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Patients with advanced cancer have reduced quality of life, which tends to worsen towards the end of life. We assessed the effect of early palliative care in patients with advanced cancer on several aspects of quality of life. The study took place at the Princess Margaret Cancer Centre (Toronto, ON, Canada), between Dec 1, 2006, and Feb 28, 2011. 24 medical oncology clinics were cluster randomised (in a 1:1 ratio, using a computer-generated sequence, stratified by clinic size and tumour site [four lung, eight gastrointestinal, four genitourinary, six breast, two gynaecological]), to consultation and follow-up (at least monthly) by a palliative care team or to standard cancer care. Complete masking of interventions was not possible; however, patients provided written informed consent to participate in their own study group, without being informed of the existence of another group. Eligible patients had advanced cancer, European Cooperative Oncology Group performance status of 0–2, and a clinical prognosis of 6–24 months. Quality of life (Functional Assessment of Chronic Illness Therapy—Spiritual Well-Being [FACIT-Sp] scale and Quality of Life at the End of Life [QUAL-E] scale), symptom severity (Edmonton Symptom Assessment System [ESAS]), satisfaction with care (FAMCARE-P16), and problems with medical interactions (Cancer Rehabilitation Evaluation System Medical Interaction Subscale [CARES-MIS]) were measured at baseline and monthly for 4 months. The primary outcome was change score for FACIT-Sp at 3 months. Secondary endpoints included change score for FACIT-Sp at 4 months and change scores for other scales at 3 and 4 months. This trial is registered with ClinicalTrials.gov, number NCT01248624. 461 patients completed baseline measures (228 intervention, 233 control); 393 completed at least one follow-up assessment. At 3-months, there was a non-significant difference in change score for FACIT-Sp between intervention and control groups (3·56 points [95% CI −0·27 to 7·40], p=0·07), a significant difference in QUAL-E (2·25 [0·01 to 4·49], p=0·05) and FAMCARE-P16 (3·79 [1·74 to 5·85], p=0·0003), and no difference in ESAS (−1·70 [−5·26 to 1·87], p=0·33) or CARES-MIS (−0·66 [−2·25 to 0·94], p=0·40). At 4 months, there were significant differences in change scores for all outcomes except CARES-MIS. All differences favoured the intervention group. Although the difference in quality of life was non-significant at the primary endpoint, this trial shows promising findings that support early palliative care for patients with advanced cancer. Canadian Cancer Society, Ontario Ministry of Health and Long Term Care.

OBJECTIVE:--The purpose of this study was to identify predictors of the onset of disturbed eating behavior (DEB) in adolescent girls with type 1 diabetes. RESEARCH DESIGN AND METHODS--In this prospective study, participants completed the Children's Eating Disorder Examination interview and self-report measures at baseline and at four follow-up assessments over 5 years. Participants were 126 girls with type 1 diabetes, aged 9-13 years at baseline. Of the 101 girls who did not have DEB at baseline, 45 developed DEB during the follow-up period; the 38 for whom data were available for the assessment before onset of DEB were compared with 38 age-matched girls who did not develop DEB. DEB was defined as dieting for weight control, binge eating, self-induced vomiting, or the use of diuretics, laxatives, insulin omission, or intense exercise for weight control. RESULTS:--Logistic regression indicated that a model including BMI percentile, weight and shape concern, global and physical appearance-based self-worth, and depression was significantly associated with DEB onset (χ² = 46.0, 5 d.f., P < 0.0001) and accounted for 48.2% of the variance. CONCLUSIONS:--Even though scores on the measures were within the published normal range, the onset of DEB was predicted by higher depression and weight and shape concerns and lower global and physical appearance-based self-worth as well as higher BMI percentile 1-2 years earlier compared with those not developing DEB. Early interventions focused on helping girls with diabetes develop positive feelings about themselves, their weight and shape, and their physical appearance may have protective value.

IntroductionThe diagnosis, progression or recurrence of cancer is often highly traumatic for family caregivers (FCs), but systematic assessments of distress and approaches for its prevention and treatment are lacking. Acute leukaemia (AL) is a life-threatening cancer of the blood, which most often presents acutely, requires intensive treatment and is associated with severe physical symptoms. Consequently, traumatic stress may be common in the FCs of patients with AL. We aim to determine the prevalence, severity, longitudinal course and predictors of traumatic stress symptoms in FCs of patients with AL in the first year after diagnosis, and to understand their lived experience of traumatic stress and perceived support needs.Methods and analysisThis two-site longitudinal, observational, mixed methods study will recruit 223 adult FCs of paediatric or adult patients newly diagnosed with AL from two tertiary care centres. Quantitative data will be collected from self-report questionnaires at enrolment, and 1, 3, 6, 9 and 12 months after admission to hospital for initial treatment. Quantitative data will be analysed using descriptive and machine learning approaches and a multilevel modelling (MLM) approach will be used to confirm machine learning findings. Semi-structured qualitative interviews will be conducted at 3, 6 and 12 months and analysed using a grounded theory approach.Ethics and disseminationThis study is funded by the Canadian Institutes of Health Research (CIHR number PJT 173255) and has received ethical approval from the Ontario Cancer Research Ethics Board (CTO Project ID: 2104). The data generated have the potential to inform the development of targeted psychosocial interventions for traumatic stress, which is a public health priority for high-risk populations such as FCs of patients with haematological malignancies. An integrated and end-of-study knowledge translation strategy that involves FCs and other stakeholders will be used to interpret and disseminate study results.

