Purpose/Objectives: To describe the adequacy of research information among people with cancer at the time they accept or decline participation in a cancer clinical trial.
Design: Cross-sectional, descriptive.
Setting: An urban, academic, National Cancer Institute-designated comprehensive cancer center.
Sample: 197 patients with advanced gastrointestinal cancer.
Methods: Mailed survey; self-reported data.
Main Research Variables: Adequacy of research information (actual knowledge, perceived adequacy of information, and perceived understanding), cancer clinical trial participation, and satisfaction with the decision to participate.
Findings: Most respondents (88%) perceived themselves as having adequate information to make an informed decision regarding cancer clinical trial participation. In addition, 35% demonstrated adequate knowledge of basic clinical research.
Conclusions: Patients decide to accept or decline cancer clinical trials without having adequate knowledge.
Implications for Nursing: Nurses have an important role in educating patients regarding cancer clinical trials. The ideal teachable moment may not occur at the time of diagnosis; other less stressful opportunities may present when the patient is more receptive.
Adams, M. (1991). Information and education across the phases of cancer care. <i>Seminars in Oncology Nursing, 7</i>, 105-111.
Avis, N.E., Smith, K.W., Link, C.L., Hortobagyi, G.N., & Rivera, E. (2006). Factors associated with participation in breast cancer treatment clinical trials. <i>Journal of Clinical Oncology, 24</i>, 1860-1867.
Biedrzycki, B.A. (2010). Decision making for cancer clinical trial participation: A systematic review [Online exclusive]. <i>Oncology Nursing Forum, 37</i>, E387-E399. doi: 10.1188/10.ONF.E387-E399
Biedrzycki, B.A. (in press). Factors and outcomes of decision making for cancer clinical trial participation. <i>Oncology Nursing Forum</i>.
Cassileth, B.R., Zupkis, R.V., & Sutton-Smith, K., & March, V. (1980). Information and participation preferences among cancer patients. <i>Annals of Internal Medicine, 92</i>, 832-836.
Comis, R.L., Miller, J.D., Aldige, C.R., Krebs, L., & Stoval, E. (2003). Public attitudes toward participation in cancer clinical trials. <i>Journal of Clinical Oncology, 21</i>, 830-835. doi:10.1200/JCO.2003.02.105
Cox, A., Jenkins, V., Catt, S., Langridge, C., & Fallowfield, L. (2005). Information needs and experiences: An audit of UK cancer patients. <i>European Journal of Oncology Nursing, 10</i>, 263-272.
Cupples, S.A., Nolan, M.T., Augustine, S.M., & Kynock, D. (1998). Perceived stressors and coping strategies among heart transplant candidates. <i>Journal of Transplant Coordination, 8</i>, 179-187.
Davis, S.W., Nealon, E.O., & Stone, J.C. (1993). Evaluation of the National Cancer Institute's clinical trial booklet. <i>Journal of the National Cancer Institute. Monographs, 14</i>, 139-145.
Dillman, D.A. (2000). <i>Mail and Internet surveys: The tailored design method</i> (2nd ed.). New York, NY: Johns Wiley and Sons.
Ellis, P.M., Butow, P.N., Tattersall, M.H., Dunn, S.M., & Houssami, N. (2001). Randomized clinical trials in oncology: Understanding and attitudes predict willingness to participate. <i>Journal of Clinical Oncology, 19</i>, 3554-3561.
Epstein, R.M., & Street, R.L., Jr. (2007). <i>Patient-centered communication in cancer care: Promoting health and reducing suffering</i>. Bethesda, MD: National Cancer Institute.
Horstmann, E., McCabe, M.S., Grochow, L., Yamamoto, S., Rubenstein, L., Budd, T., … Grady, C. (2005). Risks and benefits of phase 1 oncology trials, 1991 through 2002. <i>New England Journal of Medicine, 352</i>, 895-904. doi:10.1056/NEJMsa042220
Institute of Medicine. (2001). <i>Crossing the quality chasm: A new health system for the 21st century</i>. Washington, DC: National Academy of Sciences.
