My term as coordinator of the Clinical Trial Nurses (CTN) SIG is nearly at an end, and I want to thank those members who have been with the SIG for some time and also welcome our new members. Having been a member for a number of years, I have seen our SIG grow, not only in size but also in its accomplishments.

This year in particular has seen many accomplishments. Under the leadership of Coordinator-Elect Pam Kennedy, RN, the CTN SIG has an ongoing project that explores various CTN roles and responsibilities that lead to the development of CTN competencies.

Our newsletter has improved to include more information important to our practice. I wish to thank Maureen Edgerly, RN, MA, OCN^®, CCRC, the newsletter editor, for managing this challenging task.

Last, but not least, I wish to thank Liz Ness, RN, MS, who updated our Virtual Community, using information from the National Cancer Institute and from Rose Ermete, RN, BSN, OCN^®, CCRP. If you have not visited our Virtual Community please check it out. It includes many easy-to-use tools and programs.

In closing, I would like to say that my time as coordinator of the CTN SIG has been one of growth and the development of friendships and pride in our SIG. Please, never hesitate to contact me.

I wish you much happiness and success.

Take Care,

Pat

Clinical Trial Nurse Minimal Competency Project Goes National!

Pamela Kennedy, RN
Coodinator-Elect
Norfolk, VA
PWKENNED@sentara.com

Over the past decades, advancements in drug development have led to various new, and sometimes complex, treatment options for patients with cancer. This has favorably impacted the decline in the overall mortality rates as documented by the American Cancer Society's Web site in Cancer Facts and Figures 2008. With this growth in clinical research comes increased complexity of clinical studies, treatment modalities, and new technology (Carter, Jester, & Jones, 2007). As billions of dollars are spent on health care, with a large percentage on medical research, the need for experienced professionals in the field of clinical research is paramount.

In 1997, the CTN SIG partnered with the National Cancer Institute (NCI) and other organizations under the leadership of Jennifer L. Aikin, RN, MSN, AOCN^®, to develop the Cancer Clinical Trials Education Program (Ehrenberger, 2003). This was the beginning of the global dissemination of information about clinical trials to community settings, which increased access to participation and the demand for research professionals. As noted by Carter et al. (2007), the experience of persons entering clinical research positions for the first time ranges from novice, to experienced healthcare professionals with little or no prior clinical research training, to non-healthcare professionals.

We in the CTN SIG leadership have a different vision for the oncology CTN. We envision a nurse who is a uniquely qualified professional, one who receives specialized training and ongoing education in both specialty areas of oncology and clinical research. With this in mind, we set out to establish minimum competencies for the CTN that would span our various settings and job descriptions. We work in different practice areas, including community clinics, academic medical centers, research institutions, and cooperative groups. Our populations may be specific or variable, and our trials may be phase I, II, III, IV, or a combination. Despite our differences, a common denominator of qualifications and knowledge exists that is necessary for effective CTN role implementation. We assert that CTNs are not interchangeable with data managers or non-nurse coordinators, especially in oncology clinical research.

In 2007, following the SIG Meeting at the annual ONS Congress, the CTN SIG began the process of establishing minimal competencies for the CTN. The goal was to create a position statement that would be submitted to the ONS National Office. A team was established and several teleconferences were held with a majority of the distribution of information via the internet. Much of the initial work was based on the 2004 Oncology Nursing Forum article "Development of a Measure to Delineate the Clinical Trials Nursing Role," by Heidi Ehrenberger, PhD, RN, AOCN^®, and Linda Lillington, DNSc, RN, CCRC. A preliminary report was sent to the ONS National Office with the idea that this team would continue to develop this project.