Background The legal criteria for medical assistance in dying (MAiD) for adults with a grievous and irremediable medical condition were established in Canada in 2016. There has been concern that potentially reversible states of depression or demoralization may contribute to the desire for death (DD) and requests for MAiD. However, little is known about the emergence of the DD in patients, its impact on caregivers, and to what extent supportive care interventions affect the DD and requests for MAiD. The present observational study is designed to determine the prevalence, predictors, and experience of the DD, requests for MAiD and MAiD completion in patients with advanced or metastatic cancer and the impact of these outcomes on their primary caregivers. Methods A cohort of patients with advanced or metastatic solid tumour cancers and their primary caregivers will be recruited from a large tertiary cancer centre in Toronto, Ontario, Canada, to a longitudinal, mixed methods study. Participants will be assessed at baseline for diagnostic information, sociodemographic characteristics, medical history, quality of life, physical and psychological distress, attitudes about the DD and MAiD, communication with physicians, advance care planning, and use of psychosocial and palliative care interventions. Measures will subsequently be completed every six months and at the time of MAiD requests. Quantitative assessments will be supplemented by qualitative interviews in a subset of participants, selected using quota sampling methods. Discussion This study has the potential to add importantly to our understanding of the prevalence and determinants of the DD, MAiD requests and completions in patients with advanced or metastatic cancer and of the experience of both patients and caregivers in this circumstance. The findings from this study may also assist healthcare providers in their conversations about MAiD and the DD with patients and caregivers, inform healthcare providers to ensure appropriate access to MAiD, and guide modifications being considered to broaden MAiD legislation and policy.

At 5 years, 49.0% (48 of 98) of participants reported current DEB, 43.9% (43 of 98) active dietary restraint, 6.1 % (6 of 98) binge-eating episodes, 3.1% (3 of 98) self-induced vomiting, 3.1% (3 of 98) insulin omission, and 25.5% (25 of 98) intense, excessive exercise for weight control. The relationship between higher weight and DEB presents a management dilemma for clinicians, since both dietary restraint and higher weight are clear risk factors for the development of ED and their negative health consequences.

Background: Insulin-dependent diabetes mellitus (IDDM) and eating disorders are relatively common among young women in North America. Their coexistence could lead to poor metabolic control and an increased risk of the microvascular complications of IDDM. Methods: We studied 91 young women with IDDM at base line and four to five years later to determine the prevalence and persistence of disordered eating behavior (on the basis of self-reported eating and weight-loss practices, including the intentional omission or underdosing of insulin to control weight) and the association of such eating disorders with metabolic control, diabetic retinopathy, and urinary albumin excretion. At base line, the mean age of the young women was 15 +/- 2 years and the duration of diabetes was 7 +/- 4 years. Results: At base line, 26 of 91 young women (29 percent) had highly or moderately disordered eating behavior, which persisted in 16 (18 percent) and improved in 10 (11 percent). Of the 65 women with normal eating behavior at base line (71 percent), 14 (15 percent) had disordered eating at follow-up. Omission or underdosing of insulin to lose weight was reported by 12 of 88 young women (14 percent) at base line and 30 (34 percent) at follow-up (P=0.003). At base line, the mean (+/- SD) hemoglobin A1c value was higher in the group with highly disordered eating behavior (11.1 +/- 1.2 percent) than in the groups whose eating behavior was moderately disordered (8.9 +/- 1.7 percent) or nondisordered (8.7 +/- 1.6 percent, P<0.001). Disordered eating at base line was associated with retinopathy four years later (P=0.004), when 86 percent of the young women with highly disordered eating behavior, 43 percent of those with moderately disordered eating behavior, and 24 percent of those with nondisordered eating behavior had retinopathy. Conclusions: Disordered eating behavior is common and persistent in young women with IDDM and is associated with impaired metabolic control and a higher risk of diabetic retinopathy.

Early palliative care is increasingly recommended but seldom practised. We sought to examine perceptions of palliative care among patients with advanced cancer and their caregivers. After conducting a cluster randomized controlled trial of early palliative care versus standard care for patients with advanced cancer, we approached patients and their caregivers to participate in semistructured interviews seeking to assess, qualitatively, their attitudes and perceptions about palliative care. We used the grounded theory method for data collection and analysis. A total of 48 patients (26 intervention, 22 control) and 23 caregivers (14 intervention, 9 control) completed interviews. Participants’ initial perceptions of palliative care in both trial arms were of death, hopelessness, dependency and end-of-life comfort care for inpatients. These perceptions provoked fear and avoidance, and often originated from interactions with health care professionals. During the trial, those in the intervention arm developed a broader concept of palliative care as “ongoing care” that improved their “quality of living” but still felt that the term itself carried a stigma. Participants in the intervention group emphasized the need for palliative care to be reframed and better explained by health care professionals. Participants in the control group generally considered it pointless to rename palliative care, but many in the intervention group stated emphatically that a different name was necessary in the early outpatient setting. There is a strong stigma attached to palliative care, which may persist even after positive experiences with an early palliative care intervention. Education of the public, patients and health care providers is paramount if early integration of palliative care is to be successful.

