Advancing the Care Experience for patients receiving Palliative care as they Transition from hospital to Home (ACEPATH): Codesigning an intervention to improve patient and family caregiver experiences.

BACKGROUND: Returning home from the hospital for palliative-focused care is a common transition, but the process can be emotionally distressing and logistically challenging for patients and caregivers. While interventions exist to aid in the transition, none have been developed in partnership with patients and caregivers. OBJECTIVE: To undergo the initial stages of codesign to create an intervention (Advancing the Care Experience for patients receiving Palliative care as they Transition from hospital to Home [ACEPATH]) to improve the experience of hospital-to-home transitions for adult patients receiving palliative care and their caregiver(s). METHODS: The codesign process consisted of (1) the development of codesign workshop (CDW) materials to communicate key findings from prior research to CDW participants; (2) CDWs with patients, caregivers and healthcare providers (HCPs); and (3) low-fidelity prototype testing to review CDW outputs and develop low-fidelity prototypes of interventions. HCPs provided feedback on the viability of low-fidelity prototypes. RESULTS: Three patients, seven caregivers and five HCPs participated in eight CDWs from July 2022 to March 2023. CDWs resulted in four intervention prototypes: a checklist, quick reference sheets, a patient/caregiver workbook and a transition navigator role. Outputs from CDWs included descriptions of interventions and measures of success. In April 2023, the four prototypes were presented in four low-fidelity prototype sessions to 20 HCPs. Participants in the low-fidelity prototype sessions provided feedback on what the interventions could look like, what problems the interventions were trying to solve and concerns about the interventions. CONCLUSION: Insights gained from this codesign work will inform high-fidelity prototype testing and the eventual implementation and evaluation of an ACEPATH intervention that aims to improve hospital-to-home transitions for patients receiving a palliative approach to care. PATIENT OR PUBLIC CONTRIBUTION: Patients and caregivers with lived experience attended CDWs aimed at designing an intervention to improve the transition from hospital to home. Their direct involvement aligns the intervention with patients' and caregivers' needs when transitioning from hospital to home. Furthermore, four patient/caregiver advisors were engaged throughout the project (from grant writing through to manuscript writing) to ensure all stages were patient- and caregiver-centred.

Long-term bereavement outcomes in family members of those who died in acute care hospitals before and during the first wave of COVID-19: A cohort study.

BACKGROUND: Severe grief is highly distressing and prevalent up to 1 year post-death among people bereaved during the first wave of COVID-19, but no study has assessed changes in grief severity beyond this timeframe. AIM: Understand the trajectory of grief during the pandemic by reassessing grief symptoms in our original cohort 12-18 months post-death. DESIGN: Prospective matched cohort study. SETTINGS/PARTICIPANTS: Family members of decedents who died in an acute care hospital between November 1, 2019 and August 31, 2020 in Ottawa, Canada. Family members of patients who died of COVID (COVID +ve) were matched 2:1 with those who died of non-COVID illness (COVID -ve) during pandemic wave 1 or immediately prior to its onset (pre-COVID). Grief was assessed using the Inventory of Complicated Grief (ICG). RESULTS: Follow-up assessment was completed by 92% (111/121) of family members in the initial cohort. Mean ICG score on the 12-18-month assessment was 19.9 (SD = 11.8), and severe grief (ICG > 25) was present in 28.8% of participants. One-third (33.3%) had either a persistently high (>25) or worsening ICG score (⩾4-point increase between assessments). Using a modified Poisson regression analysis, persistently high or worsening ICG scores were associated with endotracheal intubation in the deceased, but not cause of death (COVID +ve, COVID -ve, pre-COVID) or physical presence of the family member in the final 48 h of life. CONCLUSIONS: Severe grief is a substantial source of psychological morbidity in the wake of the COVID-19 pandemic, persisting more than a year post-death. Our findings highlight an acute need for effective and scalable means of addressing severe grief.

Comorbidities, symptoms and end-of-life medication use in hospitalised decedents before and during the COVID-19 pandemic: a retrospective regional cohort study in Ottawa, Canada.

