Methods/design: The Values and Options in Cancer Care (VOICE) Study is a National Cancer Institute sponsored randomized controlled trial conducted in the Rochester/Buffalo, NY and Sacramento, CA regions. A total of 40 oncologists, approximately 400 patients with advanced cancer, and their family/friend caregivers (one per patient, when available) are expected to enroll in the study.
Methods/design: The Values and Options in Cancer Care (VOICE) Study is a National Cancer Institute sponsored randomized controlled trial conducted in the Rochester/Buffalo, NY and Sacramento, CA regions. A total of 40 oncologists, approximately 400 patients with advanced cancer, and their family/friend caregivers (one per patient, when available) are expected to enroll in the study.
Drawing upon ecological theory, the intervention uses a two-pronged approach: oncologists complete a multifaceted tailored educational intervention involving standardized patient instructors (SPIs), and patients and caregivers complete a coaching intervention to facilitate prioritizing and discussing questions and concerns. Follow-up data will be collected approximately quarterly for up to three years.
Discussion: The intervention is hypothesized to enhance patient-centered communication, quality of care, and patient outcomes. Analyses will examine the effects of the intervention on key elements of physician-patient-caregiver communication (primary outcomes), the physician-patient relationship, shared understanding of prognosis, patient well-being, and health service utilization (secondary outcomes).
Trial registration: Clinical Trials Identifier: NCT01485627
Keywords: Patient-centered care, Decision making, End-of-life care, Communication, Caregivers, Cancer, Palliative care, Quality of life, Utilization, Physician-patient relations
* Correspondence: michael_hoerger@urmc.rochester.edu 1Rochester Healthcare Decision-Making Group, University of Rochester Medical Center, Rochester, New York, USA 2Department of Psychiatry, University of Rochester Medical Center, Rochester, New York, USA Full list of author information is available at the end of the article
© 2013 Hoerger et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Hoerger et al. BMC Cancer 2013, 13:188 http://www.biomedcentral.com/1471-2407/13/188
http://clinicaltrials.gov/ct2/show/NCT01485627
mailto:michael_hoerger@urmc.rochester.edu
http://creativecommons.org/licenses/by/2.0
Background Crafting care that is concordant with the patient’s wishes in the context of serious illness requires clear, patient- centered communication [1]. Most patients with advanced cancer (>80%) want frank yet sensitive discussions with their physicians about prognosis and treatment choices, and want to be involved and informed about decisions regarding their care, regardless of whether they wish to assume responsibility for making major health care decisions [2]. Yet, few actually have these discussions [3]. Consequently, patients often overestimate prognoses, underestimate disease severity, and have unrealistic expec- tations for cure [2-5]. Having frank, sensitive discussions is associated with more realistic prognostic estimates and decisions that are better aligned with patients’ wishes [3,5-8]. When these discussions occur before patients are critically ill, patients report greater well-being and have fewer unwanted aggressive interventions in the last weeks of life, with no detrimental effect on survival [3,5,9]. The VOICE (Values and Options In Cancer Care) Study
is a randomized controlled trial of a patient-centered communication intervention for oncologists, patients with advanced cancer, and their caregivers. Initial study findings are expected to be published in 2013, with follow-up complete in 2015. This article describes the empirical and theoretical rationale for the study, the tailored education and coaching communication intervention, the study mea- sures and administration procedures, the planned analytic approach, and potential implications of this research.
Patient-centered communication VOICE targets important gaps in cancer communication research. Since the SUPPORT study [10], in which an ICU-based nurse intervention failed to influence care for critically ill patients with dire prognoses, there has been insufficient progress in improving clinical communication in the context of serious illness. The 2007 NCI monograph, Patient-centered Communication and Cancer Care [1], the Institute of Medicine [11], the American Society for Clinical Oncology, and the National Priorities Partnership all call for improvements in communication with patients who have serious and life-limiting illnesses, citing the effects of good communication on quality of care and quality of life. Poor communication is common in advanced cancer,
leading to healthcare decisions that are inadequately informed by patients’ preferences. Physicians often misjudge patients’ treatment preferences, desire for information, needs, and level of understanding [2,12]. Despite evidence that individuals with advanced cancer and their caregivers benefit from being informed about prognosis and treatment choices [1,2,13], physicians often intentionally overestimate survival [14] and avoid discussing prognosis until the patient has symptoms or there are no other treatments to offer, leading to inflated patient expectations about survival
and the benefits of cytotoxic treatment [4,15]. Patients who have not discussed prognosis and treatment choices with their physicians are 3 to 8 times more likely to receive aggressive treatments in the last week of life [3,5], reducing physical and emotional quality of life and perhaps longevity [9]. Additionally, patients often alter their treatment choices when adequately informed [16]. Furthermore, although physicians and patients find prognostic discussions stressful, concealing the truth can be more harmful [17]. Indeed, evidence suggests that these discussions neither appear to cause harm nor diminish hope [18,19]. Communication about prognosis and treatment choices
is essential for informed decision making in advanced cancer. Our intervention is designed to promote patient- centeredness [20], which is defined by the Institute of Medicine [21] as “care that is respectful of and responsive to individual patient preferences, needs, and values.” The intervention targets four key communication skills: Engaging patients and their caregivers to participate in consultations and decisions regarding the patient’s care, Responding to patients’ concerns, Informing patients about treatment choices, and Framing prognosis using balanced information about best and worst case scenarios. In other settings, these skills have been associated with improvements in psychological well-being, quality of life, symptoms, adherence to treatment, patient satisfaction, and caregiver bereavement, as well as reductions in racial and ethnic disparities [1,12,22-24]. If our hypotheses are supported, patients and their caregivers will be better informed, less psychologically distressed, and better able to participate in discussions about prognosis and treatment choices. As a result, they will be more likely to make decisions that lead to improved quality of life, a greater sense of peace, and better quality of death.
Ecological framework VOICE was designed to test an in
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