In January 2008, Barbara Lubejko, RN, MS, who is a project Manager on the ONS Education Team, notified the CTN Leadership that ONS was going to spearhead this initiative with the development of a steering group for the ONS Clinical Trials Initiative and a planning team for Clinical Trials 101, an online course. Lubejko will be attending the ONS Congress CTN SIG Meeting Friday, May 16, 2008 to discuss the details of these initiatives.
I personally want to thank the team members from this CTN SIG special projects team. Your voices were heard, and a more structured and organized process will be in place and supervised by the ONS Education Team. The following were members of the CTN SIG special projects team: Carol Brudenell, RN, MSN, AOCN^®, CCRP, Jane Bryce, RN, MSN, AOCNS^®, Liz Ness, RN, MS, Maureen Edgerly, RN, MA, OCN^®, CCRC, Maureen Tynan, RN, OCN^®, Pati Sinnett, RN, BSN, OCN^®, Rose Ermete, RN, BSN, OCN^®, CCRP, Kimberly Shields, BSN, RN, OCN^®, Becky Eickhoff, BSN, RN, Cheryl Knapp, RN, BA, Linda Mora, RN, BSN, Cherie A. Perez, BS, RN, CCRP, LMT, Carol Schmidt, RN, MSHA, OCN^®, and Pat McLaughlin, RN, MSN, AOCN^®, CCRP. Thank you again for your input and your hard work. I look forward to working with you all again when I assume the coordinator position at the annual ONS Congress.
 
References

American Cancer Society. (2008). Cancer facts and figures, 2008.
Retrieved March 27, 2008, from http://www.cancer.org/docroot/STT/content/STT_1x_cancer_facts_and_figures_2008.asp

Carter, S., Jester, P., & Jones, C. (2007). Issues in clinical research manager education and training. Research Practitioner, 8, 48-60.

Ehrenberger, H.E., & Aikin, J.L. (2003). Article highlights importance of clinical trials nurses. Oncology Nursing Forum, 30, 12.

Ehrenberger, H.E., & Lillington, L. (2004). Development of a measure to delineate the clinical trials nursing role. Oncology Nursing Forum, 31, 64-68.

Research Nursing in the Community Setting

Lora Wilson, RN, BSN, OCN^®
Nursing Instructor, Portland Community College
Research Nurse (on-call) Legacy Cancer Research
Portland, OR
lorawilsonrn@comcast.net

True or false: The majority of clinical research takes place in the academic setting. True? Think again. The public, media, and even members of the medical community typically look to medical schools for clinical trial information. However, a great deal of clinical research is actually conducted in community hospitals and oncology practices. The role of the clinical trials nurse (CTN) in the community setting varies in several aspects from the academic setting. I have worked as a research nurse in both environments and will describe a few key differences between community CTN practice and academic CTN practice.

My own community CTN experience developed through employment at two community healthcare systems in Portland, OR. Both institutions are members of a Community Clinical Oncology Program (CCOP) through which National Cancer Institute (NCI) trials are accessed and conducted. These institutions also conduct industry-sponsored trials and investigator-initiated trials. One community hospital in Portland has its own research lab and an active bench science program. In both cases, clinical trials staff are hospital employees based within the hospital. However, the customers of the clinical trials staff, both patients and oncologists, typically are located outside the hospital setting. This creates logistical problems and complicates the role of the CTN.

Access to physicians is one such complication. In academic settings attending physicians, oncology fellows, and senior residents are often on-site and available to CTNs. Clinics and research offices are usually within walking distance of each other, and the evaluation of new patients for clinical trials is standard practice.  This is often not the case in the community setting. Hospital-based CTNs may be several miles away from the oncologists they serve, and there is limited face-to-face contact with providers. Proactively screening new patients for trials and keeping oncologists informed of trials that open and close is much moiré difficult when the clinic is logistically distanced. While much information can be shared electronically, many physicians want a person on-site or instantly available on the phone to address trial questions. A great deal of marketing is needed to create and maintain relationships with physicians and their staff when there are limited face-to-face interactions.

Hospital-based tumor board meetings, sometimes referred to as "cancer conferences," are one of the best ways of keeping physicians informed about trials. CTNs can suggest trials for cases presented while educating physicians of new and closing trials. Physician attendance is often high, with many providers commuting for the networking and discussion. Nurse practitioners frequently attend as well and often express interest in trials.

