Cancer Research and 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 that 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., 2008).

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). People older than age 65 represent 63% of patients with cancer, but only 25% of these patients are in clinical 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). Additional barriers that may lead to exclusion of older adults include strict eligibility criteria and ageism, not physiologic status. 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 organization and its members to advocate for the well-being of patients with cancer. Advocating for the optimal approach for each person who is potentially or actually affected by cancer is essential to quality cancer care. This should include the assurance of complete disclosure of treatment options, potential risks and benefits associated with these options, and ongoing informed consent for the options to be pursued.

It Is the Position of ONS That

  • Federal funding for all levels of cancer research is increased significantly.
  • All clinical trials are peer reviewed and approved through an institutional review board process and all patients are well informed and provide consent.
  • Every person diagnosed with cancer has 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 are offered the opportunity to participate in cancer prevention trials.
  • All barriers to participation in clinical trials, including recruitment and retention, are minimized.
  • Participation in clinical trials is a standard benefit of all health insurance plans and legislation be adopted to prohibit denials of trial-associated patient care reimbursement costs.
  • Content related to cancer research and clinical trials is 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 are devised, implemented, and evaluated.
  • Improved strategies to facilitate the participation of underrepresented populations are devised, implemented, and evaluated.
  • Concepts of quality cancer care are incorporated into the planning and coordination of clinical trials (Oncology Nursing Society, 2009).
  • 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 is 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 are 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., Bacon, M., Deininger, H., Ford, B., Ehrenberger, Westendorp, J., et al. (2008). Manual for clinical trials nursing (2nd ed.). 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. (2009). Quality cancer care. Retrieved March 29, 2009, 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, 1997; revised 6/00, 6/02, 10/05, 9/06, 3/09.

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 (+1-866-257-4ONS; customer.service@ons.org).