Coordinator's Message
PNI and Complementary Therapies SIG Activities Are Thriving

Gwen Wyatt, RN, PhD
East Lansing, MI
gwyatt@msu.edu


I wish you a Happy New Year. I can hardly believe that we have reached 2005, but here it is. I live in Michigan, and this time of year means mittens and hot chocolate. I hope each of you has set personal and professional goals for the new year. Let’s make one of these goals connecting at Congress in Orlando, FL, from April 28–May 1. I would love to have a full SIG meeting.

Let me say a bit about the Institutes of Learning held in November 2004 in Nashville, TN. We were lucky enough to have a series of bright shiny days with pleasantly mild weather. The conference was wonderfully busy and active. Our SIG sponsored two programs: One session “Getting Back in the Flow: Flex and Bend Your Mind, Body, and Spirit” explored the content and experience of three CTs. We went through a set of seated yoga postures. Then, we were taken on a wonderful mental trip via hypnotherapy aboard a sailboat full of sensory experiences. Rose Rizzo, RN, OCN^®, CHT, presented both of these therapies. Beverly Pierce, MLS, MHD, RN, CHTP, helped us understand the various energy therapies, and we experienced a great centering exercise. I was so proud to be the moderator of this three-hour mini-institute. We have outstanding talent in our SIG. A second mini-institute was present by our SIG member, CDR Colleen Lee, RN, MS, AOCN^®. Colleen’s session was titled “Complementary and Alternative Medicine: Developing an Integrative Program.” I did not have a chance to attend this session but it also was well received.

I hope that we all can bring ideas for future sessions to our SIG meeting in Orlando. If you are a public speaker and have a complementary and alternative medicine (CAM) therapy or content to share in this area, we can help you put together a program for either the Institutes of Learning or Congress. When you participate in this way, some of your expenses can be defrayed by an honorarium provided to speakers. Let’s plan to brainstorm at our SIG meeting at Congress.

I also would like to share my own good fortune with you. As a researcher, I have attempted for a number of years to obtain funding from the National Institutes of Health for my CAM research. Recently, I received a very good score on my research proposal for a reflexology study on women with advanced breast cancer who are undergoing chemotherapy. I will not know about funding until later this year, but if funded, I would begin the study by the end of 2005. Keep your fingers crossed for me.

Be sure to read the revised ONS position statement titled “The Use of Complementary and Alternative Therapies in Cancer Care,” which is available at www.ons.org/publications/positions/ComplementaryTherapies.shtml.

Finally, I would like to thank you for the wonderful response to the needs that have come up for our SIG. Mary Beth Revak, RN, OCN^®, is our new Web master extraordinaire. Be sure to see our Virtual Community Page http://pni.ons.wego.net/?v2_group=0&p=4918 on the ONS Web site. Also, if you want to add something to the page, just let me know.

Best wishes to you for 2005, and I hope to see you at Congress.

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Editor's Message
Make Getting Involved a New Year’s Resolution

Cecilia Barron, PhD, RN
Omaha, NE
crbarron@unmc.edu


Happy New Year! A new year brings with it new opportunities and resolutions. The ONS Congress, the Institutes of Learning, and this newsletter offer several opportunities for participation during the year. Have you thought about writing an article about a complementary therapy for the newsletter, presenting your PNI- and CT-related research findings, proposing strategies that would facilitate research on or delivery of complementary and alternative medicine therapies, reviewing a PNI- or CT-related book or article, or sharing your story in an “elevator speech”? This is a new year, so resolve to get involved. Share your expertise with your colleagues. Send your contributions, ideas, and suggestions to crbarron@unmc.edu.

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Learn From Others When Recruiting for Complementary and Alternative Medicine Trials

Pamela Potter, APRN-BC, DNSc
Seattle, WA
potterpj@u.washington.edu


Recruiting for a complementary and alternative medicine (CAM) trial appears simple to the enthusiastic neophyte CAM researcher. Although we may not admit it, the thoughts that run through our heads may look like this:

We have the best and most interesting study. The design is great. The intervention really works. We just want to demonstrate statistical efficacy to satisfy the scientific standards. Of course, because of the widespread adoption of complementary therapies, people will flock to our doors to sign up for our trial. We have good intentions and divinity on our side.

