We have developed a novel and brief semi-structured psychotherapeutic intervention for patients with advanced or metastatic cancer, called Managing Cancer And Living Meaningfully. We describe here the methodology of a randomized controlled trial to test the efficacy of this treatment to alleviate distress and promote well-being in this population. The study is an unblinded randomized controlled trial with 2 conditions (intervention plus usual care versus usual care alone) and assessments at baseline, 3 and 6 months. The site is the Princess Margaret Cancer Centre, part of the University Health Network, in Toronto, Canada. Eligibility criteria include: ≥ 18 years of age; English fluency; no cognitive impairment; and diagnosis of advanced cancer. The 3–6 session intervention is manualized and allows for flexibility to meet individual patients’ needs. It is delivered over a 3–6 month period and provides reflective space for patients (and their primary caregivers) to address 4 main domains: symptom management and communication with health care providers; changes in self and relations with close others; sense of meaning and purpose; and the future and mortality. Usual care at the Princess Margaret Cancer Centre includes distress screening and referral as required to in-hospital psychosocial and palliative care services. The primary outcome is frequency of depressive symptoms and the primary endpoint is at 3 months. Secondary outcomes include diagnosis of major or minor depression, generalized anxiety, death anxiety, spiritual well-being, quality of life, demoralization, attachment security, posttraumatic growth, communication with partners, and satisfaction with clinical interactions. Managing Cancer And Living Meaningfully has the potential to relieve distress and promote psychological well-being in patients with advanced cancer and their primary caregivers. This trial is being conducted to determine its benefit and inform its dissemination. The intervention has cross-national relevance and training workshops have been held thus far with clinicians from North and South America, Europe, the Middle East, Asia and Africa. ClinicalTrials.gov NCT01506492 4 January 2012.

Patients with advanced cancer suffer from psychosocial distress that may impair quality of life and that may be ameliorated by psychotherapeutic treatment. We describe here the methodology of a randomized controlled trial (RCT) to assess the effectiveness of a novel, brief, semi-structured psychotherapeutic intervention to reduce distress and increase well-being in patients with advanced or metastatic cancer. The intervention, called Managing Cancer and Living Meaningfully (CALM), was originally developed in Canada and we are now testing its Italian adaptation (CALM-IT).

Introduction The 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 analysis This 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 dissemination This 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.

PURPOSE: Despite advances in palliative care in Uganda, there has been relatively little recent patient-centered research investigating end-of-life outcomes in this region. We assessed the quality of dying and death of patients with cancer in hospice care in Uganda. METHODS: Bereaved caregivers of patients who received hospice care in Uganda and died 2-12 months earlier (N = 201) completed the Quality of Dying and Death Questionnaire, which includes 31 items and single-item ratings of overall quality of dying and moment of death, and the FAMCARE measure of family satisfaction with cancer care. RESULTS: Caregivers reported low-intermediate overall quality of dying (mean [M] standard deviation [SD], 3.25 [2.98]) and overall quality of moment of death (M [SD], 3.59 [3.51]), with 47.0% of the ratings of these two outcomes in the poor range, but the mean family satisfaction with care was high (M [SD], 77.75 [10.26]). Most Quality of Dying and Death Questionnaire items (74.2%) were rated within the intermediate range. Items rated within the good range were religious-spiritual, interpersonal, and personal facets; two items within the poor range reflected physical functioning. Overall quality of dying was most strongly correlated with pain control (Spearman's rho [r_s] = 0.45, P < .001), and overall quality of moment of death with state of consciousness before death and being unafraid of dying (r_s = 0.42, P < .001). The FAMCARE score was not correlated with overall quality of dying or moment of death ( P = .576-.813). Only one FAMCARE item, information on managing patient's pain, was correlated with overall quality of moment of death (r_s = –0.19, P = .008). CONCLUSION: End-of-life care in hospices in Uganda requires further improvement, particularly with regard to symptom control. Patient-centered data could bolster advocacy efforts to support quality improvement of palliative care in this and other countries.

LBA10001 Background: Patients with advanced cancer experience substantial distress in response to the burden of disease and the challenge of living meaningfully in the face of impending mortality. We developed a novel, brief, manualized psychotherapeutic intervention called CALM designed to alleviate distress and facilitate adjustment in this population. CALM consists of 3-6 individual sessions delivered over 3-6 months and supports exploration in 4 broad domains: 1) symptom management and communication with health care providers; 2) changes in self and relations with close others; 3) sense of meaning and purpose; and 4) the future and mortality. Methods: Patients with advanced cancer were recruited from outpatient clinics at a comprehensive cancer center and randomized to receive either CALM or usual care (UC). Assessments of depressive symptoms (primary outcome), death-related distress and other secondary outcomes were conducted at baseline, 3 (primary endpoint) and 6 months. ANCOVA was used to test for outcome differences between groups at follow-up, controlling for baseline scores. Results: Three hundred and five participants were recruited and randomized (n = 151 CALM; n = 154 UC). Compliance with the intervention was 77.5% and attrition was 28% (16% deceased, 8% lost to follow-up, 4% withdrew). The CALM group reported less severe depressive symptoms compared to UC at 3 (Δ_M1-M2 = 1.09, p < 0.04; Cohen’s d = 0.23) and 6 months (Δ_M1-M2 = 1.33, p < 0.01; Cohen’s d = 0.29). Other statistically significant findings in psychological well-being and preparation for the end of life at 3- and 6- months also favored CALM vs UC. Conclusions: CALM is an effective intervention for patients with advanced cancer that provides a systematic approach to alleviate distress and to address predictable challenges. Clinical trial information: NCT01506492.