Five-Year Trends in Reported National Football League Injuries.

OBJECTIVE: To determine the incidence of all-cause injury and concussion in the National Football League (NFL) over a 5-season time span (2012-2016). DESIGN: Prospective descriptive epidemiological study. SETTING: National Football League Injury Report data from 2012 to 2016. PARTICIPANTS: National Football League players. INTERVENTIONS: None (descriptive study). MAIN OUTCOME MEASURES: Injury report data were collected prospectively for all NFL injuries from 5 seasons (2012-2016). The incidences of reported concussions, knee injuries, and all-cause injury were compared across the 5 seasons using the Kruskal-Wallis rank-sum test. RESULTS: A total of 10 927 injuries were identified across the 5 seasons, including 752 (6.9%) concussions. The top 3 most injured areas included the knee (17.2%), ankle (13.6%), and shoulder (8.8%). Defensive backs consistently had the highest number of all-cause injuries per season. When comparing across years, there was a significant decrease in all-cause injury in 2016 compared with 2015, a significant decrease in knee injuries in 2016 compared with 2015, and a significant increase in concussion in 2015 compared with 2014 (P < 0.05). CONCLUSIONS: Reported all-cause injury incidence and knee injury incidence is currently on the decline. However, reported concussion incidence has recently increased, perhaps due to increased awareness and rule changes implemented to aid in the detection and treatment of concussion. Strategies to reduce injury and improve injury awareness should continue to be explored.

Quality of life (QOL) and symptom burden (SB) in patients with breast cancer.

PURPOSE: The purpose of this study was to determine the quality of life (QOL) and symptom burden (SB) among breast cancer patients. METHODS: Patients with DCIS, early stage, locally advanced, or metastatic breast cancer completed the Edmonton Symptom Assessment System (ESAS) and the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B). Patients were divided into subsequent cohorts based on their last day of treatment, age at enrollment, radiation, chemotherapy, and hormone therapy. RESULTS: A total of 1513 patients were enrolled. Metastatic patients had a lower QOL and greatest SB compared to all other patient groups. Patients ≤50 years old with early stage or locally advanced breast cancer had a lower QOL and greater SB for fatigue, depression, and anxiety compared to all other age cohorts. Patients with early stage breast cancer who received chemotherapy had a lower QOL and greater SB. Patients taking selective estrogen receptor modulator (SERM) had greater SB for depression and lower QOL compared to those not on SERM. Patients 2-10 years post-treatment had a lower QOL compared to patients ≥10 years post-treatment. CONCLUSION: Patients ≤50 years old, 2-10 years post-treatment, treated with chemotherapy or SERM had increased SB and decreased QOL. Individualized interventions and programs can be developed to tailor to physical, educational, and psychosocial needs identified across the breast cancer continuum.

Impaired timing of audiovisual events in the elderly.

Perceptual binding of multisensory events occurs within a limited time span known as the temporal binding window. Failure to correctly identify whether multisensory events occur simultaneously, what their temporal order is, or whether they should be causally bound can lead to inaccurate representations of the physical world, poor decision-making, and dangerous behavior. It has been shown that the ability to discriminate simultaneity, temporal order, and causal relationships among stimuli can become increasingly difficult as we age. In the present study, we assessed the relationship between these three attributes of temporally processing multisensory information in both younger and older adults. Performance on three tasks (temporal order judgment: TOJ, simultaneity judgment: SJ, and stream/bounce illusion) was compared using a large sample within-subjects design consisting of younger and older adults to determine aging effects as well as relationships between the three tasks. Older adults had more difficulty (larger temporal binding window) discriminating temporal order and perceived collision than younger adults. Simultaneity judgments in younger and older adults were indistinguishable. Positive correlations between TOJ and SJ as well as SJ and stream/bounce tasks were found in younger adults, which identify common (SJ) and distinct (TOJ, stream/bounce) neural mechanisms that sub-serve temporal processing of audiovisual information that is lost in older adults. We conclude that older adults have an extended temporal binding window for TOJ and stream/bounce tasks, but the temporal binding window in SJ is preserved, suggesting that age-related changes in multisensory integration are task specific and not a general trait of aging.

