Quality of life and mental health in caregivers of outpatients with advanced cancer.

OBJECTIVE: This study evaluates the quality of life (QOL) and mental health (MH) of caregivers of patients with advanced cancer who are receiving ambulatory oncology care and associations with patient, caregiver and care-related characteristics. METHODS: Patients with advanced gastrointestinal, genitourinary, breast, lung or gynaecologic cancer, and their caregivers, were recruited from 24 medical oncology clinics for a cluster-randomized trial of early palliative care. Caregivers completed the Caregiver QOL--Cancer scale and the Medical Outcomes Study Short Form, version 2, and a questionnaire including care-related factors such as hours/day providing care and change in work situation. Patients completed a demographic questionnaire and measures of their QOL and symptom severity. Associations of these factors with caregiver QOL and MH were examined using linear regression analyses. RESULTS: Of the 191 caregivers, 84% were spouses/partners, 90% cohabited with the patient, half were working and 25% had a change in work situation since the patient's diagnosis. On multiple regression analysis, better caregiver QOL was associated with better caregiver MH and patient physical well-being and with not providing care for other dependents. Worse caregiver MH was associated with female caregiver sex, worse patient emotional well-being, more hours spent caregiving and change in the caregiver's work situation. CONCLUSIONS: Caregivers of ambulatory patients with advanced cancer may have compromised QOL and MH associated with worse patient physical and emotional well-being and with simultaneously caring for others and working outside the home. Early palliative care interventions directed at patient symptoms and caregiver support may improve QOL in this population.

Impact of an oncology palliative care clinic on access to home care services.

Home care (HC) is important for patients with cancer as performance status declines. Our study of 1224 patients at a Canadian cancer center examined the impact of an oncology palliative care clinic (OPCC) on HC referral. The HC referral frequency was calculated before and after the first OPCC consultation, in total and according to performance status (Palliative Performance Scale, PPS). Characteristics associated with HC referral were investigated. After the first OPCC consultation, there was an increase in HC referral from 39% (477 of 1224; 49% of those with PPS ≤60) to 69% (841 of 1224; 88% of those with PPS ≤60). Factors independently associated with HC referral were poor PPS (P < .001) and older age (P = .003). Thus OPCC involvement resulted in markedly increased HC referrals, particularly for older patients with poor performance status.

Preparation for the end of life in patients with advanced cancer and association with communication with professional caregivers.

OBJECTIVE: Previous studies regarding patients' end of life (EOL) preparation have focused mainly on practical tasks, such as advance directives. In this study, we investigate the relational and personal aspects of EOL preparation, using a patient-completed questionnaire, and examine associations with clinician-patient communication (CPC) and other variables. METHODS: Patients with advanced cancer but with good performance status were recruited from 24 medical oncology clinics, to participate in a cluster-randomised controlled trial of early palliative care intervention. Measures included the Quality of Life at the End of Life preparation for EOL subscale, and measures of CPC, functional status, comorbidity, spiritual well-being and symptom severity. Using chi-squared tests, t-tests and multivariate regression analyses, we examined the variables associated with preparation for EOL. We also examined the frequency distributions of individual EOL preparation items and used logistic regression to examine their associations with adequacy of CPC. RESULTS: In the 469 patients, characteristics associated with better EOL preparation were better CPC, older age, living alone, less symptom burden and better spiritual well-being. Thirty-one per cent agreed that they worried 'quite a bit' or 'completely' about their family's preparation to cope with the future, and 27% agreed that they would be a burden to their family. All preparation items except regrets about life were associated with adequacy of communication. CONCLUSIONS: A substantial minority of patients with advanced cancer but with good performance status are concerned about EOL preparation, particularly in relation to their families. Better CPC may help patients prepare not only practically but also personally and socially in relation to the dying process and the welfare of their families.

Spirituality and use of complementary therapies for cure in advanced cancer.

OBJECTIVE: Complementary and alternative medicine (CAM) is frequently used by patients with advanced cancer, for a variety of reasons. We examined the use of CAM in this population, and associations of use for potential cure with spiritual faith and existential well-being. METHODS: Patients with advanced cancer on a palliative care unit completed a measure of spiritual well-being (existential well-being and faith), and a survey assessing complementary therapy use and reasons for such use. Information was also gathered on demographic data, previous cancer treatment, performance status, and symptom distress. Regression analyses assessed the association between the spirituality domains of existential well-being and faith, and the use of CAM for cure. RESULTS: Of 123 participants, 85% had used CAM, 42% with curative intent. More than 95% would consider future use of CAM, 48% for potential cure. Previous use for cure predicted current interest in using CAM for cure (p<0.0001). Spiritual faith was associated with previous (p<0.02) and interest in future use for cure (p<0.0001). Poor existential well-being was associated with interest in future use of CAM for cure (p=0.04). CONCLUSIONS: Interest in considering CAM for cure was relatively high in this group of inpatients on a palliative care unit, and was associated with increased spiritual faith and decreased existential well-being. Understanding factors associated with seeking CAM for cure may help health-care professionals to support and educate patients with advanced cancer.