OBJECTIVE: To compare comorbidities, symptoms and end-of-life (EoL) palliative medication (antisecretories, opioids, antipsychotics and sedatives) use among decedents before and during the COVID-19 pandemic. DESIGN: In a retrospective cohort study, decedent records in three acute care hospitals were abstracted, generating a prepandemic (November 2019-February 2020) group (pre-COVID) and two intrapandemic (March-August 2020, wave 1) groups, one without (COVID-ve) and one with COVID-19 infection (COVID+ve). Control group decedents were matched 2:1 on age, sex and care service (medicine/intensive care unit (ICU)) with COVID+ve decedents. SETTING: Three regional acute care teaching hospitals in Ottawa, Canada PARTICIPANTS: Decedents (N=425): COVID+ve (n=85), COVID-ve (n=170) and pre-COVID (n=170). MAIN OUTCOME MEASURES: Data were abstracted regarding demographics, admission comorbidities and symptoms, and EoL medication use; opioid doses were standardised to parenteral morphine equivalent daily dose (MEDD), and the predictors of upper quartile MEDD in the last 24 hours of life were examined in multivariable logistic regression with adjusted ORs (aORs) and 95% CIs. RESULTS: The prevalence of dementia (41% vs 28% and 26%, p=0.03), breathlessness (63.5% vs 42% and 47%, p<0.01), cough (40% vs 27% and 19%, p<0.01) and fever (54% vs 9% and 13.5%) was higher in COVID+ve versus pre-COVID and COVID-ve groups, respectively. The median (IQR) of MEDD over the last 72 hours of life was 16.7 (9-36.5) vs 13.5 (5.7-21.8) and 10.5 (5.3-23.8) for COVID+ve versus pre-COVID and COVID-ve groups, respectively, (p=0.007). Male sex, COVID+ve grouping, ICU death and high-flow nasal cannula use predicted upper quartile MEDD dose, aORs (95% CIs): 1.84 (1.05 to 3.22), 2.62 (1.29 to 5.3), 5.14 (2.47 to 10.7) and 1.93 (1.05 to 3.52), respectively. COVID+ve group decedents used highest lorazepam and propofol doses. CONCLUSIONS: COVID-19 decedents, particularly those in ICU, required higher EoL opioid and sedating medication doses than matched prepandemic or intrapandemic controls. These findings should inform and guide clinical practice.

Bereavement outcomes in family members of those who died in acute care hospitals before and during the first wave of COVID-19: A cohort study.

BACKGROUND: The COVID-19 pandemic has caused millions of deaths worldwide, leading to symptoms of grief among the bereaved. Neither the burden of severe grief nor its predictors are fully known within the context of the pandemic. AIM: To determine the prevalence and predictors of severe grief in family members who were bereaved early in the COVID-19 pandemic. DESIGN: Prospective, matched cohort study. SETTING/PARTICIPANTS: Family members of people who died in an acute hospital in Ottawa, Canada between November 1, 2019 and August 31, 2020. We matched relatives of patients who died of COVID (COVID +ve) with those who died of non-COVID illness either during wave 1 of the pandemic (COVID -ve) or immediately prior to its onset (pre-COVID). We abstracted decedents' medical records, contacted family members >6 months post loss, and assessed grief symptoms using the Inventory of Complicated Grief-revised. RESULTS: We abstracted data for 425 decedents (85 COVID +ve, 170 COVID -ve, and 170 pre-COVID), and 110 of 165 contacted family members (67%) consented to participate. Pre-COVID family members were physically present more in the last 48 h of life; the COVID +ve cohort were more present virtually. Overall, 35 family members (28.9%) had severe grief symptoms, and the prevalence was similar among the cohorts (p = 0.91). Grief severity was not correlated with demographic factors, physical presence in the final 48 h of life, intubation, or relationship with the deceased. CONCLUSION: Severe grief is common among family members bereaved during the COVID-19 pandemic, regardless of the cause or circumstances of death, and even if their loss took place before the onset of the pandemic. This suggests that aspects of the pandemic itself contribute to severe grief, and factors that normally mitigate grief may not be as effective.

Adaptation, implementation, and mixed methods evaluation of an interprofessional modular clinical practice guideline for delirium management on an inpatient palliative care unit.