Quality of life and symptom burden in patients with breast cancer treated with mastectomy and lumpectomy.

INTRODUCTION: Mastectomy (MAS) and lumpectomy (LUMP) are the two common local surgical treatments for early breast cancer. There has been a debate whether MAS or LUMP results in better quality of life (QOL). The purpose of this study was to examine the symptom burden (SB) and QOL of both MAS and LUMP patients. METHODS: Patients at the Louise Temerty Breast Cancer Centre in Toronto, Canada, were approached to complete two self-administered questionnaires, the Edmonton Symptom Assessment Score (ESAS) and the Functional Assessment of Cancer Therapy-Breast (FACT-B) cancer edition. Additionally, patient demographics were recorded from medical records. Patients were divided into two cohorts depending on their surgical treatment: MAS and LUMP. The QOL and SB, assessed by FACT-B and ESAS, respectively, of MAS and LUMP patients were compared. The analysis was repeated excluding patients with metastases. RESULTS: From January to August 2014, 614 MAS and 801 LUMP patients were accrued. The MAS patients reported a lower QOL in all categories, except social well-being. There was however no statistical difference in ESAS scores for MAS and LUMP patients with non-metastatic breast cancer. CONCLUSION: This study supports existing literature that SB of MAS and LUMP patients without metastases are similar. QOL of MAS patients including those with metastases was lower than that of LUMP patients.

Quality of life and symptom burden in patients with metastatic breast cancer.

PURPOSE: The goal of this study was to examine the symptom burden (SB) and quality of life (QOL) in patients with metastatic breast cancer. METHODS: Breast cancer patients with metastases were asked to complete the Edmonton Symptom Assessment System (ESAS) and FACT-B questionnaires. Statistical analysis was performed to identify (1) any differences in SB and QOL between patients with bone metastases only and patients with visceral +/- bone metastases and (2) any associations between SB and/or QOL and various clinical factors, including treatment with bisphosphonates, participation in a clinical trial and presence of brain metastases. RESULTS: A total of 174 patients were enrolled. Treatment with bisphosphonates was significantly associated with lower ESAS well-being scores (less symptoms) in patients with bone metastases only. In this same group, receiving treatment prior to diagnosis of metastases was significantly associated with increased fatigue, anxiety and dyspnoea. The presence of brain metastases was associated with higher physical well-being scores (increased QOL). Participation in clinical trials was associated with better QOL. CONCLUSION: Breast cancer patients with metastases have different SB and QOL in relation to the type of the metastases, treatment interventions and participation in clinical trials.

Breakthrough cancer pain: a comparison of surveys with European and Canadian patients.

INTRODUCTION: Breakthrough cancer pain is defined as a transient exacerbation of pain that occurs spontaneously or in response to a trigger, despite stable and controlled background pain. Breakthrough pain often causes significant functional impairments for patients and can decrease quality of life. OBJECTIVE: The objective of the study was to determine differences between breakthrough cancer pain incidence and management in Canada and Europe. METHODS: Data collected from previous studies of breakthrough cancer pain in Canada and Europe was compared. A standard survey with identical inclusion/exclusion criteria was utilized for both patient populations. RESULTS: Both groups of patients had a similar number and duration of breakthrough pain episodes, and similar pain intensity and pain interference with their daily activities. European patients reported better analgesic efficacy and satisfaction with management, and a greater percentage of European patients were prescribed a transmucosal fentanyl formulation (19.1 vs 2.9 %). More European patients (55 %) than Canadian patients (32.5 %) took their rescue medication every time they had a breakthrough pain episode. CONCLUSIONS: Breakthrough cancer pain in both Canadian and European patients greatly impacts their daily living, and both groups of patients had similar experiences with breakthrough cancer pain. Currently, this pain is not adequately managed for many patients. The role for new analgesic treatments in management of breakthrough cancer pain needs further study.

