Volume 15, Issue 2, July 2004   
The ONS Nurse Practitioner SIG Newsletter is underwritten through a grant from Amgen, Inc.
     
2004 Advanced Practice Nursing Retreat Focuses on Nursing Sensitive Outcomes

Diane Cope, PhD, ARNP, BC, AOCN®
Fort Myers, FL
ecope@attglobal.net


The 2004 Advanced Practice Nursing (APN) Retreat was held March 18–20, 2004, in Tucson, AZ. The theme of the retreat focused on nursing outcomes. Planning team members included Laura Fennimore, RN, MS, (ONS director of education), Barbara Lubejko, RN, MS, OCN® (ONS education associate), Barbara Holmes Gobel, RN, MS, AOCN® and me (co-chairs), Janet Fulton, PhD, RN, Mary Pat Johnston, RN, MS, AOCN®, Sandra Mitchell, CRNP, MScN, AOCN®, and Janet Van Cleave, MSN, ACNP-CS, AOCN®. The keynote speaker, Diane Doran, RN, PhD, associate dean of research and international relations at the University of Toronto in Ontario, Canada, and editor of the book Nursing-Sensitive Outcomes: State of the Science (Jones and Bartlett), opened the retreat with a lecture and discussion presenting the concept of nursing sensitive outcomes, applications to patient care, and study findings.

Outcomes, which involve how patients and their healthcare problems are affected by nursing interventions, have been identified and are described as “nursing sensitive outcomes.” Nursing sensitive outcomes are those stemming from, or significantly impacted by, nursing interventions. The interventions must be within the scope of nursing practice and integral to the processes of nursing care. Nursing sensitive outcomes represent the consequences or effects of nursing interventions and result in changes in patients’ symptom experience, functional status, safety, psychological distress, and/or costs. Because of the chronic and often life-threatening nature of cancer, as well as the cost of curative and palliative therapies, examining outcomes that describe quality of life, performance status, patient satisfaction, and cost is important.

ONS, recognizing the need for nurses to document the quality of their contributions to patients’ health outcomes, has developed the ONS Outcomes Project Team. Retreat participants had the opportunity to advance their knowledge of nursing sensitive outcomes by working with the ONS Outcomes Project Team faculty and authors to review recently developed oncology nursing sensitive outcomes templates. Faculty involved in the template development and present at the retreat were Verna Rhodes, RN, MED, EdS, FAAN, Jeanne Erickson, RN, MSN, AOCN®, Chris Friese, RN, MS, OCN®, and Meg Bourbonniere, PhD, RN.

Other presentations at the retreat included, “Evidence-Based Education Guidelines,” by Lubejko, “Education Outcomes,” by Rhonda Scott, PhD, RN, CS, “Medication Safety Outcomes,” by Ginette Pepper, PhD, RN, FAAN, and “ONCC APN Role Delineation Survey Results,” by Barbara Rogers, CRNP, MN, AOCN®.

The 2004 APN Retreat was the last of four scheduled retreats funded by a grant from the ONS Foundation’s Center for Leadership, Information and Research with support from Aventis. The overall objective of these retreats has been to provide an innovative and creative opportunity for APNs to network and grow as individuals and as a community of advanced practice professionals. Previous APN retreats focused on strategies to implement evidence-based practice outcomes as well as to provide a forum for new and experienced APNs to network and mentor one another.

 
 

Special Interest Group Newsletter  July 2004
 
   


ONCC Advanced Nursing Certification Undergoes Changes

Wendy H. Vogel, MSN, FNP, AOCN®
Bristol, TN
wvogel@charter.net


Several members of the Nurse Practitioner (NP) SIG attended the meeting at the 29th Annual ONS Congress, “Advanced Certification for Advanced Practice Nurses (APNs): What Does the Future Hold?” Following is a summary of the information given, questions that were asked, and answers that were given.

The meeting was held on Saturday and was conducted by Cyndi Miller Murphy, RN, MSN, CAE, executive director of the Oncology Nursing Certification Corporation (ONCC); Barbara Rogers, CRNP, MN, AOCN®, chair of the Advanced Practice Test Development Committee; and Julie Ponto, RN, MS, APRN-BC, AOCN®, president of the ONCC Board of Directors.

Murphy discussed the history of regulation of advanced nursing practice. State legislatures enact the Nurse Practice Act, which defines the authority of the state board of nursing. The board of nursing then develops rules and regulations that are consistent with the Nurse Practice Act. She discussed the differences between RN licensure and specialty certification, recognizing that certification does not include a legal scope of practice and that certification is voluntary and issued by nongovernmental organizations, usually reflecting a higher standard of specialty knowledge.

Murphy discussed the role that the National Council of State Boards of Nursing (NCSBN) has played in the regulation of advanced practice nursing. NCSBN is an umbrella organization that supports the 60 state boards of nursing in the United States and its territories in providing leadership to advance regulatory excellence for public protection. All of the individual state boards are members of NCSBN and comprise the NCSBN delegate assembly. In 1995, the NCSBN began to collaborate with NP specialty certification organizations to make progress toward psychometrically sound and legally defensible NP examinations that would be sufficient for regulatory purposes. This was also the year that the first AOCN® examination was administered. From 1996–1999, NCSBN and NP certification organizations continued to collaborate, and accreditation by the National Commission for Certifying Agencies was determined to be acceptable criteria for use of certifying examinations for regulatory purposes. In 2000, NCSBN developed the Uniform Advanced Practice Registered Nurse Licensure/Authority to Practice Requirements, which were adopted by state boards of nursing. These requirements include an unencumbered RN license, graduation from an accredited graduate-level APN program, national APN certification appropriate to educational preparation, and maintenance of certification. Because only 15%–20% of AOCN® candidates graduate from oncology-focused programs and the number of oncology-focused programs is sparse, ONCC does not require an oncology-focused master’s degree and therefore does not meet the criterion of APN certification appropriate to educational preparation. In 2002, NCSBN developed updated criteria for the state boards to use in evaluating certification programs. ONCC meets all of the recommended criteria, except the criterion that requires consistency between educational preparation specialization and certification. This criterion indicates that the certifying body should require each candidate to have had graduate education with concentration in the advanced practice specialty, 500 supervised clinical hours, and clinical experience directly related to the knowledge and role of the specialty and category within the educational program. NCSBN also developed a position paper in 2002 about the regulation of advanced practice nursing stating that certification programs must meet established criteria and be based in broad categories only, not subspecialties such as disease entities (e.g., cancer). Examples of these broad categories are adult, pediatrics, and psychiatric nursing.

