Patient-reported outcomes in cancer care - hearing the patient voice at greater volume.

Recording of patient-reported outcomes (PROs) enables direct measurement of the experiences of patients with cancer. In the past decade, the use of PROs has become a prominent topic in health-care innovation; this trend highlights the role of the patient experience as a key measure of health-care quality. Historically, PROs were used solely in the context of research studies, but a growing body of literature supports the feasibility of electronic collection of PROs, yielding reliable data that are sometimes of better quality than clinician-reported data. The incorporation of electronic PRO (ePRO) assessments into standard health-care settings seems to improve the quality of care delivered to patients with cancer. Such efforts, however, have not been widely adopted, owing to the difficulties of integrating PRO-data collection into clinical workflows and electronic medical-record systems. The collection of ePRO data is expected to enhance the quality of care received by patients with cancer; however, for this approach to become routine practice, uniquely trained people, and appropriate policies and analytical solutions need to be implemented. In this Review, we discuss considerations regarding measurements of PROs, implementation challenges, as well as evidence of outcome improvements associated with the use of PROs, focusing on the centrality of PROs as part of 'big-data' initiatives in learning health-care systems.

Clinical Trial Participants With Metastatic Renal Cell Carcinoma Differ From Patients Treated in Real-World Practice.

PURPOSE: Although narrow eligibility criteria improve the internal validity of clinical trials, they may result in differences between study populations and real-world patients, threatening generalizability. Therefore, we evaluated whether patients treated for metastatic renal cell cancer (mRCC) in routine clinical practice are similar to those enrolled onto clinical trials. PATIENTS AND METHODS: In this cohort study, we compared baseline characteristics of patients with mRCC in phase III clinical trials of new targeted therapies and those in a retrospective registry composed of academic (Duke) and community (ACORN Network) practices. RESULTS: A total of 438 registry patients received sunitinib, sorafenib, temsirolimus, or pazopanib (most commonly used agents) in first-line treatment. Registry patients receiving tyrosine kinase inhibitors (sunitinib, sorafenib, or pazopanib) were more likely to have poor-risk disease by Memorial Sloan Kettering Cancer Center criteria (poor, 7.4% v 2.9%; P < .001; favorable, 30.1% v 43.8%; P < .001) and to have impaired performance status (Eastern Cooperative Oncology Group > 1, 11.1% v 0.6%; P < .001). However, registry patients receiving temsirolimus were less likely to have poor-risk disease (poor, 10.2% v 69.4%; P < .001; favorable, 16.9% v 0%; P < .001). Thus, 39.0% of registry patients would have been excluded from the phase III clinical trial testing the drug they received. CONCLUSION: Patients with mRCC treated with tyrosine kinase inhibitors in real-world clinical practice are sicker than those enrolled onto pivotal clinical trials, and more than one third are trial ineligible. Application of clinical trial findings to dissimilar populations may result in patient harm. Clinical research with more inclusive eligibility criteria is needed to appropriately guide real-world practice.

Setting the vision: applied patient-reported outcomes and smart, connected digital healthcare systems to improve patient-centered outcomes prediction in critical illness.

PURPOSE OF REVIEW: Prediction models in critical illness are generally limited to short-term mortality and uncommonly include patient-centered outcomes. Current outcome prediction tools are also insensitive to individual context or evolution in healthcare practice, potentially limiting their value over time. Improved prognostication of patient-centered outcomes in critical illness could enhance decision-making quality in the ICU. RECENT FINDINGS: Patient-reported outcomes have emerged as precise methodological measures of patient-centered variables and have been successfully employed using diverse platforms and technologies, enhancing the value of research in critical illness survivorship and in direct patient care. The learning health system is an emerging ideal characterized by integration of multiple data sources into a smart and interconnected health information technology infrastructure with the goal of rapidly optimizing patient care. We propose a vision of a smart, interconnected learning health system with integrated electronic patient-reported outcomes to optimize patient-centered care, including critical care outcome prediction. SUMMARY: A learning health system infrastructure integrating electronic patient-reported outcomes may aid in the management of critical illness-associated conditions and yield tools to improve prognostication of patient-centered outcomes in critical illness.

Building the palliative care evidence base: Lessons from a randomized controlled trial of oxygen vs room air for refractory dyspnea.