Validation of the long-term quality of life breast cancer scale (LTQOL-BC) by health care professionals.

INTRODUCTION: Quality of life has become an important measure of treatment success and is currently being explored not only for patients on active treatment, but also for long-term breast cancer survivors. The long-term quality of life breast cancer scale (LTQOL-BC) is a tool to assess QOL in breast cancer survivors. This study aimed to validate the tool with health care professionals (HCPs). METHODS: Six HCPs with extensive experience working with breast cancer survivors were selected. HCPs completed the LTQOL-BC and were asked to assess the relevance of each included item to the disease-free breast cancer population. They were also instructed to identify items that could be upsetting for patients, irrelevant to this population, and to assess the tool's breadth of coverage. RESULTS: Feedback indicated that some items such as the body image and sexual functioning questions were potentially upsetting to patients and should be rephrased or removed. The overall breadth of coverage of the tool was inadequate, with employment status, economic situation, ability to meet needs of family, health care insurance coverage, and overall sense of well-being not being addressed by the LTQOL-BC. HCPs also identified that certain items should be edited including those specifying pain in the lower body and the item containing the term "homemaker". CONCLUSION: The LTQOL-BC may need to be modified to take into the recommendations provided by HCPs.

Prophylactic dexamethasone effectively reduces the incidence of pain flare following spine stereotactic body radiotherapy (SBRT): a prospective observational study.

PURPOSE: The purpose of this study was to determine the incidence of pain flare (PF) in patients receiving spine stereotactic body radiotherapy (SBRT) treated with prophylactic oral dexamethasone (DEX) 1 h before and for 4 days following SBRT. METHODS: Forty-seven patients were accrued on this prospective observational study. The first cohort of 24 patients was treated with 4 mg, while a second cohort of 23 patients treated with 8 mg of DEX. The Brief Pain Inventory (BPI) was used to score pain and functional interference each day during SBRT and for 10 days following. Comparisons between the 4 and 8 mg cohorts, in addition to our previously reported steroid naïve patients post SBRT (n = 41), were also performed. RESULTS: The total incidence of PF was 19 % (9/47). The incidence in the 4 and 8 mg cohorts was 25 % (6/24) and 13 % (3/23), respectively, and the difference was not statistically significant (p = 0.46). Comparing functional interference, the 4 mg cohort had better profile in walking ability (p < 0.005) and relationships with others (p < 0.035) compared to the 8 mg cohort. Compared to our previously reported steroid naïve cohort, prophylactic DEX significantly reduced the incidence of PF (68 vs. 19 %, p < 0.0001, respectively), patients had lower worst pain scores, and improved general activity interference outcome. CONCLUSION: We recommend prophylactic DEX for patients treated with spine SBRT. Our current practice is based on the 4 mg protocol primarily due to the improved functional interference outcomes. A randomized trial is required to finalize the optimal regimen and schedule.

Minimal clinically important differences in the EORTC QLQ-BN20 in patients with brain metastases.

INTRODUCTION: Quality of life (QOL) is an important treatment endpoint in advanced cancer patients with brain metastases. In clinical trials, statistically significant changes can be reached in a large enough population; however, these changes may not be clinically relevant. OBJECTIVE: The objective of this study was to determine the minimal clinically important difference (MCID) for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire brain module (EORTC QLQ-BN20) in patients with brain metastases. METHODS: Patients undergoing radiotherapy for brain metastases completed the EORTC QLQ-BN20 and QLQ-C30/C15-PAL at baseline and 1-month follow-up. MCIDs were calculated for both improvement and deterioration using anchor- and distribution-based approaches. The anchor of overall QOL (as assessed by question 30 or question 15 on the QLQ-C30 and QLQ-C15-PAL, respectively) was used to determine meaningful change. RESULTS: A total of 99 patients were included. The average age was 61 years, and the most common primary cancer sites were the lung and breast. Statistically significant meaningful differences were seen on two scales. A decrease of 6.1 (95 % confidence interval (CI) 0.8 to 11.4) units and 13.8 (0.2 to 27.4) units was required to represent clinically relevant deterioration of seizures and weakness of legs, respectively. Distribution-based MCID estimates tended to be closer to 0.5 SD on the EORTC QLQ-BN20. CONCLUSION: Understanding MCIDs allows physicians to determine the impact of treatment on patients' QOL and allows for determination of sample sizes for clinical trials. Future studies should be conducted to validate our findings in a larger population of patients with brain metastases.

