Most of the women recruited into PAL were between the ages of 50 and 54 yr, and the age distribution of randomized study participants was similar to the distribution of age in the state registry (Table 4). Racial self-identification data were collected on 652 women who completed at least part of the phone screening for the study: 401 women were white and 223 self-identified as African American. Of the 371 consented women, 124 self-identified as minorities and 112 identified as African American. Of the total 295 randomized women, 103 self-identified as minorities. This exceeded the a priori goal of recruiting 98 self-identified minority women. Ninety-four of the 103 minority women randomized into the PAL trial were African American. Table 4 includes specific information on white, African American/black, and Asian races. All other races were included in the other category, and all unknowns were excluded. In the Pennsylvania and the New Jersey state cancer registries, 81% and 84% of breast cancer survivors identified as white, respectively. By comparison, 62% of women screened for PAL were white and 65% of randomized PAL participants were white. Further, the proportion of African American participants were 32.4%, 30.1%, and 31.8% among those screened, consented, and randomized, respectively.
Table 5 shows baseline characteristics of the 295 women randomized into the PAL trial within lymphedema and treatment group status. The groups are well balanced across treatment group status, within lymphedema status, for all demographic, cancer history, and lymphedema variables at baseline. There were no between-group differences (across treatment status, within lymphedema status) in any variables included in Table 5 (results not shown).
As the number of cancer survivors continues to increase, more behavioral intervention research will be needed to test approaches to preventing, controlling, or treating late and long-term effects of necessary life-saving cancer therapies. Further, not all of these interventions can be home, phone, or Web based. It is desirable that such interventions be disseminable within the community. Accordingly, it is important for researchers to be able to efficiently recruit cancer survivors into interventions that are community based. In the PAL trial, the majority of participants recruited into a community-based exercise intervention heard about the study through letters sent in cooperation with two state cancer registries. That said, although support groups and events and media attention were not the most successful means of recruitment, they provided staff with social and networking ties, which are an immeasurable asset to recruitment in a community-based intervention. It is not possible to know whether the recruitment letters sent through the registries would have been as successful without the social and networking ties from support groups and media attention. However, there are examples in the literature of other survivorship studies that have successfully recruited through registries that have not focused on media attention (9,11). These two prior examples differ from the PAL trial in two ways: one was larger than PAL but was survey based only (11), the other was much smaller and did not deal with the geographic recruitment issue addressed herein, as all exercise occurred at a single health club or in the home (9).
Letters from hospital registries only accounted for 3% of randomized participants. Despite this low percentage, it is still considered a vital part of the recruitment plan because hospital registries may allow access to women sooner after diagnosis than is possible from state cancer registry data. Cost and staff time are two components to consider when working with a hospital registry. It is essential to meet with hospital staff and physicians to get "buy in" for the study from key decision makers. Once IRB approval is granted, there is also a significant burden of hospital administrative staff time. It has been observed that when recruiting through hospital registries and using physician signed letters, it is helpful to be able to review the possible participants for eligibility before approaching physicians. This creates a smaller list for physicians to review, creating a quicker turnaround (2). By comparison to working with hospital registries, working with state registries is much less costly and seems to net a much larger potential pool of participants. The amount of time required to get nearly 25,000 addresses of recruitable survivors from the Pennsylvania state cancer registry was a matter of weeks, and little staff time was allocated to this effort. The amount of time required for getting the 969 letters mailed through the hospital registries was months, and the staff time required was manyfold greater. From the perspective of return on investment, state cancer registries are clearly a superior method of recruiting.
Another issue with hospital-based registries is that it may be necessary to recruit through several hospital registries to find a diverse enough sample. Pakilit et al. (11) observed that a cancer center registry had a higher response rate than a community hospital, but the community hospital registry was provided a more diverse sample. Compared with a state registry, hospitals may offer a much smaller and possible homogeneous sample. Another challenge of hospital registries for behavioral trials that require attendance to regular onsite intervention activities is geography. For example, we observed very few women within the targeted zip codes who had been seen at HUP (n = 94) despite a very large breast cancer program at the University of Pennsylvania (approximately 800 surgeries per year).