NCSBN is not a regulatory body in and of itself but rather a membership organization for state boards. Therefore, state boards are under no obligation to adopt the policies or rules recommended by NCSBN, even if they are approved by the NCSBN delegate assembly. Therefore, the regulation of APNs varies widely from state to state and even among APN categories (NP versus clinical nurse specialist [CNS]) within a state. In 1994, ONCC began communicating with NCSBN and individual state boards of nursing regarding the recognition of AOCN® certification. The AOCN® credential currently is recognized in 26 states. However, the NCSBN APRN advisory panel recently has communicated to ONCC that it considers oncology a subspecialty, especially in the NP role, and does not consider oncology certification suitable for the purposes of licensure. ONCC will continue to communicate with NCSBN and apply for recognition of the new examinations in each state and communicate regularly with oncology APRNs about this issue. More information about NCSBN can be found at www.ncsbn.org

Following this presentation, Rogers described the ONCC Role Delineation Study (RDS) of oncology APNs that was conducted during 2003. Accrediting agencies such as the American Board of Nursing Subspecialties and the National Commission for Certifying Agencies indicate that role delineation studies be conducted on a regular basis to validate that the content of a certification examination is representative of practice of the profession. ONCC conducts role delineation studies every five years for each certification offered. The first step in the RDS process was the development of the survey. The purpose of the survey is to determine the roles and responsibilities of advanced practice oncology nurses, as well as the knowledge required to carry out the responsibilities. The Internet-based survey was disseminated to 4,447 oncology APNs, including all AOCNs® and ONS members with a master’s degree in nursing. The response rate was 565 (12.7%). Upon analysis, Chauncey Group International, a subsidiary of Education Testing Services, which conducted the survey, indicated that, although low, the responses received were representative of the advanced oncology nurse population and therefore sufficient to meet the purpose of role delineation. Rogers went on to describe the results of the survey. The role delineation survey provided evidence that although oncology NPs and oncology CNSs share a core knowledge base, discernable differences exist in work responsibilities between the two advanced practice nursing roles. A 17-person task force of AOCNs®, including NPs and CNSs, met for two days to review survey results, identify tasks and knowledge appropriate for future examinations, and link tasks to knowledge statements. Test blueprints for each role were developed and refined. The Oncology NP Certification Test Blueprint and the Oncology CNS Test Blueprint for the two new certification examinations are available on the ONCC Web site at www.oncc.org.

Ponto then presented information regarding the phase-in of the new ONCC examinations. The AOCN® item bank has been reviewed, and all items were recoded based on the new blueprints. The content areas in which new questions are needed have been determined and the Advanced Practice Item Writing Council has been assigned to write items about these topics. In addition, an item-writing workshop was held at the ONCC National Office in Pittsburgh, PA, to generate items for the new examinations. Fourteen AOCNs® participated as item writers. Item writers and council members are eligible to take any of the advanced examinations. The AOCN® Test Development Committee has been renamed the Advanced Practice Test Development Committee and will be expanded to consist of four oncology NPs and four oncology CNSs. ONCC currently is seeking three new members for this committee. To be eligible for the committee, current AOCN® certification and attendance at an ONCC item-writing workshop is required. Test Development Committee members are responsible for assembling and reviewing all forms of the examination and therefore are not eligible to take the examinations while on the committee and for three years thereafter.

The new certification examinations will be administered via computer for the first time in January, April, July, and October 2005. Paper-and-pencil forms will be administered at the site of the ONS 30th Annual Congress in Orlando, FL, on April 27, 2005. The new certification for NPs is Advanced Oncology Certified NP (AOCNP) and for CNSs is Advanced Oncology Certified CNS (AOCNS). Eligibility criteria for the NP examination include (a) a current RN license, (b) a master’s degree or higher in nursing from an accredited institution, (c) completion of an accredited NP program, and (d) a minimum of 500 hours supervised clinical hours as an oncology NP. These hours may be obtained within the NP program or following graduation. Eligibility criteria for the CNS examination include a (a) current, active, unrestricted RN license, (b) master’s degree or higher in nursing from and accredited institution, and (c) minimum of 500 hours of supervised practice in an advanced practice role in oncology nursing. These hours may be obtained within the graduate educational program or following graduation from the program. Renewal of these certifications will be every four years, either by retesting or by Oncology Nursing Certification Points Renewal Option (ONC-PRO).

The final administration of the AOCN® examination will be October 2004. Candidates for the new examinations must meet the eligibility requirements and pass the respective examination to earn the AOCNP or AOCNS credentials. Those who wish to maintain their AOCN® certification must recertify every four years by ONC-PRO.

Many questions and concerns were expressed at the meeting, and I have attempted to summarize them below.