BACKGROUND: Using delirium clinical guidelines may align interprofessional clinical practice and improve the care of delirious patients and their families. The aim of this project was to adapt, implement and evaluate an interprofessional modular delirium clinical practice guideline for an inpatient palliative care unit. METHODS: The setting was a 31-bed adult inpatient palliative care unit within a university-affiliated teaching hospital. Participants for the evaluation were interprofessional team members. Using integration of guideline adaptation and an education initiative, an interprofessional guideline adaptation group developed a face-to-face 'starter kit' module and four online self-learning modules. The mixed methods evaluation comprised pre-and post-implementation review of electronic patient records, an online survey, and analysis of focus groups/ interviews using an iterative, inductive thematic analysis approach. RESULTS: Guideline implementation took 12 months. All palliative care unit staff attended a 'starter kit' session. Overall completion rate of the four e-Learning modules was 80.4%. After guideline implementation, nursing documentation of non-pharmacological interventions occurring before medication administration was observed. There was 60% less scheduled antipsychotic use and an increase in 'as needed' midazolam use. The online survey response rate was 32% (25/77). Most participants viewed the guideline's implementation favourably. Six key themes emerged from the qualitative analysis of interviews and focus groups with ten participants: prior delirium knowledge or experiences, challenges of facilitating change, impacts on practice, collaborative effort of change, importance of standardized guidelines, and utility of guideline elements. CONCLUSIONS: Guideline implementation warrants concerted effort, time, and management support. Interprofessional team support facilitates the modular approach of guideline adaptation and implementation, leading to a change in clinical practice.

Comparative end-of-life communication and support in hospitalised decedents before and during the COVID-19 pandemic: a retrospective regional cohort study in Ottawa, Canada.

OBJECTIVE: To compare end-of-life in-person family presence, patient-family communication and healthcare team-family communication encounters in hospitalised decedents before and during the COVID-19 pandemic. DESIGN: In a regional multicentre retrospective cohort study, electronic health record data were abstracted for a prepandemic group (pre-COVID) and two intrapandemic (March-August 2020, wave 1) groups, one COVID-19 free (COVID-ve) and one with COVID-19 infection (COVID+ve). Pre-COVID and COVID-ve groups were matched 2:1 (age, sex and care service) with the COVID+ve group. SETTING: One quaternary and two tertiary adult, acute care hospitals in Ottawa, Canada. PARTICIPANTS: Decedents (n=425): COVID+ve (n=85), COVID-ve (n=170) and pre-COVID (n=170). MAIN OUTCOME MEASURES: End-of-life (last 48 hours) in-person family presence and virtual (video) patient-family communication, and end-of-life (last 5 days) virtual team-family communication encounter occurrences were examined using logistic regression with ORs and 95% CIs. End-of-life (last 5 days) rates of in-person and telephone team-family communication encounters were examined using mixed-effects negative binomial models with incidence rate ratios (IRRs) and 95% CIs. RESULTS: End-of-life in-person family presence decreased progressively across pre-COVID (90.6%), COVID-ve (79.4%) and COVID+ve (47.1%) groups: adjusted ORs=0.38 (0.2-0.73) and 0.09 (0.04-0.17) for COVID-ve and COVID+ve groups, respectively. COVID-ve and COVID+ve groups had reduced in-person but increased telephone team-family communication encounters: IRRs=0.76 (0.64-0.9) and 0.61 (0.47-0.79) for in-person, and IRRs=2.6 (2.1-3.3) and 4.8 (3.7-6.1) for telephone communications, respectively. Virtual team-family communication encounters occurred in 17/85 (20%) and 10/170 (5.9%) of the COVID+ve and COVID-ve groups, respectively: adjusted OR=3.68 (1.51-8.95). CONCLUSIONS: In hospitalised COVID-19 pandemic wave 1 decedents, in-person family presence and in-person team-family communication encounters decreased at end of life, particularly in the COVID+ve group; virtual modalities were adopted for communication, and telephone use increased in team-family communication encounters. The implications of these communication changes for the patient, family and healthcare team warrant further study.

Learner Experiences Matter in Interprofessional Palliative Care Education: A Mixed Methods Study.

