Search

Background Cancer patients' attitudes toward progression-free survival (PFS) gains offered by treatment are not well understood, particularly in the absence of overall survival (OS) gains. The objectives were to describe patients' willingness to accept treatment that offers PFS gains without OS gains, to compare these findings with treatments offering OS gains, and to qualitatively summarize patients' reasons for their preferences. Methods A multicenter, cross-sectional, convergent mixed-methods study design recruited patients who had received at least 3 months of systemic therapy for incurable solid tumors. A treatment trade-off exercise determined the gains in imaging PFS that patients require to prefer additional systemic treatment for a scenario of a newly diagnosed, asymptomatic, incurable abdominal tumor. A qualitative, descriptive, thematic analysis explored factors influencing patients' decisions, and a narrative method integrated the quantitative and qualitative findings. Results In total, 100 patients participated (63% were older than 60 years of age). If additional treatment with added toxicity offered no OS advantage, 17% would prefer it for no PFS benefit; 26% for some PFS benefit (range, 3-9 months), whereas 51% would decline it regardless of PFS benefit. Similarly, 71% preferred additional treatment offering a 6-month OS advantage dependent on described toxicity levels (P  =  .03). A spectrum of reasons for these preferences reflected the complexity of participants' attitudes and values. Conclusions Prolongation of time to progression was not universally valued. Most patients did not prefer treatments that negatively affect quality of life for PFS gains alone. Implications for individual decision making, policy, and trials research are discussed. [ABSTRACT FROM AUTHOR]

Randomized clinical trials are critical for evaluating the safety and efficacy of interventions in oncology and informing regulatory decisions, practice guidelines, and health policy. Patient-reported outcomes (PROs) are increasingly used in randomized trials to reflect the impact of receiving cancer therapies from the patient perspective and can inform evaluations of interventions by providing evidence that cannot be obtained or deduced from clinicians' reports or from other biomedical measures. This commentary focuses on how PROs add value to clinical trials by representing the patient voice. We employed 2 previously published descriptive frameworks (addressing how PROs are used in clinical trials and how PROs have an impact, respectively) and selected 9 clinical trial publications that illustrate the value of PROs according to the framework categories. These include 3 trials where PROs were a primary trial endpoint, 3 trials where PROs as secondary endpoints supported the primary endpoint, and 3 trials where PROs as secondary endpoints contrast the primary endpoint findings in clinically important ways. The 9 examples illustrate that PROs add valuable data to the care and treatment context by informing future patients about how they may feel and function on different treatments and by providing clinicians with evidence to support changes to clinical practice and shared decision making. Beyond the patient and clinician, PROs can enable administrators to consider the cost-effectiveness of implementing new interventions and contribute vital information to policy makers, health technology assessors, and regulators. These examples provide a strong case for the wider implementation of PROs in cancer trials. [ABSTRACT FROM AUTHOR]

Purpose. To compare relative accuracy and relative response times (RTs) as well as impact of foreground and background colors in a treatment decision context of judging larger/smaller when the following [...]

Background: Use of value framework thresholds in the design of clinical trials may increase the proportion of randomized controlled trials that identify clinically meaningful advances for patients. Existing frameworks have not been applied to the research output of a cooperative cancer trials group. We apply value frameworks to the randomized controlled trial output of the Canadian Cancer Trials Group (CCTG).Methods: Statistical design, study characteristics, and results of all published phase III trials of CCTG were abstracted. We applied the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) and American Society of Clinical Oncology Net Health Benefit to study results and the statistical power calculations to identify the proportion of all trials that were designed to detect a substantial clinical benefit.Results: During 1979 to 2017, CCTG published 113 phase III trials; 52.2% (59 of 113) of these trials were positive. One-half (50.4%, 57 of 113) of the trials were conducted in the palliative setting. In 37.2% (42 of 113) of trials, the primary endpoint was overall survival; disease-free survival or progression-free survival was used in 38.9% (44 of 113) of trials. The ESMO-MCBS could be applied to the power calculation for 69 trials; 73.9% (51 of 69) of these trials were designed to detect an effect size that could meet ESMO-MCBS thresholds for substantial benefit. Among the 51 positive trials for which the ESMO-MCBS could be applied, 41.1% (21 of 51) met thresholds for substantial benefit.Conclusions: Most CCTG phase III trials were designed to detect clinically meaningful differences in outcome, although less than one-half of positive trials met the threshold for substantial benefit. Application of value frameworks to the design of clinical trials is practical and may improve research efficiency and treatment options for patients. [ABSTRACT FROM AUTHOR]

