Communication and consumer decision making about cancer clinical trials

Communication and consumer decision making about cancer clinical trials

Patient Education and Counseling 50 (2003) 39–42 Communication and consumer decision making about cancer clinical trials夽 Terrance L. Albrecht a,b,∗ ...

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Patient Education and Counseling 50 (2003) 39–42

Communication and consumer decision making about cancer clinical trials夽 Terrance L. Albrecht a,b,∗ , John C. Ruckdeschel a,c , Dawn L. Riddle a , Christina G. Blanchard a , Louis A. Penner a,d , Michael D. Coovert a,d , Gwendolyn Quinn a,b a Medical Interaction Research Group, Department of Interdisciplinary Oncology MDC-44, College of Medicine, H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida, MRC-CANCONT, 12902 Magnolia Drive, Tampa, FL 33612, USA b Department of Interdisciplinary Oncology, College of Medicine, University of South Florida, Tampa, FL, USA c Barbara Ann Karmanos Cancer Institute, Detroit, MI, USA d Department of Psychology, University of South Florida, Tampa, FL, USA

Abstract Communication between patients and physicians likely mediates traditional patient and physician predispositions in determining patient outcomes, including perceptions and decision making. However, the extent to which a mediating effect occurs is unclear. The purpose of this essay is to outline the need for conceptualizing more holistic models of consumer–provider interaction that demonstrate the role of the therapeutic relationship in treatment outcomes. We focus on an important communicative context for exploring this question: the situation where patients, with the help of oncologists, are faced with making treatment choices, particularly whether to enroll in a clinical trial in response to their life-threatening cancer diagnosis. We explore the question from the perspectives of the medical provider, the patient, and the accompanying family member, in order to better frame the complex interactional dynamics occurring during the interaction. © 2003 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Clinical trials; Mediating effects; Uncertainty

1. Introduction Some researchers have repeatedly argued that until scientific inquiry in psychosocial and behavioral oncology moves beyond the focus on individual differences to the study of interactions and processes in context, empirical gains will be modest at best [1]. Conversely, other researchers assert there has been an overemphasis on the study of physician–consumer/patient communication at the expense of investigating individual perceptions and larger system influences on health interactions, behavior, and outcomes. Overall, it is most likely the case that communication processes intersect with traditional patient and physician predispositions in determining outcomes such as patient perceptions and decision making, but how and to what extent? The purpose of this essay is to begin to answer this question by pursuing more focused consumer/provider translational communication research in oncology. In this brief article, we specifically outline the need for conceptualiz夽 Manuscript for Patient Education and Counseling on “Consumer/ Provider Communication Research: Implications for Cancer Prevention and Control.” ∗ Corresponding author. Tel.: +1-813-979-6722; fax: +1-813-979-6747. E-mail address: [email protected] (T.L. Albrecht).

ing more holistic models of consumer/provider interaction that demonstrate the role of the relationship in treatment outcomes. An important context for exploring this question is the situation where patients, with the help of oncologists, are faced with making treatment choices, particularly whether to accept experimental therapy (clinical trials) in response to a life-threatening cancer diagnosis. The circumstance for decisions regarding whether to use experimental therapies in cancer treatment is generally unlike that of primary care encounters; the cancer setting usually involves providers/oncologists and patients/families in more uncertain, time-pressured, and stressful conditions that implicate life and death. Physicians differ in the ways they explain clinical trials and treatment options to patients and their families and this difference is systematically related to the decisions that patients make about treatment options (i.e. whether to participate in a clinical trial [2]). For example, patients’ intentions to accrue to a clinical trial are significantly related to the type of information physicians give to them about the study (i.e. whether positive, ambiguous, or negative [3]). However, patients may still accrue even when given negative information, if the physician describes the benefits of the clinical trial, and directly responds to the patient’s concerns by

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Fig. 1. The mediating role of communication in cancer patients’ treatment decisions.