CONTEXT: Interprofessional collaboration is needed in palliative care and many other areas in health care. Pallium Canada's two-day interprofessional Learning Essential Approaches to Palliative care Core courses aim to equip primary care providers from different professions with core palliative care skills. OBJECTIVES: Explore the learning experience of learners from different professions who participated in Learning Essential Approaches to Palliative care Core courses from April 2015 to March 2017. METHODS: This mixed methods study was designed as a secondary analysis of existing data. Learners had completed a standardized course evaluation survey online immediately post-course. The survey explored the learning experience across several domains and consisted of seven closed ended (Likert Scales; 1 = "Total Disagree", 5 = "Totally Agree") and three open-ended questions. Quantitative data were analyzed using descriptive statistics and Kruskal-Wallis non-parametric test tests, and qualitative data underwent thematic analysis. RESULTS: During the study period, 244 courses were delivered; 3045 of 4636 participants responded (response rate 66%); physicians (662), nurses (1973), pharmacists (74), social workers (80), and other professions (256). Overall, a large majority of learners (96%) selected "Totally Agree" or "Agree" for the statement "the course was relevant to my practice". A significant difference was noted across profession groups; X2 (4) = 138; p < 0.001. Post-hoc analysis found the differences to exist between physicians and pharmacists (X2 = -4.75; p < 0.001), and physicians and social workers (X2 = -6.63; p < 0.001). No significant differences were found between physicians and nurses (X2 = 1.31; p = 1.00), and pharmacists and social workers (X2 = -1.25; p = 1.00). Similar results were noted for five of the other statements. CONCLUSION: Learners from across profession groups reported this interprofessional course highly across several learning experience parameters, including relevancy for their respective professions. Ongoing curriculum design is needed to fully accommodate the specific learning needs of some of the professions.

Acculturation and Perceptions of a Good Death Among Japanese Americans and Japanese Living in the U.S.

CONTEXT: Acculturation is the phenomenon of the attitudinal changes of individuals who come into continuous contact with another culture. Despite the long history of Japanese immigration to America, little is known about the impact of acculturation on perceptions of a good death. OBJECTIVES: To examine differences in perceptions of a good cancer death among Japanese Americans (JA/A), Japanese living in America (J/A), and the Japanese living in Japan (J/J). METHODS: We administered surveys among JA/A and J/A and used historical J/J data for reference. Primary endpoint was the proportion of respondents who expressed the necessity of core and optional items of the Good Death Inventory. Group differences ≥20% were deemed clinically important. RESULTS: In total, 441 survey responses in America and 2548 in Japan were obtained. More than 80% of respondents consistently considered nine of 10 core items necessary without significant group differences. No core item reached a ≥20% group difference. Three of the eight optional items reached ≥20% group difference: fighting against disease until one's last moment (49%, P < 0.0001; 52%, P < 0.0001; and 73% in JA/A, J/A, and J/J, respectively), knowing what to expect about one's condition in the future (83%, P < 0.0001; 80%, P < 0.0001; and 58%, respectively), and having faith (64%, P = 0.0548; 43%, P = 0.0127; and 38%, respectively). CONCLUSION: Although most core items of a good death were preserved throughout the levels of acculturation, perceptions of some optional items shifted away from Japanese attitudes as individuals became more acculturated. Understanding of different levels of acculturation may help clinicians provide culturally sensitive end-of-life care.

The effects of curcumin (diferuloylmethane) on body composition of patients with advanced pancreatic cancer.

BACKGROUND: Curcumin is a natural product that is often explored by patients with cancer. Weight loss due to fat and muscle depletion is a hallmark of pancreatic cancer and is associated with worse outcomes. Studies of curcumin's effects on muscularity show conflicting results in animal models. METHODS AND RESULTS: Retrospective matched 1:2 case-control study to evaluate the effects of curcumin on body composition (determined by computerized tomography) of 66 patients with advanced pancreatic cancer (22 treated,44 controls). Average age (SEM) was 63(1.8) years, 30/66(45%) women, median number of prior therapies was 2, median (IQR) time from advanced pancreatic cancer diagnosis to baseline image was 7(2-13.5) months (p>0.2, all variables). All patients lost weight (3.3% and 1.3%, treated vs. control, p=0.13). Treated patients lost more muscle (median [IQR] percent change -4.8[-9.1,-0.1] vs. -0.05%[-4.2, 2.6] in controls,p<0.001) and fat (median [IQR] percent change -6.8%[-15,-0.6] vs. -4.0%[-7.6, 1.3] in controls,p=0.04). Subcutaneous fat was more affected in the treated patients. Sarcopenic patients treated with curcumin(n=15) had survival of 169(115-223) days vs. 299(229-369) sarcopenic controls(p=0.024). No survival difference was found amongst non-sarcopenic patients. CONCLUSIONS: Patients with advanced pancreatic cancer treated with curcumin showed significantly greater loss of subcutaneous fat and muscle than matched untreated controls.

[Information disclosure and decision making preferences of patients with advanced cancer in a Pain and Palliative Care Unit in Chile]. / ¿Cuánta información desean recibir y cómo prefieren tomar sus decisiones pacientes con cáncer avanzado atendidos en una Unidad del Programa Nacional de Dolor y Cuidados Paliativos en Chile?

