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

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

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.This study was funded by research grants from the Canadian Institutes of Health Research (CIHR #MOP 106473) and the German Research Society (DFG). This research was also supported in part by the Princess Margaret Cancer Foundation (Al Hertz, Kirchmann and Kirsh Family Funds), the Campbell Family Cancer Research Institute and the Ontario Cancer Institute at the Princess Margaret Cancer Centre, and by the Ontario Ministry of Health and Long Term Care (OMOHLTC). The views expressed do not necessarily reflect those of the OMOHLTC. Dr.Rodin is also supported by the University of Toronto/UHN Harold and Shirley Lederman Chair in Psychosocial Oncology and Palliative Care. The funders had no role in the final design, analysis, and writing of this study.The views expressed do not necessarily reflect those of the funders

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

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, randomization, attrition, intervention non-compliance and usual care contamination. Primary outcome: depressive symptoms (Patient Health Questionnaire-9; PHQ-9). Secondary outcomes: major depressive disorder (MDD), generalized anxiety, death anxiety, spiritual wellbeing, attachment anxiety and avoidance, self-esteem, experiential avoidance, quality of life and posttraumatic growth. Bayesian conjugate analysis was used in this low-powered setting. Setting/participants: Sixty adult patients with advanced cancer from the Princess Margaret Cancer Centre. Results: Rate of consent was 32%, randomization 78%, attrition 25%, non-compliance 37% and contamination 17%. There was support for potential treatment effects on: PHQ-9, Odds Ratio (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 7 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. Registration: ClinicalTrials.govNCT02353546.This study was funded by research grants from the University Health Network Department of Psychiatry and the Canadian Institutes of Health Research (CIHR #MOP 106473). This research was also supported by the Princess Margaret Cancer Foundation Hertz Centre and Kirchmann Funds, the Campbell Family Cancer Research Institute and the Ontario Cancer Institute at the Princess Margaret Cancer Centre, and by the Ontario Ministry of Health and Long Term Care (OMOHLTC). Dr. Rodin is also supported by the University of Toronto/University Health Network Harold and Shirley Lederman Chair in Psychosocial Oncology and Palliative Care. The funders had no role in the final design, analysis and writing of this study. The views expressed do not necessarily reflect those of the funders

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.Pilot funding for this trial was received from the University Health Network Department of Psychiatry. The RCT is supported by a grant from the Canadian Institutes of Health Research (CIHR #MOP 106473). This research is also supported in part by the Princess Margaret Cancer Foundation, the Campbell Family Cancer Research Institute and Ontario Cancer Institute at the Princess Margaret Cancer Centre, and by the Ontario Ministry of Health and Long Term Care. The views expressed do not necessarily reflect those of the OMOHLTC. GR is also supported by the University of Toronto/University Health Network Harold and Shirley Lederman Chair in Psychosocial Oncology and Palliative Care.The authors would like to thank our research and clinical staff and our volunteers who have contributed to the development and implementation of this trial, especially our RCT therapists: Valerie Heller, Cheryl Kanter,Rhonda Kibrick-Lazear, Fiorella Lubertacci, Jenny Shaheed, and Dr. Peter Fitzgerald; and our more recent research staff members: Danielle Petricone-Westwood and Joanna Shnall. The authors also give their sincere thanks to all of our study participants who have so kindly given their time and effort to this project

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

Abstract 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 wellbeing and growth. Design: CALM is a brief, manualized, semistructured 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 wellbeing 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: Fifty patients with advanced or metastatic cancer were recruited from the Princess Margaret Cancer Centre, Toronto, Canada. Results: Thirty-nine 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, CI.95 (-0.23, -0.022), and death anxiety, beta = -0.23, CI.95 (-0.40, -0.061), and an increase in spiritual wellbeing, 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.This study was funded by a research grant from the University Health Network Department of Psychiatry (SH, CL, GR) and partly funded by the Canadian Institutes of Health Research (CIHR #MOP 106473). This research was also supported by the Princess Margaret Cancer Foundation Hertz Centre Fund, the Campbell Family Cancer Research Institute and the Ontario Cancer Institute at Princess Margaret Cancer Centre, and by the Ontario Ministry of Health and Long Term Care (OMOHLTC). The views expressed do not necessarily reflect those of the OMOHLTC. Dr. Rodin is also supported by the University of Toronto/University Health Network Harold and Shirley Lederman Chair in Psychosocial Oncology and Palliative Care. The funders had no role in the final design, analysis and writing of this study

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

Additional file 1: of Managing Cancer And Living Meaningfully: study protocol for a randomized controlled trial

The Clinical Evaluation Questionnaire (CEQ)*