Palliative care is increasingly seen as a standard component of high-quality comprehensive cancer care. However, several challenges remain to its widespread integration into clinical oncology practice, including workforce problems, reimbursement concerns, and a fledgling evidence base. This article discusses issues surrounding evidence base development in palliative cancer care, using the example of a recently published randomized controlled trial of oxygen versus room air. The Oxygen Trial randomized patients with refractory dyspnea and adequate Pao2 to oxygen or room air, administered via nasal cannula. Both groups experienced improvements in self-rated dyspnea scores, but no statistical differences were seen between intervention arms. These results suggest that supplementary oxygen is often unnecessary in the palliative setting, and that room air is similarly efficacious. This example highlights the importance and need for ongoing development of the evidence base in palliative medicine. The Palliative Care Research Cooperative (PCRC) is a novel National Institute of Nursing Research-funded research infrastructure that seeks to expand the palliative care evidence base. Its first multisite trial was recently completed, assessing the pragmatic question of whether statin medications can be safely discontinued in end-of-life settings. The PCRC will be a vehicle through which a high-quality evidence base will continue to expand and develop. Such ongoing research efforts are needed to inform and improve palliative care practice.

A decision exercise to engage cancer patients and families in deliberation about Medicare coverage for advanced cancer care.

BACKGROUND: Concerns about unsustainable costs in the US Medicare program loom as the number of retirees increase and experiences serious and costly illnesses like cancer. Engagement of stakeholders, particularly cancer patients and their families, in prioritizing insured services offers a valuable strategy for informing Medicare coverage policy. We designed and evaluated a decision exercise that allowed cancer patients and family members to choose Medicare benefits for advanced cancer patients. METHODS: The decision tool, Choosing Health plans All Together (CHAT) was modified to select services for advanced cancer patients. Patients with a cancer history (N = 246) and their family members (N = 194) from North Carolina participated in 70 CHAT sessions. Variables including participants' socio-demographic characteristics, health status, assessments of the exercise and results of group benefit selections were collected. Routine descriptive statistics summarized participant characteristics and Fisher's exact test compared group differences. Qualitative analysis of group discussions were used to ascertain reasons for or against selecting benefits. RESULTS: Patients and family members (N = 440) participated in 70 CHAT exercises. Many groups opted for such services as palliative care, nursing facilities, and services not currently covered by the Medicare program. In choosing among four levels of cancer treatment coverage, no groups chose basic coverage, 27 groups (39%) selected intermediate coverage, 39 groups (56%) selected high coverage, and 4 groups (6%) chose the most comprehensive cancer coverage. Reasons for or against benefit selection included fairness, necessity, need for prioritizing, personal experience, attention to family needs, holistic health outlook, preference for comfort, freedom of choice, and beliefs about the proper role of government. Participants found the exercise very easy (59%) or fairly easy (39%) to understand and very informative (66%) or fairly informative (31%). The majority agreed that the CHAT exercise led to fair decisions about priorities for coverage by which they could abide. CONCLUSIONS: It is possible to involve cancer patients and families in explicit discussions of their priorities for affordable advanced cancer care through the use of decision tools designed for this purpose. A key question is whether such a conversation is possible on a broader, national level.

Development of a symptom index for patients with primary brain tumors.

OBJECTIVES: This study's primary goals included identifying the highest priority symptoms of patients with advanced brain tumors on treatment, comparing patient priority ratings with those of oncology experts, and constructing a brief symptom index using combined input to assess these symptoms and concerns. METHODS: Fifty patients with advanced primary brain tumors and 10 physician experts were recruited from the National Comprehensive Cancer Network institutions and community support agencies. By using a 40-item symptom checklist, patients first selected up to 10 of the most important symptoms/concerns to monitor when assessing the value of drug treatment for brain tumors, then nominated up to 5 of the very most important concerns, and finally generated additional symptoms/concerns. By using the same checklist as patients, physicians rated each symptom/concern as disease- or treatment-related. RESULTS: By using the combined input, a 24-item National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Brain Symptom Index (NFBrSI-24) was developed. The NFBrSI-24 showed good internal consistency (α = 0.84), significantly differentiated patients with different levels of functional status (F2,47 = 8.21; P < .001), and demonstrated good convergent validity with the Functional Assessment of Cancer Therapy-General functional, physical, social, emotional, and brain tumor-specific concerns (ρ = 0.59, 0.57, 0.40, 0.35, and 0.50, respectively; Ps < 0.05). CONCLUSIONS: The NFBrSI-24, an index of the symptoms in advanced brain tumors perceived as most important by both patients and clinicians, improves upon existing measures of brain tumor symptoms through better satisfaction of regulatory requirements for measure development. The findings suggest good reliability and validity, indicating that the NFBrSI-24 is a promising brief assessment of high-priority advanced brain tumor symptoms for research and clinical settings.