offering resources to address perceived costs/barriers of enrolling in the study [2]. 2. The mediating role of communication in decision making Though patients usually choose to enroll in therapeutic trials based on the recommendation of the physician, other factors also influence the patient’s decision, including age, the perception of physician trustworthiness [2], and the behaviors of the family members/significant others [4]. It is only by analyzing individual self-report data on patient, physician, and family/significant others together with interaction process data that we can fully delineate the precise role of provider–patient communication in the overall decision making process. Previous work [2] suggests that communication has a mediating role in influencing patient decision making. That is, communication provides the means through which predisposing factors of the patient and family member (sociodemographic and attitudinal variables), the characteristics of the physician (sociodemographic and attitudinal), and the features of the protocol (i.e. trial phase, differentiation of study arms, etc.) impact the patient’s decision making, comfort with the decision, and perceived therapeutic alliance with the physician (for a brief schematic, see Fig. 1). A federally funded study is now being conducted by the authors to fully evaluate this predictive model. The study is designed to test the extent to which all these components, as incorporated into a more elaborated structural equation model, independently and collectively explain patient perceptions of the physician and patient decisions regarding treatment.1 1 NCI/NIH #RO1 CA75003, Terrance Albrecht, Principal Investigator, 4/1/01–3/31/04. For more information about this study that is currently underway, please contact the first author.

2.1. Provider communication behavior For the provider, accruing patients to clinical trials is a communication task comprised of multiple and at times conflicting goals, including: providing the patient with the best care, enrolling patients in studies (clinical trials are the only means for determining the most efficacious cancer treatments and cures), yet also maintaining a neutral position on the patient’s decision for scientific and ethical reasons. Though often difficult, the physician is expected to follow the principle of “equipoise,” where the physician-scientist must actually be uncertain regarding which treatment is better; thus, he/she is truly unable to offer expert scientific advice to the patient on whether standard therapy or experimental therapy is preferable. In other words, even if the physician is the principal investigator of the study and enrolling patients in the trial is, therefore, clearly in his/her personal interest, the physician is still expected to maintain an equivocal position on the possible outcomes of the experimental versus standard treatments. Current empirical research on these interactions by the authors is providing descriptive data on the strategies that physicians use to accomplish these diverse interactional goals. The texts of written consent forms for patients to read and sign prior to accepting treatment are governed by legal strictures. In contrast, few specific guidelines exist directing what a provider should say to a patient and his/her family about choosing a clinical trial versus standard therapy as a cancer treatment option. Legal/informational messages, if they do not excessively tax the patient’s understanding, meet an ethical and legal mandate, convey necessary medical knowledge, enhance the physician’s medical credibility, and relate to individual treatment preferences [5–8]. At the same time, supportive messages also influence patients in different ways. Physicians who are supportive and responsive to patient concerns are likely to be the most effective in enrolling patients in studies [2]. Supportive, responsive

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strategies may include emphasizing patient-relevant benefits for participating in the study, and helping patients overcome perceived barriers to study participation (such as remedies for managing excessive side effects, transportation to and from treatment sessions and so on, thus helping patients to better manage uncertainty) [9]. Information about the study’s benefits and the physician’s responsiveness to the patient’s concerns (e.g. offering supportive resources and reassurance) provide tangible and emotional support to the patient. Personally focused supportive messages create a way for the patient to frame the medical information in terms of his/her own situation and needs [10,11]. Physicians who lack responsiveness and supportiveness are likely to exacerbate the patient’s misunderstanding regarding the treatment experience, and/or that of the family member (see [12]), leading a patient (and family member) to question the physician’s motives in recommending enrollment in a clinical trial. A physician who gives too much information too quickly is likely to overload a patient’s cognitive and emotional capacity. Not overloading the patient is crucial, particularly if the patient is distressed and having difficulty coping with the disease; such patients may indeed want less information [13]. They may become “reluctant collaborators” [14], wanting less direct information verbally, but more reassurance that the physician cares about helping him/her choose the best treatment option, regardless of what it is. In short, by being supportive, the physician is relating differently to his/her patients, according to their needs, so that “individual differences in patient preferences can be respected” [15], p. 651. 2.2. Patient and family member communication behavior The major focus of the discussion in this paper is on physician behavior given that the interaction involving cancer treatments is largely physician-dominated. The patient and family member are primarily in response-based roles where they react to the behavior of the physician [2]. Current research by the authors is investigating the extent to which patients perceive that their information and support needs are met after the encounter, and how their relationship with the family member, and the family member’s relationship with the physician, enhance or impede their own connection with the physician. 2.3. Provider–consumer communication as “alliance-building” The kind of relationship that can emerge between the oncologist and the cancer patient has been termed a “therapeutic alliance,” where together they face the uncertainty of the disease course, treatment, and aftermath [7,16,17]. Such a therapeutic relationship is characterized by the patient’s trust in the physician, a key factor linked to accrual [6,18], p. 114. Other elements of the alliance besides trust in the