Background: Missing patient reported outcomes data threaten the validity of PRO‐specific findings and conclusions from randomized controlled trials by introducing bias due to data missing not at random. Clinical Research Associates are a largely unexplored source for informing understanding of potential causes of missing PRO data. The purpose of this qualitative research was to describe factors that influence missing PRO data, as revealed through the lived experience of CRAs. Methods: Maximum variation sampling was used to select CRAs having a range of experiences with missing PRO data from academic or nonacademic centers in different geographic locations of Canada. Semistructured interviews were audio‐recorded, transcribed verbatim, and analyzed according to descriptive phenomenology. Results: Eleven CRAs were interviewed. Analysis revealed several factors that influence missing PRO data that were organized within themes. PROs for routine clinical care compete with PROs for RCTs. Both the paper and electronic formats have benefits and drawbacks. Missing PRO data are influenced by characteristics of the instruments and of the patients. Assessment of PROs at progression of disease is particularly difficult. Deficiencies in center research infrastructure can contribute. CRAs develop relationships with patients that may help reduce missing PRO data. It is not always possible to provide sufficient time to complete the instrument. There is a need for field guidance and a motivation among CRAs to contribute their knowledge to address issues. Conclusion: These results enhance understanding of factors influencing missing PRO data and have important implications for designing operational solutions to improve data quality on cancer RCTs. [ABSTRACT FROM AUTHOR]

Background: The growing burden of cancer within India has implications across the health system including operational delivery of cancer care and planning for human health resources. Here, we report the Indian results of a global survey of medical oncology (MO) workload in comparison to medical oncologists (MOs) in other low-middle-income countries (LMICs). Methods: An online survey was distributed through a snowball method through national oncology societies to chemotherapy-prescribing physicians in 22 LMICs. The survey was distributed to Indian MOs by the Indian Society of Medical and Pediatric Oncology and the National Cancer Grid of India. The workload was measured as the annual number of new cancer patient consults seen per oncologist. Results: One hundred and forty-seven oncologists from LMICs completed the survey; 82 from India and 65 from other LMICs. About 59% (48/82) of Indian MOs reported working exclusively in the private health system compared to 23% (15/65) of MOs in other LMICs (P < 0.001). The median number of annual consults per MO was 475 in India compared with 350 in other LMICs. The proportion of MOs seeing >1000 new consults/year was 24% (20/82) in India and 20% (13/65) in other LMICs (P = 0.530). The median number of patients seen in a full-day clinic was 35 in India and 25 in other LMCs (P = 0.003); 26% of Indian MO reported seeing >50 patients per day. Compared to other LMICs, Indian MOs worked more days/week (median 6 vs. 5, P < 0.001) and hours/week (median 51-60 vs. 41-50, P = 0.004) and had less annual leave for vacation (3 weeks vs. 4, P = 0.017). Conclusion: Indian MOs have higher clinical volumes and workload than MOs in other LMICs and substantially higher workload than MOs in high-income countries. Indian health policymakers should consider alternative models of care and increasing MO workforce supply to address the growing burden of cancer. [ABSTRACT FROM AUTHOR]

Background To our knowledge, there is no literature that has described medical oncology (MO) workload in the global context. Here, we report results of an international study of global MO workload. Methods An online survey was distributed through a snowball method via national oncology societies to chemotherapy-prescribing physicians in 65 countries. Countries were classified into low- or low-middle–income countries (LMICs), upper-middle–income countries (UMICs), and high-income countries (HICs) on the basis of World Bank criteria. Workload was measured as the annual number of new consultations provided to patients with cancer per oncologist. Results A total of 1,115 physicians completed the survey: 13% (147 of 1,115) from LMICs, 17% (186 of 1,115) from UMICs, and 70% (782 of 1,115) from HICs. Eighty percent (897 of 1,115) of respondents were medical oncologists, 10% (109 of 1,115) were clinical oncologists, and 10% (109 of 1,115) were other. The median number of annual consults per oncologist was 175 (interquartile range, 75 to 275); 13% (140 of 1,103) saw ≥ 500 new patients in a year. Annual case volume in LMICs (median consults, 425; 40% of respondents seeing > 500 consults) was substantially higher than in UMICs (median consults, 175; 14% > 500) and HICs (median consults, 175; 7% > 500; P < .001). Among LMICs, UMICs, and HICs, median working days per week were 6, 5, and 5, respectively (P < .001). The highest annual case volumes per oncologist were in Pakistan (median consults, 950; 73% > 500 consults), India (median consults, 475; 43% > 500), and Turkey (median consults, 475; 27% > 500). Conclusion There is substantial global variation in medical oncology case volumes and clinical workload; this is most striking among LMICs, where huge deficits exist. Additional work is needed, particularly detailed country-level mapping, to quantify activity-based global MO practice and workload to inform training needs and the design of new pathways and models of care. [ABSTRACT FROM AUTHOR]