Logistics is problematic for reasons other than recruitment. Caseloads may include patients from multiple community oncology clinics (outside the hospital setting), requiring CTNs to drive significant distances for protocol-driven trial visits. In addition to these visits, adverse event monitoring may require additional visits. Much of the time, CTNs must rely on clinic staff to capture toxicity information in sufficient detail for toxicity grading. Providing clinic staff with study-specific tools and worksheets facilitates stronger data collection.

As in all research settings, a crucial CTN function is educating clinic staff. Clinic nurses are more likely to adhere to protocol requirements if the rationale for doing so is understood. Setting up in-services when new trials open provides a great opportunity to engage clinic nurse support and address questions. Indeed, the CTN benefits from such meetings as clinic operational concerns are often not anticipated by the hospital-based CTN. However, these in-services require extra time and travel when multiple clinics are participating, and CTN desk-time suffers.

With that in mind, thank goodness for clinical research associate (CRA) support! Without CRAs, the CTN role would be difficult, if not impossible. In my experience, CRAs most commonly perform essential non-nursing functions. These include coordinating blood draws with clinics, facilitating biologic sample shipments, interfacing with diagnostic imaging for radiology reviews, and sometimes completing case report forms (with CTN input on adverse events). Some institutions allow CRAs to meet with study monitors; others require CTNs to do so. CRAs also assist in reporting serious adverse events and safety reports to the Institutional Review Board and the Sponsor. They also respond to sponsor data queries. CRA support allows CTNs to focus on recruitment and enrollment; patient, physician, and clinic education; adverse event monitoring; and dose modification tracking.

Because our work is done outside the actual clinic setting, community hospital-based CTNs rarely are involved in the care of non-trial patients. However, some oncology practice groups do hire on-site CTNs, primarily for industry-sponsored protocols. I cannot speak to how such roles are defined. Indeed, clinic-based CTNs also may be involved in the case management of non-study patients along with study patients. Each practice is unique in how CTNs are utilized.

Community-based clinical trials are also complex in regard to billing. Coordination with multiple clinics takes a great deal of time and effort. Communication is obviously key when ordering labs and tests for research-related procedures. Yet, even in the best of circumstances, research expenses may be billed to private insurance incorrectly. One strategy used by a hospital partner clinic involved the electronic sharing of patient fee slips prior to insurance billing. CTNs reviewed study patient fee slips and indicated which charges were research-based. It is a proactive system that works well.

Unfortunately, such a system is not efficient for all research-related procedures, such as outpatient imaging centers, nuclear medicine departments, and outpatient labs. The coordination of billing is cumbersome and should not be the responsibility of the CTN alone. Fortunately, many large hospital-based research departments have someone on staff tracking billing, thus freeing the CTN for other functions.

CTN turnover in the community setting varies depending upon the culture of the working environment. Yet, because CTNs must interface with so many different customers, staff consistency is vital to any program. A familiar face and voice on the phone goes a long way in creating allies. CTN salaries are generally good, but workloads are at times unmanageable. As in all nursing areas, nurses must speak up when expectations are unrealistic. Preventing burn-out and maintaining a stable workforce benefits all involved.

Physicians Play Major Role in Clinical Trial Recruitment NCI Stakeholders Offer Ways to Increase Participation

Sona Thakkar, MA
National Cancer Institute
Office of Communications and Education
Rockville, MD
thakkars@mail.nih.gov

In recent interviews examining the role that healthcare providers play in clinical trial recruitment, key National Cancer Institute (NCI) stakeholders affirmed that physicians are the most trusted sources of clinical trial information. The interviewees, representatives from national provider organizations related to cancer, primary care, clinical trials, and the pharmaceutical industry, also indicated that including clinical trials education for younger providers or those in training is a key step toward early involvement.