UNLABELLED: Information disclosure and decision making process are important steps in advanced cancer patients management; however, there is no research done in this area in Chile. AIMS: To know the preferences of patients with advanced cancer related to information disclosure and style of decision making process. METHODS: Prospective observational study with patients in the Palliative Care Unit of Sótero del Río Hospital, in Santiago, Chile. The preferences were evaluated with a Disclosure Information and a Decision Making Preferences Questionnaire. RESULTS: 100 patients were recruited, 52% males, average age 63 years; 90% wanted to receive complete information about diagnosis and 89% complete information about prognosis. The preferences related to decision making process style were: 60% shared, 27% passive and 13% active. The expressed satisfaction with the information received was 89% and 87% with the way decisions were actually made. CONCLUSIONS: A majority of patients preferred to receive complete information about diagnosis and prognosis and to make shared decisions. The satisfaction with information disclosure and decision making process was very high. The data of this study supports the need of an adequate information disclosure and of exploring the individual preferences of our patients, with the goal of promoting an informed decision making process that respects the preferences of our patients.

¿Cuánta información desean recibir y cómo prefieren tomar sus decisiones pacientes con cáncer avanzado atendidos en una Unidad del Programa Nacional de Dolor y Cuidados Paliativos en Chile? / Information disclosure and decision making preferences of patients with advanced cancer in a Pain and Palliative Care Unit in Chile

Information disclosure and decision making process are important steps in advanced cancer patients management; however, there is no research done in this area in Chile. Aims: To know the preferences of patients with advanced cancer related to information disclosure and style of decision making process. Methods: Prospective observational study with patients in the Palliative Care Unit of Sótero del Río Hospital, in Santiago, Chile. The preferences were evaluated with a Disclosure Information and a Decision Making Preferences Questionnaire. Results: 100 patients were recruited, 52% males, average age 63 years; 90% wanted to receive complete information about diagnosis and 89% complete information about prognosis. The preferences related to decision making process style were: 60% shared, 27% passive and 13% active. The expressed satisfaction with the information received was 89% and 87% with the way decisions were actually made. Conclusions: A majority of patients preferred to receive complete information about diagnosis and prognosis and to make shared decisions. The satisfaction with information disclosure and decision making process was very high. The data of this study supports the need of an adequate information disclosure and of exploring the individual preferences of our patients, with the goal of promoting an informed decision making process that respects the preferences of our patients.

Decisional control preferences, disclosure of information preferences, and satisfaction among Hispanic patients with advanced cancer.

CONTEXT: Studies to determine the decisional control preferences (DCPs) in Hispanic patients receiving palliative care are limited. OBJECTIVES: The aims of this study were to describe DCPs, disclosure of information, and satisfaction with decision making among Hispanics and to determine the degree of concordance between patients' DCPs and their self-reported decisions. METHODS: We surveyed 387 cancer patients referred to outpatient palliative care clinics in Argentina, Chile, Guatemala, and the U.S. DCPs were measured with the Control Preference Scale, disclosure preferences with the Disclosure of Information Preferences questionnaire, and satisfaction with care with the Satisfaction with Decision Scale. RESULTS: In this study, 182 patients (47.6%) preferred shared decisional control, 119 (31.2%) preferred active decisional control, and 81 (21.2%) preferred a passive approach. Concerning their diagnosis and prognosis, 345 (92%) patients wanted to know their diagnosis, and 355 (94%) wanted to know their prognosis. Three hundred thirty-seven (87%) patients were satisfied with the decision-making process. DCPs were concordant with the self-reported decision-making process in 264 (69%) patients (weighted kappa = 0.55). Patients' greater satisfaction with the decision-making process was correlated with older age (P ≤ 0.001) and with a preference for enhanced diagnostic disclosure (P ≤ 0.024). Satisfaction did not correlate with concordance in the decision-making process. CONCLUSION: The vast majority preferred a shared or active decision-making process and wanted information about their diagnosis and prognosis. Older patients and those who wanted to know their diagnosis seemed to be more satisfied with the way treatment decisions were made.

A pilot study of temsirolimus and body composition.

