Managing Cancer And Living Meaningfully (CALM): randomised feasibility trial in patients with advanced cancer.

BACKGROUND: Managing Cancer And Living Meaningfully (CALM) is a brief individual psychotherapy for patients with advanced cancer. In an intervention-only phase 2a trial, CALM showed promising results, leading to the present 2b pilot, which introduces procedures for randomisation and improved rigour in preparation for a phase 3 randomised controlled trial (RCT). AIMS: To test trial methodology and assess feasibility of a confirmatory RCT. DESIGN: A parallel-arm RCT (intervention vs usual care) with 3 and 6-month follow-ups. Assessment of feasibility included rates of consent, randomisation, attrition, intervention non-compliance and usual care contamination. PRIMARY OUTCOME: depressive symptoms (Patient Health Questionnaire-9; PHQ-9). SECONDARY OUTCOMES: major depressive disorder (MDD), generalised anxiety, death anxiety, spiritual well-being, attachment anxiety and avoidance, self-esteem, experiential avoidance, quality of life and post-traumatic growth. Bayesian conjugate analysis was used in this low-powered setting. SETTING/PARTICIPANTS: 60 adult patients with advanced cancer from the Princess Margaret Cancer Centre. RESULTS: Rate of consent was 32%, randomisation 78%, attrition 25%, non-compliance 37% and contamination 17%. There was support for potential treatment effects on: PHQ-9, OR=1.48, 95% Credible Interval (CRI.95) (0.65, 3.38); MDD, OR=1.56, CRI.95 (0.50, 4.84); attachment anxiety, OR=1.72, CRI.95 (0.73, 4.03); and attachment avoidance, OR=1.58, CRI.95 (0.67, 3.71). There was no support for effects on the seven remaining secondary outcomes. CONCLUSIONS: A phase 3 CALM RCT is feasible and should aim to detect effect sizes of d=0.40, with greater attention to issues of compliance and contamination. TRIAL REGISTRATION NUMBER: NCT02353546.

Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychological Intervention for Patients With Advanced Cancer.

Purpose Individuals with advanced cancer experience substantial distress in response to disease burden and impending mortality. Managing Cancer And Living Meaningfully (CALM) is a novel, brief, manualized psychotherapeutic intervention intended to treat and prevent depression and end-of-life distress in patients with advanced cancer. We conducted a randomized controlled trial to compare CALM with usual care (UC) in this population. Methods Patients with advanced cancer were recruited from outpatient oncology clinics at a comprehensive cancer center into an unblinded randomized controlled trial. Permuted block randomization stratified by Patient Health Questionnaire-9 depression score allocated participants to CALM plus UC or to UC alone. Assessments of depressive symptoms (primary outcome), death-related distress, and other secondary outcomes were conducted at baseline, 3 months (primary end point), and 6 months (trial end point). Analyses were by intention to treat. Analysis of covariance was used to test for outcome differences between groups at follow-up, controlling for baseline. Mixed-model results are reported. Results Participants (n = 305) were recruited between February 3, 2012, and March 4, 2016, and randomly assigned to CALM (n = 151) or UC (n = 154). CALM participants reported less-severe depressive symptoms than UC participants at 3 months (Δ = 1.09; P = .04; Cohen's d = 0.23; 95% CI, 0.04 to 2.13) and at 6 months (Δ = 1.29; P = .02; d = 0.29; 95% CI, 0.24 to 2.35). Significant findings for greater end-of-life preparation at 6 months also favored CALM versus UC. No adverse effects were identified. Conclusion Findings suggest that CALM is an effective intervention that provides a systematic approach to alleviating depressive symptoms in patients with advanced cancer and addresses the predictable challenges these patients face.

A concept map of death-related anxieties in patients with advanced cancer.

OBJECTIVES: Fear of death and dying is common in patients with advanced cancer, but can be difficult to address in clinical conversations. We aimed to show that the experience of death anxiety may be deconstructed into a network of specific concerns and to provide a map of their interconnections to aid clinical exploration. METHODS: We studied a sample of 382 patients with advanced cancer recruited from outpatient clinics at the Princess Margaret Cancer Centre, Toronto, Canada. Patients completed the 15-item Death and Dying Distress Scale (DADDS). We used item ratings to estimate a regularised partial correlation network of death and dying-related concerns. We calculated node closeness-centrality, clustering and global network characteristics. RESULTS: Death-related anxieties were highly frequent, each associated with at least moderate distress in 22%-55% of patients. Distress about 'Running out of time' was a central concern in the network. The network was organised into two areas: one about more practical fears concerning the process of dying and another about more psychosocial or existential concerns including relational problems, uncertainty about the future and missed opportunities. Both areas were yet closely connected by bridges which, for example, linked fear of suffering and a prolonged death to fear of burdening others. CONCLUSIONS: Patients with advanced cancer may have many interconnected death-related fears that can be patterned in individual ways. The bridging links between more practical and more psychosocial concerns emphasise that the alleviation of death anxiety may require interventions that integrate symptom management, advance care planning and psychological treatment approaches.

Managing Cancer And Living Meaningfully: study protocol for a randomized controlled trial.

BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT01506492 4 January 2012.

Managing Cancer And Living Meaningfully (CALM): phase 2 trial of a brief individual psychotherapy for patients with advanced cancer.

BACKGROUND: Advanced cancer brings substantial physical and psychosocial challenges that may contribute to emotional distress and diminish well-being. In this study, we present preliminary data concerning the effectiveness of a new brief individual psychotherapy, Managing Cancer And Living Meaningfully (CALM), designed to help individuals cope with this circumstance. AIM: To test the feasibility and preliminary effectiveness of CALM to reduce emotional distress and promote psychological well-being and growth. DESIGN: CALM is a brief, manualized, semi-structured individual psychotherapy for patients with advanced cancer. This study employed a phase 2 intervention-only design. The primary outcome was depressive symptoms and the secondary outcomes were death anxiety, attachment security, spiritual well-being and psychological growth. These were assessed at 3 months (t1) and 6 months (t2). Multilevel regression was used to model change over time. SETTING/PARTICIPANTS: A total of 50 patients with advanced or metastatic cancer were recruited from the Princess Margaret Cancer Centre, Toronto, Canada. RESULTS: A total of 39 patients (78%) were assessed at baseline, 24 (48%) at t1, and 16 (32%) at t2. Analyses revealed reductions over time in depressive symptoms: beta = -0.13, confidence interval (CI.95) = (-0.23, -0.022) and death anxiety: beta = -0.23, CI.95 (-0.40, -0.061); and an increase in spiritual well-being: beta = 0.14, CI.95 (0.026, 0.26). CONCLUSIONS: CALM may be a feasible intervention to benefit patients with advanced cancer. The results are encouraging, despite attrition and small effect sizes, and support further study.