Background: The ICON6 trial showed that cediranib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, improved clinical outcomes for patients with platinum-sensitive relapsed ovarian cancer when it was used with chemotherapy and was continued as maintenance therapy. This study describes health-related quality of life (QOL) during the first year of treatment.Methods: Four hundred fifty-six women were randomly allocated to receive standard chemotherapy only, chemotherapy with concurrent cediranib, or chemotherapy with cediranib administered concurrently and continued as maintenance. Patients completed QOL questionnaires until disease progression every 3 weeks during chemotherapy and then every 6 weeks to 1 year. Patients alive with disease progression completed a QOL form 1 year after randomization. The primary QOL endpoint was the global score from the Quality of Life Questionnaire Core 30 (of the European Organization for Research and Treatment of Cancer) at 1 year, with the standard chemotherapy group compared with the concurrent-maintenance cediranib group.Results: The rate of questionnaire compliance was 90% at the baseline and 76% at 1 year and was similar across the 3 groups. The mean global QOL score at 1 year was 62.6 points for the standard chemotherapy group and 68.7 points for the concurrent-maintenance group (+4.5; 95% confidence interval, -2.0 to 11.0; P = .18). Sensitivity analyses suggested that this finding was robust to the effect of missing data, and the improvement became statistically significant after adjustments for self-reported diarrhea.Conclusions: The 6th study by the International Collaboration in Ovarian Neoplasm (ICON6) showed a significant improvement in progression-free survival with cediranib as concurrent and maintenance therapy. No QOL detriment with cediranib was found 1 year after treatment was commenced. The maintenance of QOL along with prolonged cancer control suggests that cediranib has a valuable role in the treatment of relapsed ovarian cancer. Cancer 2017;123:2752-61. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. [ABSTRACT FROM AUTHOR]