Although this picture may be somewhat exaggerated, such thinking is naive, unrealistic, and more than a little biased. When the institutional gatekeepers are less than enthusiastic, participants are not lining up to sign up for a study, and our most heartfelt prayers for study participants go unanswered, we may just have to resort to a reasonable plan. Still, success is not guaranteed, and even the most reasonable plan may be fraught with creative challenges.

Westcombe et al. (2003) wrote about their experience recruiting for a randomized clinical trial (RCT) of aromatherapy massage for patients with advanced cancer. The purpose of this article is to review their report of the difficulties they encountered, to discuss the changes they made to address recruitment problems, and to speculate on how the wisdom they “learned the hard way” might inform oncology nursing research in CAM therapies.

The researchers gave priority to designing a rigorous study that would objectively measure meaningful patient-related outcomes. The randomized control design featured both a no-intervention control and comparison group that received relaxation therapy. Recruitment from the sample population, palliative care patients who demonstrated moderate amounts of psychological distress, would ensure a population with sufficient potential for positive change that would demonstrate a significant effect if one were present.

The study was based on a three-group design with a power of 90%. The researchers hoped to show a 20% decrease in morbidity rates in an aromatherapy group, with a 0.05 level of significance. The researchers planned to recruit 508 participants for the three-year study.

What They Learned
Westcombe et al. (2003) learned that low numbers of referrals and high levels of declined participants and exclusions among those referred makes for less-than-adequate recruitment.

Low levels of referral: A larger pool of possible referrals (approximately 18,000 per year) resulted from looking at all diagnoses for every patient who met the inclusion criteria; however, this also had an exponential effect on the barriers encountered. Because recruiting spanned such a large number of patient clinics, proportionately few clinicians had a stake in the study. Many potential clinician referrers were skeptical of the benefits of complementary therapy, believed that the benefit of the therapy to be studied was self-evident and did not warrant study, were uncomfortable with randomizing patients to a no-treatment control, and thought that the study might be burdensome to patients.

High levels of declines: Ten potential participants were considered for each patient randomized to the study, which is not unusual for any clinical trial. Of those who declined (37%), 8% were too ill and 11% already were receiving therapy to address their distress. Patients primarily declined to participate when faced with the prospect of traveling to a regional center to receive the complementary therapy. Others declined because they wanted a specific therapy or because they wanted it immediately.

Study Design Modifications
Because of their effort to be more rigorous in their research than the generally acceptable standards, the researchers discovered that conducting the trial under real-life circumstances became unrealistic. Including more than one control group, limiting the sample to only those with advanced disease, and recruiting a large number of participants within the three-year time frame required by most funding sources made the trial too complicated and caused a higher demand for participants than was achievable with the available population. Recruitment barriers and competition with other interventions addressing psychological distress were not considered. The researchers had to rethink their study design; as a result, they opened the trial to all patients with cancer, removed the relaxation therapy group, revised the statistical power to 80% at a 0.05 significance level, and added another recruitment center. These modifications expanded the pool of potential participants, simplified the research design, and reduced the required number of participants to 258.

Hindsight for Future Research
Westcombe et al. (2003) offered a number of suggestions to consider before implementing an RTC. Three are considered here.

Maintain reasonable expectations: Keep your study simple and be flexible to real-world requirements. The flawless study design may not be feasible in the everyday clinical setting.

Invest time and money in carrying out a full exploratory phase prior to rolling out your RCT: Take the time to do the preliminary exploratory work to identify and remedy potential obstacles ahead of time. Merely knowing the size of the potential participant pool contributes little to understanding how individuals might be approached and recruited for the study within the healthcare setting.

Establish and maintain a high profile prior to and throughout the data collection period: An ongoing and respected relationship with clinician referrers is essential for building and sustaining study momentum.

