A Review of Shared Decision-Making and Patient Decision Aids in Radiation Oncology

Cancer treatment decisions are complex and may be challenging for patients, as multiple treatment options can often be reasonably considered. As a result, decisional support tools have been developed to assist patients in the decision-making process. A commonly used intervention to facilitate shared decision-making is a decision aid, which provides evidence-based outcomes information and guides patients towards choosing the treatment option that best aligns with their preferences and values. To ensure high quality, systematic frameworks and standards have been proposed for the development of an optimal aid for decision making. Studies have examined the impact of these tools on facilitating treatment decisions and improving decision-related outcomes. In radiation oncology, randomized controlled trials have demonstrated that decision aids have the potential to improve patient outcomes, including increased knowledge about treatment options and decreased decisional conflict with decision-making. This article provides an overview of the shared-decision making process and summarizes the development, validation, and implementation of decision aids as patient educational tools in radiation oncology. Finally, this article reviews the findings from decision aid studies in radiation oncology and offers various strategies to effectively implement shared decision-making into clinical practice.     

Decision making in oncology: a review of patient decision aids to support patient participation

Although cancer management is becoming more structured with disease- specific guidelines and clinical pathways, many decisions remain complex. Contributing to this complexity is the need to make value tradeoffs between benefits and harms across cancer treatment and/or screening options. Since there is no "best" option for everyone, decisions are defined as being of higher quality when informed with the latest scientific evidence and based on patients' informed values associated with outcomes of options. However, clinicians are not good judges of patients' values, and patients often have inadequate knowledge, unrealistic expectations, and decisional conflict that interfere with their involvement in decision making. Effective approaches to support patient involvement into clinical decisions include clinicians trained in shared decision making, question prompt sheets, patient decision aids, and decision coaching by nurses and other allied health professionals. Based on systematic review of 23 randomized trials of cancer patient decision aids, patients exposed to decision aids are more likely to participate in decision making and achieve higher-quality decisions. This review highlights key historical changes leading to patient involvement in decision making, summarizes evidence on effective interventions to support shared decision making, explores strategies to implement these interventions in oncology practices, and identifies future directions.     

Decision aids for breast and nodal surgery in patients with early breast cancer: development and a pilot study

Aim: As survival rates for aggressive and conservative breast and lymph node surgery are similar, surgical treatment decisions for patients with early‐stage breast cancer should take patient preference into account. Decision aids have been demonstrated to increase patient knowledge and satisfaction with decision making, while decreasing decisional conflict. Hundreds of decision aids exist; however, few address lymph node surgery in any detail, and none acknowledge that there is a choice comparable to that between mastectomy and breast‐conserving therapy. Methods: A systematic process was employed to develop decision aids for mastectomy versus breast‐conserving therapy, axillary dissection versus sentinel node biopsy, and options following a positive sentinel node biopsy. The first two of these decision aids were evaluated in a small pilot study. Choice of operation, knowledge and decisional conflict and satisfaction were compared with outcomes in an historical control group. Results: Women reported favorably on the decision aids. The numbers in the pilot group were too small to allow definitive conclusions to be drawn, but suggested a possible reduction in decisional conflict, and possibly increase in decisional satisfaction, knowledge and choice of axillary clearance (rather than sentinel node biopsy) in the intervention group. Conclusion: These decision aids could improve decision making for the surgical treatment of early breast cancer. A prospective randomized, control trial is needed to further evaluate the impact of these decision aids, particularly in the case of nodal surgery.     

Patient decision aids for cancer treatment

BACKGROUND:

Although patient decision aids (pDAs) are effective, widespread use of pDAs for cancer treatment has not been achieved. The objectives of this study were to perform a systematic review to identify alternate types of decision support interventions (DSIs) for cancer treatment and a meta‐analysis to compare the effectiveness of these DSIs to pDAs.

METHODS:

The inclusion criteria for the study were: 1) all published studies using a randomized, controlled trial design, and 2) DSIs involving treatment decision‐making for breast, prostate, colorectal, and/or lung cancer. For this analysis, DSIs were classified as pDAs if: 1) one reported outcome measure mapped onto the International Patient Decision Aids Standards Collaboration effectiveness criterion, and 2) the DSI was evaluated relative to standard consultation. Random effects models were used to compare the effectiveness of pDAs relative to other identified DSIs for reported outcomes.