"Not the 'grim reaper service'": an assessment of provider knowledge, attitudes, and perceptions regarding palliative care referral barriers in heart failure.

BACKGROUND: Although similar to cancer patients regarding symptom burden and prognosis, patients with heart failure (HF) tend to receive palliative care far less frequently. We sought to explore factors perceived by cardiology, primary care, and palliative care providers to impede palliative care referral for HF patients. METHODS AND RESULTS: We conducted semistructured interviews regarding (1) perceived needs of patients with advanced HF; (2) knowledge, attitudes, and experiences with specialist palliative care; (3) perceived indications for and optimal timing of palliative care referral in HF; and (4) perceived barriers to palliative care referral. Two investigators analyzed data using template analysis, a qualitative technique. We interviewed 18 physician, nurse practitioner, and physician assistant providers from 3 specialties: cardiology, primary care, and palliative care. Providers had limited knowledge regarding what palliative care is, and how it can complement traditional HF therapy to decrease HF-related suffering. Interviews identified several potential barriers: the unpredictable course of HF; lack of clear referral triggers across the HF trajectory; and ambiguity regarding what differentiates standard HF therapy from palliative care. Nevertheless, providers expressed interest for integrating palliative care into traditional HF care, but were unsure of how to initiate collaboration. CONCLUSIONS: Palliative care referral for HF patients may be suboptimal due to limited provider knowledge and misperceptions of palliative care as a service reserved for those near death. These factors represent potentially modifiable targets for provider education, which may help to improve palliative care referral for HF patients with unresolved disease-related burden.

Development and initial validation of the NCCN/FACT symptom index for advanced kidney cancer.

OBJECTIVES: There is a need for a brief symptom index for advanced kidney cancer that includes perspectives of both patients and clinicians and is consistent with the Food and Drug Administration's guidance for patient-reported outcome measures. This study developed and examined the preliminary reliability and validity of the new National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19. METHODS: Fifty patients with advanced kidney cancer provided open-ended and survey responses ranking their most important symptoms. Responses were reconciled with published clinician reports of the most important symptoms. Ten experienced oncologists rated symptoms as disease- or treatment-related. Patients completed quality-of-life and performance status measures. RESULTS: A 19-item index was produced from symptoms that were rated as most important by patients or clinicians. It includes three subscales: disease-related symptoms (DRS), treatment side effects (TSE), and general function and well-being (FWB). Internal consistency was good for the full instrument (α = 0.83), the DRS subscale (α = 0.76), and the FWB subscale (α = 0.78) but lower for the TSE subscale (α = 0.59). Convergent validity was demonstrated through correlations with the FACT-General. Patients with differing performance status were distinguished by the total score (F2,47 = 17.37; P < .0001), the DRS subscale (F2,47 = 14.22; P < .0001), and the FWB subscale (F2,47 = 13.40; P < .0001) but not the TSE subscale (F2,47 =1.48; P = 0.2380). CONCLUSIONS: The National Comprehensive Cancer Network/FACT-Kidney Symptom Index 19 combines symptoms deemed most important by patients and clinicians. Preliminary evidence suggests that the total score and DRS and FWB subscales are reliable and valid as summary indexes. The TSE subscale may be least relevant given the advent of newer therapies.

"Real world" treatment of metastatic renal cell carcinoma in a joint community-academic cohort: progression-free survival over three lines of therapy.

