to dis­ease man­age­ment, but it’s still come a long way. Tra­di­tion­ally, fea­tures of a tumor were described based on its appear­ance under a micro­scope. Today, we know that the mol­e­c­u­lar pro­file of a tumor is critical.

“The genetic makeup of a patient’s spe­cific tumor can be used to guide health­care prac­ti­tion­ers in how best to treat an individual’s can­cer,” ONS mem­ber Teresa Knoop, MSN, RN, AOCN^®, CCRP, explains.

A New Focus for Research
In her work as the man­ager of the Clin­i­cal Tri­als Infor­ma­tion Pro­gram at the Van­der­bilt Ingram Can­cer Cen­ter (VICC) in Nashville, TN, Knoop con­nects eli­gi­ble patients to clin­i­cal tri­als and then helps them nav­i­gate their way into VICC to be eval­u­ated for trial options.

“It seems that almost every can­cer trial being intro­duced at our cen­ter includes some aspect of per­son­al­ized med­i­cine,” says Knoop, who is a mem­ber of the Mid­dle Ten­nessee ONS Chapter.

Stud­ies under way at VICC that relate to per­son­al­ized med­i­cine involve match­ing a par­tic­u­lar type of muta­tion to a spe­cific trial agent or con­duct­ing cor­rel­a­tive stud­ies in which tumor tis­sue is tested to ensure that the agent is used most effec­tively based on the genetic makeup of a par­tic­u­lar tumor.

Knoop explains, “We cur­rently have clin­i­cal tri­als that tar­get muta­tions in mol­e­cules such as PIK3CA, ALK, BRAF, EGFR1, and KRAS. It seems every day I am learn­ing about a new mol­e­c­u­lar path­way and the poten­tial impli­ca­tion for can­cer treatment.”

Alli­son Vorder­strasse, DNSc, APRN, says that although genomic tests aren’t always cov­ered by insur­ance, costs con­tinue to decrease.

Antic­i­pat­ing the way per­son­al­ized med­i­cine will trans­form health­care, sci­en­tists at Duke Uni­ver­sity in Durham, NC, have also been con­duct­ing per­son­al­ized med­i­cine research. Alli­son Vorder­strasse, DNSc, APRN, is an assis­tant pro­fes­sor at Duke Uni­ver­sity School of Nurs­ing and mem­ber of Duke’s new Cen­ter for Per­son­al­ized Med­i­cine (CPM), which was founded in 2010.

“The work of CPM is cur­rently focused on five major areas: research, clin­i­cal prac­tice, pol­icy, edu­ca­tion, and part­ner­ships,” Vorder­strasse explains.

She is cur­rently explor­ing whether health behav­iors and clin­i­cal out­comes for patients at risk for heart dis­ease are changed by com­bin­ing tra­di­tional risk coun­sel­ing with genetic risk test­ing and sup­port modal­i­ties (health coach­ing) for behav­ior modification.

“Ulti­mately, we want to know what moti­vates peo­ple with heart dis­ease to improve their risk fac­tors,” she says. “We antic­i­pate that offer­ing these per­son­al­ized approaches to risk infor­ma­tion and behav­ior mod­i­fi­ca­tion may improve lifestyle behav­iors, risk pro­files, and even­tu­ally clin­i­cal outcomes.”

Sim­i­lar stud­ies are under way in oncol­ogy to eval­u­ate risk-​​screening trig­gers and risk-​​reducing inter­ven­tions, in addi­tion to phar­ma­coge­nomics applications.

Trans­lat­ing Research Into Prac­tice
The full poten­tial of per­son­al­ized med­i­cine has yet to be real­ized, but many aspects of it have already moved from the bench to the bedside.

“We now have the abil­ity in cer­tain cancers—such as non-​​small cell lung can­cer, colon can­cer, and melanoma—to iden­tify spe­cific muta­tions in can­cer cells that help guide which drugs might be most effi­ca­cious for the patient or to which drugs the tumor might be resis­tant,” Knoop says.

Tumor geno­typ­ing is rou­tinely offered to patients at Vanderbilt’s Per­son­al­ized Can­cer Med­i­cine Ini­tia­tive (PCMI), which was launched in 2010.

“Van­der­bilt is one of the lead­ers in the nation in using per­son­al­ized med­i­cine in can­cer care through PCMI,” Knoop says. “We are con­duct­ing geno­typ­ing at our cen­ter on patients with lung can­cer, melanoma, and breast can­cer and soon will be offer­ing this test­ing to patients with colon can­cer. The geno­typ­ing of these par­tic­u­lar tumor types helps guide treat­ment deci­sions regard­ing both exist­ing stan­dard ther­a­pies and emerg­ing ther­a­pies offered in clin­i­cal trials.”

Vorder­strasse attests that one of the most com­mon ques­tions for prac­ti­tion­ers and patients is whether tests will be cov­ered by insurers.