RESULTS:

A total of 71 studies were reviewed, and 24 met the inclusion criteria. Overall, there were no significant differences in knowledge, satisfaction, anxiety, or decisional conflict scores between pDAs and other DSIs.

CONCLUSIONS:

This study showed that the effectiveness of other DSIs, including question prompt lists and audiorecording of the consultation, is similar to pDAs. This is important because it may be that these less complex DSIs may be all that is necessary to achieve similar outcomes as pDAs for cancer treatment. Cancer 2013. © 2012 American Cancer Society.     

What is lacking in current decision aids on cancer screening?

Recent guidelines on cancer screening have provided not only more screening options but also conflicting recommendations. Thus, patients, with their clinicians' support, must decide whether to get screened, which modality to use, and how often to undergo screening. Decision aids could potentially lead to better shared decision‐making regarding screening between the patient and the clinician. A total of 73 decision aids concerning screening for breast, cervical, colorectal, and prostate cancers were reviewed. The goal of this review was to assess the effectiveness of such decision aids, examine areas in need of more research, and determine how the decision aids can be currently applied in the real‐world setting. Most studies used sound study designs. Significant variation existed in the setting, theoretical framework, and measured outcomes. Just over one‐third of the decision aids included an explicit values clarification. Other than knowledge, little consistency was noted with regard to which patient attributes were measured as outcomes. Few studies actually measured shared decision‐making. Little information was available regarding the feasibility and outcomes of integrating decision aids into practice. In this review, the implications for future research, as well as what clinicians can do now to incorporate decision aids into their practice, are discussed. CA Cancer J Clin 2013. © 2013 American Cancer Society.     

Who makes the decision regarding the treatment of clinically localized prostate cancer–the patient or physician?

BACKGROUND:

The current study examined how patients' sociodemographic, cancer‐related, and subjective affective factors impacted their role in treatment decision‐making.

METHODS:

The patient sample (N = 788) was taken from a prospective follow‐up study of a population‐based cohort. Participants included 343 African American and 445 Caucasian‐American patients with clinically localized prostate cancer. Multinomial logistic regression was used to investigate relations between the explanatory variables and the nominal 3‐level decision‐making variable: patient‐only, patient‐physician shared, and physician‐only.

RESULTS:

Approximately 41% of patients reported patient‐only decision‐making, 45% reported shared decision‐making, and 13% reported physician‐only decision‐making. The odds of patient‐only over physician‐only decision‐making were greater for younger men (vs those aged ≥ 65 years) (odds ratio [OR], 1.68; 95% confidence interval [95% CI], 1.03‐2.74), and were less for men with high (vs low) cancer aggressiveness (OR,0.29; 95% CI, 0.15‐0.55). The odds of shared over physician‐only decision‐making were less for men with high (vs low) cancer aggressiveness (OR, 0.40; 95% CI, 0.22‐0.73). Greater odds of patient‐only and shared decision‐making also were found to be associated with greater concerns about the physical impact of treatment and having enough time for decision‐making and lower scores of receiving advice from others.

CONCLUSIONS:

The findings of the current study indicate that, to facilitate a more patient‐oriented decision‐making process regarding treatment in those with clinically localized prostate cancer, clinicians need to tailor their interventions according to patient age and cancer aggressiveness, help reduce patient concerns and misconceptions regarding the physical impact of treatments, allow sufficient time for patients to consider treatment options, and assist patients in balancing advice and information received from different sources. Cancer 2013. © 2012 American Cancer Society.     

Anxiety and distress during active surveillance for early prostate cancer

BACKGROUND:

Patients on active surveillance (AS) for early prostate cancer (PC) may experience feelings of anxiety and distress while living with “untreated” cancer. In this study, these feelings were quantified, and their associations with various psychologic, medical, demographic, and decision‐related factors were assessed.

METHODS:

Men with recently diagnosed PC who participated in a prospective protocol‐based AS program (the Prostate Cancer Research International: Active Surveillance study [PRAIS]) received a questionnaire (N = 150). Scores concerning decisional conflict (the Decisional Conflict Scale), depression (the Center for Epidemiologic Studies Depression Scale), generic anxiety (the abridged State‐Trait Anxiety Inventory), and PC‐specific anxiety (the Memorial Anxiety Scale for Prostate Cancer) were compared with reference values and the literature. Associations with scores on physical health (the Medical Outcomes Study 12‐item short‐form Physical Component Summary), personality (the Eysenck Personality Questionnaire), shared decision‐making, knowledge of PC, and demographic and medical parameters were determined with univariate and multivariate linear regression analyses.