The NCI Office of Communications and Education (OCE) conducted this qualitative research to learn about the organizations' involvement in clinical trials education or recruitment, experience in education and outreach, and collaboration with NCI.

After completing a literature search on best practices of clinical trial recruitment, OCE developed and shared a fact sheet, "Supporting Providers for Effective Recruitment to Clinical Trials," with the stakeholders prior to their discussions with them to obtain their views. The fact sheet (included in this newsletter) summarized the critical role of providers in patient recruitment and outlined evidence-based and promising practices from published research that can be followed to support providers in recruitment efforts.

The majority of stakeholders confirmed the already-published, supportive practices listed in the fact sheet. Based on their own experiences and support activities, they offered their insights and recommendations for increasing participation in clinical trials of all types.

Beyond healthcare provider involvement and training, additional suggestions included

• Broadening protocol eligibility and adding more tumor types
• Increasing the number of community-based trials, because facility location is such a critical factor in participation
• Enhancing the availability of shared, accessible, centralized, or coordinated database management via the Web for patients and providers
• Obtaining more federal funding for clinical trials recruitment and operations.

NCI/OCE will be using this information to continue to explore ways it can support providers to educate their patients about cancer. For more information, contact Rose Mary Padberg, BA, MA, RN, at padbergr@mail.nih.gov.

Supporting Providers for Effective Recruitment to Clinical Trials

The National Cancer Institute (NCI) recently commissioned a review of best practices in clinical trial recruitment, and this fact sheet summarizes key findings from the literature.

The Role of Providers
Healthcare providers play a key role in recruiting patients into clinical trials. Engaging providers starts with their knowledge of available trials, followed by training/support to help them assist patients in locating, assessing, and interpreting study information. Providers face a number of barriers to fully engaging in clinical trial recruitment, such as the lack of awareness of trials, lack of access to trials, provider doubts about the clinical trial process, fear of competition, and costs (e.g., time, resources).

All providers are key gatekeepers in accrual of patients into clinical trials. Relationships established during standard care visits, for instance, are attributable to successful enrollment of patients in clinical trials (McCaskill-Stevens, et al. 1999). A survey of patients with cancer found they were more likely to participate in a clinical trial when their doctor helped them find an appropriate one, educated them about the pros and cons of participation, and encouraged them to consider it (Sateren, et al. 2002).

Most primary care physicians have positive attitudes toward clinical trials but do not bring up the topic, preferring to leave the discussion to the oncologist. Nearly all (94%) indicated that they would be supportive of oncologists’ recommendations that patients participate in clinical trials given their significant "confidence in the oncologist’s judgment (Crosson, Eisner, Brown, & Ter Maat, 2001)."

From the Literature: Evidence-Based Practices

• Having personnel dedicated to recruitment and collaborating with professional societies can help ease the burden of recruitment. There is a considerable difference in resources available—especially staffing—between providers at academic centers and those in private practice (Ford, et al. 2005).
• Coordinated community and provider outreach is the most productive way to recruit participants (Canavan, Grossman, Kush, & Walker 2006). In addition, patients are more likely to participate when the notification and supportive information is provided in a healthcare setting.
• Creating partnerships with local physicians, healthcare organizations, and cancer advocacy groups can significantly increase the visibility and accessibility of cancer prevention and treatment trials among key populations and within targeted communities.