PURPOSE: Body weight and composition play a role in cancer etiology, prognosis, and treatment response. Therefore, we analyzed the weight, body composition changes, and outcome in patients treated with temsirolimus, an mTor inhibitor that has weight loss as one of its side effects. PATIENTS AND METHODS: Sixteen patients with advanced solid tumors treated with temsirolimus were studied; body composition was evaluated utilizing computerized tomography images. Sarcopenia was defined as skeletal muscle index lower than 38.5 cm(2)/m(2) for women and 52.4 cm(2)/m(2) for men. RESULTS: Five of 16 patients (31 %) were men; median age, 60 years. Forty-four percent (7/16) of patients were sarcopenic. Fatigue, anemia, hyperglycemia, and hyperlipidemia were common. Baseline sarcopenia and body composition did not correlate with worse toxicity or treatment outcome. However, there was a trend for greater loss of adipose area (p = 0.07), fat mass (p = 0.09), and adipose index (p = 0.07) for patients with grade 3 or 4 toxicities versus those with grade 1 and 2 side effects. CONCLUSION: Patients with higher grade toxicities tended to lose more body fat, suggesting a possible end-organ metabolic effect of temsirolimus. These observations merit exploration in a larger cohort of patients.

A multicenter survey of Hispanic caregiver preferences for patient decision control in the United States and Latin America.

BACKGROUND: Understanding family caregivers' decisional role preferences is important for communication, quality of care, and patient and family satisfaction. The family caregiver has an important role in a patient's decisional role preferences. There are limited studies on family caregivers' preferences of the patient's decision control at the end of life among Hispanics. AIMS: To identify Hispanic caregivers' preferences of the decision control of patients with advanced cancer and to compare the preferences of caregivers in Hispanic Latin American and Hispanic American caregivers. DESIGN: We surveyed patients and their family caregivers referred to outpatient palliative care clinics in the United States, Chile, Argentina, and Guatemala. Caregiver preferences of patient's decision control were evaluated using the Control Preference Scale. Caregivers' and patients' sociodemographic variables, patient performance status, and Hispanic American patient acculturation level were also collected. PARTICIPANTS: A total of 387 caregivers were surveyed: 100 (26%) in Chile, 99 (26%) in Argentina, 97 (25%) in Guatemala, and 91 (24%) in the United States. The median age was 56 years, and 59% were female. RESULTS: Caregiver preference of patient's decision control was passive, shared, and active for 10 (11%), 45 (52%), and 32 (37%) Hispanic American caregivers and 54 (19%), 178 (62%), and 55 (19%) Hispanic Latin American caregivers (p = 0.0023), respectively. Caregiver acculturation level did not affect the preferences of the Hispanic American sample (p = 0.60). CONCLUSIONS: Most Hispanic family caregivers preferred the patient to make shared decisions. Hispanic Latin American caregivers more frequently preferred patients to assume a passive decisional role. Acculturation did not influence the preferences of Hispanic American caregivers.

Frequency and predictors of patient deviation from prescribed opioids and barriers to opioid pain management in patients with advanced cancer.

CONTEXT: Approximately 80% of patients with advanced cancer report pain and receive opioids. Information is limited about deviations from prescribed opioid doses and barriers to pain control, but poor opioid adherence has been reported in 49%-70% of patients. OBJECTIVES: To evaluate the frequency and severity of self-reported opioid deviation and barriers to opioid pain management in outpatients with advanced cancer. METHODS: We surveyed 198 patients and collected pain scores (0-10), prescribed opioid dose, confidential patient-reported opioid prescription dose and intake (as long as there was no severe opioid deviation), barriers to pain management (Barriers Questionnaire-II [BQ-II]) scores, and adherence scores. Opioid deviation was defined as <70% or >130% of the prescribed dose. RESULTS: Median patient age was 55 years; 91 (46%) were female. Median pain intensity and morphine equivalent daily dose were 4 (interquartile range=3-7) and 120mg (interquartile range=45-270mg), respectively. Prescribed and patient-reported prescribed doses were highly correlated for regular (r=0.90, P<0.001) and regular plus breakthrough opioid intake (r=0.94, P<0.001). Nineteen (9.6%) patients deviated. Deviation was more frequent in males (P=0.039) and nonwhites (P=0.0270). Nonwhite patients had higher scores on the BQ-II than white patients (P=0.038). Low adherence scores were significantly associated with higher BQ-II scores (1.99±0.80) for lower motivation score vs. 1.61±0.77 for higher score, P=0.007; and 2.13±0.79 for lower knowledge score vs. 1.57±0.72 for higher score, P=0.001. CONCLUSION: Very few patients reported dose deviations, which were mostly toward lower dose. More research is necessary to better characterize the frequency and predictors of opioid deviation in this population.

Spirituality, religiosity, and spiritual pain among caregivers of patients with advanced cancer.