“At this time, the sim­ple answer is that rel­a­tively few are. How­ever, more research into the clin­i­cal util­ity and clin­i­cal effectiveness—and even cost effectiveness—of these approaches or tests needs to be done so that evi­dence is gen­er­ated to either sup­port or deny the util­ity and cov­er­age for aspects of per­son­al­ized med­i­cine,” she says. “In com­par­i­son to cur­rent approaches in clin­i­cal care to pre­dic­tive, diag­nos­tic, and prog­nos­tic test­ing, genomic test­ing may become cost neu­tral or even cost sav­ing in the future as the costs con­tinue to decrease.”

Per­son­al­ized Med­i­cine in Prac­tice
Nurses are impor­tant con­trib­u­tors to the inter­dis­ci­pli­nary approaches of per­son­al­ized med­i­cine. At Duke, Vorder­strasse says, “it really began with dis­cus­sions about the Duke School of Nursing’s involve­ment in per­son­al­ized med­i­cine, par­tic­u­larly given our empha­sis on imple­men­ta­tion sci­ence. Through con­ver­sa­tions, col­lab­o­ra­tions, and mem­ber­ship meet­ings of the CPM lead­er­ship team, I became excited to con­tribute my exper­tise in imple­men­ta­tion sci­ence and facil­i­tate ini­tia­tives and research to move for­ward the agenda to inte­grate per­son­al­ized med­i­cine into the main­stream of health care.”

Per­son­al­ized med­i­cine can impact all areas of nurs­ing prac­tice. “As oncol­ogy nurses, we are all going to have to be knowl­edge­able about per­son­al­ized med­i­cine to be able to give guid­ance and infor­ma­tion to our patients,” Knoop says.

Vorder­strasse agrees. “The con­cep­tual frame­work of per­son­al­ized med­i­cine may seem famil­iar to nurses, as we tend to prac­tice from a per­son­al­ized approach based on our train­ing and model of care. How­ever, we must con­sider that per­son­al­ized med­i­cine or care incor­po­rates var­i­ous tools and tech­nolo­gies, such as fam­ily his­tory and genetic tests, that we may not auto­mat­i­cally con­sider in our approach with­out fur­ther knowl­edge or training.”

Aca­d­e­mic insti­tu­tions are approach­ing the need for nurs­ing edu­ca­tion by thread­ing impor­tant con­cepts through­out the cur­ricu­lum or by offer­ing spe­cific related courses. Vorder­strasse says that this spring, Duke will be offer­ing a new mul­ti­dis­ci­pli­nary elec­tive, “Applied Genomics and Per­son­al­ized Med­i­cine in Clin­i­cal Care,” which was devel­oped by rep­re­sen­ta­tives from the School of Nurs­ing, the Insti­tute for Genome Sci­ences and Pol­icy, and the Cen­ter for Per­son­al­ized Med­i­cine. Stu­dents from mul­ti­ple dis­ci­plines will learn about the tenets of genomics and per­son­al­ized med­i­cine, gain skills in eval­u­at­ing emerg­ing evi­dence for clin­i­cal appli­ca­tion, and dis­cuss eth­i­cal, legal, social, pol­icy, and prac­tice issues.

In addi­tion to gen­er­at­ing a new body of knowl­edge, devel­op­ments in per­son­al­ized med­i­cine are cre­at­ing new roles for oncol­ogy nurses.

“Nurses in mul­ti­ple areas and lev­els of prac­tice have an oppor­tu­nity to explore the clin­i­cal out­comes related to per­son­al­ized med­i­cine as it becomes more preva­lent,” Vorder­strasse explains. “They can par­tic­i­pate in inter­dis­ci­pli­nary research, imple­ment evidence-​​based per­son­al­ized strate­gies into all lev­els of clin­i­cal prac­tice, take part in pol­icy ini­tia­tives related to cov­er­age and guide­lines in per­son­al­ized med­i­cine approaches, edu­cate nurses to ensure they are pre­pared to work in this evolv­ing envi­ron­ment, and part­ner within and out­side of insti­tu­tions to enhance and advo­cate for per­son­al­ized medicine.”

Informatics-​​related roles will also be needed. “Per­son­al­ized med­i­cine will require nurses who are skilled in the crosstalk between can­cer spe­cial­ists and infor­ma­tion tech­nol­ogy spe­cial­ists so that the infor­ma­tion gained in per­son­al­ized med­i­cine can be trans­lated, doc­u­mented, and included as part of the patient’s record,” Knoop says.

“Given our philo­soph­i­cal model and approach to care, we can par­tic­i­pate and be on the fore­front of imple­men­ta­tion sci­ence, trans­lat­ing val­i­dated prac­tices into per­son­al­ized care, rec­og­niz­ing and research­ing the imple­men­ta­tion process, and eval­u­at­ing the out­comes,” Vorder­strasse explains.

Knoop, who has been involved with can­cer clin­i­cal can­cer tri­als for the past 15 years, is begin­ning to see that hap­pen in her own work. “It has been excit­ing to see the can­cer treat­ment agents we have worked with in the clin­i­cal trial set­ting obtain FDA approval for use in the stan­dard set­ting. It has been par­tic­u­larly inter­est­ing to be able to see the emer­gence of mol­e­c­u­larly tar­geted agents and their evo­lu­tion into the per­son­al­iza­tion of can­cer care.”