BACKGROUND: New targeted therapeutics approved for metastatic renal cell carcinoma (mRCC) offer multiple options in each line of therapy; however, there are few prospective data beyond the first-line settings, and overall comparative effectiveness data are limited. In the targeted therapy era, progression-free survival (PFS) has been the most common regulatory end point for demonstrating the benefit of new therapies. PATIENTS AND METHODS: Drawing on a joint community-academic retrospective mRCC registry, we analyzed all patients who had undergone at least 1 line of systemic therapy (N = 325) for PFS. Patients were grouped according to treatment choice (sorafenib, sunitinib, temsirolimus, everolimus, and "other") for up to 3 lines of therapy. PFS by treatment choice and line of therapy was evaluated using Kaplan-Meier and Cox regression analyses. RESULTS: PFS was longest in patients treated with sunitinib in the first and second lines of therapy. First-line PFS for sorafenib, sunitinib, temsirolimus, everolimus, and "other" was 6.9, 8.9, 4.2, not analyzed (too few patients), and 10.8 months, respectively. Second-line PFS was 4.6, 7.0, 3.2, 3.8, and 4.1 months, respectively. Third-line PFS was 4.5, 4.6, 9.9, 4.2, and 2.9, months, respectively. The risk of progression in patients treated with temsirolimus was about twice that of patients treated with sunitinib in the first and second lines of therapy. CONCLUSION: Patients treated with sunitinib had the longest PFS in the first and second lines of therapy. PFS from practice-based data appear consistent with trial-based expectations; however, practice variation was still evident.

Evaluation of treatment- and disease-related symptoms in advanced head and neck cancer: validation of the national comprehensive cancer network-functional assessment of cancer therapy-head and neck cancer symptom index-22 (NFHNSI-22).

CONTEXT: The Functional Assessment of Cancer Therapy-Head and Neck is a well-validated assessment of quality of life used with patients diagnosed with head and neck cancers (HCNs). The present study is an attempt to evaluate and modify this instrument as necessary in light of the recent regulatory guidelines from the Food and Drug Administration on the use of patient-reported outcomes in clinical trials. OBJECTIVES: Overall, the goal was to identify patients' highest priority cancer symptoms, compare these symptoms with those suggested by oncology experts, and construct a brief symptom index to assess these symptoms and categorize them as treatment-related, disease-related, or related to general function and well-being. METHODS: Patients (N=49) with advanced (Stages III and IV) HCNs were recruited from participating National Comprehensive Cancer Network institutions and community cancer support organizations in the Chicago area. Patients completed open-ended interviews and symptom checklists. Participating oncology physician experts also rated symptoms. Content validity was obtained by evaluating results alongside items in the Functional Assessment of Chronic Illness Therapy system. Eleven oncologists categorized symptoms in terms of importance and also whether the symptoms were primarily related to disease, treatment, or functional well-being. RESULTS: HCN-related symptoms endorsed as high priority by both patients and oncology experts were selected for the new National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Head and Neck Cancer Symptom Index-22. The final version includes 22 items, which are broken down into disease-related symptoms, treatment side effects, or general function and well-being. The new scale has acceptable internal consistency (Cronbach's coefficient alpha=0.86), content validity for use in chemotherapy trials of patients with advanced disease, and concurrent validity as demonstrated by moderate-to-strong correlations with the existing Functional Assessment of Chronic Illness Therapy measure. CONCLUSION: The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Head and Neck Cancer Symptom Index-22 adequately reflects symptom and side effect concerns of advanced HCN patients as well as oncology physicians. This instrument can be used to evaluate the most important disease-related symptoms, treatment side effects, and function/well-being in patients with advanced HCNs in clinical practice and research.

Development and validation of a symptom index for advanced hepatobiliary and pancreatic cancers: the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy (NCCN-FACT) Hepatobiliary-Pancreatic Symptom Index (NFHSI).

BACKGROUND: The 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire assesses health-related quality of life in patients with liver, bile duct, and pancreatic cancers. Although the FACT-Hep was initially derived from patient input, this study's researchers sought to verify adequate coverage of items by soliciting open-ended input from patients with advanced disease. METHODS: As part of a larger study in collaboration with the National Comprehensive Cancer Network (NCCN), 50 people (60% male, 80% caucasian, average age 60.4 years) with stage 3 or 4 hepatobiliary or pancreatic cancer were recruited. Participants generated and ranked up to 10 important symptoms and concerns that physicians should monitor when assessing the value of chemotherapy. Patients were also able to provide open-ended, qualitative information that was evaluated systematically. Ten expert physicians also provided input on priority symptoms. RESULTS: The resulting 18-item NCCN-FACT Hepatobiliary-Pancreatic Symptom Index (NFHSI-18) demonstrated high internal consistency (α = .89) and moderate to strong correlations with measures of physical well-being (ρ = .76), emotional well-being (ρ = 0.52), and functional well-being (ρ = 0.57). Scores on the NFHSI-18 were also highly correlated with the original hepatobiliary scale of the FACT-Hep (ρ = .82; all P < .001). Compared with patients with better performance status, patients with poor performance status had worse NFHSI-18 symptom scores, F(3,47) = 9.74; P = .0003. CONCLUSIONS: The NFHSI-18 assesses symptoms of importance to patients with hepatobiliary and pancreatic cancers and demonstrates promising measurement properties. The scale is a good candidate for brief symptom assessment in clinical trials.