BACKGROUND: Caregivers of patients with advanced cancer often face physical, social, and emotional distress as well as spiritual pain. Limited research has focused on the spiritual aspects of caregivers' suffering in the palliative care setting. METHODS: We interviewed 43 caregivers of patients with advanced cancer in our palliative care outpatient clinic. We determined demographic characteristics, religious affiliation, and relationship to the patient. Levels of spirituality, religiosity, and spiritual pain were self-reported using numeric rating scales (0 = lowest; 10 = highest). The participants completed various validated questionnaires to assess sleep disturbances, psychosocial distress, coping skills, and quality of life (QOL). RESULTS: The median age was 52 years (range, 21-83); 29 (67%) were women, 34 (78%) were white, 7 (17%) were African American, and 2 (5%) were Hispanic; 39 (91%) were Christian, 1 (2%) was Jewish, and 1 (2%) was agnostic; 37 (86%) were married; 18 (42%) were working full time; and 25 (58%) were spouses. All considered themselves spiritual, and 98% considered themselves religious, with median scores of 8 (interquartile range, 6-10) and 8 (interquartile range, 4-9), respectively. All the caregivers reported that spirituality and religiosity helped them cope with their loved one's illness, and many reported that spirituality and religiosity had a positive impact on their loved one's physical (58%) and emotional (76%) symptoms. Spiritual pain was reported by 23 (58%), with a median score of 5 (interquartile range, 2-8). Caregivers with spiritual pain had higher levels of anxiety (median 10 vs 4; P = .002), depression (6 vs 2; P = .006), and denial (3 vs 2; P = .01); more behavioral disengagement (3 vs 2; P = 0.011) more dysfunctional coping strategies (19 vs 16; P < .001) and worse QOL (70 vs 51; P < .001) than those who did not have spiritual pain. CONCLUSIONS: The majority of caregivers of patients with advanced cancer considered themselves spiritual and religious. Despite this, there is high prevalence of spiritual pain in this population. Caregivers with spiritual pain experienced worse psychological distress and worse QOL. These findings support the importance of spiritual assessment of and spiritual support for caregivers in this setting.

Decisional control preferences of Hispanic patients with advanced cancer from the United States and Latin America.

CONTEXT: Understanding cancer patients' preferences in decisional roles is important in providing quality care and ensuring patient satisfaction. There is a lack of evidence on decisional control preferences (DCPs) of Hispanic Americans, the fastest growing population in the U.S. OBJECTIVES: The primary aims of this study were to describe DCPs of Hispanics with advanced cancer in the U.S. (HUSs) and compare the frequency of passive DCPs in this population with that of Hispanics with advanced cancer in Latin America (HLAs). METHODS: We conducted a prospective survey of patients with advanced cancer referred to outpatient palliative care clinics in the U.S., Chile, Argentina, and Guatemala. Information was collected on sociodemographic variables, Karnofsky Performance Scale scores, acculturation (Marin Acculturation Assessment Tool), and DCP (Control Preference Scale). Chi-square tests were used to determine the differences in DCPs between HUSs and HLAs. RESULTS: A total of 387 patients were surveyed: 91 in the U.S., 100 in Chile, 94 in Guatemala, and 99 in Argentina. The median age of HUSs was 56 years, 59% were female, and the median Karnofsky Performance Scale score was 60; the corresponding values for HLAs were 60 years, 60%, and 80. HLAs used passive DCP strategies significantly more frequently than HUSs did with regard to the involvement of the family (24% vs. 10%; P=0.009) or the physician (35% vs. 16%; P<0.001), even after age and education were controlled for. Eighty-three percent of HUSs and 82% of HLAs preferred family involvement in decision making (P=non-significant). No significant differences were found in DCPs between poorly and highly acculturated HUSs (P=0.91). CONCLUSION: HUSs had more active DCPs than HLAs did. Among HUSs, acculturation did not seem to play a role in DCP determination. Our findings confirm the importance of family participation for both HUSs and HLAs. However, HUSs were less likely to want family members to make decisions on their behalf.

Concepts and definitions for "supportive care," "best supportive care," "palliative care," and "hospice care" in the published literature, dictionaries, and textbooks.