From the Literature: Promising Practices

• Make a wider variety of protocols available, based on disease site and stage—particularly for underrepresented populations—to help providers match patients to the most appropriate trial (Go, et al. 2006).
• Raise provider awareness of their vital role in patient recruitment, possibly via examples from colleagues that have successfully recruited patients. Offer examples of what can be done to reduce provider fears of losing patients and decrease the feeling of mistrust of centers sponsoring the trials.
• Offer providers who are protective of their client base examples of best practices that demonstrate, for example, that relationships between clinical trial groups and a referring physician can—and are—managed successfully without client attrition, and that they reflect client satisfaction in participation in clinical trial.
• Distribute critical and time-sensitive information about the availability of trials at the community, academic, and cancer center level to enhance the likelihood providers will refer patients to them. Partner with key medical, nursing, and allied health associations and Comprehensive Cancer Control coalitions to disseminate the information.Colleagues serve as the main source of information about clinical trials, while journals and other traditional sources also are cited as channels to seek information (Crosson, et al. 2001).
• Offer tools and other supports to help providers identify potential participants. Electronic health records may offer providers an opportunity to easily identify which of their patients may be appropriate for a clinical trial (Embi, Jain, Clark, & Harris, 2005). By providing trial alerts from which physicians can analyze patient data, practices can decrease staff time and effort required to find potential participants.
• Enlist prominent medical, nursing, and allied health associations to lead partnership efforts with continuing medical education (CME) certified/online courses; clinical trial education/training can become part of the requirement for application and renewal to medical, nursing, and allied health associations, with CME offered as bonus.
• Establish partnerships between providers and social worker associations to increase dialogue between these two important sectors. Social workers possess the skills that engage clients and are adept at discussing sensitive subjects, which might help build enough trust among patients to learn about the possible benefits and risks that participation in clinical trials can bring (Mason, 2005).

References

Canavan, C., Grossman, S., Kush, R., & Walker, J. (2006).
Integrating recruitment into eHealth patient records. Retrieved March 27, 2008, from http://actmagazine.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=334569

Crosson, K., Eisner, E., Brown, C., & Ter Maat, J. (2001).
Primary care physicians’ attitudes, knowledge, and practices related to cancer clinical trials. Journal of Cancer Education, 16, 188-192.

Embi, P.J., Jain, A., Clark, J., & Harris, C.M. (2005).
Development of an electronic health record-based clinical trial alert system to enhance recruitment at point of care. AMIA Annual Symposium Proceedings (pp. 231-235).

Ford, J.G., Howerton, M.W., Bolen, S., Gary, T.L., Lai, G.Y.,
Tilburt, J., et al. (2005). Knowledge and access to information on recruitment of underrepresented populations to cancer clinical trials. Evidence Report/Technology Assessment 122. AHRQ Publication 05-E019-2. Agency for Healthcare Research and Quality, Rockville, MD, June. Retrieved January 24, 2007, from  www.ahrq.gov/clinic/tp/recruittp.htm

Go, R.S., Frisby, K.A., Lee, J.A., Mathiason, M.A., Meyer, C.M., Ostern, J.L. et al. (2006). Clinical trial accrual among new cancer patients at a community-based cancer center. Cancer, 106(2), 426-433.

Mason, S.E. (2005). Offering African Americans opportunities to participate in clinical trials research: how social workers can help. Health & Social Work, 30, 296-304.

McCaskill-Stevens, W., Pinto, H., Marcus, A.C., Comis, R.,
Morgan, R., Plomer, K., et al. (1999). Recruiting minority cancer patients into cancer clinical trials: A pilot project involving the Eastern Cooperative Oncology Group and the National Medical Association. Journal of Clinical Oncology, 17, 1029-1039.

Sateren, W.B., Trimble, E.L., Abrams, J., Brawley, O., Breen,

N., Ford, L., et al. (2002). How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. Journal of Clinical Oncology, 20, 2109-2117.

Legislative Thoughts on Insurance Coverage for Clinical Trial Expenses

Karen Burton, RN, BS, CRNI, OCN^®, CCRP
Oncology Research Associate
OSF Center for Cancer Care
Rockford, IL
Karen.Burton@osfhealthcare.org

All states are not created equal, at least when it comes to reimbursement for clinical trial expenses. In our state (Illinois), insurance companies are not required to cover clinical trials for their members. Often, our patients have been prevented from participating in clinical trials, for which they were eligible, because insurance coverage was not available for the planned trial therapy and out-of-pocket expenses for administration costs, lab tests, radiological screenings, etc., would be prohibitive to these patients. We even had one insurance company tell us that they would provide coverage for participation in a clinical trial (all intended medications were being provided by study sponsor), but if experimental therapy failed, they would not pay an additional cent for any further cancer-related needs for this patient. We find that negotiating treatment plans is much easier when a nurse case manager is involved, especially one with oncology experience.