Symptom clusters of gastrointestinal cancer patients undergoing radiotherapy using the Functional Living Index-Emesis (FLIE) quality-of-life tool.

OBJECTIVE: The Functional Living Index-Emesis (FLIE) instrument is a validated nausea and vomiting specific quality of life (QOL) tool originally created as a 3-day test of the impact of chemotherapy-induced nausea and vomiting on cancer patients' daily life. The primary objective of the present study was to retrospectively explore the use of the FLIE from data obtained in a previously published study of patients with gastrointestinal radiation-induced nausea and vomiting (RINV) and compare the extracted symptom clusters on a weekly basis for the entirety of gastrointestinal cancer patients' radiotherapy treatments. METHODS: QOL was assessed on a weekly basis using the 18-item FLIE questionnaire for patients' radiotherapy treatments. A principal component analysis with varimax rotation was performed at each visit. The internal consistency and reliability of the derived clusters was assessed with Cronbach's alpha. Robust relationship and correlation among symptoms was displayed with biplot graphics. RESULTS: A total of 460 FLIE assessments were completed for the 86 gastrointestinal patients who underwent radiotherapy. Two components were consistently identified except for week 5 where only one component was identified. Component 1 contained the items "Q10-Q18" which included all vomiting items. Component 2 included all nausea items from "Q1 to Q9". All the variables were well accounted for by two components for most weeks of treatment with excellent internal consistency. Biplots indicate that the two symptom clusters were evident at each week, with the exception of the first week of treatment. Strong correlations were seen between the effect of nausea on patients' ability to make meals, patients' ability to do tasks within the home, and patients' willingness to spend time with family and friends. CONCLUSION: The high internal consistency at all timepoints indicates that the FLIE QOL instrument is useful for the RINV population.

Student Accomplishments in the Rapid Response Radiotherapy Program: A 10-Year Review.

In 1996, the Toronto Sunnybrook Regional Cancer Centre developed the Rapid Response Radiotherapy Program (RRRP). The objective of this clinic is to consult, simulate, plan, and treat patients with palliative radiotherapy on the same day. In 2004, the RRRP initiated a program to provide clinical and research experience to undergraduate students interested in health sciences. The purpose of this study is to review the 10-year (2004-2013) experience of the RRRP and to examine whether the goals of the student program have been met. Students who worked in the RRRP from 2004 to 2013 were contacted to complete a short survey regarding their overall experience with the program and their current endeavors. Student accomplishments were collected from an internal database as well as PubMed. Descriptive statistics were used to analyze results. A total of 54 students from ten postsecondary institutions have worked in the RRRP; 29 were from the University of Waterloo undergraduate co-op program. In total, 214 articles with first authorship from students were published, 93 (43%) of which can be found on PubMed. Other accomplishments include 40 book chapters, 58 invited presentations, and 99 awards cumulatively. Qualitative data regarding student perspectives of their experience in the RRRP were also analyzed. Over the past 10 years, the RRRP has achieved its goal of providing quality medical and research experience to students interested in the health sciences. Using the responses of past and present students, we hope to continue to shape our program and provide unique opportunities to future students.

A prospective study of gastrointestinal radiation therapy-induced nausea and vomiting.