PURPOSE: Commonly used terms such as "supportive care," "best supportive care," "palliative care," and "hospice care" were rarely and inconsistently defined in the palliative oncology literature. We conducted a systematic review of the literature to further identify concepts and definitions for these terms. METHODS: We searched MEDLINE, PsycInfo, EMBASE, and CINAHL for published peer-reviewed articles from 1948 to 2011 that conceptualized, defined, or examined these terms. Two researchers independently reviewed each citation for inclusion and then extracted the concepts/definitions when available. Dictionaries/textbooks were also searched. RESULTS: Nine of 32 "SC/BSC," 25 of 182 "PC," and 12 of 42 "HC" articles focused on providing a conceptual framework/definition. Common concepts for all three terms were symptom control and quality-of-life for patients with life-limiting illness. "SC" focused more on patients on active treatment compared to other categories (9/9 vs. 8/37) and less often involved interdisciplinary care (4/9 vs. 31/37). In contrast, "HC" focused more on volunteers (6/12 vs. 6/34), bereavement care (9/12 vs. 7/34), and community care (9/12 vs. 6/34). Both "PC" and "SC/BSC" were applicable earlier in the disease trajectory (16/34 vs. 0/9). We found 13, 24, and 17 different definitions for "SC/BSC," "PC," and "HC," respectively. "SC/BSC" was the most variably defined, ranging from symptom management during cancer therapy to survivorship care. Dictionaries/textbooks showed similar findings. CONCLUSION: We identified defining concepts for "SC/BSC," "PC," and "HC" and developed a preliminary conceptual framework unifying these terms along the continuum of care to help build consensus toward standardized definitions.

Outcomes of phase II clinical trials with single-agent therapies in advanced/metastatic non-small cell lung cancer published between 2000 and 2009.

PURPOSE: We analyzed the outcomes of single-agent phase II clinical trials in non-small cell lung cancer (NSCLC) to determine trial parameters that predicted clinical activity. EXPERIMENTAL DESIGN: Data on response rate (RR), progression-free survival (PFS), and overall survival (OS) from all English language, single-agent phase II trials in advanced/metastatic NSCLC indexed by PubMed (January 2000 through December 2009) were abstracted. RESULTS: A total of 143 single-agent phase II trials (7,701 patients) were identified. The median RR was 10%, PFS 2.8 months, and OS 7.6 months. RR and PFS correlated with OS (r = 0.46, P < 0.001, r = 0.52, P < 0.001, respectively) and RR correlated with PFS (r = 0.61, P < 0.001). Treatment arms enriched for patients with molecular targets had a higher median RR (48.8% vs. 9.7%, P = 0.005), longer median PFS (6 vs. 2.8 months, P = 0.005), and OS (11.3 vs. 7.5 months, P = 0.05) as compared with those of unselected patients. In multivariate analysis, only studies enriched for patients with molecular targets or including drugs that eventually gained FDA/EMA approval were associated with a higher RR, and longer PFS/OS. CONCLUSIONS: In phase II trials in NSCLC, RR and PFS correlated with OS. Studies enriched for patients with putative molecular drug targets were associated with higher therapeutic benefit as compared with those of unselected populations.

The relationship between body composition and response to neoadjuvant chemotherapy in women with operable breast cancer.

INTRODUCTION: Overweight women diagnosed with breast cancer have greater recurrence and mortality risks. Recent studies in advanced cancer showed that the combination of sarcopenia and an overweight or obese body mass index (BMI) is associated with poor clinical outcomes. OBJECTIVES: To compare pathological complete response (pCR) cases with controls and evaluate associations among a pCR, survival outcome, and sarcopenia as well as the combination of both sarcopenia and a BMI ≥25 kg/m(2). METHODS: Sixty-seven breast cancer patients with a pCR to neoadjuvant chemotherapy (NC) were matched with controls who did not have a pCR to NC. Patients were matched by age, Black's nuclear grading system, clinical cancer stage, and estrogen receptor and progesterone receptor status. Body composition was analyzed using computed tomography images taken prior to NC. RESULTS: BMI was associated with pCR. Among normal weight patients, the pCR rate was higher in sarcopenic patients and the progression-free survival (PFS) interval was significantly longer than in overweight or obese BMI patients. The death hazard was 2% higher for each unit higher skeletal muscle index and 0.6% higher for each unit higher visceral adipose tissue. CONCLUSIONS: Overweight patients treated with NC had a lower pCR rate and shorter PFS time. Among patients with a normal BMI, the pCR rate was better in sarcopenic patients. More research is required to evaluate the negative impact of sarcopenic obesity on prognosis and the contributors to better response rates in operable, normal weight breast cancer patients with sarcopenia.