RESULTS:

The questionnaire response rate was 86% (129 of 150 men). Of all respondents, 81%, 92%, 83%, and 93% scored better than reference values for clinically significant uncertainty regarding the treatment decision, depression, generic anxiety, and PC‐specific anxiety, respectively. Scores were comparable to or more favorable than those of men (reported in literature) who underwent other treatments for localized PC. In multivariate analysis, the following associations emerged: a perceived important role of the physician in shared decision‐making was associated with higher decisional conflict, better physical health was associated with lower depression, neurotic personality was associated with higher depression and with generic and PC‐specific anxiety, and higher prostate‐specific antigen level was associated with higher PC‐specific anxiety.

CONCLUSIONS:

Men on protocol‐based AS mainly reported favorable levels of anxiety and distress. A neurotic personality score was associated with unfavorable effects. These findings may help to optimize patient selection for AS or to select men for supportive measures. Cancer 2009. © 2009 American Cancer Society.     

Patient Decision Aids for Prostate Cancer Treatment: A Systematic Review of the Literature

Treatment decision‐making can be difficult and complex for patients with low‐risk prostate cancer. To the authors' knowledge, there is no consensus regarding an optimal treatment strategy and the choice of therapy involves tradeoffs between differing harms and benefits that are sensitive to patient values. In such situations, patients are often asked to participate actively in the decision‐making process, and high‐quality decisions require a well‐informed patient whose values and preferences have been taken into consideration. Prior studies have indicated that patients have poor knowledge and unrealistic expectations regarding treatment, and physician judgments concerning patient preferences are often inaccurate. Decision aids (DAs) have been developed to help inform patients with low‐risk prostate cancer about treatment options and assist in the decision‐making process; however, little is currently known regarding the effects of such programs in this population. Thirteen studies of DAs for patients with prostate cancer were reviewed and it was found that the use of DAs can improve knowledge, encourage more active patient involvement in decision‐making, and decrease levels of anxiety and distress. The effect of DAs on treatment choice was less clear, although fewer patients chose surgery compared with historical controls, particularly in Europe. Further studies are needed to determine how best to implement DAs into practice, and whether they improve the consistency between patient preferences and treatment choice. CA Cancer J Clin 2009. © 2009 American Cancer Society, Inc.     

Interventions to improve patient participation in the treatment process for culturally and linguistically diverse people with cancer: A systematic review

Disparities in cancer outcomes for people from culturally and linguistically diverse (CALD) groups are well known. Improving CALD patients' active participation in treatment processes holds potential to improve outcomes, but little is known of effective strategies to facilitate this. This systematic review investigated interventions to improve three aspects of participation in cancer care among CALD groups, namely involvement in decision‐making, communication with health providers and treatment adherence. A comprehensive search of electronic bibliographic databases was conducted to identify intervention studies that reported outcomes relevant to patient participation for CALD groups. Two reviewers independently critically appraised the studies and abstracted data. Of 10 278 potential articles, seven met the inclusion criteria, including three randomized controlled, three non‐randomized and one mixed‐method experimental studies. Interventions included the use of patient navigators, videos and decision aids. The impact on patient participation was varied. The effect of a decision aid and patient navigator interventions on communication with health providers was positive. While the use of a decisions aid successfully facilitated shared decision‐making and patients' perception of treatment adherence, the use of patient navigators was ineffective. A computer support system was found to improve general patient participation; however little clarification of what this involved was provided. This systematic review identified few rigorous evaluations of interventions to improve treatment participation for CALD people with cancer, highlighting the lack of a robust evidence base to improve this crucial aspect of care. The development and evaluation of interventions for diverse populations remains a priority.     

