Cancer Research and Cancer Clinical Trials

Financial support for all facets of cancer research is essential to prevent, effectively treat, and manage the short- and long-term effects of cancer. The spectrum of cancer research includes basic science that promotes the understanding of the molecular and genetic bases of cancer as well as the translation of this knowledge to practice for prevention, early detection, and disease management. Cancer clinical trials facilitate discovery and implementation of preventive and early detection strategies, provide evidence to support treatment and symptom management modalities, and define patients’ rehabilitation and survivorship needs. Oncology nurses have a critical role in the conduct of cancer treatment and prevention trials (Aikin, 2002; Klimaszewski et al., 2000).

Not all patients who are eligible to participate in cancer clinical trials enroll in one. Overall, only 3% of patients with cancer participate in clinical trials (Lara et al., 2005), and older patients are significantly underrepresented in such trials (Townsley, Selby, & Siu, 2005). Inhibiting access and enrollment are system barriers (particularly limited funding for clinical trials), healthcare provider barriers (e.g., protocol complexity, general lack of knowledge), and patient barriers (e.g., discomfort about the research process, fear of potential side effects) (Mills et al., 2006). Modifying attitudes, changing perceptions, and increasing awareness about clinical trials among these groups are paramount to overcoming many of the present barriers.

The ONS Health Policy Agenda identifies the commitment and responsibility of the Society and its members to advocate for the well-being of people with cancer. Advocating for the optimal approach for each person potentially or actually affected by cancer, including the assurance of complete disclosure of treatment options and potential risks and benefits associated with these options and ongoing informed consent to the option to be pursued, is essential to quality cancer care.

It Is the Position of ONS That

• Federal funding for all levels of cancer research must be increased significantly .
• All clinical trials must be peer reviewed, include participant informed decision making and consent, and be approved through an institutional review board process.
• Every person diagnosed with cancer must have the right to participate in a clinical trial if medically indicated.
• Individuals at high risk for cancer or those who wish to change behaviors that increase cancer risk must be offered the opportunity to participate in cancer prevention trials.
• All barriers to participation in clinical trials, including recruitment and retention, must be abolished.
• Participation in clinical trials must be a standard benefit of all health insurance plans, and legislation must be adopted to prohibit denials of trial-associated patient care reimbursement costs.
• Content related to cancer research and clinical trials must be incorporated into basic educational curricula of healthcare professionals and fostered through continuing education.
• More effective strategies to promote public awareness and understanding of cancer research and clinical trials must be devised, implemented, and evaluated.
• Improved strategies to facilitate the participation of underrepresented populations must be devised, implemented, and evaluated.
• Concepts of quality cancer care must be incorporated into the planning and coordination of clinical trials (Oncology Nursing Society, 2005).
• Coordination of clinical trials (e.g., coordination of clinical sites, development of standardized treatment orders, symptom management, patient education and advocacy, facilitation of informed consent, assistance with participant accrual and retention) is accomplished best by RNs who have been educated and certified in oncology nursing.
• Nurses design, initiate, and facilitate clinical research studies to address quality-of-life issues for people with cancer.
• Continuing informed consent must be ensured for all individuals considering or participating in clinical trials.
• Solutions or innovative strategies to decrease financial burdens associated with institutional participation in clinical trials must be devised.

References

Aikin, J. (2002). Chemoprevention. In K. Jennings-Dozier & S. Mahon (Eds.), Cancer prevention, detection, and control: A nursing perspective (pp. 257-275). Pittsburgh, PA: Oncology Nursing Society.

Klimaszewski, A., Aikin, J., Bacon, M., DiStasio, S., Ehrenberger, H., et al. (2000). Manual for clinical trials nursing. Pittsburgh, PA: Oncology Nursing Society.

Lara, P.N., Paterniti, D.A., Chiechi, C., Turrell, C., Morain, C., Horan, N., et al. (2005). Evaluation of factors affecting awareness of and willingness to participate in cancer clinical trials. Journal of Clinical Oncology, 23, 9282–9289.

Mills, E.J., Seely, D., Rachlis, B., Griffith, L., Wu, P., Wilson, K., et al. (2006). Barriers to participation in clinical trials of cancer: A meta-analysis and systematic review of patient-reported factors. Lancet Oncology, 7, 141–148.

Oncology Nursing Society. (2005). Quality cancer care. Retrieved September 18, 2005, from http://www.ons.org/publications/positions/QualityCancerCare.shtml

Townsley, C.A., Selby, R., & Siu, L.L. (2005). Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. Journal of Clinical Oncology, 23, 3112–3124.

Approved by the ONS Board of Directors 6/98; Revised 6/00, 07/02, 8/04, 10/06.

To obtain copies of this or any ONS position, contact the Customer Service Center at the ONS National Office at 125 Enterprise Drive, Pittsburgh, PA 15275-1214 (866-257-4ONS; customer.service@ons.org). Positions also may be downloaded from the ONS Web site (www.ons.org).