PC-FACS.

PC-FACS (Fast Article Critical Summaries for Clinicians in Palliative Care), an electronic publication of the American Academy of Hospice and Palliative Medicine, provides palliative care clinicians with concise summaries of the most important findings from more than 50 medical and scientific journals. Each month, structured summaries and insightful commentaries on 6-10 articles help palliative care clinicians stay on top of the research that is critical to contemporary practice. PC-FACS is free to AAHPM members and members can earn up to 3 CME credits quarterly. Following are excerpts from recent issues, and comments from readers are welcomed at resources@aahpm.org.

Gastrointestinal symptoms in cancer patients with advanced disease: new methodologies, insights, and a proposed approach.

PURPOSE OF REVIEW: This review summarizes recent developments in the management of gastrointestinal symptoms experienced by cancer patients and provides a framework for education, assessment and monitoring, and treatment. RECENT FINDINGS: Although many viable treatment options exist, gastrointestinal symptoms - particularly nausea and vomiting, constipation, and diarrhea - continue to challenge both patients and clinicians. Current clinical guidelines now recommend that patients treated with moderate emetic risk chemotherapy regimens be preferentially treated with the 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, palonosetron, in combination with dexamethasone. A large randomized trial has also recently validated that single-dose fosaprepitant is equivalent to the standard 3-day, aprepitant regimen. New medications, such as skin patch delivery of granisetron for nausea or methylnaltrexone for constipation, show promise in both the management of symptoms and as preventive agents. The integration of complementary and alternative therapies, such as relaxation techniques, ginger, and electroacupuncture may also assist with symptom relief. Accurate assessment is essential, but often problematic, especially as the patient's experience of gastrointestinal distress is often disproportionate with objective measures. New methodologies that harness technology to collect patient-reported outcomes may improve the accuracy of assessment, provide a better picture of the patient's experience of gastrointestinal symptoms, and deliver a means to simultaneously monitor symptoms, educate patients, and collect longitudinal data. SUMMARY: Palliative management of gastrointestinal symptoms in advanced cancer patients requires a multipronged approach that entails effective assessment, judicious use of latest evidence-based approaches, and monitoring that incorporates both clinical measures and patient-reported outcomes. When combined with refinements in the overall clinical approach to symptom management, standardized instruments that streamline data collection and enable data warehousing will support better symptom management.

A brief symptom index for advanced lung cancer.

BACKGROUND: Advanced lung cancer is often symptomatic; thus the goals of treatment include maintenance of function and palliation of symptoms. Symptom management requires accurate systematic symptom assessment. This study, which focused on lung cancer, is part of a larger study to obtain patient input that, in combination with previously obtained physician and nurse input, was used to develop symptom indexes for 11 advanced cancers. PARTICIPANTS AND METHODS: Fifty patients with advanced lung cancer were recruited from National Comprehensive Cancer Network (NCCN) member institutions and community support agencies; 10 physician experts were recruited from NCCN institutions. Patients reported symptoms associated with their disease in open-ended format and then completed a checklist of symptoms, rating their 5 most important symptoms. Patient and provider ratings of symptom importance were tabulated to construct the NCCN-Functional Assessment of Cancer Therapy (FACT) Lung Symptom Index-17 (NFLSI-17). Patients also completed the Functional Assessment of Cancer Therapy-Lung (FACT-L), which was used to preliminarily validate the NFLSI-17. RESULTS: Based on combined patient, physician, and nurse input, the NFLSI-17 is composed of 17 priority symptoms, 11 that are disease related, 3 that are treatment related, and 3 that are related to general functional well-being (FWB). Data on 15 of 17 NFLSI-17 symptoms showed good internal consistency (alpha = 0.74) and strong association with the FACT-L total and most subscale scores (r = 0.42-0.92). Both the NFLSI-15 (F(2,47) = 4.46; P = .017) and the NFLSI-disease related subscale (DRS) (F(2,47) = 5.56; P = .007) significantly discriminated patients among performance status groups. CONCLUSION: The NFLSI-17 reflects the most important patient- and clinician-rated targets of chemotherapy for advanced lung cancer; further validation will follow.