PAL spent a significant amount of time dedicated to the recruitment of minority participants. The majority of minority recruitment efforts were focused on African American women. PAL staff attended proportionally more support groups and conferences focused on African American than white women. However, the registry still proved to be the most successful recruitment tool for both racial groups, indicating that registries can provide a racially diverse sample. At the recommendation of African American research colleagues at the University of Pennsylvania, extra materials (including photographs of African American exercise leaders) were included in letters sent to African American survivors. It is not possible to know whether this positively affected the recruitment efforts. However, the success of minority recruitment in the PAL trial supports the use of this approach in future studies.
Registries are not uniform in their research and information policies. One report indicated that 71% of state cancer registries had a passive approach in telling patients about the registry, such as through a Web site or a brochure in a waiting room; therefore, most patients are unaware that their personal information is being collected this way (4). Policies are state specific; some may allow patients to be contacted for research purposes whereas others may not. For those that allow contact, many require a signed physician's approval before letters can be sent. PAL was successful in part because of the cooperation of two state registries that allowed survivors to be contacted without prior permission from a treating physician. It is not known exactly what effect a requirement of written physician approval before contacting patients would have had on recruitment for the PAL trial. It can be assumed that recruitment would have certainly been extended beyond 17 months and cost more.
Another valid concern when recruiting with registry data is the possibility of violating patient confidentiality. However, there is some evidence that most patients are open to contact. In a survey of 33 nationwide cancer registry directors, Beskow et al. (4) observed that 51.5% categorized less than 1% of their patients as flagged (flagged patients have declined to be contacted for research purposes). In our study, only 12 women were upset by being contacted through the registry (0.0004% of total letters mailed from the Pennsylvania cancer registry mailing list). If more patients were actively notified about the existence of a registry, patients who would not want to be contacted could opt out at the time of notification. As other studies have indicated, an awareness of the registry may make patients more likely to respond to invitations to participate in research and potentially allowing the registries to keep in better contact with survivors (3).
To summarize, state cancer registries were a useful tool in recruiting racially and geographically diverse participants into a community-based exercise intervention for breast cancer survivors. This supports the goal of conducting health behavior interventions within communities where the survivors live. The geographic recruitment and the community-based intervention approaches described herein may support the sustainability and the dissemination of health behavior interventions to cancer survivors beyond the end of research funding.
This study was supported by the National Cancer Institute (R01-CA106851 to Schmitz) and by the Public Health Services Research Grant RR024134 from the National Institutes of Health to the University of Pennsylvania.
The results of the present study do not constitute endorsement by the American College of Sports Medicine.
The authors thank Robin Otto and Craig Edelman, Pennsylvania Cancer Registries, Pennsylvania Department of Health, Harrisburg, PA; Constance Sumner, R.N., and Jazmine Alaverez, Black Women's Health Alliance; Elyse Caplan, M.A., and Amy B. Grillo, Living Beyond Breast Cancer; Jennifer Leith, Susan G. Komen Foundation Philadelphia Affiliate; Donna Dunkin, Linda Creed Foundation; Wilma Morgan, O.T.R./L., Janice Buhler, M.S., P.T., O.C.S., Vicki Moran, Cheri Doll, M.S.P.T., and Carolyn Weaver, R.N., B.S.N., A.O.C.N., Fox Chase Cancer Center Philadelphia, PA; Judy Neuman, Director, Oncology Data and Clinical Data, Phyllis Duda, Nurse Practitioner, Doug Marshall, Community Educator, Barbara Francks, R.N., Eric