American Cancer Society Guideline for the Early Detection of Prostate Cancer: Update 2010

In 2009, the American Cancer Society (ACS) Prostate Cancer Advisory Committee began the process of a complete update of recommendations for early prostate cancer detection. A series of systematic evidence reviews was conducted focusing on evidence related to the early detection of prostate cancer, test performance, harms of therapy for localized prostate cancer, and shared and informed decision making in prostate cancer screening. The results of the systematic reviews were evaluated by the ACS Prostate Cancer Advisory Committee, and deliberations about the evidence occurred at committee meetings and during conference calls. On the basis of the evidence and a consensus process, the Prostate Cancer Advisory Committee developed the guideline, and a writing committee drafted a guideline document that was circulated to the entire committee for review and revision. The document was then circulated to peer reviewers for feedback, and finally to the ACS Mission Outcomes Committee and the ACS Board of Directors for approval. The ACS recommends that asymptomatic men who have at least a 10‐year life expectancy have an opportunity to make an informed decision with their health care provider about screening for prostate cancer after they receive information about the uncertainties, risks, and potential benefits associated with prostate cancer screening. Prostate cancer screening should not occur without an informed decision‐making process. Men at average risk should receive this information beginning at age 50 years. Men in higher risk groups should receive this information before age 50 years. Men should either receive this information directly from their health care providers or be referred to reliable and culturally appropriate sources. Patient decision aids are helpful in preparing men to make a decision whether to be tested. CA Cancer J Clin 2010;60:70–98. © 2010 American Cancer Society, Inc.     

Measuring decisional control preferences in men newly diagnosed with prostate cancer

The Control Preferences Scale is widely used in decision research to measure patient preferences for participation in treatment decision making with health care providers. Following anecdotal reports of confusion with the scale the authors conducted an exploratory interview study to examine perceptions of the meaning and applicability of the Control Preferences Scale for men with localized prostate cancer seeking treatment in a multidisciplinary urology clinic. The preliminary data suggest potential validity challenges when the Control Preferences Scale is used in a multidisciplinary prostate cancer care setting, including the clinical context of localized prostate cancer and the meaning of shared decision making.     

Measuring Decisional Control Preferences in Men Newly Diagnosed with Prostate Cancer

The Control Preferences Scale is widely used in decision research to measure patient preferences for participation in treatment decision making with health care providers. Following anecdotal reports of confusion with the scale the authors conducted an exploratory interview study to examine perceptions of the meaning and applicability of the Control Preferences Scale for men with localized prostate cancer seeking treatment in a multidisciplinary urology clinic. The preliminary data suggest potential validity challenges when the Control Preferences Scale is used in a multidisciplinary prostate cancer care setting, including the clinical context of localized prostate cancer and the meaning of shared decision making.     

The association of treatment-related symptoms with quality-of-life outcomes for localized prostate carcinoma patients

BACKGROUND: Most studies of treatment outcomes in men with localized prostate carcinoma have emphasized sexual, urinary, and bowel symptoms with the assumption that they have an impact on quality of life. However, very few studies have directly examined and compared the impact of these symptoms on overall and cancer specific quality of life. METHODS: The authors examined 783 incident cases of localized prostate carcinoma, diagnosed from 1993 to 1998, and 1928 age-matched healthy controls from the Health Professionals Follow-Up Study cohort. Information on frequency of ejaculation and urinary symptoms were collected before cancer diagnosis. After cancer diagnosis, the authors mailed a questionnaire including the Medical Outcomes Study Short Form-36 Health Status Survey (SF-36), the Cancer Rehabilitation Evaluation System-Short Form (CARES-SF), and the University of California at Los Angeles Prostate Cancer Index in 1998. RESULTS: Cases had slightly lower scores on most of the SF-36 scales and reported much more bother from sexual, urinary, and bowel symptoms compared with healthy controls. Among prostate carcinoma patients, bowel symptoms had the greatest negative impact on quality of life, followed by sexual and urinary symptoms. As expected, treatment-related symptoms were associated with the physical domains of quality of life, but psychosocial domains were just as strongly affected. CONCLUSIONS: Patients and health care providers need to consider the potential mental quality-of-life impacts associated with prostate carcinoma treatment symptoms when making treatment decisions. Even after patients have completed cancer treatment, significant health impairments may remain. Health care providers should continue to address the mental and physical well-being of prostate carcinoma patients in follow-up care.     