Janz, N.K., Wren, P.A., Copeland, L.A., Lowery, J.C., Goldfarb, S.L., & Wilkins, E.G. (2004). Patient-physician concordance: Preferences, perceptions, and factors influencing the breast cancer surgical decision. <i>Journal of Clinical Oncology, 22</i>, 3091-3098.
Jenkins, V., Fallowfield, L., & Saul, J. (2001). Information needs of patients with cancer: Results from a large study in UK cancer centers. <i>British Journal of Cancer, 84</i>, 48-51. doi:10.1054/bjoc.2000.1573
Kass, N.E., Sugarman, J., Faden, R., & Schoch-Spana, M. (1996). Trust: The fragile foundation of contemporary biomedical research. <i>Hastings Center Report, 26</i>, 25-29. doi:10.2307/3528467
Lara, P.N., Jr., Paterniti, D.A., Chiechi, C., Turrell, C., Morain, C., Horan, N., … Chen, M.S., Jr. (2005). Evaluation of factors affecting awareness of and willingness to participate in cancer clinical trials. <i>Journal of Clinical Oncology, 23</i>, 9282-9289.
Mathews, C., Restivo, A., Raker, C., Weitzen, S., & DiSilvestro, P. (2009). Willingness of gynecologic cancer patients to participate in clinical trials. <i>Gynecologic Oncology, 112</i>, 161-165.
Meropol, N.J., Buzaglo, J.S., Millard, J., Damjanov, N., Miller, S.M., Ridgway, C., … Watts, P. (2007). Barriers to clinical trial participation as perceived by oncologists and patients. <i>Journal of the National Comprehensive Cancer Network, 5</i>, 655-664.
Nolan, M.T., Cupples, S.A., Brown, M., Pierce, L., Lepley, D., & Ohler, L. (1992). Perceived stress and coping strategies among families of cardiac transplant patients during the organ waiting period. <i>Heart and Lung, 21</i>, 540-547.
O'Connor, A.M. (1995). Validation of a decisional conflict scale. <i>Medical Decision Making, 15</i>, 25-30.
Quinn, G.P., Bell, B.A., Bell, M.Y., Caraway, V.D., Conforte, D., Graci, L.B., … Bepler, G. (2007). The guinea pig syndrome: Improving clinical trial participation among thoracic patients. <i>Journal of Thoracic Oncology, 2</i>, 191-196. doi:10.1097/JTO.0b013e318031cdb6
Sood, A., Prasad, K., Chhatwani, L., Shinozaki, E., Cha, S.S., Loehrer, L.L., & Wahner-Roedler, D.L. (2009). Patients' attitudes and preferences about participation and recruitment strategies in clinical trials. <i>Mayo Clinical Proceedings, 84</i>, 243-247. doi:10.4065/84.3.243
Swanson, J., & Koch, L. (2010). The role of the oncology nurse navigator in distress management of adult inpatients with cancer: A retrospective study. <i>Oncology Nursing Forum, 37</i>, 69-76. doi:10.1188/10.ONF.69-76
Toubassi, D., Himel, D., Winton, S., & Nyhof-Young, J. (2006). The informational needs of newly diagnosed cervical cancer patients who will be receiving combined chemoradiation treatment. <i>Journal of Cancer Education, 21</i>, 263-268. doi:10.1080/08858190701347937
Treacy, J.T., & Mayer, D.K. (2000). Perspectives on cancer patient education. <i>Seminars in Oncology Nursing, 16</i>, 47-56.
Umutyan, A., Chiechi, C., Beckett, L.A., Paterniti, D.A., Turrell, C., Gandara, D.R., … Lara, P.N., Jr. (2008). Overcoming barriers to cancer clinical trial accrual: Impact of a mass media campaign. <i>Cancer, 112</i>, 212-219. doi:10.1002/cncr.23170
Villejo, L., & Meyers, C. (1991). Brain function, learning styles, and cancer patient education. <i>Seminars in Oncology Nursing, 7</i>, 97-104.