OBJECTIVE: Nausea and vomiting are common side effects from radiotherapy that can interfere with gastrointestinal (GI) cancer patients' quality of life (QOL). A prospective study among patients with GI cancers was conducted to document the timing, incidence and risk factors of radiation therapy-induced nausea and vomiting (RINV). METHODS: Forty-eight patients planned to receive curative or palliative intent abdominal and/or pelvic radiotherapy alone or with concomitant chemoradiotherapy were followed prospectively. All episodes of nausea, vomiting, retching and antiemetic use were recorded daily for the entire treatment period and for the week following completion of therapy. QOL was assessed weekly using the Functional Living Index--Emesis Quality of Life Tool and the EORTC QLQ-C30 core questionnaire. RESULTS: Nausea occurred in 83 % of patients and emesis in 54 %. Pancreatic cancer was significantly correlated to higher proportions of nausea and emesis (p = 0.002 and p = 0.0003) compared to other primary sites. There were no significant difference between concomitant chemoradiotherapy and radiotherapy only patients for nausea and emesis. Patients had significantly greater proportions of RINV during the first, second and fifth weeks of treatment and during the first week following treatment. Vomiting was found to impair patients' usual recreation or leisure activities and enjoyment of their meals. Worse physical, role and social functioning and greater fatigue and appetite loss over the course of treatment correlated directly with the timing of RINV symptoms. CONCLUSION: RINV worsened QOL and was experienced even after treatment was completed; physicians should therefore be cognizant and monitor patients in the week following radiotherapy. Concomitant chemoradiotherapy should potentially be included in the moderate emetogenic risk category.

Psychometric validation of the functional assessment of cancer therapy--brain (FACT-Br) for assessing quality of life in patients with brain metastases.

OBJECTIVE: This study aimed to test the reliability, psychometric, and clinical validity of the use of the Functional Assessment of Cancer Therapy--Brain (FACT-Br) in patients with brain metastases. METHODS: Patients with brain metastases were interviewed using the FACT-Br (including the FACT-general) 1 week prior to treatment. All patients completed a follow-up assessment 1 month post-treatment. Patients with a good performance status and receiving stereotactic radiosurgery completed an additional 1 week follow-up assessment after the initial baseline interview to assess test-retest reliability. RESULTS: Forty patients had complete 1 month follow-up data. Ten of these patients also completed the 1 week follow-up assessment from baseline. The median Karnofsky performance status of patients was 80 and the median age was 64 years. All subscales of the FACT-Br were found to be conceptually related (except for two correlations) using the following subscales: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), FACT-G total score, brain cancer subscale (BrC), and the FACT-Br total score. All FACT-Br scores demonstrated excellent reliability, except for the SWB scale which revealed good reliability. The FACT-Br scores showed no significant change in the quality of life (QoL) of patients from baseline to 1 month follow-up. CONCLUSION: The use of the combined FACT-G and FACT-Br Subscale to assess QoL specifically in patients with brain metastases has successfully undergone psychometric validation. Future clinical trials should use the FACT-G and FACT-Br Subscale to assess QoL in this patient population.

The effects of denosumab on calcium profiles in advanced cancer patients with bone metastases.