Unmet spiritual care needs impact emotional and spiritual well-being in advanced cancer patients.

PURPOSE: Spiritual care is an important part of healthcare, especially when facing the crisis of advanced cancer. Do oncology inpatients receive spiritual care consistent with their needs? When inconsistent, are there deleterious effects on patient outcomes? METHODS: Patients with advanced cancer (N = 150) were surveyed during their inpatient stay at a southeastern medical center using validated instruments documenting spirituality, quality of life, mood, and satisfaction with care. Relationships between the receipt of less spiritual care than desired and patient outcomes were examined. RESULTS: Almost all patients had spiritual needs (91%) and the majority desired and received spiritual care from their healthcare providers (67%; 68%), religious community (78%; 73%), and hospital chaplain (45%; 36%). However, a significant subset received less spiritual care than desired from their healthcare providers (17%), religious community (11%), and chaplain (40%); in absolute terms, the number who received less care than desired from one or more sources was substantial (42 of 150). Attention to spiritual care would improve satisfaction with care while hospitalized for 35% of patients. Patients who received less spiritual care than desired reported more depressive symptoms [adjusted ß (SE) = 1.2 (0.47), p = 0.013] and less meaning and peace [adjusted ß (SE) = -2.37 (1.15), p = 0.042]. CONCLUSIONS: A substantial minority of patients did not receive the spiritual care they desired while hospitalized. When spiritual needs are not met, patients are at risk of depression and reduced sense of spiritual meaning and peace. Spiritual care should be matched to cancer patients' needs.

Enhancing communication between oncologists and patients with a computer-based training program: a randomized trial.

BACKGROUND: Quality cancer care requires addressing patients' emotions, which oncologists infrequently do. Multiday courses can teach oncologists skills to handle emotion; however, such workshops are long and costly. OBJECTIVE: To test whether a brief, computerized intervention improves oncologist responses to patient expressions of negative emotion. DESIGN: Randomized, controlled, parallel-group trial stratified by site, sex, and oncologic specialty. Oncologists were randomly assigned to receive a communication lecture or the lecture plus a tailored CD-ROM. (ClinicalTrials.gov registration number: NCT00276627) SETTING: Oncology clinics at a comprehensive cancer center and Veterans Affairs Medical Center in Durham, North Carolina, and a comprehensive cancer center in Pittsburgh, Pennsylvania. PARTICIPANTS: 48 medical, gynecologic, and radiation oncologists and 264 patients with advanced cancer. INTERVENTION: Oncologists were randomly assigned in a 1:1 ratio to receive an interactive CD-ROM about responding to patients' negative emotions. The CD-ROM included tailored feedback on the oncologists' own recorded conversations. MEASUREMENTS: Postintervention audio recordings were used to identify the number of empathic statements and responses to patients' expressions of negative emotion. Surveys evaluated patients' trust in their oncologists and perceptions of their oncologists' communication skills. RESULTS: Oncologists in the intervention group used more empathic statements (relative risk, 1.9 [95% CI, 1.1 to 3.3]; P = 0.024) and were more likely to respond to negative emotions empathically (odds ratio, 2.1 [CI, 1.1 to 4.2]; P = 0.028) than control oncologists. Patients of intervention oncologists reported greater trust in their oncologists than did patients of control oncologists (estimated mean difference, 0.1 [CI, 0.0 to 0.2]; P = 0.036). There was no significant difference in perceptions of communication skills. LIMITATIONS: Long-term effects were not examined. The findings may not be generalizable outside of academic medical centers. CONCLUSION: A brief computerized intervention improves how oncologists respond to patients' expressions of negative emotions. PRIMARY FUNDING SOURCE: National Cancer Institute.

