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Why Learning to Communicate With Our Patients Is So Important: Using Communication to Enhance Accrual to Cancer Clinical Trials

Department of Social and Behavioral Health, School of Medicine; and the Massey Cancer Center, Virginia Commonwealth University, Richmond, VA

Clinical trials are the avenue through which breakthroughs in the treatment and care of cancer patients are made. Yet, the pace of accruing patients to cancer clinical trials can be maddeningly slow. No more than 5% of all adult cancer patients actually participate in a clinical trial during the course of their therapy,¹ and that number has changed little from the 1980s.² In truth, despite the clamor by the public to more quickly develop new and better therapeutics, patients seem unwilling to participate in large numbers in clinical trials.

Although most Americans realize that the goal of better cancer treatment can be reached only through medical research, which includes research using human subjects, the public are only dimly aware of what that specifically entails; the concepts of blinding, placebo controls, randomization, and clinical equipoise are unfamiliar.³ Nonetheless, the attitudes of the general public support and recognize the need for medical research.^3,4

Patients report that they consent to participate in trials because they believe that refusal represents a serious threat to their health, perceive their physicians as strongly wanting them to participate, rely heavily on and trust their physicians’ treatment recommendations, and believe that a clinical trial offers the best care.⁵ Patient refusals have been reported to be associated with discomfort with or not understanding randomization, fear of being a "guinea pig," insurance difficulties, or concerns about cost and convenience.^3,4,6

Slow and limited trial accrual is not just a patient problem, however, but encompasses physician and health care system barriers as well. Although nurses frequently take care of the formal consent process (such as the signing of the consent form), the physician remains the key player in presenting the option of a clinical trial. Moreover, patients look to physicians to guide their decision making. Most practicing oncologists are familiar with the question, "What would you do if this was your wife/husband?" How the trial is presented, the time the physician spends discussing the trial, and whether the physician implicitly or explicitly endorses the trial have a strong influence on cancer patients’ decision making.^7-9 In one study, my colleagues and I, for example, found that surgeon endorsement of clinical trial participation influenced breast cancer patients’ decisions about participating in phase III trials offered by a medical oncologist.¹⁰

Moreover, physicians often do not like the available trial options or are convinced by preliminary reports that the experimental arm of an ongoing trial is best, leading to the practice of offering the experimental arm to patients off-label even before the final patient has been accrued and the data analyzed. Finally, physicians frequently fail to even mention trial participation to their cancer patients, as was reported in this and other studies.^11-13

The health care system also poses significant barriers. Ethically and informationally, adequate discussions of clinical trials take time. The current structure of the US health care system does not reward physicians for speaking with or counseling their patients. Time has become a precious commodity in our health care system. Importantly, many practices, including academic ones, do not have adequate infrastructures to support trials, and private practice physicians fear loss of patients and income.

The study by Albrecht et al¹⁴ in this issue of Journal of Clinical Oncology demonstrates the importance of communication to accomplish the goals of clinical oncology: to provide the best patient care available and to advance the field through clinical research for the benefit of future patients. Although the study is limited by its small sample size, the rigor of its methods and the confirmation and extension of other studies makes this an important contribution to our understanding of why patients are not accrued to trials in a timely way and how we might start to solve this problem. Although the study's primary focus was on patient decision making, the authors paradoxically demonstrated the primacy of the physician's role in clinical trial accrual. Of all patients approached with a trial, 75% consented but no more than 20% of patients who were eligible were offered a trial. By "offer," Albrecht et al used an interesting and clinically meaningful distinction. They define an offer as a discussion in which the trial was explicitly offered to the patient. In this sample, a trial was never mentioned to 43% of patients; in 30% of cases, it was raised but was either overtly discouraged or there was no follow-through in the discussion of a trial. The data indicate that the greatest source of lost opportunities for recruiting patients to trials is physician failure to take action.

The other important component of this study is the pivotal role that communication plays in the trial accrual process. Discussions in which patients and physicians created alliances by engaging patients, offering support, and conveying important message content about costs and adverse effects, enhance patient trust in physicians and result in greater patient participation in the offered clinical trial.

From both a scientific and an ethical viewpoint, it is extremely desirable that every patient who meets the criteria of a clinical trial has a chance to participate. Scientifically, widespread recruitment minimizes biases in a trial's sample. Although a tacit assumption of no bias resulting from subject refusal is usually made, selection bias has been demonstrated, compromising the generalizability of trial results to patient populations.^15-17 When trials are not completed in a timely fashion, treatment decisions must be based on incomplete data. Rapid diffusion of treatment information into the larger health care community is hampered. This study by Albrecht et al¹⁴ is a compelling argument for the need for more research and investment in our clinical trials infrastructure, including communication skills training. Future research in this area needs to be powered to examine sex and racial/ethnic variations (if any) in larger and more geographically dispersed samples.

We also recognize that medical schools and residency programs must make a commitment to real communication skills training for medical students and postgraduate trainees. It is critical that physicians be trained to communicate effectively and efficiently with patients and their families by mastering the skills of relational communication.¹⁸ Pinpointing the content and informational needs of patients for decision making should add efficiency and effectiveness to this process. Finally, well-designed decision aids may provide needed support for this important activity.¹⁹

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author(s) indicated no potential conflicts of interest.

REFERENCES

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8. Siminoff LA, Fetting JH, and Abeloff MD: Doctor-patient communication about breast cancer adjuvant therapy. J Clin Oncol 7:1192-1200, 1989[Abstract]

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14. Albrecht TL, Eggly SS, Gleason MEJ, et al: Influence of clinical communication on patients’ decision making on participation in clinical trials. J Clin Oncol 26:2666-2673, 2008[Abstract/Free Full Text]

15. Antman K, Amato D, Wood W, et al: Selection bias in clinical trials. J Clin Oncol 3:1142-1147, 1985[Abstract/Free Full Text]

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17. Robinson D, Woemer MG, Pollak S, et al: Subject selection biases in clinical trials: Data from a multicenter schizophrenia treatment study. J Clin Psychopharmacol 16:170-176, 1992[CrossRef]

18. Siminoff LA, Step MM: A communication model of shared decision making: Accounting for cancer treatment decisions. Health Psychol 24:S99-S105, 2005 (suppl)[CrossRef][Medline]

19. Barnato A, Llewellyn-Thomas H, Peters E, et al: Communication and decision making in cancer care: Setting research priorities for decision support/patients’ decision. Med Decis Making 27:626-634, 2007[Abstract/Free Full Text]

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This Article Full Text (PDF) Publisher's Note Erratum (v26,p4053) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Siminoff, L. A. Search for Related Content PubMed Articles by Siminoff, L. A. Social Bookmarking                            What's this?