  1. Is this session being recorded so that we can take it back to our colleagues? No, this is not an official Congress session for continuing education credit and, therefore, it has not been recorded.
  2. Were the results of the role delineation study published? ONCC is in the process of developing publications.
  3. Why wasn’t this discussed with the CNS and NP SIGs and input and opinions sought? This was the first opportunity to summarize and disseminate the information in an organized manner. The results of the RDS were presented at the ONS APN retreat on March 18–20, 2004. The opinions of all oncology CNS and NP were sought in several ways. Several e-mail “calls” were issued to all AOCNs® who are certified and APN members of ONS seeking volunteers for the various task forces, interviewees, and pilot test participants who worked on the role delineation study. Sixty APNs participated in this way. Keep in mind that a RDS is a scientific process, and decisions regarding changes to a certification examination are data driven. Input was sought from all AOCNs® and APNs who are members of ONS through the survey process.
  4. What about “grandfathering” present AOCNs® in? Because the eligibility criteria and content of the new examinations will differ significantly from the current AOCN® examination, those who hold AOCN® certification cannot be “grandfathered.” The standards of certification accrediting agencies indicate that granting a credential in the absence of evaluating the knowledge and/or skill of an individual is not acceptable. Part of the purpose of certification is to inform the public of the particular specialized experience and knowledge of the individual who holds the credential. The certifying organization is responsible to ensure that the individual has the experience required and has demonstrated the knowledge through an objective assessment.
  5. If ONCC cannot “grandfather” in present AOCNs®, then can it allow them to test for free? ONCC pays a significant amount of money to the agency with which it contracts to administer the examination and therefore cannot offer free testing. ONCC will, however, offer a $100 discount for those taking the new examinations during the first two administrations of the examinations in January and April 2005.
  6. Won’t these new certification make AOCNs® obsolete? Will they be seen as dinosaurs? ONCC will endeavor to ensure that employers and other stakeholders understand that the AOCN® credential is still valid because it was the highest certification in oncology at the time the participants obtained it.
  7. Will ONCC make some written statement about the continued credibility of the AOCN® such as a position statement? ONCC will consider this.
  8. If the goal of NCSBN is to make certification more broad based, why is ONCC separating advanced practice nurses yet again and making two more specific and focused tests? The decision to develop role-based examinations is based on the results of the RDS. ONCC would be remiss if it ignored the results of this research. NCSBN does not take issue with role-specific examinations at all. In fact, the opposite is true, in that role-specific CNS and NP examinations are recognized readily by state boards of nursing. Several state boards of nursing have refused to recognize the AOCN® examination because it is not role specific. NCSBN has recommended the recognition of adult, pediatric, and geriatric NP examinations, as well as the critical care CNS examination. When NCSBN recommended the recognition of broad-based examinations, it was not referring to combining NP and CNS roles but rather focusing on broad-based (not disease-specific) care within advanced practice roles. NCSBN has labeled oncology a subspecialty. However, NCSBN has not really specified its definition of a specialty versus a subspecialty. ONCC has requested that NCSBN provide its definition of a specialty.
  9. Who may supervise or document the supervision of the NP or CNS? If the hours are obtained within the educational program, faculty or the preceptor may provide documentation of supervision. For the hours obtained after graduation, a supervisor, physician, or APN may provide the documentation.
  10. If anyone may supervise or document supervision, where is the validity? ONCC trusts candidates’ professionalism and integrity and also will audit a percentage of applications.
  11. What study materials will be available and when? The new test blueprints currently are available on the ONCC Web site. New reference lists also will be available soon. Many of the references on the current AOCN® list also will be used for the new examinations. ONCC cannot provide test preparation because it is a conflict of interest. This will be up to ONS and/or OES. As with any new examinations, it may take some time for the preparatory materials to catch up.
Several concerns also were expressed.
  1. Some were concerned that this role delineation could impact billing and prescriptive authority. ONCC will work with CMS and state boards of nursing regarding recognition of the new credentials.
  2. Advanced nursing educators were concerned that when the new certifications come out they will be subspecializing themselves out of a job. The role of CNSs and NPs are well defined within other specialties. Role specificity is quite different then subspecialization.
  3. This could be a problem for nurses who already are performing the tasks of NPs or CNSs and to certify would mean that possibly additional education would be a requirement. All currently certified AOCNs® may maintain certification through ONC-PRO. The ONCC Board of Directors, along with the Advanced Practice Task Force, established the eligibility criteria for the new examinations in an effort to provide public protection while meeting the needs of oncology APNs.
  4. Some were concerned about the communication between ONS, ONCC, and the NP and CNS SIGs. Some believed that they have been “left out of the loop” on something that affects their practice. ONCC maintains very high standards for the development and administration of its certification programs. Standard procedure calls for completing regular RDSs for each certification program. RDSs were completed for the OCN® examination in 1989, 1995, and 2001. RDSs were completed for the CPON® examination in 1997 and 2003. Because of the evaluation of advanced practice nursing in oncology, RDSs were completed more frequently for advanced certification in 1994, 1998, and 2003. For the most recent advanced practice RDS, batch e-mails were sent to all APNs in ONCC’s database calling for volunteers to participate on the content expert panels. Sixty AOCNs® participated on the various panels that developed the new test blueprints. In addition, the survey was disseminated to all AOCNs® and all APN members of ONS (a total of 4,447). Role delineation is a scientific process, and input is obtained through the survey instrument rather than by opinion. Changes to a certification examination are based on the date obtained through the scientific process.
I am sure that many of you will have more questions or concerns. If you do, please contact Pearl Moore, chief executive officer, or Cynthia Miller Murphy, executive director, both at 877-769-ONCC, as soon as possible and copy your question or concern to Diane Cope (ecope@attglobal.net) or me (wvogel@charter.net). We want to hear from you! This is our certification. Where we are 10 years from now depends on our response today!


 
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Special Interest Group Newsletter  July 2004
 
   


Cetuximab Decreases Tumor Size and Delays Growth

Wendy H. Vogel, MSN, FNP, AOCN®
Bristol, TN
wvogel@charter.net


The U.S. Food and Drug Administration (FDA) recently approved cetuximab for use either in combination with irinotecan in patients with epidermal growth factor- (EGFR-) expressing metastatic colorectal cancer refractory to irinotecan or alone in patients who are intolerant to irinotecan. Cetuximab is the first monoclonal antibody approved for use in colorectal cancer and is a chimeric monoclonal antibody that targets the ligand-binding site of EGFR. Although treatment with cetuximab has not been shown to affect patient survival, it has demonstrated decrease in tumor size and delay of tumor growth, especially in use in combination therapy (FDA, 2004).

In the United States, approximately 148,000 people are diagnosed annually with colorectal cancer, and half of these patients have metastatic disease at diagnosis (ImClone Systems Inc., 2004). EGFR is expressed in many normal epithelial tissues, which also includes the hair follicle and skin. Many human cancers, including colon and rectum, overexpress EGFR. Expression occurs up to 77% of colorectal tumors. EGFR is a transmembrane glycoprotein and is a member of a subfamily of type I receptor tyrosine kinases, which include EGFR (HER1), HER2, HER3, and HER4 (FDA Center for Drug Evaluation, 2004). Studies demonstrate that cetuximab competes with Iodine-123–labeled epidermal growth factor for binding to EGFR, thus modulating tumor cell proliferation, cell cycle phase distribution, apoptosis, and radiosensitivity. Other research has shown that cetuximab exhibits cytostatic activity when used alone and synergetic activity when combined with ineffective or marginally ineffective chemotherapy resulting in improvement in antitumor activity (Saltz et al., 2004).