OBJECTIVE: To retrospectively examine the incidence and management of hypocalcemia for patients with bone metastases treated with denosumab. METHODS: Patients who had a record of filling a prescription of denosumab for treatment of bone metastases at the outpatient pharmacy at the Odette Cancer Centre from May 2011 to February 2013 were included in the analysis. Demographic information, previous bisphosphonate usage, calcium and albumin values, and adverse events were obtained using the Sunnybrook Electronic Patient Record system (EPR) and the Oncology Symptom Control and Information Resource (OSCIR). Hypocalcemia was defined as a calcium value below 2.0 mmol/L within a 28-day±7-day window after the last injection of denosumab based on the Common Terminology Criteria for Adverse Events (CTCAE) grade 2 hypocalcemia. RESULTS: A total of 55 patients had record of a prescription for denosumab filled with an average age of 62 years (range 40 to 93 years), 18 (32.7%) were males and 37 (67.3%) were females. Twenty-nine (52.7%) patients had primary breast cancer, 12 (21.8%) prostate, 10 (18.2%) lung, and 4 (7.3%) with other types. Using CTCAE grading of hypocalcemia, 17 (32.7%) patients experienced grade 1, 4 (7.7%) patients grade 2, 4 (7.7%) patients grade 3, and 1 (1.9%) patient grade 4. The number of injections before the incident of hypocalcemia was a median of one injection (range 1 to 14). Time from the first hypocalcemia lab value to normocalcemia was a median of 33 days. CONCLUSIONS: This study found that 9 of 52 (17.3%) patients had at least one incidence of hypocalcemia of grade 2 or higher after receiving denosumab. Cautionary measures should be taken to avoid hypocalcemia in patients receiving denosumab.

Comparison of the EORTC QLQ-BN20 and the FACT-Br quality of life questionnaires for patients with primary brain cancers: a literature review.

PURPOSE: This review compares and contrasts the development, validity, and characteristics of two quality of life (QOL) assessment tools used in patients with primary brain cancers: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Brain Cancer Module (EORTC QLQ-BN20) and the Functional Assessment of Cancer Therapy-Brain (FACT-Br). METHODS: A literature search was conducted using the Cochrane Central Register of Controlled Trials (June 2013), Ovid EMBASE (1947 to 2013, week 27), and Ovid MEDLINE (1946 to July 2013, week 1) to identify studies that discussed the development, characteristics, validity, and reliability of the EORTC QLQ-BN20 or the FACT-Br. RESULTS: The EORTC QLQ-BN20 consists of 20 items that assess future uncertainty, visual disorder, motor dysfunction, and communication deficit. Items are presented as questions on a scale ranging from 1 = "not at all" to 4 = "very much." Reliability and validity testing of the QLQ-BN20 revealed a Cronbach's alpha coefficient that ranged from 0.71 to 0.90. The FACT-Br consists of 23 items that assess general well-being and brain cancer-specific concerns that include concentration, memory, seizures, eyesight, hearing, speech, personality, expression of thoughts, weakness, coordination, and headaches. These items are presented as statements on a scale ranging from 0 = "not applicable" to 4 = "extremely relevant." The FACT-Br underwent validity as well as test-retest reliability testing with 101 and 46 patients, respectively. Validity testing found low to moderate correlation with the FACT-G questionnaire, while reliability testing for the brain subscale revealed an acceptable correlation coefficient (r = 0.66; p < 0.001). CONCLUSIONS: The QLQ-BN20 and the FACT-Br are both valid and reliable tools that have been used extensively in the primary brain cancer population. Choice between the two tools should consider each instrument's individual strengths and weaknesses.

Fatigue scores in patients with brain metastases receiving whole brain radiotherapy.

