Background No trials have tested multifaceted mental health interventions recommended by public health organisations during COVID-19. The objective of this trial was to evaluate the effect of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Program on anxiety symptoms and other mental health outcomes among people vulnerable during COVID-19 owing to a pre-existing medical condition. Methods The SPIN-CHAT Trial was a pragmatic, two-arm, parallel, partially nested, randomised, controlled trial (1:1 allocation to intervention or waitlist). Eligible participants with systemic sclerosis were recruited from the international SPIN COVID-19 Cohort. SPIN COVID-19 Cohort participants were eligible for the trial if they completed baseline measures and had at least mild anxiety symptoms, had not tested positive for COVID-19, and were not currently receiving mental health counselling. SPIN-CHAT is a 4-week (3 sessions per week) videoconference-based group intervention that provided education and practice with mental health coping strategies, and provided social support to reduce isolation. Groups included 6–10 participants. The primary outcome analysed in the intention-to-treat population was anxiety symptoms (PROMIS Anxiety 4a version 1.0) immediately post-intervention. This trial is registered with ClinicalTrials.gov , NCT04335279 and is complete. Findings Of participants who completed baseline measures between April 9, 2020, and April 27, 2020, 560 participants were eligible and 172 participants were randomly assigned to intervention (n=86) or waitlist (n=86). Mean age was 55·0 years (SD 11·4 years), 162 (94%) were women, and 136 (79%) identified as White. In intention-to-treat analyses, the intervention did not significantly reduce anxiety symptoms post-intervention (−1·57 points, 95% CI −3·59 to 0·45; standardised mean difference [SMD] −0·22 points) but reduced symptoms 6 weeks later (−2·36 points, 95% CI −4·56 to −0·16; SMD −0·31). Depression symptoms were significantly lower 6 weeks post-intervention (−1·64 points, 95% CI −2·91 to −0·37; SMD −0·31); no other secondary outcomes were significant. No adverse events were reported. Interpretation The intervention did not significantly improve anxiety symptoms or other mental health outcomes post-intervention. However, anxiety and depression symptoms were significantly lower 6 weeks later, potentially capturing the time it took for new skills and social support between intervention participants to affect mental health. Multi-faceted interventions such as SPIN-CHAT have potential to address mental health needs in vulnerable groups during COVID-19, yet uncertainty remains about effectiveness. Funding Canadian Institutes of Health Research (CIHR; VR4-172745, MS1-173066); McGill Interdisciplinary Initiative in Infection and Immunity Eme...

Introduction No studies have reported mental health symptom comparisons prior to and during COVID-19 in vulnerable medical populations. Objective To compare anxiety and depression symptoms among people with a pre-existing medical condition and factors associated with changes. Methods Pre-COVID-19 Scleroderma Patient-centered Intervention Network Cohort data were linked to COVID-19 data from April 2020. Multiple linear and logistic regression were used to assess factors associated with continuous change and ≥ 1 minimal clinically important difference (MCID) change for anxiety (PROMIS Anxiety 4a v1.0; MCID = 4.0) and depression (Patient Health Questionnaire-8; MCID = 3.0) symptoms, controlling for pre-COVID-19 levels. Results Mean anxiety symptoms increased 4.9 points (95% confidence interval [CI] 4.0 to 5.7). Depression symptom change was negligible (0.3 points; 95% CI -0.7 to 0.2). Compared to France ( N = 159), adjusted anxiety symptom change scores were significantly higher in the United Kingdom ( N = 50; 3.3 points, 95% CI 0.9 to 5.6), United States ( N = 128; 2.5 points, 95% CI 0.7 to 4.2), and Canada ( N = 98; 1.9 points, 95% CI 0.1 to 3.8). Odds of ≥1 MCID increase were 2.6 for the United Kingdom (95% CI 1.2 to 5.7) but not significant for the United States (1.6, 95% CI 0.9 to 2.9) or Canada (1.4, 95% CI 0.7 to 2.5). Older age and adequate financial resources were associated with less continuous anxiety increase. Employment and shorter time since diagnosis were associated with lower odds of a ≥ 1 MCID increase. Conclusions Anxiety symptoms, but not depression symptoms, increased dramatically during COVID-19 among people with a pre-existing medical condition.

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Background Advanced lung cancer patients face significant physical and psychological burden leading to reduced physical function and quality of life. Separately, physical activity, nutrition, and palliative symptom management interventions have been shown to improve functioning in this population, however no study has combined all three in a multimodal intervention. Therefore, we assessed the feasibility of a multimodal physical activity, nutrition, and palliative symptom management intervention in advanced lung cancer. Methods Participants received an individually tailored 12-week intervention featuring in-person group-based exercise classes, at-home physical activity prescription, behaviour change education, and nutrition and palliative care consultations. Patients reported symptom burden, energy, and fatigue before and after each class. At baseline and post-intervention, symptom burden, quality of life, fatigue, physical activity, dietary intake, and physical function were assessed. Post-intervention interviews examined participant perspectives. Results The multimodal program was feasible, with 44% (10/23) recruitment, 75% (75/100) class attendance, 89% (8/9) nutrition and palliative consult attendance, and 85% (17/20) assessment completion. Of ten participants, 70% (7/10) completed the post-intervention follow-up. Participants perceived the intervention as feasible and valuable. Physical activity, symptom burden, and quality of life were maintained, while tiredness decreased significantly. Exercise classes prompted acute clinically meaningful reductions in fatigue, tiredness, depression, pain, and increases in energy and well-being. Conclusion A multimodal physical activity, nutrition, and palliative symptom management intervention is feasible and shows potential benefits on quality of life that warrant further investigation in a larger cohort trial. Trial registration NCT04575831, Registered 05 October 2020 – Retrospectively registered.