To examine the presence of death anxiety in patients with advanced cancer and to identify the psychosocial and disease-related factors associated with it. Cross-sectional analysis of baseline data from a phase 2 pilot intervention trial. Princess Margaret Cancer Centre, University Health Network, Toronto, Canada. 60 adult outpatients with metastatic breast, endocrine, gastrointestinal, gynaecological, genitourinary and lung cancer. Death anxiety, as measured by the Death and Dying Distress Scale (DADDS). Thirty-two per cent of the sample reported death anxiety of at least moderate severity. The most distressing concern involved fears about the impact of one's death on others, and the least distressing concerns were related to dying alone or suddenly. According to regression analyses, death anxiety was negatively associated with self-esteem, b=-1.73, CI0.95 (-2.57 to -0.90) and positively associated with physical symptom burden, b=1.38, CI0.95 (0.44 to 2.31), having children under 18 years of age in the family, b=13.3, CI0.95 (2.15 to 24.5), and age, b=0.40, CI0.95 (0.0023 to 0.79). The physical symptoms most strongly associated with death anxiety were changes in physical appearance, b=18.8, CI0.95 (8.21 to29.5), and pain, b=10.1, CI0.95 (0.73 to 19.5). The findings suggest that death anxiety in patients with advanced cancer is common and determined by the interaction of individual factors, family circumstances and physical suffering. Multidimensional interventions that take into account these and other factors may be most likely to be effective to alleviate this death-related distress.

Background: Although psychosocial care has been regarded as central to palliative and supportive care, there have been few empirically tested approaches to individual intervention. Aim: The subjective experience of advanced cancer patients receiving a new manualized brief individual psychotherapy, referred to as Managing Cancer and Living Meaningfully (CALM), was examined prior to the initiation of a randomized controlled trial testing the effectiveness of this intervention. Design: Semi-structured interviews were conducted with patients who had a diagnosis of advanced cancer, and who underwent the intervention. Setting/Participants: Patients were recruited from a large urban regional cancer center in Toronto, Canada. The 10 interviewees included seven women and three men. All had completed between three to six CALM sessions prior to the interview. Results: The CALM intervention was associated with profound and unique patient-identified benefits and no patient-identified risks or concerns. Five interrelated benefits of the intervention were identified: (1) a safe place to process the experience of advanced cancer; (2) permission to talk about death and dying; (3) assistance in managing the illness and navigating the healthcare system; (4) resolution of relational strain; and (5) an opportunity to ‘be seen as a whole person’ within the healthcare system. These benefits were regarded by participants as unique in their cancer journey. Conclusions: Findings from a qualitative study suggest that the CALM intervention provides substantial benefits for patients with advanced cancer prior to the end of life. Findings informed the development of a randomized controlled trial to evaluate the effectiveness of this intervention.

Purpose We designed a novel, manualized intervention called Emotion And Symptom-focused Engagement (EASE) for acute leukemia (AL) and report here on a phase II randomized controlled trial (RCT) to assess its feasibility and preliminary efficacy. Methods Patients were recruited within 1 month of hospital admission and randomized to EASE plus usual care (UC) or UC alone. EASE includes (1) EASE-psy, a tailored psychotherapy delivered over 8 weeks, and (2) EASE-phys, weekly physical symptom screening over 8 weeks to trigger early palliative care. The primary outcome was traumatic stress symptoms; secondary outcomes included physical symptom burden and quality of life. Assessments were conducted at baseline and at 4, 8, and 12 weeks. Between-group differences were evaluated using multilevel modeling. Results Forty-two patients were randomized to EASE ( n  = 22) or UC ( n  = 20), with 76% retention at 12 weeks. Predefined feasibility outcomes were met: 86% (19/22) of EASE participants completed ≥ 50% of EASE-psy sessions (goal ≥ 64%); 100% received Edmonton Symptom Assessment System (ESAS, modified for AL) screenings, 64% (14/22) of whom completed ≥ 50% of planned screenings (goal ≥50%); and 100% with scores ≥ 4/10 on any physical ESAS-AL item had ≥ 1 meeting with the EASE-phys team (goal 100%). Significant treatment-group differences favoring EASE were observed in traumatic stress symptoms at 4 and 12 weeks, and pain intensity and interference at 12 weeks (all p  < .05). Conclusions EASE is feasible in patients newly diagnosed with AL and shows promise of effectiveness. These results warrant a larger RCT to provide evidence for its more routine use as a standard of care.