PURPOSE: Whole brain radiotherapy (WBRT) is a treatment strategy used commonly to relieve burdensome symptoms and improve quality of life (QOL) in patients with multiple brain metastases. The purpose of this study is to determine changes in fatigue score following WBRT as it is a common symptom experienced in this population. METHODS: Fatigue and overall QOL scores were collected prospectively in patients for up to 3 months post-WBRT by several questionnaires at different times including the following: Edmonton Symptom Assessment System (ESAS), Brain Symptom and Impact Questionnaire (BASIQ), Spitzer Questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), EORTC brain module (EORTC QLQ-BN20+2), EORTC QLQ-C15-PAL, and Functional Assessment of Cancer Therapy-General (FACT-G). Questionnaires were grouped for analysis by Wilcoxon Signed Rank test according to the scale of ranking into 0-10, 1-4, and 0-4. RESULTS: Thirty-six patients were interviewed with the ESAS or BASIQ. The median age was 65 years old, and median Karnofsky Performance Status (KPS) was 70. There was a significant increase in fatigue score from baseline to month 1 (p=0.02), and months 2 and 3 had no significant change. There was a significant correlation between fatigue and overall QOL score at baseline and month 1 (p=0.01, p<0.0001), respectively. Two hundred and twenty-eight patients were surveyed with Spitzer, C15-PAL, BN20+2, QLQ-C30, or FACT-G. Median age was 64 years old and median KPS was 80. Compared to baseline, fatigue score was significantly higher at month 1 (p<0.0001) and month 2 (p=0.001), with no significant change at month 3. Significant correlation was found between fatigue and overall QOL at baseline, months 1, 2 (p<0.0001), and 3 (p=0.0009). For all groups, there was no significant change in fatigue score between patients with or without dexamethasone (Dx), except for the fatigue changed score of the group with scale 0-4. CONCLUSIONS: Fatigue was significantly increased from baseline to month 1 in all patients, and most patients experienced no difference in fatigue if they were receiving Dx. Increased fatigue was significantly related with decreased overall QOL.

Minimal clinically important differences in the brief pain inventory in patients with bone metastases.

PURPOSE: The brief pain inventory (BPI) is often used to assess pain and functional interference as a result of pain in cancer patients. Minor improvements or deteriorations in BPI may be statistically significant due to large sample sizes but may not necessarily be clinically relevant. The purpose of this study was to determine the minimal clinically important differences (MCID) in the functional BPI in patients with pain due to bone metastases. METHODS: BPI scores were collected from patients with painful bone metastases who visited the Rapid Response Radiotherapy Program for palliative radiotherapy. Pain and functional interferences scores were also collected monthly for three months. Patients were categorized into "complete or partial response," "pain progression," and "indeterminate response" based on their pain scores as recommended by the latest consensus definitions. Anchor-based determination of MCIDs of functional interference scores was calculated by determining the difference between the mean follow-up scores and the mean baseline scores for patients from each of the three response groups. Distribution-based estimates were obtained utilizing 0.2, 0.3, and 0.5 standard deviation (SD) effect sizes and the standard error of measurement. The anchor-based method results were compared with the distribution-based method results. RESULTS: Statistically significant MCIDs were determined for all of the functional interference items of BPI for patients with "complete or partial response"; whereas, no statistically significant MCIDs in BPI scores could be determined for patients with "pain progression." Some of the functional interference items of BPI had statistically significant MCIDs for patients with "indeterminate response," although these were generally smaller than patients with complete or partial response. Using the distribution-based approach, an effect size of 0.5 SD was the closest estimate for determining the MCID for both patients with complete or partial response and those with indeterminate response. CONCLUSIONS: The MCIDs determined for pain improvement were rather large, where as statistically significant MCIDs could not be detected for pain deterioration. Knowledge of MCIDs utilizing the BPI will allow physicians to evaluate the impact of treatment (or no treatment) on a patient's functional abilities. Knowledge of MCIDs may allow for sample size determination in future clinical trials.

A survey of Canadian cancer patients' perspectives on the characteristics and treatment of breakthrough pain.

OBJECTIVE: Breakthrough pain is defined as a transient exacerbation of pain that occurs spontaneously or in response to a trigger despite stable and controlled background pain. The purpose of this study was to explore Canadian patients' awareness of and experience with breakthrough pain in cancer (BTPc). METHODS: Four Canadian cancer centers participated in a non-interventional survey recruiting cancer patients who experienced breakthrough pain. These patients were asked about their pain, its impact on functioning, current management and interest in new treatments of BTPc. RESULTS: Ninety-four Canadian cancer patients participated in this study, with 96% stating that cancer pain impacted their daily living with over half unable to go to work or shopping. Fifty percent of patients said that an episode of BTPc lasted greater than 60 minutes, with the pain score being on average 7.8/10, impacting normal work (7.2/10) and general activity (7.1/10). Only 35% of patients were very satisfied with the speed of relief of their medications. Those who did not take their breakthrough pain medication for every episode stated that was because the pain was not always severe (37%), or they were afraid of becoming tolerant (23%) or addicted (12%). Patients stated that the most important features of a new treatment for BTPc were the ability to relieve pain completely (47%), and quickly (43%). Patients expressed willingness to try transmucosal products (80%) or nasal products (59%). CONCLUSION: Breakthrough cancer pain in Canadian cancer patients greatly impacts their daily lives. There is room for improvement in the management of BTPc, and the majority of patients would be willing to try new treatments.