Treatment decision-making strategies and influences in patients with localized prostate carcinoma

BACKGROUND: Patients diagnosed with localized prostate carcinoma need to interpret complicated medical information to make an informed treatment selection from among treatments that have comparable efficacy but differing side effects. The authors reported initial results for treatment decision-making strategies among men receiving definitive treatment for localized prostate carcinoma. METHODS: One hundred nineteen men treated with radical prostatectomy (44%) or brachytherapy (56%) consented to participate. Guided by a cognitive-affective theoretic framework, the authors assessed differences in decision-making strategies, and treatment and disease-relevant beliefs and affects, in addition to demographic and clinical variables. RESULTS: Approximately half of patients reported difficulty (49%) and distress (45%) while making treatment decisions, but no regrets (74%) regarding the treatment choice they made. Patients who underwent prostatectomy were younger, were more likely to be employed, had worse tumor grade, and had a shorter time since diagnosis (P < 0.01) compared with patients who did not undergo prostatectomy. In multivariate analyses, compared with patients who received radical prostatectomy, patients who received brachytherapy were more likely to say that they chose this treatment because it was "the least invasive" and they "wanted to avoid surgery" (P < 0.0001). CONCLUSIONS: In general, patients who received brachytherapy chose this treatment because of quality of life considerations, whereas "cure" and complete removal of the tumor were the main motivations for patients selecting radical prostatectomy. Long-term data are needed to evaluate distress and decisional regret as patients experience treatment-related chronic side effects and efficacy outcomes. Decision-making aids or other interventions to reduce decisional difficulty and emotional distress during decision making were indicated.     

Decision aids for patients considering options affecting cancer outcomes: evidence of efficacy and policy implications

Some cancer screening and treatment decisions are not clear cut because outcomes are uncertain or options have different benefit/risk profiles. "Decision aids" have been developed as adjuncts to counseling so that patients can learn about benefits and risks, can consider their personal values, and can participate with their practitioner in decision making. The purpose of this paper is to review published evidence about the efficacy of decision aids focused on cancer outcomes and to outline research and dissemination issues. Studies evaluating cancer-related decision aids demonstrate that they are acceptable to patients and help those who are uncertain at baseline to make choices. They also increase the likelihood that choices are based on better knowledge, realistic expectations of outcomes, and personal values. Decision aids reduce some dimensions of decisional conflict, and their effect on decisions is variable. Few studies examine the downstream effects of decision aids on long-term persistence with choices, regret, and quality of life. The differences between simpler and more intensive methods of decision support appear to be negligible in terms of knowledge and satisfaction as well as variable in terms of decisions and decisional conflict. However, more intensive methods are superior in terms of user acceptability and of the extent to which choices are based on realistic expectations and personal values. The clinical importance of these differences and the cost-effectiveness remain to be established. On the basis of this review, several recommendations for research are made, and dissemination issues are identified.     

Implementing and evaluating shared decision making in oncology practice

Answer questions and earn CME/CNE Engaging individuals with cancer in decision making about their treatments has received increased attention; shared decision making (SDM) has become a hallmark of patient‐centered care. Although physicians indicate substantial interest in SDM, implementing SDM in cancer care is often complex; high levels of uncertainty may exist, and health care providers must help patients understand the potential risks versus benefits of different treatment options. However, patients who are more engaged in their health care decision making are more likely to experience confidence in and satisfaction with treatment decisions and increased trust in their providers. To implement SDM in oncology practice, physicians and other health care providers need to understand the components of SDM and the approaches to supporting and facilitating this process as part of cancer care. This review summarizes recent information regarding patient and physician factors that influence SDM for cancer care, outcomes resulting from successful SDM, and strategies for implementing SDM in oncology practice. We present a conceptual model illustrating the components of SDM in cancer care and provide recommendations for facilitating SDM in oncology practice. CA Cancer J Clin 2014;64:377–388. © 2014 American Cancer Society .     