Determinants of quality of life in patients with advanced cancer.

PURPOSE: Improving health-related quality of life (HRQL) is the main goal of palliative care and an important outcome for oncology trials. This study examines medical and sociodemographic determinants of HRQL in outpatients with advanced cancer. METHODS: Patients with metastatic gastrointestinal, genitourinary, breast, lung or gynecological cancer, ECOG 0-2, and clinical prognosis of 6 months to 2 years were recruited from outpatient medical oncology clinics. HRQL was measured using the FACT-G questionnaire and the FACIT-Sp meaning and peace (existential) subscale. The influence of demographic and medical characteristics on HRQL was determined using t tests and analysis of variance, with Tukey's correction for multiple comparisons. Multivariate linear regression was used to determine independent predictors. RESULTS: Of 285 patients, 57% were female and the median age was 61 years; 44% were alive at latest follow-up; and of those deceased, the mean survival time was 10 months. The strongest determinants of overall HRQL were increased age (p < 0.001), good performance status (PS; p < 0.001) and survival time >6 months (p = 0.001). Compared to patients receiving cancer treatment, those awaiting new treatment had worse emotional well-being (p < 0.001), while those on surveillance or whose treatment had been stopped had worse existential well-being (p = 0.03). Male gender predicted better emotional and physical well-being and lower income predicted worse social well-being. CONCLUSIONS: Age, PS, survival time, and treatment status are important determinants of HRQL in patients with advanced cancer. Decision aids, open communication, and involvement of supportive care specialists may improve emotional and existential distress associated with changing or stopping cancer treatment.

Validation of the QUAL-EC for assessing quality of life in patients with advanced cancer.

OBJECTIVE: Improving quality of life is the main goal of palliative cancer care. However, there is a lack of measures validated specifically for advanced cancer. The purpose of this study was to validate the Quality of Life at the End of Life (QUAL-E) measure in a sample of patients with advanced cancer. METHODS: Data were analysed for 464 patients with advanced cancer who were participating in a randomised controlled trial of early palliative care intervention versus routine care. Patients completed the 26-item QUAL-E, the Functional Assessment of Cancer Therapy (FACT-G) quality of life measure and measures of spiritual well-being, performance status, symptom burden, satisfaction with care and communication with health care providers. We conducted a confirmatory factor analysis on the QUAL-E to test for the hypothesised four-factor structure and examined construct validity by calculating correlations with relevant scales. RESULTS: A 17-item reduced version of the QUAL-E, the QUAL-E-Cancer (QUAL-EC) achieved an acceptable fit to a four-factor model. Both the full and reduced versions of the QUAL-E were internally reliable and showed good construct validity. Symptom Control was correlated with other measures of physical functioning; Relationship with Healthcare Provider was correlated with satisfaction with care and better physician and nurse communication; Preparation for End of Life was strongly associated with emotional well-being; and Life Completion was strongly associated with social and spiritual well-being. CONCLUSIONS: Due to its good factor structure and sound psychometrics, we recommend the reduced QUAL-EC scale to assess quality of life in patients with advanced cancer.

Interconversion of three measures of performance status: an empirical analysis.

PURPOSE: To construct empirically a conversion table to convert performance status scores among the Eastern Cooperative Oncology Group (ECOG), Karnofsky Performance Status (KPS) and Palliative Performance Scale (PPS) measures, using a large sample of patients with advanced cancer. METHODS: Seven physicians completed assessments on 1385 consecutive patients attending an oncology palliative care clinic, or admitted to an acute cancer palliative care unit. The three measures were distributed as a questionnaire package; the order in which they were presented was randomly assigned for each week. Scales were compared using the hit rate and the weighted kappa coefficient (κ(w)). The KPS and PPS were compared directly; for comparisons of either scale with the ECOG, all 70 possible categorisations of KPS and PPS were computed. An 'ideal' categorisation was selected based on maximisation of both statistical methods. RESULTS: The KPS and PPS matched in 1209 out of 1385 assessments (hit rate 87%; κ(w) 0.97). For both the KPS and the PPS, the categorisation of 100 (ECOG 0), 80-90 (1), 60-70 (2), 40-50 (3), 10-30 (4) had the highest hit rate (75%), and the second highest κ(w) (0.84, p<0.0001). One other combination had a slightly higher κ(w) (0.85 for both KPS and PPS), but a lower hit rate (73% for KPS, 72% for PPS). CONCLUSIONS: We have derived empirically a conversion scale among the ECOG, KPS and PPS scales. The proposed scale provides a means of translating amongst these measures, which may improve accuracy of communication about performance status amongst oncology clinicians and researchers.