Former palliative caregivers who identify that additional spiritual support would have been helpful in a population survey.

BACKGROUND: Palliative care encompasses physical, psychosocial and spiritual care for patients and caregivers. No population data are available on bereaved people who subsequently report that additional spiritual support would have been helpful. METHODS: In a population survey, a respondent-defined question was asked regarding 'additional spiritual support' that would have been helpful if someone 'close to them had died' an expected death in the previous five years. Data (socio-demographic [respondent]); clinical [deceased]) directly standardized to the whole population were analysed. RESULTS: There were 14,902 participants in this study (71.6% participation rate), of whom 31% (4665) experienced such a death and 1084 (23.2%) provided active hands-on (day-to-day or intermittent) care. Fifty-one of the 1084 (4.7%) active caregivers identified that additional spiritual support would have been helpful. The predictors in a regression analysis were: other domains where additional support would have been helpful (OR 1.69; 95% CI 1.46-1.94; p<0.001); and being female (OR 3.23; 95% CI 1.23 to 8.33; p=0.017). 'Additional spiritual support being helpful' was strongly associated with higher rates where additional support in other domains would also have been helpful in: all bereaved people (2.7 vs 0.6; p<0.0001); and in active caregivers (3.7 vs 0.8; p<0.0001). CONCLUSION: People who identify that additional spiritual support would have been helpful have specific demographic characteristics. There is also a strong association with the likelihood of identifying that a number of other additional supports would have been helpful. Clinically, the need for additional spiritual support should open a conversation about other areas where the need for further support may be identified.

Correlates of quality of life-related outcomes in breast cancer patients participating in the Pathfinders pilot study.

OBJECTIVE: In a pilot study, participation in the Pathfinders program was associated with reductions in distress and despair and improvements in quality of life (QOL) among advanced breast cancer patients. This study explores the relationship between psychosocial resources invoked through the Pathfinders intervention and outcomes. METHODS: Advanced breast cancer patients were enrolled in a prospective, single-arm, pilot study of the Pathfinders psychosocial program. Participants met at least monthly with a licensed clinical social worker who administered the Pathfinders intervention, which focused on strengthening adaptive coping skills, identifying inner strengths, and developing a self-care plan. Longitudinal assessments over 6 months used validated instruments to assess changes in Pathfinders targets (coping, social support, self-efficacy, spirituality, and optimism) and outcomes (distress, despair, QOL, and fatigue). Multiple linear regression models examined the joint effect of average changes in target subscales on average outcome changes, adjusted for baseline outcome scores and patient characteristics. RESULTS: Participants (n=44) were: mean age 51 (SD, 12), 20% non-Caucasian, 50% college degree, and 75% married. Improvements in active coping skills, self-efficacy, and spiritual meaning/peace significantly correlated with an improvement in despair after adjustment for demographic characteristics (all P<0.05). Improvements in social support significantly correlated with positive changes in distress (P<0.05). Gains in learned optimism independently correlated with an increase in overall QOL (P<0.01). CONCLUSIONS: In this pilot assessment, changes in pre-defined Pathfinders targets such as coping skills, social support, self-efficacy, spirituality, and optimism correlated with improvements in patient-reported outcomes.

Rapid-learning system for cancer care.

Compelling public interest is propelling national efforts to advance the evidence base for cancer treatment and control measures and to transform the way in which evidence is aggregated and applied. Substantial investments in health information technology, comparative effectiveness research, health care quality and value, and personalized medicine support these efforts and have resulted in considerable progress to date. An emerging initiative, and one that integrates these converging approaches to improving health care, is "rapid-learning health care." In this framework, routinely collected real-time clinical data drive the process of scientific discovery, which becomes a natural outgrowth of patient care. To better understand the state of the rapid-learning health care model and its potential implications for oncology, the National Cancer Policy Forum of the Institute of Medicine held a workshop entitled "A Foundation for Evidence-Driven Practice: A Rapid-Learning System for Cancer Care" in October 2009. Participants examined the elements of a rapid-learning system for cancer, including registries and databases, emerging information technology, patient-centered and -driven clinical decision support, patient engagement, culture change, clinical practice guidelines, point-of-care needs in clinical oncology, and federal policy issues and implications. This Special Article reviews the activities of the workshop and sets the stage to move from vision to action.