The FDA submission data included information from a randomized two-arm phase II clinical study conducted by Merck KGaA. This clinical trial evaluated cetuximab in combination with irinotecan or as a single agent. Initial doses of 400 mg/m2 were followed with 250 mg/m2 on a weekly basis. Patients who received cetuximab and irinotecan had an objective response rate of 22.9%, a median duration of response of 5.7 months, and median time to progression of 4.1 months. When given alone, cetuximab had an objective response rate of 10.8%, median duration of response of 4.2 months, and median time to disease progression of 1.5 months. In two single-arm studies, cetuximab given in combination with irinotecan had a 15% objective response rate compared to a 9% objective response rate when given alone. The median duration of responses were 6.5 months and 4.2 months, respectively (FDA, 2004).

Patient Safety Information
Severe infusion reactions occurred during infusion in approximately 3% of patients, rarely with fatal outcomes (less than 1 in 1,000), characterized by the rapid onset of airway obstruction (bronchospasm, stridor, and hoarseness), hypotension, and/or urticaria. Approximately 90% of these severe infusion reactions happened during the initial infusion despite prophylactic antihistamines. Epinephrine, corticosteroids, IV antihistamines, bronchodilators, and oxygen should be available at the bedside for use in severe infusion reactions. If a severe reaction occurs, cetuximab should be stopped immediately and discontinued permanently, appropriate medical therapy should be applied, and the patient should be observed until complete resolution of all symptoms (FDA Center for Drug Evaluation, 2004). Mild to moderate infusion reactions were managed by slowing infusion rate and permanently reducing the dosage by 50%, as well as continuing use of antihistamine medications (e.g., diphenhydramine) in subsequent doses for this reaction. Subsequent infusions should be given at this slower rate (FDA Center for Drug Evaluation).

Interstitial lung disease (ILD) was reported in 3 of 633 patients (< 0.5%) receiving cetuximab, resulting in death in one reported case. If a patient develops acute onset or worsening pulmonary symptoms, treatment with cetuximab should be interrupted and a prompt investigation should be initiated. If ILD is confirmed, then cetuximab treatment should be terminated and the patient treated appropriately (FDA Center for Drug Evaluation, 2004).

Dermatologic toxicities, including acneform rash, skin drying and fissuring, and inflammatory and infectious squeal (e.g., blepharitis, cheilitis, cellulites, cyst), occurred in 88% of treated patient and were severe (grade 3 or 4) in 12% of patients. The development of severe dermatologic toxicities led to reported complications of S. aureus sepsis and abscesses requiring incision and drainage as well as topical or oral antibiotics (FDA Center for Drug Evaluation, 2004). Patients should use sunscreen, wear a hat, and limit sun exposure after receiving the drug because sunlight can exacerbate any skin reaction that may occur.

In clinical trials, other reported serious adverse events associated with cetuximab were fever (5%), sepsis (3%), (5% in patients receiving irinotecan plus cetuximab, 2% receiving monotherapy), kidney failure (2%), pulmonary embolus (1%), and dehydration and diarrhea (6% irinotecan plus cetuximab, 0% in monotherapy) (ImClone Systems Inc., 2004).

Other common adverse reactions reported during clinical trials in patients receiving irinotecan plus cetuximab or monotherapy were acneform rash (88% and 90%, respectively), asthenia and malaise (73% and 49%), diarrhea (72% and 28%), nausea (55% and 29%), abdominal pain (45% and 25%), vomiting (41% and 25%) fever (34% and 33%), and constipation (30% and 28%) (ImClone Systems Inc., 2004).

Dosage
Using immunohistochemistry, patients should be screened for EGFR expression prior to treatment to determine if they are appropriate candidates for treatment. Cetuximab is given as an IV infusion and never should be given by push or bolus method. Premedication with H1 antagonist (e.g., diphenhydramine 50 mg IV) given 30 minutes prior to the infusion is recommended to help reduce the risk of serious adverse reaction. appropriate emergency medications should be at the bedside (FDA Center for Drug Evaluation, 2004).

The recommended dosing for cetuximab is 400 mg/m2 for the initial loading dose over 120 minutes IV. Subsequent weekly doses are 250 mg/m2 over 60 minutes. It must be administered with a low-protein binding 0.22 micrometer inline filter and piggybacked to a patient’s infusion line. The maximum infusion rate should not exceed 5 ml per minute. A 0.9% saline solution should be used to flush the line at the end of the infusion. After each infusion, the patient should be observed for one hour (FDA Center for Drug Evaluation, 2004).

Dose Modifications
For a severe rash, treatment may be delayed for one to two weeks. If improvement occurs, the dose may be continued at 250 mg/m2. If no improvement occurs, cetuximab should be discontinued. If the dose is restarted and a severe rash recurs, treatment should be delayed again for one to two weeks and then restarted with a dosage of 200 mg/m2. Further reductions to 150 mg/m2 may be necessary for recurrence of severe rash. At the fourth occurrence, cetuximab should be stopped permanently. If the dose is ever reduced, it should not be raised to previous doses (FDA Center for Drug Evaluation, 2004).

Conclusion
Cetuximab brings new hope to patients with metastatic colorectal cancer. It can help to maintain remissions, allowing a break from chemotherapy but continuing an effective treatment, and be used in patients who previously were deemed treatment-refractory. But several questions still are unanswered. Researchers still need to investigate how the drug works in patients who are EGFR-negative. Cetuximab may be useful as first-line therapy, in combination with chemotherapy. Researchers may find that it is be effective in lung, gastric, or pancreatic cancers that also overexpress EGFR. Healthcare providers do not yet know how long to give cetuximab or if it can be used as adjuvant therapy or maintenance therapy. So, keep your eyes and ears open. We will be hearing more about this drug for a while to come.

References
ImClone Systems Inc. (2004). Erbitux–cetuximab–receives FDA approval to treat irinotecan refractory or intolerant metastatic colorectal cancer. Retrieved May 15, 2004, from http://ir.thomsonfn.com/InvestorRelations/PubNewsStory.aspx?partner=4918&storyId=107225

Saltz, L.B., Meropol, N.J., Loehrer, P.J., Sr., Needle, M.N., Kopit, J., & Mayer, R.J. (2004). Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. Journal of Clinical Oncology, 22, 1201–1209.