Background Young adults affected by cancer face physical and psychological challenges and desire online supportive care. Yoga can be delivered online and may improve physical and psychological outcomes. Yet, yoga has rarely been studied with young adults affected by cancer. To address this, an 8-week yoga intervention was developed, and a pilot study was deemed necessary to explore feasibility, acceptability, implementation, and potential benefits. Methods A mixed-methods, single-arm hybrid effectiveness-implementation pilot study evaluating the yoga intervention was conducted. Feasibility was assessed by tracking enrollment, retention, attendance, completeness of data, and adverse events. Acceptability was explored through interviews. Implementation metrics included training time, delivery resources, and fidelity. Potential effectiveness was evaluated by exploring changes in physical (i.e., balance, flexibility, range of motion, functional mobility) and psychological (i.e., quality of life, fatigue, resilience, posttraumatic growth, body image, mindfulness, perceived stress) outcomes at pre- (week 0), post- (week 8), and follow-up (week 16) time points. Data were analyzed with descriptive statistics, repeated measures analysis of variance, and content analysis. Results Thirty young adults participated in this study (recruitment rate = 33%). Retention to study procedures was 70%, and attendance ranged from 38 to 100%. There were little missing data (< 5%) and no adverse events. Though most participants were satisfied with the yoga intervention, recommendations for improvement were shared. Sixty study-specific training hours and > 240 delivery and assessment hours were accrued and fidelity was high. Functional mobility, flexibility, quality of life (energy/fatigue, social well-being), body image (appearance evaluation), mindfulness (non-reactivity), and perceived stress improved significantly over time (all p< 0.050; $$\eta_{p}{}^{2}s=0.124-0.292$$ η p 2 s = 0.124 - 0.292 ). No other significant changes were observed (all p> 0.050; $$\eta_{p}{}^{2}s=0.005-0.115$$ η p 2 s = 0.005 - 0.115 ). Conclusions The yoga intervention may confer physical and psychological benefits, though intervention and study-specific modifications are required to improve feasibility and acceptability. Requiring study participation and providing greater scheduling flexibility could enhance recruitment and retention. Increasing the frequency of classes offered each week and offering more opportunities for participant interaction could improve satisfaction. This study highlights the value of doing pilot work and provides data that has directly informed intervention and study modifications. Findings could also be used by others offering yoga or supportive care by videoconference to young adults affected by cancer. Trial registration Not available—not registered

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Introduction: Advanced lung cancer patients face significant physical and psychological burden leading to reduced quality of life. Physical activity, nutrition, and palliative care interventions may enhance quality of life, however no study has combined these modalities in a multimodal intervention. Therefore, we assessed the feasibility and preliminary efficacy of an exercise, nutrition, and palliative symptom management intervention to improve quality of life in advanced lung cancer. Methods: Participants received an individually-tailored 12-week intervention featuring in-person group-based exercise classes, at-home physical activity prescription, and nutritional and palliative care consults. Patients reported symptom burden and quality of life pre-/post-class, as well as pre-/post-intervention, along with self-reported physical activity and a physical function assessment. Post-intervention interviews examined participant perspectives. Results: The multimodal program was feasible, with 44% recruitment, 75% class attendance, 89% nutrition and palliative consult attendance, and 85% assessment completion. Participants perceived the intervention as feasible and valuable. Physical activity, symptom burden, and quality of life were maintained, while tiredness decreased significantly. Exercise classes prompted acute clinically meaningful reductions in fatigue, tiredness, depression, pain, and increases in energy and well-being. Conclusion: A multimodal exercise, nutrition, and palliative symptom management intervention is feasible and shows potential benefits on quality of life that warrant further investigation.

The SPIN-CHAT Program was designed to support mental health among individuals with systemic sclerosis (SSc; commonly known as scleroderma) and at least mild anxiety symptoms at the onset of COVID-19. The program was formally evaluated in the SPIN-CHAT Trial. Little is known about program and trial acceptability, and factors impacting implementation from the perspectives of research team members and trial participants. Thus, the propose of this follow-up study was to explore research team members’ and trial participants’ experiences with the program and trial to identify factors impacting acceptability and successful implementation. Data were collected cross-sectionally through one-on-one, videoconference-based, semi-structured interviews with 22 research team members and 30 purposefully recruited trial participants (Mage = 54.9, SD = 13.0 years). A social constructivist paradigm was adopted, and data were analyzed thematically. Data were organized into seven themes: (i) getting started: the importance of prolonged engagement and exceeding expectations; (ii) designing the program and trial: including multiple features; (iii) training: research team members are critical to positive program and trial experiences; (iv) offering the program and trial: it needs to be flexible and patient-oriented; (v) maximizing engagement: navigating and managing group dynamics; (vi) delivering a videoconference-based supportive care intervention: necessary, appreciated, and associated with some barriers; and (vii) refining the program and trial: considering modification when offered beyond the period of COVID-19 restrictions. Trial participants were satisfied with and found the SPIN-CHAT Program and Trial to be acceptable. Results offer implementation data that can guide the design, development, and refinement of other supportive care programs seeking to promote psychological health during and beyond COVID-19.