Predictors of symptom severity and response in patients with metastatic cancer.

We examined determinants of symptom severity and response to treatment among 150 patients with cancer participating in a phase II trial of a palliative care team intervention. Patients completed a modified Edmonton Symptom Assessment Scale (ESAS) at baseline and 1 week. Women had a worse baseline ESAS Distress Score (EDS; P = .003) and Total Distress Score (TDS; P = .005); differences were particularly marked for anxiety and appetite. Performance status was inversely associated with EDS, TDS, well-being, appetite, and fatigue (Kruskal-Wallis, all P < .005). Multivariate analysis of covariance (ANCOVA) showed that symptom improvement was independently predicted by worse baseline EDS score and female gender. Performance status, gender, and baseline symptom severity should be accounted for in trials of palliative care interventions; inclusion criteria based on symptom severity should also be considered.

Phase II trial of mirtazapine for cancer-related cachexia and anorexia.

We performed an open-label single-institution phase II trial of mirtazapine (15-30 mg by mouth [po] every day [qd]), a tetracyclic antidepressant that may lead to weight gain, for 8 weeks in nondepressed patients with cancer-related cachexia/anorexia (CRCA). The primary end point was the proportion of patients who gained > or =1 kg at week 4. Secondary end points were quality of life and appetite. From June 2006 to July 2007, 17 of 58 eligible patients were enrolled. On intention-to-treat analysis at week 4, 4 of 17 patients (24%) gained 1 kg or more, 1 patient maintained weight (gain of 400 g) and 2 patients lost weight (800 g and 1.2 kg); 24% and 6% improved appetite and health-related quality of life (HQOL), respectively. Mirtazapine is a promising agent for the treatment of CRCA.

Nurse and physician inter-rater agreement of three performance status measures in palliative care outpatients.

INTRODUCTION: Performance status (PS) scales are used widely in oncology practice and research. We compared inter-rater agreement, between nurses and physicians, for three commonly used PS scales. MATERIALS AND METHODS: Patients attending an oncology palliative care clinic were assessed by a physician and nurse who blindly completed Eastern Cooperative Oncology Group (ECOG), Karnofsky PS (KPS), and palliative PS (PPS) scales. Patients completed the Edmonton symptom assessment system (ESAS). RESULTS: Inter-rater agreement (weighted kappa) for the 457 patients was 0.67 for the ECOG, 0.74 for the KPS, and 0.72 for the PPS. There was no difference between proportions of physicians' vs. nurses' ratings of KPS, >60 vs.

The FAMCARE-Patient scale: measuring satisfaction with care of outpatients with advanced cancer.

OBJECTIVE: To provide confirmatory results concerning the psychometric properties of a measure of satisfaction with oncology care for use with advanced stage cancer patients, and test its sensitivity to change. METHODS: We analysed data from 315 outpatients with advanced cancer participating in a randomised controlled trial of early palliative care intervention versus routine oncology care, and their caregivers. Patients completed a 16-item measure of patient satisfaction (FAMCARE-P16), based on the FAMCARE measure of family satisfaction with cancer care, and measures assessing interactions with healthcare providers, performance status and symptom burden. Caregivers completed the original FAMCARE measure. We used confirmatory factor analysis to test the patient satisfaction measure for a single-factor structure. To determine construct validity, we assessed correlations between patient satisfaction and the other patient and caregiver measures. To assess responsiveness to change, we repeated paired t-test analyses on the 13-item and 16-item scales for 150 patients participating in a phase II trial of palliative care effectiveness, in which the FAMCARE-P was measured at baseline, 1-week and 1-month after an outpatient palliative care intervention. RESULTS: A reduced 13-item version of our measure (FAMCARE-P13) possessed a one-factor structure with high reliability. Patient satisfaction was correlated in predicted directions with physical distress, communication and relationship with healthcare providers, and caregiver satisfaction. There were statistically significant increases in patient satisfaction at 1 week (p<0.0001) and 1 month (p<0.001). CONCLUSIONS: We recommend the use of the FAMCARE-P13 to assess satisfaction with outpatient palliative care interventions of patients with advanced stage cancer.

Measuring patient satisfaction in oncology palliative care: psychometric properties of the FAMCARE-patient scale.