U.S. Food and Drug Administration. (2004). FDA approves Erbitux for colorectal cancer. Retrieved May 15, 2004, from http://www.fda.gov/bbs/topics/NEWS/2004/NEW01024.html

U.S. Food and Drug Administration Center for Drug Evaluation. (2004). Erbitux (cetuximab). Retrieved May 15, 2004, from http://www.fda.gov/cder/foi/label/2004/125084lbl.pdf



 
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Special Interest Group Newsletter  July 2004
 
   


Clinical Update
Advances Are Made in the Treatment of Several Cancers

Janet H. Van Cleave, MSN, ACNP-CS, AOCN®
New York, NY
janethvc@earthlink.net


Early-Stage Breast Cancer
In early-stage breast cancer, where the goal of treatment is the cure of disease, clinical trials demonstrate the importance of near full planned dose intensity for best chemotherapy outcomes (Bonadonna, Valagussa, Moliterni, Zambetti, & Brambilla, 1995; Budman et al., 1998; Citron et al, 2003). Lyman, Dale, and Crawford (2003) published a retrospective review of 20,799 patients with early-stage breast cancer, revealing that approximately 55.5% of patients received reduced relative dose intensity (RDI) chemotherapy of less than 85%. The reduced dose intensity was associated with increased age; chemotherapy with cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide, doxorubicin, and fluorouracil; a 28-day schedule; body-surface area greater than 2 m2; and no primary colony-stimulating factors (CSFs). Another finding was that CSFs often were initiated late in the chemotherapy. Although data concerning nonhematologic toxicities were limited, the authors suggested that myelosuppression in general and neutropenia in particular were thought to be the major dose-limiting toxicities. These research findings are concerning given the potential for cure in early stage breast cancer with near full planned dose intensity chemotherapy. And this information was concerning particularly in older patients where advanced age is correlated with an increased incidence of neutropenic complications; consequently, older women with breast cancer are more likely than younger women to receive reduced RDI.

This data may suggest that decreased use of CSFs may be associated with neutropenic complications and decreased dose intensity chemotherapy. Lyman et al. (2003) commented that the cost of filgrastim precluded treating all patients with filgrastim for primary prophylaxis for neutropenia. However, the literature has several recommendations regarding the use of CSFs. In 2000, the American Society of Clinical Oncology (ASCO) published an update of recommendations for CSF use that include using primary CSF with chemotherapy regimens where randomized clinical trial evidence of expected incidence of febrile neutropenia is greater than or equal to 40%. CSF primary prophylaxis also may be beneficial in patients who are at high risk of febrile neutropenia (see Figure 1) (Ozer et al., 2000). Based on several studies of older patients receiving chemotherapy, the National Comprehensive Cancer Network (NCCN) made recommendation for CSF primary prophylaxis in patients aged 70 years and older receiving moderately toxic chemotherapy with dose-intensity comparable to CHOP (Balducci & Yates, 2000). For secondary prophylaxis with CSF in patients undergoing chemotherapy, Silber et al. (1993) created a predictive model using first-cycle absolute neutrophil count to cost-effectively prescribe CSFs for patients at risk for and decrease risk for hospitalization for neutropenia and reduced dose intensity of chemotherapy.

References
Balducci, L., & Yates, J. (2000). General guidelines for the management of older patients with cancer. Oncology (Huntingdon), 14, 221–227.

Bonadonna, G., Valagussa, P., Moliterni, A., Zambetti, M., & Brambilla, C. (1995). Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: The results of 20 years of follow-up. New England Journal of Medicine, 332, 901–906.

Budman, D.R., Berry, D.A., Currincione, C.T., Henderson, I.C., Wood, W.C., Weiss, R.B., et al. (1998). Dose and dose intensity as determinants of outcome in the adjuvant treatment of breast cancer. Journal of the National Cancer Institute, 90, 1205–1211.

Citron, M.L., Berry, D.A., Cirrincione C., Hudis, C., Weiner, E.P., Gradishar, W.J., et al. (2003). Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: First report of Intergroup trial C0741/Cancer and Leukemia Group B trial 9741. Journal of Clinical Oncology, 21, 1431–1439.

Lyman, G.H., Dale, D.C., & Crawford, J. (2003). Incidence and predictors of low dose-intensity in adjuvant breast cancer chemotherapy: A nationwide study of community practices. Journal of Clinical Oncology, 21, 4524–4531.

Ozer, H., Armitage, J.O., Bennett, C.L., Crawford, J., Demetri, G.D., Pizzo, P.A., et al. (2000). 2000 update of recommendations for the use of hematopoietic colony-stimulating factors: Evidence-based, clinical practice guidelines. Journal of Clinical Oncology, 18, 3558–3585.

Silber, J.H., Fridman, M., DiPaola, R.W., Erder, M.H., Pauly, M.V., & Fox, K.R. (1993). First cycle blood counts and subsequent neutropenia, dose reduction, or delay in early-stage breast cancer therapy. Journal of Clinical Oncology, 16, 2392–2400.


Multiple Myeloma
In a 2003 issue of the New England Journal of Medicine, two articles were published that will influence the care of multiple myeloma patients. Tian et al. (2003) published research findings that begin to demonstrate the physiologic mechanism of osteolytic lesion formation in patients with multiple myeloma. Immunohistochemical analysis of bone marrow biopsy specimens demonstrated that elevated dickkopf1 (DKK1) levels in bone marrow plasma and peripheral blood in patients with multiple myeloma correlated with the gene-expression patterns of DKK1. This was associated with the presence of focal bone lesions. DKK1 is important in patients with multiple myeloma because it is essential for the growth and development of osteoblasts and seems to cause an imbalance between osteoblasts and osteoclasts in favor of bone resorption.

Attal et al. (2003) published research from a randomized trial of patients with multiple myeloma who received high-dose chemotherapy followed by either one or two successive autologous stem cell transplants. A total of 399 previously untreated patients younger than 50 years were randomly assigned to receive either a single or double transplant. The patients undergoing a single transplant received the preparative regimen of melphalan and total-body irradiation. The patients who received a double transplant underwent the preparative regimen of melphalan alone for the first transplant and melphalan plus total-body irradiation for the second transplant. The double-transplantation regimen demonstrated a survival advantage especially in those with an unsatisfactory response after a single transplantation. The authors commented that that a plateau was absent in the curve for event-free survival, which justified further research into new strategies to control multiple myeloma.