Predictive factors for overall quality of life in patients with advanced cancer.

OBJECTIVE: This study examined which domains/symptoms from the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 15 Palliative (QLQ-C15-PAL), an abbreviated version of the health-related EORTC QLQ-C30 questionnaire designed for palliative cancer patients, were predictive of overall quality of life (QOL) in advanced cancer patients. METHODS: Patients with advanced cancer from six countries completed the QLQ-C15-PAL at consultation and at one follow-up point. Univariate and multivariate regression analyses were conducted to determine the predictive value of the EORTC QLQ-C15-PAL functional/symptom scores for global QOL (question 15). RESULTS: Three hundred forty-nine patients completed the EORTC QLQ-C15-PAL at baseline. In the total patient sample, worse emotional functioning, pain, and appetite loss were the most significant predictive factors for worse QOL. In the subgroup of patients with bone metastases (n = 240), the domains mentioned above were also the most significant predictors, whereas in patients with brain metastases (n = 109), worse physical and emotional functioning most significantly predicted worse QOL. One-month follow-up in 267 patients revealed that the significant predictors changed somewhat over time. For example, in the total patient sample, physical functioning, fatigue, and appetite loss were significant predictors at the follow-up point. A sub-analysis of predictive factors affecting QOL by primary cancer (lung, breast, and prostate) was also conducted for the total patient sample. CONCLUSION: Deterioration of certain EORTC QLQ-C15-PAL functional/symptom scores significantly contributes to worse overall QOL. Special attention should be directed to managing factors most influential on overall QOL to ensure optimal management of advanced cancer patients.

Determinants of quality of life in advanced cancer patients with bone metastases undergoing palliative radiation treatment.

PURPOSE: Assessment of health-related quality of life (HRQOL) is critical to effective delivery of palliative care in patients with advanced cancer. The current study analyzes relationships between baseline social determinants of health and medical factors, and self-reported HRQOL in patients with bone metastases receiving palliative radiotherapy. METHODS AND MATERIALS: Advanced cancer patients referred for radiotherapy treatment of bone metastases completed the EORTC QLQ-C30 questionnaire in multiple outpatient clinics internationally. Demographics and social determinants were collected as baseline information. Univariate and Bonferroni-adjusted multivariate linear regression analyses were used to detect significant correlations between baseline determinants and different HRQOL domains. RESULTS: Karnofsky Performance Status (KPS) was correlated with better physical (p = 0.0002), role (p < 0.0001), emotional (p < 0.0001), and social (p < 0.0001) functioning, and global health scores (p = 0.0015) and predicted lower symptom scores for fatigue (p < 0.0001), pain (p < 0.0001), appetite loss (p < 0.0001), and constipation (p < 0.0001). Increased age was predictive of better social functioning (p < 0.0001) and less insomnia (p = 0.0036), higher education correlated with better global health status (p = 0.0043), and patients who were employed or retired had improved physical functioning (p = 0.0004 and p = 0.0030, respectively) and less financial challenges compared to patients who were unemployed (p = 0.0005). CONCLUSIONS: Baseline KPS had the greatest influence on EORTC QLQ-C30 domain scores. Age, education level, and employment status had significant impacts, although on fewer domains. Further studies that investigate baseline determinants are worthwhile to clarify relationships in order to care for patients more effectively at the end of life.