PURPOSE: We provide preliminary psychometric results concerning the use of a modified FAMCARE scale, adapted for patient use, to assess satisfaction with outpatient care in advanced stage cancer patients. METHODS: Participants were 145 outpatients with advanced cancer who were participating in a phase II trial of an outpatient palliative care intervention. Patients completed our modified FAMCARE measure of patient satisfaction and the Edmonton Symptom Assessment Scale, a measure of symptom burden. Individuals were also assessed for performance status using the Eastern Cooperative Oncology Group scale. We conducted an exploratory factor analysis of the patient satisfaction measure and performed correlations of satisfaction with symptom burden as well as with performance status. RESULTS: Factor analysis of the satisfaction measure revealed a one-factor structure and suggested the removal of one nonloading item, producing a 16-item scale (FAMCARE-P16) with high internal reliability. Patient satisfaction was not correlated with performance status, but was inversely associated with symptom burden, particularly with depression and anxiety. CONCLUSIONS: The FAMCARE-P16 may be used to assess satisfaction with outpatient palliative care interventions of patients with advanced stage cancer in both clinical settings and prospective trials.

Relationship of the ApoE polymorphism to plasma lipid traits among South Asians, Chinese, and Europeans living in Canada.

BACKGROUND: The prevalence of cardiovascular risk factors and atherosclerosis vary between ethnic groups. We examined the apolipoprotein E (ApoE) polymorphism, its association with lipid traits and atherosclerosis, and its influence on ethnic variations on lipid traits. METHODS: In a randomly sampled cross-sectional study of 985 South Asian, Chinese, and European Canadians, three common isoforms of ApoE (E2, E3 and E4), plasma lipid concentrations and atherosclerosis of the carotid artery were measured. RESULTS: The E2, E3 and E4 allele frequencies were 5.7%, 84.0%, and 10.2%, respectively, and differed significantly between ethnic groups. There was a strong, stepwise association between ApoE and each plasma lipid trait, except triglycerides. The E4 genotype was associated with higher low-density lipoprotein cholesterol (p for trend<0.001), ApoB (p<0.001), ApoB/ApoA ratio (p<0.001) and lipoprotein (a) (p<0.001), and lower ApoA (p<0.001) and high-density lipoprotein cholesterol (HDL-C) (p=0.005). A similar pattern of effects was observed across all ethnic groups. Ethnicity accounted for modest variation in ApoA, ApoB/ApoA ratio and HDL-C (4.2-5.0%), whereas ApoE isoforms explained only a small proportion of variability (0.3-1.4%). Dietary and lifestyle factors accounted for modest variation in several traits including HDL-C (5.6% and 5.0%, respectively). Carotid atherosclerosis was lower among individuals with E2 isoform in keeping with the effect of E2 on lipid levels. CONCLUSIONS: The ApoE isoform is associated with plasma lipoproteins in all ethnic groups, yet explains only a small proportion of the inter-ethnic variation for most plasma lipoproteins. Additional genetic variants and/or health behaviors likely contribute to ethnic variations in plasma lipid traits.

Phase II study of an outpatient palliative care intervention in patients with metastatic cancer.

PURPOSE: Although there is increasing advocacy for timely symptom control in patients with cancer, few studies have assessed outpatient palliative care clinics. This study assessed prospectively the efficacy of an Oncology Palliative Care Clinic (OPCC) in improving patient symptom distress and satisfaction. PATIENTS AND METHODS: Eligible patients were new referrals to an OPCC, had metastatic cancer, were at least 18 years old, and were well enough and able to speak and read English sufficiently to provide informed consent and complete questionnaires. Patients received a consultation by a palliative care team. The primary end points of symptom control and patient satisfaction were assessed using the Edmonton Symptom Assessment Scale (ESAS) and patient-adapted Family Satisfaction with Advanced Cancer Care (FAMCARE) scale at baseline, 1 week, and 1 month. Initial and follow-up scores were compared using paired t tests. RESULTS: Of 150 patients enrolled, 123 completed 1-week assessments, and 88 completed 4-week assessments. At baseline, the mean ESAS Distress Score (EDS) was 39.5. The mean improvement in EDS was 8.8 points (P < .0001) at 1 week and 7.0 points (P < .0001) at 1 month. Statistically significant improvements were observed for pain, fatigue, nausea, depression, anxiety, drowsiness, appetite, dyspnea, insomnia, and constipation at 1 week (all P < or = .005) and 1 month (all P < or = .05). The mean improvement in FAMCARE score was 6.1 points (P < .0001) at 1 week and 5.0 points (P < .0001) at 1 month. CONCLUSION: This phase II study demonstrates efficacy of an OPCC for improvement of symptom control and patient satisfaction with care. Randomized controlled trials are indicated to further evaluate the effectiveness of specialized outpatient palliative care.