References
Attal, M., Harousseau, J., Facon, T., Guilhot, F., Doyen, C., Fuzibet, J.G., et al. (2003). Single versus double autologous stem-cell transplantation for multiple myeloma. New England Journal of Medicine, 249, 2495–2502.

Tian, E., Shan, F., Walker, R., Rasmussen, E., Ma, Y., Barlogie, B., et al. (2003). The role of Wnt-signaling antagonist DKK1 in the development of osteolytic lesions in multiple myeloma. New England Journal of Medicine, 349, 2483–2494.


Non-Small Cell Lung Cancer
New data suggest that cisplatin-based adjuvant chemotherapy improves survival among patients with completely resected non-small cell lung cancer. A total of 1,867 patients with pathologic stage I, II, or III disease were randomized to receive cisplatin-based chemotherapy plus or minus radiation therapy versus no chemotherapy. The chemotherapy combined with cisplatin included etoposide, vinorelbine, vinblastine, or vindesine. Per judgment of the center treating each patient, postoperative radiation therapy could be given to patients with pathologic stage N2 only or pathologic stages N1 and N2 after chemotherapy in the chemotherapy group and after randomization in the control group. After 56 months of median duration of follow-up, patients assigned to chemotherapy had a significantly higher survival rate than patients randomized to observation (p < 0.03). The two-year survival rates were 70.3% in the chemotherapy group and 66.7% in the control group. The authors concluded that the results supported the use of three or four cycles of cisplatin-based chemotherapy after complete surgical resection in patients with non-small cell lung cancer (International Adjuvant Lung Cancer Trial Collaborative Group, 2004).

Reference
International Adjuvant Lung Cancer Trial Collaborative Group. (2004). Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small cell lung cancer. New England Journal of Medicine, 350, 351–360.


 
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Special Interest Group Newsletter  July 2004
 
   


Coordinator's Corner
Nurse Practitioner SIG Recognizes Member Contributions

Diane Cope, PhD, ARNP, BC, AOCN®
Fort Myers, FL
ecope@attglobal.net


Hello to everyone. It was great seeing some of you at Congress, and I hope that everyone is looking forward to a relaxing summer. For those of you who attended the ONS 29th Annual Congress in Anaheim, CA, I am sure that you will agree that it was “The Ride of Your Life.” Once again, Congress was very busy with outstanding educational sessions. The Nurse Practitioner (NP) SIG sponsored two sessions: “Management of Medical Problems in Patients with Cancer,” presented by Marianne Davies, RN, MSN, APRN, ACNP, me, and Brenda Shelton, MS, RN, CCRN, AOCN®, and “Opioid Rotation” presented by Kristen Fessele, RN, MSN, AOCN®, Christine Miaskowski, RN, PhD, FAAN, and Polly Mazanec, RN, MSN, AOCN®. Wendy Vogel, MSN, FNP, AOCN®, presented a roundtable session titled “Nurse Practitioner: Issues and Impact” and a dinner program, “Stopping the Roller Coaster Ride: Cancer Treatment Induced Diarrhea.” Marianne and Christy Erickson, RN, MSN, NP, AOCN®, presented a poster on their successful NP mentorship program titled “Development and Implementation of Nurse Practitioner Mentorship Program.” Christy also presented the program at the SIG leadership workshop that convenes all SIG leaders. Many SIGs are anxious to model Christy and Marianne’s hard work!

The NP SIG has undergone some recent changes and is in dire need of more volunteers! Janet Van Cleave, MSN, ACNP-CS, AOCN® (editor), and Christie Hancock, RN, MSN, APN, CS, OCN® (coeditor), will be stepping done from their positions with the NP SIG Newsletter. Thank you, Janet and Christie, for all of your diligent, outstanding work. The newsletters have been excellent and provide the membership with important information about the SIG and current, pertinent clinical material. Marianne also will be stepping done from her role with the mentorship program. Thank you, Marianne, for your assistance in creating such a successful mentorship program for the NP SIG. Please, if you would like to volunteer, contact me, and I will orient you and help you help the NP SIG! Besides the newsletter and mentorship workgroups, assistance also is needed with the legislative/reimbursement and archives work groups.

We also would like to welcome Wendy Vogel to her new position as coordinator-elect. Wendy has been very active with the legislative/reimbursement workgroup. In this newsletter, you will find an article from Wendy concerning the new changes to the AOCN® certification presented at Congress. Cyndi Miller Murphy from ONCC has provided additional information regarding the changes. Please read carefully because this will impact all of us. We welcome any questions or concerns.

In closing, I hope that you have a safe and fun summer. If you have any questions, concerns, suggestions, or ideas for the NP SIG, please feel free to e-mail me.

 
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Special Interest Group Newsletter  July 2004
 
   


Inaugural Oncology Nurse Practitioner Conference Will Be Held in Conjunction With Institutes of Learning

Cathryn Lee, MSN, CRNP, AOCN®
Rockville, MD
Cathryn.lee3@verizon.net


Visit the National Nurse Practitioner Conference website now!

Oncology nurse practitioners (NPs) spoke, and ONS listened. NPs specializing in oncology have been seeking a conference tailored to their needs. Oncology NPs often have commented that primary care conferences usually lack oncology content and that NP-focused content was inadequate at most oncology nursing conferences. In January 2004, the ONS steering council presented a plan to hold an oncology NP conference in conjunction with the Institutes of Learning (IOL). This pairing would allow NPs to take advantage of the exhibits and some sessions of the well-established IOL. The plan was approved, and the first conference will be held November 4–6, 2004, in Nashville, TN.

Six experienced NPs formed the team, supported by two members from the ONS National Office. The first meeting was held at the ONS National Office on March 12–14, 2004. Using results of the advanced practice nurse survey conducted in 2000 by ONS as well as the NP SIG 2002 online survey as guides, the team narrowed topics, made a schedule and identified potential speakers. Among the topics to be included are comorbidities, advances in radiology, diagnosis and assessment, newly released drugs, and disease updates.

Preparations are well under way for this exciting new conference. At least 500 NPs from across the country are expected to attend. Your attendance is vital if this program is to continue. The future direction and content of the conference will be guided by the feedback of inaugural attendees. Keep an eye out for registration information and be sure to sign up for the first ONS Oncology NP Conference—you won’t want to miss it!
 
