Disclosures:The authors indicated no financial relationships. ABSTRACTPurpose. Although breast cancer is a highly treatable disease, some women reject conventional treatment opting for unproven "alternative therapy" that may contribute to poor health outcomes. This study sought to understand why some women make this decision and to identify messages that might lead to greater acceptance of evidencebased treatment.Patients and Methods. This study explored treatment decision making through in-depth interviews with 60 breast cancer patients identified by their treating oncologists. Thirty refused some or all conventional treatment, opting for alternative therapies, whereas 30 accepted both conventional and alternative treatments. All completed the Beck Anxiety Inventory and the Rotter Locus of Control scale.Results. Negative first experiences with "uncaring, insensitive, and unnecessarily harsh" oncologists, fear of side effects, and belief in the efficacy of alternative therapies were key factors in the decision to reject potentially lifeprolonging conventional therapy. Refusers differed from controls in their perceptions of the value of conventional treatment, believing that chemotherapy and radiotherapy were riskier (p < .0073) and less beneficial (p < .0001) than did controls. Controls perceived alternative medicine alone as riskier than did refusers because its value for treating cancer is unproven (p < .0001). Refusers believed they could heal themselves naturally from cancer with simple holistic methods like raw fruits, vegetables, and supplements.Conclusion. According to interviewees, a compassionate approach to cancer care plus physicians who acknowledge their fears, communicate hope, educate them about their options, and allow them time to come to terms with their diagnosis before starting treatment might have led them to better treatment choices. The Oncologist 2012;17:607-612

Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation.Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions.In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

Objective: Women with unilateral, early-stage breast cancer and low genetic risk are increasingly opting for contralateral prophylactic mastectomy (CPM), a concerning trend because CPM offers few clinical benefits while increasing risks of surgical complications. Few qualitative studies have analyzed factors motivating this irreversible decision. Using qualitative methods, this study sought to understand women's decision making and the impact of CPM on self-confidence, sense of femininity, sexual intimacy, and peace of mind.Methods: Women who had CPM within the last 10 years were recruited to participate in the study. We conducted a thematic analysis of the data.Results: Forty-five women were interviewed. When making the decision for CPM, most had incomplete knowledge of potential negative outcomes. However, all believed CPM had more benefits than harms and would confer the most peace of mind and the fewest regrets should cancer return. They knew their contralateral breast cancer risk was low but were not persuaded by statistics. They wanted to do everything possible to reduce their risk of another breast cancer, even by a minimal amount, but most reported paying an unexpectedly high price for this small reduction in risk. Nevertheless, 41 of 45 reported that they would make the same decision again.Conclusions: These findings highlight an opportunity for physicians to reframe the conversation to focus on the patient experience of the tradeoffs of CPM rather than statistical odds of future cancers. Our findings suggest that more data may not dissuade women from CPM but may better prepare them for its outcomes. KEYWORDS breast cancer, breast cancer surgery, cancer, contralateral prophylactic mastectomy, CPM, decision-making, oncology, psychosocial, quality of life, surgery

Objective:To identify the elements necessary for successful collaboration between patient groups and academic and industry sponsors of clinical trials, in order to develop recommendations for best practices for effective patient group engagement.Methods:In-depth interviews, informed by a previously reported survey, were conducted to identify the fundamentals of successful patient group engagement. Thirty-two respondents from 3 sectors participated: patient groups, academic researchers, and industry. The findings were presented to a multistakeholder group of experts in January 2015. The expert group came to consensus on a set of actionable recommendations for best practices for patient groups and research sponsors.Results:Interview respondents acknowledged that not all patient groups are created equal in terms of what they can contribute to a clinical trial. The most important elements for effective patient group engagement include establishing meaningful partnerships, demonstrating mutual benefits, and collaborating as partners from the planning stage forward. Although there is a growing appreciation by sponsors about the benefits of patient group engagement, there remains some resistance and some uncertainty about how best to engage. Barriers include mismatched expectations and a perception that patient groups lack scientific sophistication and that “wishful thinking” may cloud their recommendations.Conclusions:Patient groups are developing diverse skillsets and acquiring assets to leverage in order to become collaborators with industry and academia on clinical trials. Growing numbers of research sponsors across the clinical trials enterprise are recognizing the benefits of continuous and meaningful patient group engagement, but there are still mindsets to change, and stakeholders need further guidance on operationalizing a new model of clinical trial conduct.