The bottom line is that we need to educate our legislative representatives about the necessity of clinical trials in advancing oncology care. Equally important, we must explain the nuances of insurance coverage (or lack thereof) for clinical trails, so that states can facilitate coverage for their citizens by working in collaboration with the insurance companies.

The following link may be of help to you and your patients as you explore the ins and outs of insurance coverage in your state.

Editorial
Come to Our SIG Meeting at Congress

Maureen Edgerly, RN, MA, OCN^®, CCRC
Bethesda, MD
edgerlym@mail.nih.gov

Time flies and Congress will be here soon. This year promises an interesting agenda, but what I am most interested in is our SIG Planning/Networking Meeting on Friday, May 16, 2008, from 2:30–4 pm, in Room 207-AB of the Pennsylvania Convention Center. These meetings always generate enthusiasm and renewed commitment to SIG goals. This year is no exception.

Pat McLaughlin, RN, MSN, AOCN^®, CCRP, our SIG coordinator will lead the meeting with a recap of past accomplishments and a discussion of future goals. Time will be allotted to review our Web site and plan future newsletters, but, most importantly, we will be discussing our SIG project that is "going national." (Please see Pam Kennedy’s article in this newsletter for the details.) This is a very important agenda item, and we hope that as many SIG members as possible will be able to attend and contribute to the discussion.

Pamela Kennedy, RN, will assume the position of SIG coordinator following Congress. Please come to meet Pam and wish her well, and also to thank Pat McLaughlin for the hard work and countless hours she has devoted to our SIG.

In this issue of the newsletter, we tried to focus on the CTN in the community setting. Lora Wilson, RN, BSN, OCN^®, presented an overview of the community CTN that those of us in the larger academic settings may not be familiar with. Karen Burton, RN, BS, CRNI, OCN^®, CCRP, raised important insurance reimbursement issues facing those in community settings. Sona Thakkar, MA, discussed the important role of physicians in referring patients to clinical trials.

Putting Evidence Into Practice
ONS PEP Resources Provide Quick Information on Evidence-Based Interventions

Margaretta S. Page, MS, RN, primary author of the ONS Putting Evidence Into Practice (PEP) card on sleep-wake disturbances and its corresponding article in the Clinical Journal of Oncology Nursing, recounts her first-hand experience using the PEP resources. Click here for the article.

Next NCI Teleconference
Understanding the Role of NCI's Clinical Trials Advisory Committee

Don’t miss NCI's Office of Advocacy Relations (OAR) next Understanding NCI teleconference, Understanding the Role of NCI's Clinical Trials Advisory Committee, on Wednesday, May 21, 2008 from 2:00 – 3:00 p.m. EST.  The featured speaker will be Dr. Sheila Prindiville, Executive Secretary, Clinical Trials Advisory Committee (CTAC), NCI's Office of the Director.  No registration is required for participation.  To join the teleconference, dial toll-free within the U.S. 1-800-857-6584.  The passcode is: CTAC.

If you, a friend, family member, or colleague missed the last OAR Understanding NCI: Toll-Free Teleconference, Clinical Trials in Your Community: NCI's Community Clinical Oncology Program, you can still hear the replay of the call by dialing toll-free 1-800-284-7027 through May 10, 2008. 

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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

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• If you already have log-in credentials generated from the ONS Web site, use this information instead of attempting to generate new information.
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Subscribe 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,

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Participate in Your SIG’s Virtual Community Discussion Forum

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As an added feature, members also are able to register to receive their SIG’s announcements by e-mail.

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Clinical Trial Nurses SIG Officers

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ONS Membership/Leadership Team Contact Information

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astengel@ons.org
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