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physician include cordiality, responsiveness, and a shared language code, or sense of shared meaning. 3. Summary Patient–family–physician relationships in oncology often develop in contexts where uncertainty regarding the disease and the nature of treatment, particularly experimental therapeutics, affects each member in different ways. Coping with that uncertainty is probably best achieved through provider communication behaviors that balance content and relational dimensions in ways that support patients and their families in making complex treatment decisions [19]. Such alliances form a structure capable of continued ability to manage uncertainty throughout the subsequent stages of the disease as the patient progresses through treatment and the aftermath. Current research is helping to answer the question of precisely how patient–family–physician interactions mediate the individual dispositions and situational constraints that affect patient outcomes. References [1] Ruckdeschel JC, Blanchard CG, Albrecht T. Psychosocial oncology research: where we have been, where we are going, and why we will not get there. Cancer 1994;74:1458–63. [2] Albrecht TL, Blanchard C, Ruckdeschel JC, Coovert M, Strongbow R. Strategic physician communication and oncology clinical trials. J Clin Oncol 1999;17:3324–32. [3] Blanchard CG, Forthofer M, Albrecht T, Ruckdeschel J, Strongbow R. The role of physician influence and companions on intention to enroll in a clinical trial. In: Proceedings of the Presentation at the Fourth International Congress of Psycho-Oncology. Hamburg, Germany; 1998. [4] Blanchard CG, Albrecht TL, Ruckdeschel JC. Patient-family communication with physicians. In: Baider L, Cooper CL, Kaplan De-Nour A, editors. Cancer and the family. London, England: Wiley; 2000. p. 477–95. [5] Blanchard CG, Labrecque M, Ruckdeschel JC, Blanchard EB. Information and decision-making preferences of hospitalized adult cancer patients. Soc Sci Med 1998;27:1139–45. [6] Richards MA, Ramirez AJ, Degner LF, Fallowfield LF, Maher EJ, Neuberger J. Offering choice of treatment to patients with cancers: a review based on a symposium held at the 10th Annual Conference of the British Psychosocial Oncology Group, December 1993. Eur J Cancer 1995;31:112–6. [7] Ruckdeschel JC, Albrecht TL, Blanchard C, Hemmick RM. Communication, accrual to clinical trials and the physician–patient relationship. J Cancer Educ 1996;11:73–9. [8] van der Donk J, Levendag PC, Kuijpers AF, Roest FH, Habbena JD, Meeuwis CA, et al. Patient participation in clinical decision making for treatment of T3 laryngeal cancer: a comparison of state and process utilities. J Clin Oncol 1995;13:2369–78. [9] Fetting JH, Siminoff LA, Piantadosi S, Abeloff MD, Damron DJ, Sarsfield AM. Effect of patients’ expectations of benefit with standard breast cancer adjuvant chemotherapy on participation in a randomized clinical trial: a clinical vignette study. J Clin Oncol 1990;8: 1476–82. [10] Albrecht TL, Goldsmith DJ. Social support, social networks, and health. In: Thompson TL, Dorsey A, Miller K, editors. Handbook of health communication. Hillsdale, NJ: Erlbaum, in press.

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[11] Newcomb PA, Carbone PP. Choosing reconstruction after mastectomy: a qualitative analysis. Oncol Nurs Forum 1993;25:97–104. [12] Mortensen CD. Miscommunication. Thousand Oaks, CA: Sage; 1997. [13] Risberg T, Bremnes RM, Widt E, Kaasa S, Jacobsen BK. Communicating with and treating cancer patients: how does the use of non-proven therapies and patients’ feeling of mental distress influence the interaction between the patient and the hospital staff. Eur J Cancer 1997;33:883–90. [14] Waterworth S, Luker KA. Reluctant collaborators: do patients want to be involved in decisions concerning care. J Adv Nurs 1990;15:971–6. [15] Gafni CC, Whelan T. Decision making in the physician patient encounter: revising the shared treatment decision making model. Soc Sci Med 1999;49:651–61.

[16] Gutheil TG, Bursztajn H, Brodsky A. Malpractice prevention through the sharing of uncertainty: informed consent and the therapeutic alliance. New Engl J Med 1984;311:49–51. [17] Suchman AL, Matthews DA. What makes the patient-doctor relationship therapeutic? Exploring the connexional dimension of medical care. Ann Intern Med 1998;108:125–30. [18] Penman DT, Holland JC, Bahna GF. Informed consent for investigational chemotherapy: patients’ and physicians’ perceptions. J Clin Oncol 1984;2:849–55. [19] Watzlawick P, Beavin J, Jackson D. Pragmatics of human communication. New York: Norton; 1967.