Background: To our knowledge, there is no literature that has described medical oncology (MO) workload in the global context. Here, we report results of an international study of global MO workload. Methods: An online survey was distributed through a snowball method via national oncology societies to chemotherapy-prescribing physicians in 65 countries. Countries were classified into low- or low-middle – income countries (LMICs), upper-middle – income countries (UMICs), and high-income countries (HICs) on the basis of World Bank criteria. Workload was measured as the annual number of new consultations provided to patients with cancer per oncologist. Results: A total of 1,115 physicians completed the survey: 13% (147 of 1,115) from LMICs, 17% (186 of 1,115) from UMICs, and 70% (782 of 1,115) from HICs. Eighty percent (897 of 1,115) of respondents were medical oncologists, 10% (109 of 1,115) were clinical oncologists, and 10% (109 of 1,115) were other. The median number of annual consults per oncologist was 175 (interquartile range, 75 to 275); 13% (140 of 1,103) saw ≥ 500 new patients in a year. Annual case volume in LMICs (median consults, 425; 40% of respondents seeing > 500 consults) was substantially higher than in UMICs (median consults, 175; 14% > 500) and HICs (median consults, 175; 7% > 500; P <.001). Among LMICs, UMICs, and HICs, median working days per week were 6, 5, and 5, respectively (P <.001). The highest annual case volumes per oncologist were in Pakistan (median consults, 950; 73% > 500 consults), India (median consults, 475; 43% > 500), and Turkey (median consults, 475; 27% > 500). Conclusion: There is substantial global variation in medical oncology case volumes and clinical workload; this is most striking among LMICs, where huge deficits exist. Additional work is needed, particularly detailed country-level mapping, to quantify activity-based global MO practice and workload to inform training needs and the design of new pathways and models of care. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcomes (PROs) (eg, symptoms, functioning) can inform patient management. However, patients and clinicians often have difficulty interpreting score meaning. The authors tested approaches for presenting PRO data to improve interpretability.Methods: This mixed-methods study included an Internet survey of cancer patients/survivors, oncology clinicians, and PRO researchers circulated via snowball sampling, plus individual in-person interviews. Clinical importance was conveyed using 3 approaches (presented in random order): normal score range shaded green, concerning scores circled in red, and red threshold lines indicating normal versus concerning scores. Versions also tested 2 approaches to score directionality: higher = more (better for function, worse for symptoms) and higher = better for both function and symptoms. Qualitative data from online comments and in-person interviews supplemented quantitative results on interpretation accuracy, clarity, and the "most useful" format.Results: The survey included 1113 respondents: 627 survivors, 236 clinicians, and 250 researchers, plus 10 patients and 10 clinicians who were purposively sampled interviewees. Interpretation accuracy ranged from 53% to 100%. The formats in which higher = better were interpreted more accurately versus those in which higher = more (odds ratio [OR], 1.30; 95% confidence interval [CI], 1.07-1.58) and were more likely to be rated "very"/"somewhat" clear (OR, 1.39; 95% CI, 1.13-1.70) and "very" clear (OR, 1.36; 95% CI, 1.18-1.58). Red circle formats were interpreted more accurately than green-shaded formats when the first format presented (OR, 1.29; 95% CI, 1.00-1.65). Threshold-line formats were more likely to be rated "very" clear than green-shaded (OR, 1.43; 95% CI, 1.19-1.71) and red-circled (OR, 1.22, 95% CI, 1.02-1.46) formats. Threshold lines were most often selected as "most useful."Conclusions: The current results support presenting PRO data with higher = better directionality and threshold lines indicating normal versus concerning scores. Cancer 2017;123:1848-1859. © 2017 The Authors. Cancer published byWiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations aremade. [ABSTRACT FROM AUTHOR]

These reviews, among others, consistently identify both patient decision-making factors (ie, those influencing a patient accepting trial participation) and system or structural or clinician factors (those influencing if a patient has the opportunity to choose) as barriers to accrual. Further, the finding that patient acceptance rates varied little among racial and ethnic groups implies that observed disparities in clinical trial participation arise predominantly from system and/or clinical barriers rather than from patient decision-making. They found that more than half of the patients in these pooled studies were willing to participate (55.0% among the 30 studies examining participation in clinical trials of cancer treatment and 55.3% in the 5 cancer control trial studies). [Extracted from the article]

The article discusses a study to evaluate if values clarification exercises included in patient decision aids have a discernible impact on post-decisional regret in patients with early-stage prostate cancer. Participants included a total of 156 patients. The study concluded that the values clarification exercises led to better preparation for decision making and to less regret. The impact, however, only emerged after the decision was made.

In this broad overview for the Conference: “State of the Science in Cancer Care”, we review a conceptual framework of physician-patient communication and use the framework to inform the application of theory regarding communication and patient preferences in clinical practice. Using a selection of research, we illustrate how problematic issues in communication can be represented by the framework. We further illustrate how interventions designed to improve communication or to elicit patients’ preferences in a medical encounter may have their desired effect, or may be optimally evaluated. [ABSTRACT FROM AUTHOR]

Objective: To review resources available to aid family physicians in their care of prostate cancer patients and develop an algorithm to summarize these findings.Sources Of Information: MEDLINE, EMBASE, and relevant website search. All relevant guidelines were level III evidence.Main Message: Improved screening and treatment of patients with prostate cancer is resulting in an increasing number of survivors. These men require ongoing monitoring, a responsibility that is largely falling to family physicians. We review the expected prostate-specific antigen (PSA) responses to different prostate cancer treatment modalities and provide an appropriate schedule of follow-up and monitoring techniques for prostate cancer patients.Conclusion: In light of the paucity of resources for family physicians in their ongoing care of prostate cancer patients, we present an algorithm, primarily based on PSA kinetics, for practical use in the continuing care of these patients. [ABSTRACT FROM AUTHOR]