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Special Interest Group Newsletter  July 2004
 
   


Update on Advanced Certification

Cyndi Miller Murphy, RN, MSN, CAE
Executive Director of the Oncology Nursing Certification Corporation
Pittsburgh, PA
cmillermurphy@ons.org


This article is a follow-up to the article “ONCC Completes Advanced Practice Nurse Role Delineation Study,” which appeared in the November 2003 Nurse Practitioner (NP) SIG Newsletter. The November 2003 article described the most recent role delineation study (RDS) of oncology advanced practice nursing and indicated that the Oncology Nursing Certification Corporation (ONCC) Board of Directors would be reviewing the results of the RDS and making decisions as to whether separate certification examinations would be developed for oncology CNSs and oncology NPs. The decisions were finalized in April 2004 and announced through e-mails to oncology certified nurses and ONS members, at a special session during the 2004 ONS Congress (see "ONCC Advanced Nursing Certification Undergoes Changes"), and through a brochure distributed at 2004 Congress.

Beginning in January 2005, ONCC will administer role-specific advanced practice certification examinations for oncology nurse practitioners (NPs) and oncology clinical nurse specialists (CNSs). The AOCN® examination, which first was administered in 1995, will be given for the last time via computer-based testing on October 18–30, 2004. Current AOCNs® may continue to renew AOCN® certification through the Oncology Nursing Certification Points Renewal Option for as long as the desire to keep the AOCN® credential. Testing no longer will be an option for the renewal of AOCN® certification.

The decision to develop role-specific NP and CNS examinations was data driven and based on the results of the RDS of advanced practice oncology nurses, conducted by ONCC and Chauncey Group International (a subsidiary of Educational Testing Services) in 2003. RDSs validate that the content of a certification examination is representative of the actual practice of the profession on which it is based. Accreditation standards for certifying organizations indicate that RDSs must be conducted on a regular basis. ONCC is accredited by the National Commission for Certifying Agencies and the American Board of Nursing Specialties. ONCC policy requires that RDSs be conducted every five years for each certification. In addition to the 2003 study, advanced practice RDSs were conducted by ONCC in 1994 and 1998. Because the previous studies did not reveal differences in the practice of oncology NPs and oncology CNSs, one examination was valid to test both roles in oncology. However, the most recent study revealed that although oncology CNSs and oncology NPs continue to share a common knowledge base, discernable differences now are evident in their work responsibilities. The differences are significant enough to warrant the development of role-specific examinations.

Because oncology NPs and oncology CNSs share a common knowledge base, the new test blueprints (content outlines) for the oncology CNS examination and the oncology NP examination are very similar. The major differences between the two blueprints are in the weighting of the content areas and that the roles of the CNS (other than clinical practice) are not represented on the oncology NP examination. The test blueprints can be found on the ONCC Web site at www.oncc.org.

The decisions regarding eligibility criteria for the new advanced examinations were made carefully in an effort to ensure that they are rigorous enough to be meaningful, yet attainable by most advanced practice nurses specializing in oncology. The eligibility criteria for the Advanced Oncology Certified NP (AOCNP) Certification Examination include

  • Current, active, unrestricted RN license at the time of application and examination
  • Master's degree or higher in nursing from an accredited institution
  • Successful completion of an accredited nurse practitioner program
  • Minimum of 500 hours of supervised clinical practice as an oncology nurse practitioner. These hours may be obtained within the nurse practitioner program or following graduation from the program.
The eligibility criteria for the Advanced Oncology Certified CNS (AOCNS) include
  • Current, active, unrestricted RN license at the time of application and examination
  • Master's degree or higher in nursing from an accredited institution
  • Minimum of 500 hours of supervised practice in an advanced practice role in oncology nursing. These hours may have been obtained within the graduate educational program or following graduation from the program.
The required practice hours must be verified by a faculty member, preceptor, physician, or supervisor. Because the eligibility criteria and content of the new examinations will differ significantly from the current AOCN® examination, those who hold AOCN® certification cannot be "grandfathered." The standards of certification accrediting agencies indicate that granting a credential in the absence of evaluating the knowledge and/or skill of an individual is not acceptable. Part of the purpose of certification is to inform the public of the particular specialized experience and knowledge of an individual who holds the credential. The certifying organization is responsible to ensure that an individual has the experience required and has demonstrated the knowledge through an objective assessment.

ONCC will, however, offer a $100 discount to all eligible nurses who take one of the new examinations during the first two computer-based administrations on January 17–29, 2005, or April 18–30, 2005. The respective deadlines to register for these administrations are October 13, 2004, and January 15, 2005. Because many state boards of nursing require advanced practice nursing certification for the regulation of advanced practice nurses, ONCC will contact all state boards and inform them of the changes to advanced practice nursing certification in oncology. Several state boards previously did not recognize the AOCN® examination because it was not role specific and may now be willing to grant recognition for the new examinations. All advanced practice nurses must fully understand the requirements of their individual state boards of nursing and comply with those requirements. ONCC maintains a list of state boards that recognize the AOCN® certification on the ONCC Web site and will develop a similar list for the new credentials. ONCC also will seek recognition of the new credentials by the Centers for Medicare and Medicaid Services, which previously recognized the AOCN® credential.

Please contact ONCC at oncc@ons.org or 877-769-6622 with specific questions about the new certifications.
 
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Special Interest Group Newsletter  July 2004
 
   


ONS Wants Your Feedback


ONS plans to publish a second edition of the book Clinical Manual for the Oncology Advanced Practice Nurse, and the editors are interested in your feedback on how to improve this manual. How could it be made more useful to your practice? What symptoms or diseases could be added to the manual?

Please submit your comments by September 1, 2004, to Becca Hawkins, RN, MSN, ANP, AOCN® (becca@oregontrail.net) or Dawn Camp-Sorrell, RN, MSN, FNP, AOCN® (onpdawn@aol.com). The editors welcome your suggestions
 
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Special Interest Group Newsletter  July 2004
 
   


Unapproved 2004 Nurse Practitioner SIG Planning/Networking Meeting Minutes


The Nurse Practitioner SIG held its annual planning meeting on Thursday, April 29, 2004, during the ONS 29th Annual Congress in Anaheim, CA. To view the minutes from this meeting, click here and select “NP SIG 2004 Unapproved Minutes PDF.”