Implications for the PNI/CT SIG
Plan to address barriers before beginning a study. Barriers caused by clinicians often result from a lack of knowledge and a subsequent devaluing of clinical research of CAM therapies. The prevalence of CAM use among people with cancer does not necessarily indicate an interest in and willingness of potential study participants to participate in CAM research. Clinicians and patients know the purpose of medical clinical trials, but they may not understand the purpose of a CAM trial with an unfamiliar intervention. Consider an educational campaign among clinicians, and ensure that promotional literature offers enough explanation to pique the interest of potential participants. Make sure to budget adequately for study promotion.
Good clinician-researcher partnerships are essential to conducting a successful clinical trial. Oncology nurses interested in research with CAM therapies make ideal partners with nurse scientists who want to conduct CAM research. Who knows the particularities of the clinical setting and the needs of the patient population better than nurses who specialize in oncology? Nurse scientists bring theoretical and structural study design expertise to the research partnership.

Are you participating in a PNI/CT clinical trial with people living with cancer? What kind of partnerships have you formed? What works? What does not? Send your comments via e-mail to potterpj@u.washington.edu;snail mail to Pamela Potter, APRN-BC, DNSc, Postdoctoral Fellow, Biobehavioral Nursing and Health Systems, University of Washington, Box 357266, Seattle, WA 98195-7266; or phone at 206-616-3065.

Reference
Westcombe, A.M., Gambles, M.A., Wilkinson, S.M., Barnes, K., Fellowes, D., Maher, E.J., et al. (2003). Learning the hard way. Setting up an RCT of aromatherapy massage for patients with advanced cancer. Palliative Medicine, 17, 300–307.

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Elevator Speech
Integrate Your Personal and Professional Experience

Pamela Potter, APRN-BC, DNSc
Seattle, WA
potterpj@u.washington.edu



My conversation took place in the elevator of a local hospital in Seattle, WA. I’ve been living in Seattle less than two months. “Do you work here?” asks a woman whose scrubs and name tag identify her as a nurse. “No, but I look like I do. Actually, I am a nurse,” I reply. “My spouse is a patient here.”

After completing my doctor of nursing science degree at the School of Nursing at Yale University, I moved to Seattle with my spouse to accept a postdoctoral fellowship in biobehavioral nursing research at the University of Washington (UW). My dissertation research was a clinical trial of a complementary energy therapy called Reiki that was used to decrease the distress of having a breast biopsy. At UW, I plan to build on my dissertation research to develop a program for measuring biological and psychological outcomes of energy therapies such as Reiki and Qigong for women facing the diagnosis and treatment of breast cancer. I will be studying immune function in healthy individuals, patients newly diagnosed with breast cancer, and patients responding to radiation therapy so that I can identify possible outcome measures. Right now, however, I’m an observer, living with a partner diagnosed with advanced cancer. As a consequence of personal and research experience, I have become more interested in identifying how to integrate CTs into the conventional care offered to patients undergoing cancer diagnosis and treatment. I certainly am learning the workings of the healthcare system from the inside out. The professors in the School of Nursing at UW are brilliant, kind, and wonderfully supportive of my attempt to achieve balance during this challenging time. My planned publications include dissertation findings, a methods paper, and a personal experience piece. For me, the experience includes CT self-care activities (self-Reiki, Qigong movement meditation, knitting, and regular foot-reflexology appointments) and building a good support system (family, old friends, new friends, a cancer support organization, a knitting group, and a good psychotherapist). This helps me have the resources to be supportive of my husband as he orchestrates his integrative healthcare treatment plan. Most important of all is the love that I share with my spouse, a love that has grown stronger as we endeavor together to bring healing into our everyday living.

“So, yes, I do work here. I’m a holistic nurse offering Reiki treatments to a patient newly diagnosed with cancer. He finds the treatment comforting and says it has facilitated his recovery. I’m doing the work I love.”

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Attend the 12th Annual Psychoneuroimmunology Research Society Meeting


The 12th Annual Meeting of the Psychoneuroimmunology Research Society (PNIRS) is planned for June 9–11, 2005, in Denver, CO. PNIRS is an international organization for researchers in a number of scientific and medical disciplines, including psychology, neurosciences, immunology, pharmacology, psychiatry, behavioral medicine, infectious diseases, and rheumatology, who are interested in interactions between the nervous system and the immune system and the relationship between behavior and health. See its Web site at http://www.pnirs.org/ for more information.

