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.

(1) Background: Patients and survivors of head and neck cancer (HNC) are at a high risk of developing body image concerns. Despite the prevalence of body image concerns in patients with HNC, there is a lack of longitudinal research exploring the wide array of its associated determinants. The current longitudinal study examined the determinants and longitudinal course of body image dissatisfaction in patients with HNC. (2) Methods: Patients participated in Structured Clinical Interviews and self-administered questionnaires at four time-points: (T1) upon cancer diagnosis, (T2) at 3 months post-diagnosis, (T3) at 6 months post-diagnosis, and (T4) at 12 months post-diagnosis. They also underwent a disfigurement rating on an objective scale. (3) Results: Two hundred and twenty-four patients participated in our study. Fourteen percent to twenty-eight percent of patients reported at least moderate body image concerns across time points, with the lowest rates at baseline and the highest at 3 months (T1). It was found that patients more predisposed to developing higher levels of body image concerns presented physical markers (i.e., advanced cancer stage, lower physical functioning, higher disfigurement), psychosocial markers (i.e., higher depression, higher anxiety, and higher levels of coping with denial), and health disparities (i.e., younger age, female sex, French language, and marital status, with divorced and widowers most affected). (4) Conclusions: The findings of this study highlight the multifaceted nature of body image concerns in patients with HNC and its biopsychosocial determinants. Clinicians should pay specific attention to these biopsychosocial markers in their clinics to predict high levels of body image concerns and tailor communication/refer for support accordingly.

Importance: Ketamine-assisted psychotherapy (KAP) is an emerging treatment option to alleviate treatment-resistant affective disorders, but its long-term effectiveness remains unclear. Objective: To examine the treatment effects of KAP on anxiety, depression, and post-traumatic stress disorder (PTSD) at 1, 3, and 6 months post-treatment. Design, Setting, and Participants: This retrospective effectiveness study included self-reported outcomes from adults with a history of major depressive disorder, generalized anxiety disorder (GAD), or PTSD who had not responded to prior treatment interventions and received KAP administered across 11 Field Trip Health clinics in North America between March 13, 2020, and June 16, 2022. The evaluable sample sizes were 346 and 94 participants at 3 and 6 months, respectively, representing loss to follow-up rates of 82% and 95%. Intervention: KAP consists of 4–6 guided ketamine sessions (administered through intramuscular injection or sublingual lozenge) with psychotherapy-only integration visits after doses 1 and 2 and then after every 2 subsequent doses. Mean number of doses administered was 4, standard deviation (SD) = 3, and mean number of integration sessions was 3, SD = 2. Main Outcomes and Measures: Primary outcomes were changes in symptoms of depression, anxiety, and PTSD at 3 months relative to baseline, assessed, respectively, using the 9-item Patient Health Questionnaire, the 7-item GAD measure, and the 6-item PTSD checklist. Secondary outcomes were changes at 1 and 6 months relative to baseline. Results: Large treatment effects were detected at 3 months ( d' s = 0.75–0.86) and were sustained at 6 months ( d' s = 0.61–0.73). Case reductions (identified based on cutoff values) ranged from 39% to 41% at 3 months and 29% to 37% at 6 months. In total, 50–75% reported a minimal clinically important difference at 3 months and 48–70% at 6 months. Conclusions and Relevance: KAP produced sustained reductions in anxiety, depression, and PTSD, with symptom improvement lasting well beyond the duration of dosing and integration sessions. These effects extended to as much as 5 months after the last KAP session. However, the high rates of attrition may limit validity of the results. Given the growing mental health care crises and the need for effective therapies and models of care, especially for intractable psychiatric mood-related disorders, these data support the use of KAP as a viable alternative. Further prospective clinical research should be undertaken to provide evidence on the safety and effectiveness of ketamine within a psychotherapeutic context.

Childhood trauma may be prevalent in the general population, and the psychosocial treatment of patients with cancer may require consideration of the effects of such early adversity on the healing and recovery process. In this study, we investigated the long-term effects of childhood trauma in 133 women diagnosed with breast cancer (mean age 51, SD = 9) who had experienced physical, sexual, or emotional abuse or neglect. We examined their experience of loneliness and its associations with the severity of childhood trauma, ambivalence about emotional expression, and changes in self-concept during the cancer experience. In total, 29% reported experiencing physical or sexual abuse, and 86% reported neglect or emotional abuse. In addition, 35% of the sample reported loneliness of moderately high severity. Loneliness was directly influenced by the severity of childhood trauma and was directly and indirectly influenced by discrepancies in self-concept and emotional ambivalence. In conclusion, we found that childhood trauma was common in breast cancer patients, with 42% of female patients reporting childhood trauma, and that these early experiences continued to exert negative effects on social connection during the illness trajectory. Assessment of childhood adversity may be recommended as part of routine oncology care, and trauma-informed treatment approaches may improve the healing process in patients with breast cancer and a history of childhood maltreatment.