Purpose: Adjuvant endocrine therapy (ET) can reduce the risk of recurrence among females with hormone receptor-positive breast cancer. Overall, initiation and adherence to ET are suboptimal, though reasons are not well described. The study's objective was to better understand ET decision making, prescribing, and patient management from oncology providers' perspectives. Methods: Using purposive sampling, we recruited oncology providers who saw five or more breast cancer patients per week (n=20). We conducted 30-45-minute telephone interviews, using a semistructured guide to elicit perspectives on ET use. We used thematic content analysis to systematically identify categories of meaning and double-coded transcripts using Atlas.ti. Results: Providers recommend ET to all eligible patients except those with contraindications or other risk factors. Providers base their ET prescribing decisions on the patient's menopausal status, side effects, and comorbidities. ET is typically discussed multiple times: at the onset of breast cancer treatment and in more detail after other treatment completion. Providers felt that the associated recurrence risk reduction is the most compelling argument for patients during ET decision making. While providers rarely perceived noninitiation as a problem, nonadherence was prevalent, often due to unresolvable side effects. Conclusion: From the clinicians' perspectives, side effects from ET are the dominant factor in nonadherence. Efforts to improve adherence should focus on strategies to minimize side effects and ensure clinicians and patients are well informed regarding optimal side effect management. This finding has important implications for novel endocrine regimens that offer improved outcomes through longer duration or more intensive therapy.

Background: Atrial fibrillation is associated with stroke, yet approximately 50% of patients are not treated with guideline-directed oral anticoagulants (OACs). Aims: Given that the etiology of this gap in care is not well understood, we explored decision-making by patients and physicians regarding OAC use for stroke prevention in atrial fibrillation. Methods and results: We conducted a descriptive qualitative study among providers (N=28) and their patients with atrial fibrillation for whom OACs were indicated (N=25). We used purposive sampling across three outpatient settings in which atrial fibrillation patients are commonly managed: primary care (n=14), geriatrics (n=10), and cardiology (n=4). Eligible patients were stratified by those prescribed OAC (n=13) and not prescribed OAC (n=12). Semi-structured, in-depth interviews assessed decision-making regarding risk and OAC use. Classical content analysis was used to code narratives and identify themes. Results among patients consisted of the overarching theme of trust in provider recommendations. Sub-themes included: awareness of increased risk of stroke with atrial fibrillation; willingness to accept medications recommended by their physician; and low demand for explanatory decision aids. Among physicians, the overarching theme was decisional conflict regarding the balance between stroke and bleeding risk, and the optimal medication to prescribe. Subthemes included: absence of decision aids for communication; and misperceptions around the assessment and management of stroke risk with atrial fibrillation. Conclusions: Patient involvement in decision-making around OAC use did not occur in this study of patients with atrial fibrillation. Improved access to decision aids may increase patient engagement in the decision-making process of OAC use for stroke prevention.

PurposeAdjuvant endocrine therapy (ET) can reduce the risk of recurrence among females with hormone receptor-positive breast cancer. Overall, initiation and adherence to ET are suboptimal, though reasons are not well described. The study’s objective was to better understand ET decision making, prescribing, and patient management from oncology providers’ perspectives.MethodsUsing purposive sampling, we recruited oncology providers who saw five or more breast cancer patients per week (n=20). We conducted 30–45-minute telephone interviews, using a semistructured guide to elicit perspectives on ET use. We used thematic content analysis to systematically identify categories of meaning and double-coded transcripts using Atlas.ti.ResultsProviders recommend ET to all eligible patients except those with contraindications or other risk factors. Providers base their ET prescribing decisions on the patient’s menopausal status, side effects, and comorbidities. ET is typically discussed multiple times: at the onset of breast cancer treatment and in more detail after other treatment completion. Providers felt that the associated recurrence risk reduction is the most compelling argument for patients during ET decision making. While providers rarely perceived noninitiation as a problem, nonadherence was prevalent, often due to unresolvable side effects.ConclusionFrom the clinicians’ perspectives, side effects from ET are the dominant factor in nonadherence. Efforts to improve adherence should focus on strategies to minimize side effects and ensure clinicians and patients are well informed regarding optimal side effect management. This finding has important implications for novel endocrine regimens that offer improved outcomes through longer duration or more intensive therapy.

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