Predictors of distress and quality of life in patients undergoing cancer therapy: impact of treatment type and decisional role

Purpose: The purpose of this secondary investigation was to examine the impact of the type of treatment received and the perceived role in treatment decision making in predicting distress and cancer‐specific quality of life in patients newly diagnosed with breast or prostate cancer. Method: Participants included 1057 newly diagnosed breast and prostate cancer patients from four Canadian cancer centers who partook in a randomized controlled trial examining the utility of providing patients with an audio‐recording of their treatment planning consultation. A MANCOVA was performed to predict distress and cancer‐specific quality of life at 12 weeks post‐consultation based on control variables (patient age, education, residence, tumor size (breast sample), gleason score (prostate sample), and receipt of an initial treatment consultation recording), predictor variables (treatment type—chemotherapy, hormone therapy, radiation therapy; decisional role—active, collaborative, passive), and interactions between these predictors. Results: Women who received chemotherapy and reported having played a more passive role in treatment decision making had significantly greater distress and lower cancer‐specific quality of life at 12‐week post‐consultation. There were no statistically significant predictors of these outcomes identified for men with prostate cancer. Conclusion: Receipt of chemotherapy places women with breast cancer at risk for distress and reduced quality of life, but only for the subset of women who report playing a passive role in treatment decision making. Prospective, longitudinal studies are needed to confirm the present findings and to explicate the antecedents, composition, and consequences of the ‘passive’ decisional role during the treatment phase of the cancer trajectory. Copyright © 2009 John Wiley & Sons, Ltd.     

Educating African American men about the prostate cancer screening dilemma: a randomized intervention.

BACKGROUND: Until there is a definitive demonstration that early diagnosis and treatment of prostate cancer reduces disease-related mortality, it is imperative to promote informed screening decisions by providing balanced information about the potential benefits and risks of prostate cancer screening. Within a community/academic collaboration, we conducted a randomized trial of a printed booklet and a videotape that were designed for African American (AA) men. The purpose of the trial was to determine the effect of the interventions on knowledge, decisional conflict, satisfaction with the screening decision, and self-reported screening. METHODS: Participants were 238 AA men, ages 40 to 70 years, who were members of the Prince Hall Masons in Washington, DC. Men were randomly assigned to the (a) video-based information study arm, (b) print-based information study arm, or (c) wait list control study arm. Intervention materials were mailed to men at home. Assessments were conducted at baseline, 1 month, and 12 months postintervention. Multivariate analyses, including ANCOVA and logistic regression, were used to analyze group differences. RESULTS: The booklet and video resulted in a significant improvement in knowledge and a reduction in decisional conflict about prostate cancer screening, relative to the wait list control. Satisfaction with the screening decision was not affected by the interventions. Self-reported screening rates increased between the baseline and the 1-year assessment, although screening was not differentially associated with either of the interventions. In exploratory analyses, prostate-specific antigen testing at 1 year was more likely among previously screened men and was associated with having low baseline decisional conflict. CONCLUSIONS: This study represents one of the first randomized intervention trials specifically designed to address AA men's informed decision making about prostate cancer screening. We have developed and evaluated culturally sensitive, balanced, and disseminable materials that improved knowledge and reduced decisional conflict about prostate cancer screening among AA men. Due to the high incidence and mortality rates among AA men, there is a need for targeted educational materials, particularly materials that are balanced in terms of the benefits and risks of screening.     

A decision aid to assist in adjuvant therapy choices for breast cancer

BACKGROUND: Decision aids are tools that help patients make specific and deliberative choices among options. This study was a group randomized controlled trial of a novel decision aid to help patients with breast cancer make adjuvant therapy (AT) decisions. METHODS: Fourteen oncology practices (n=58 physicians) were randomized to receive the decision aid or a control pamphlet. Complete data were obtained from 405 patient-oncologist pairs. Eligible patients had stage I-III disease and had completed their primary treatment. The decision aid is a simple to use computer program, titled Adjuvant!, that provides estimates of outcome with and without AT. Graphical representations of outcome are shared with patients. Consultations were audiotaped, patients interviewed, and physicians completed a self-administered survey. RESULTS: In a multivariable model, the 54 patients (13.3%) who took no AT were more likely to have received the decision aid (p=0.02). A differential effect of the Adjuvant! Decision Guide was noted between node negative and positive patients. It was stated by 86.2% of patients that the decision aid was influential when making their treatment decision. Over 95% of patients reported that the Adjuvant Decision Guide was easy to understand and 75% of physicians believed that it helped them understand their patient's treatment preferences and 81.4% reported the information as useful for themselves. CONCLUSIONS: This study showed that a decision aid made a difference in the choice of whether or not to take AT. The decision aid allowed patients and physicians to consider the benefits of AT in an easy to understand format. Treatment decisions were more individualized for patients in the intervention than in the control group. The use of the decision aid was acceptable to both patients and physicians.