Miller, M.D., and Adrienne Kirby, Ph.D., F.A.C.H.E., R.N., Virtua Health System; Serena Harris, Family YMCA of Burlington County; Gregory Lyles, Executive Director, and Alonzo Holder, Fitness Director, West Philadelphia YMCA; Mary Francis Reilly and Claine Crew, Main Line YMCA; Kathy Perry and Kathy Disque, Ambler Area Branch YMCA; Duane Johnson, Executive Director, and Miriam Ranalli, Lansdowne YMCA; Debbie Mignogna, Branch Director, Ridley Area YMCA; Donna Kern, Northeast YMCA; Ann Stephanie, Nurse Practitioner, Cancer Institute of NJ Cooper University Hospital; Tracy Harper, D.P.T., Christine Hayes Physical Therapy; Carol Waties, Director, Special Populations and Advocacy of the American Cancer Society; J. Ehmann, M.P.T., C.W.S., C.L.T., and Amanda Zavodnick, M.S.W., L.S.W., Chestnut Hill Hospital; Anne Matthews, O.T.R., C.H.T., C.L.T.-L.A.N.A., Suzanne R. Smith, R.N., M.S.N., Oncology Clinical Specialist/IRB Coordinator, Deborah Markiewicz, M.D., Monica E. Smith, M.D., Rachelle M. Lanciano, M.D., Linda S. Callans, M.D., and Mark A. Rovito, M.D., Delaware County Memorial Hospital; Amy Davis; LympheDIVAs; Assistant Professor Patricia K. Bradley, Ph.D., R.N., C.S., Villanova University College of Nursing; Kay Stevens, Director, Community Outreach of Mercy Hospital of Philadelphia; Veronica Suber, Christian Stronghold Baptist Church, Philadelphia, PA; Stephanie Evans, Salvation Army; Melanie Marchand, Sisters in Shape Fitness; Karen Neyer, LSW Assistant Program Director, Wellness Community of Philadelphia; Lia Daniels and Kara Stephenson, Breast Cancer Resource Center at the Princeton YWCA; Loretta Mikulski, South Jersey Breast Cancer Coalition; Ernestine Delmoor, M.P.H., National Black Leadership Initiative on Cancer; Janet Cash, Sisters Health Initiative; Joanne Poorman, Church Secretary, Ardmore Presbyterian Church; Novella K. Lyons, Executive Director, Women of Faith and Hope, Inc; and Rena Rowan, Breast Center, Abramson Cancer Center of the University of Pennsylvania.
1. Ahmed RL, Thomas W, Yee D, Schmitz K. Weight training does not increase incidence of lymphedema in breast cancer survivors. J Clin Oncol
2. Andersen MR, Schroeder T, Gaul M, Moinpour C, Urban N. Using a population-based cancer registry for recruitment of newly diagnosed patients with ovarian cancer. Am J Clin Oncol
3. Arora NK, Hamilton AS, Potosky AL, Rowland JH, Aziz NM, Bellizzi KM, et al. Population-based survivorship research using cancer registries: a study of non-Hodgkin's lymphoma survivors. J Cancer Surviv
4. Beskow LM, Sandler RS, Weinberger M. Research recruitment through US central cancer registries: balancing privacy and scientific issues. Am J Public Health
5. Demark-Wahnefried W, Clipp EC, McBride C, Lobach DF, Lipkus I, Peterson B, et al. Design of FRESH START: a randomized trial of exercise and diet among cancer survivors. Med Sci Sports Exerc
6. Demark-Wahnefried W, Morey MC, Clipp EC, Pieper CF, Snyder DC, Sloane R, et al. Leading the Way in Exercise and Diet (Project LEAD): intervening to improve function among older breast and prostate cancer survivors. Control Clin Trials
7. Friebel TM, Beutler RA, Lee SM, Bernhardt BA, Helzlsouer KJ, Griffin CA. Active recruitment increased enrollment in a hereditary cancer registry. J Clin Epidemiol
8. Hewitt M, Rowland J, Yancik R. Cancer survivors in the United States: age, health, and disability. J Gerontol A Biol Med Sci
9. Irwin ML, Cadmus L, Alvarez-Reeves M, O'Neil M, Mierzejewski E, Latka R, et al. Recruiting and retaining breast cancer survivors into a randomized controlled exercise trial: the Yale Exercise and Survivorship Study. Cancer
10. National Cancer Institute. The NCI Strategic Plan for Leading the Nation: To Eliminate the Suffering and Death Due to Cancer
. Bethesda (MD): US Department of Health and Human Services, NIH; 2006. p. 81.
11. Pakilit AT, Kahn BA, Petersen L, Abraham LS, Greendale GA, Ganz PA. Making effective use of tumor registries for cancer survivorship research. Cancer
12. Rowland JH. Cancer survivorship: rethinking the cancer control continuum. Semin Oncol Nurs
13. Sallis JF, Hovell MF, Hofstetter CR, Elder JP, Hackley M, Caspersen CJ, et al. Distance between homes and exercise facilities related to frequency of exercise among San Diego residents. Publ Health Rep
Keywords:©2009The American College of Sports Medicine
BREAST NEOPLASMS; WEIGHT LIFTING; LYMPHEDEMA; PATIENT SELECTION