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The National Center for Complementary and Alternative Medicine Announces Six New Research Centers


In October 2004, the National Center for Complementary and Alternative Medicine (NCCAM) announced the addition of six new centers to its research centers program. NCCAM funds the Centers of Excellence for Research on CAM and the Developmental Centers for Research on CAM. The Centers of Excellence provide five years of support for experienced researchers at leading universities, whereas the Developmental Centers provide three years of support to build research programs in major CAM institutions through partnerships with established research institutions.

The three new Centers of Excellence for Research on CAM are the Center on Mindfulness-Based Stress Reduction, Stress Arousal, and Immune Response in Early HIV at the Osher Center for Integrative Medicine, University of California, San Francisco (principal investigator [PI]: Susan Folkman, PhD), Alternative Therapies for Alcohol and Drug Abuse at the McLean Hospital/Harvard Medical School, Belmont, MA (PI: Yue-Wei Lee, PhD), and Translational Research Center for CAM Therapy of Asthma at the University of North Carolina, Chapel Hill (PI: David Peden, MD).

The three new Developmental Centers are Trametes Versicolor (mushroom)-Induced Immunopotentiation (PI: Joel Slaton, MD; Partner Institutions: University of Minnesota, Center for Spirituality and Healing, Minneapolis, and Bastyr University, Kenmore, WA), CAM: Expectancy and Outcome (PI: Barry Oken, MD; Partner Institutions: Oregon Health and Science University, National College of Naturopathic Medicine, Oregon College of Oriental Medicine, and Western States Chiropractic College, Portland, OR), and Mechanisms of Osteopathic Manipulative Medicine (PI: Michael Smith, PhD; Partner Institutions: University of North Texas Health Science Center and Texas College of Osteopathic Medicine, Fort Worth, and Arizona College of Osteopathic Medicine, Glendale).

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We Are Looking for New Writers and Expert Mentors


Do you know of an oncology topic that needs to be addressed from your perspective as a direct caregiver, but the thought of developing a manuscript overwhelms you? Are you an experienced author with expertise in writing for publication and a willingness to mentor?

If so, the Clinical Journal of Oncology Nursing (CJON) Mentor/Fellow Writing Program, sponsored by AMGEN, is for you. We are seeking direct caregivers who have a desire to write for publication and experienced authors who are willing to offer them guidance and support. Eight direct caregivers will be selected to participate. Each selected applicant will be paired with a mentor, who will guide the novice writer through the manuscript preparation process. Six months will be allotted to complete and submit the manuscripts to the CJON editor. All manuscripts will undergo the standard CJON peer-review process. Accepted manuscripts will be published in an issue of CJON. Each mentor/fellow pair will be allotted a budget to cover telephone and postage expenses. Each mentor will receive an honorarium when the completed manuscript is submitted and be given second authorship on the manuscript.

All applicants must be ONS members. For more information or to obtain an application, visit the Publications area of the ONS Web site (www.ons.org) or contact Laura Schnable, ONS Publishing Division administrative assistant, at 412-859-6271 or pubCJON@ons.org. Applications are due February 15.

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Membership Information


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PNI and Complementary Therapies SIG Officers

Coordinator Gwen Wyatt, RN, PhD Michigan State University B422 W. Fee Hall East Lansing, MI 48824-1315 517-432-5511 (O) 517-353-8536 (fax) gwyatt@msu.edu Ex Officio Jo Ann C. Owen, BSN, RN 1609 Cedar St. Broomfield, CO 80020-1334 303-438-0638 (H) joann.owen@med.va.gov Editor Cecilia Barron, PhD, RN 9658 Maple Dr. Omaha, NE 68134-5658 402-391-8476 (H) 402-559-4303 (fax) crbarron@unmc.edu

Coeditor Pamela Potter, APRN-BC, DNSc Postdoctoral Fellow Biobehavioral Nursing & Health Systems University of Washington Box 357266 Seattle, WA 98195-7266 206-616-3065 (O) 206-543-4771 (fax) potterpj@u.washington.edu ONS Publishing Division Staff Jacqueline Moore, BA Copy Editor 412-859-6322 jmoore@ons.org

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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, Director of Membership/Leadership
astengel@ons.org
412-859-6244

Diane Scheuring, Manager of Member Services
dscheuring@ons.org
412-859-6256

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

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
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