 
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Special Interest Group Newsletter  July 2004
 
   

Membership Information


SIG Membership Benefits

  • Network with colleagues in an identified subspecialty area around the country.
  • Contribute articles for your SIG’s newsletter.
  • Participate in discussions with other SIG members.
  • Contribute to the future path of the SIG.
  • Share your expertise.
  • Support and/or mentor a colleague.
  • Receive information about the latest advancements in treatments, clinical trials, etc. Participate in ONS leadership by running for SIG coordinator-elect or join SIG work groups. Acquire information with a click of a mouse: sig.ons.wego.net/?v2_group=0&p=4918
    • Educational opportunities for your subspecialty
    • Education material on practice
    • Calls to action
    • News impacting or affecting your specific SIG
    • Newsletters
    • Communiqués
    • Meeting minutes
Join a Virtual Community

A great way to stay connected to your SIG is to join its Virtual Community. It’s easy to do so. All you will need to do is
  • Log on to the ONS Web site (www.ons.org).
  • Select "Membership" from the tabs above.
  • Then, click on "ONS Chapters and Special Interest Groups".
  • Scroll down to "Visit the ONS Special Interest Groups (SIG) Virtual Community" and click.
  • Now, select "Find a SIG."
  • Locate and click on the name of your SIG from the list of all ONS SIGs displayed.
  • Once the front page of your SIG's Virtual Community appears on screen, select "New User" from the top left. (This allows you to create log-in credentials.)
  • Type in required information into the text fields as prompted.
  • Click "Join Group" (at the bottom right of the text fields) when done.


  • Special Notices
    • If you already have log-in credentials generated from the ONS Web site, use this information instead of attempting to generate new information.
    • If you created log-in credentials for the ONS Web site and wish to have different log-in information, you will not be able to use the same e-mail address to generate your new credentials. Instead, use an alternate e-mail address.
Subscribing to Your SIG’s Virtual Community Discussion Forum

All members are encouraged to participate in their SIG’s discussion forum. This area affords the opportunity for exchange of information between members and nonmembers on topics specific to all oncology subspecialties. Once you have your log in credentials, you are ready to subscribe to your SIG’s Virtual Community discussion forum. To do so
  • Select “Log In,” located next to “New User” and enter your information.
  • Next, click on the “Discussion” tab on the top right of the title bar.
  • Now, select “Featured Discussion” from the left drop-down menu.
  • Locate and select “Subscribe to Discussion” inside the “Featured Discussion” section.
  • Go to “Subscription Options” and select “Options.”
  • When you have selected and entered all required criteria, you will receive a confirmation message.
  • Click “Finish.”
  • You are now ready to begin participating in your SIG’s discussion forum.
To Participate in Your SIG’s Virtual Community Discussion Forum
  • First, log in. (This allows others to identify you and enables you to receive notification (via e-mail) each time a response or new topic is posted.
  • Click on "Discussion" from the top title bar.
  • Select "Featured Discussion" from the left drop-down menu.
  • Click on any posted topic to view contents and post responses.
Signing Up To Receive Your SIG’s Virtual Community Announcements

As an added feature, members also are able to register to receive their SIG’s announcements by e-mail!
  • From your SIG’s Virtual Community page, locate the “Sign Up Here to Receive Your SIG’s Announcements” section. This appears above the posted announcements section.
  • Select the “Click Here” feature, which will take you to a link to subscribe.
  • Once the “For Announcement Subscription Only” page appears on screen, select how you wish to receive your announcements:
    • As individual e-mails each time a new announcement is posted
    • One e-mail per day comprised of all new daily announcements posted
    • Opt-out, indicating that you will frequently browse your SIG’s Virtual Community page for new postings
  • Enter your e-mail address.
  • Click on "Next Page."
  • Because you have already joined your SIG’s Virtual Community, you will receive a security prompt with your registered user name already listed. Enter your password at this prompt and click "Finish."
  • This will bring up a listing of your SIG’s posted announcements. Click on "My SIG’s Page" to view all postings in their entirety or to conclude the registration process and begin browsing.
 
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Special Interest Group Newsletter  July 2004
 
   


Nurse Practitioner SIG Officers

Coordinator (2003–2005)
Diane Cope, PhD, ARNP-BC, AOCN®
605 Astarias Circle
Fort Myers, FL 33919-3247
239-437-3571 (H)
239-437-4444 (O)
ecope@attglobal.net

Coordinator-Elect (2004–2005)
Wendy Vogel, RN, MSN, FNP, AOCN®
405 Pettyjohn Rd.
Kingsport, TN 37664-4716
423-323-0715 (H)
423-968-2311 (O)
wvogel@charter.net

Coeditor
Barbara Biedrzycki, RN, MSN, AOCN®
709 W Baker Ave.
Abingdon, MD 21009-1457
410-538-7946 (H)
410-614-6894 (O)
NPBiedrzycki@aol.com


 

Coeditor
Deborah Heim, RN, MSN, ARNP, AOCN®
5150 Harborage Dr.
Fort Myers, FL 33908-4542
239/466-4990 (H)
239/275-6400 (O)
heimcats@yahoo.com

ONS Publishing Division Staff
Elisa Becze, BA
Copy Editor
412-859-6317
ebeceze@ons.org

 

Know someone who would like to receive a print copy of this newsletter?
To print a copy of this newsletter from your home or office computer, click here or on the printer icon located on the SIG Newsletter front page. Print copies of each online SIG newsletter also are available through the ONS National Office. To have a copy mailed to you or another SIG member, contact Membership/Leadership Administrative Assistant Carol DeMarco at cdemarco@ons.org or 866-257-4ONS, ext. 6230.

ONS Membership/Leadership Team Contact Information
Angie Stengel, BA, Director of Membership/Leadership
astengel@ons.org
412-859-6244

Diedrea White, BA, Manager of Member Relations and Diversity Initiatives
dwhite@ons.org
412-859-6256

Carol DeMarco, Membership/Leadership Administrative Assistant
cdemarco@ons.org
412-859-6230

To view past newsletters click here.

The Oncology Nursing Society (ONS) does not assume responsibility for the opinions expressed and information provided by authors or by Special Interest Groups (SIGs). Acceptance of advertising or corporate support does not indicate or imply endorsement of the company or its products by ONS or the SIG. Web sites listed in the SIG newsletters are provided for information only. Hosts are responsible for their own content and availability.

Oncology Nursing Society
125 Enterprise Dr.
Pittsburgh, PA 15275-1214
866-257-4ONS
412-859-6100
www.ons.org

 
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