Combating Fraudulent Participation in Urban American Indian and Alaska Native Virtual Health Research: Protocol for Increasing Data Integrity in Online Research (PRIOR).

BACKGROUND: While the advantages of using the internet and social media for research recruitment are well documented, the evolving online environment also enhances motivations for misrepresentation to receive incentives or to "troll" research studies. Such fraudulent assaults can compromise data integrity, with substantial losses in project time; money; and especially for vulnerable populations, research trust. With the rapid advent of new technology and ever-evolving social media platforms, it has become easier for misrepresentation to occur within online data collection. This perpetuation can occur by bots or individuals with malintent, but careful planning can help aid in filtering out fraudulent data. OBJECTIVE: Using an example with urban American Indian and Alaska Native young women, this paper aims to describe PRIOR (Protocol for Increasing Data Integrity in Online Research), which is a 2-step integration protocol for combating fraudulent participation in online survey research. METHODS: From February 2019 to August 2020, we recruited participants for formative research preparatory to an online randomized control trial of a preconceptual health program. First, we described our initial protocol for preventing fraudulent participation, which proved to be unsuccessful. Then, we described modifications we made in May 2020 to improve the protocol performance and the creation of PRIOR. Changes included transferring data collection platforms, collecting embedded geospatial variables, enabling timing features within the screening survey, creating URL links for each method or platform of data collection, and manually confirming potentially eligible participants' identifying information. RESULTS: Before the implementation of PRIOR, the project experienced substantial fraudulent attempts at study enrollment, with less than 1% (n=6) of 1300 screened participants being identified as truly eligible. With the modified protocol, of the 461 individuals who completed a screening survey, 381 did not meet the eligibility criteria assessed on the survey. Of the 80 that did, 25 (31%) were identified as ineligible via PRIOR. A total of 55 (69%) were identified as eligible and verified in the protocol and were enrolled in the formative study. CONCLUSIONS: Fraudulent surveys compromise study integrity, validity of the data, and trust among participant populations. They also deplete scarce research resources including respondent compensation and personnel time. Our approach of PRIOR to prevent online misrepresentation in data was successful. This paper reviews key elements regarding fraudulent data participation in online research and demonstrates why enhanced protocols to prevent fraudulent data collection are crucial for building trust with vulnerable populations. TRIAL REGISTRATION: ClinicalTrials.gov NCT04376346; https://www.clinicaltrials.gov/study/NCT04376346. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52281.

Participant Bias in Community-Based Physical Activity Research: A Consistent Limitation?

Physical activity is a beneficial, yet complex, health behavior. To ensure more people experience the benefits of physical activity, we develop and test interventions to promote physical activity and its associated benefits. Nevertheless, we continue to see certain groups of people who choose not to, or are unable to, take part in research, resulting in "recruitment bias." In fact, we (and others) are seemingly missing large segments of people and are doing little to promote physical activity research to equity-deserving populations. So, how can we better address recruitment bias in the physical activity research we conduct? Based on our experience, we have identified 5 broad, interrelated, and applicable strategies to enhance recruitment and engagement within physical activity interventions: (1) gain trust, (2) increase community support and participation, (3) consider alternative approaches and designs, (4) rethink recruitment strategies, and (5) incentivize participants. While we recognize there is still a long way to go, and there are broader community and societal issues underlying recruitment to research, we hope this commentary prompts researchers to consider what they can do to try to address the ever-present limitation of "recruitment bias" and support greater participation among equity-deserving groups.

Yoga versus iPad active control for fatigue in paediatric cancer therapy: a randomised controlled trial.

OBJECTIVES: The primary objective was to determine if individualised yoga for hospitalised children receiving intensive chemotherapy was associated with less fatigue using the Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL MFS) compared with iPad control. METHODS: This was a multicentre randomised controlled trial of individualised yoga in paediatric patients aged 8-18 years who were inpatients receiving intensive chemotherapy for leukaemia, lymphoma or haematopoietic cell transplantation. Participants were randomised to yoga or iPad groups; allocated programme was delivered individually by trained yoga instructors 5 days/week for 21 days. The primary outcome was day 21 guardian-reported general fatigue using the PedsQL MFS. Secondary outcomes included day 21 PedsQL sleep/rest and cognitive fatigue, Fatigue Scale and PedsQL Acute Cancer Module, and systemic opioid administration. RESULTS: The study was closed early for poor accrual when 125/210 planned participants had been enrolled and randomised to yoga (n=62) or iPad (n=63). Guardian-reported PedsQL MFS general fatigue scores on day 21 were not significantly different between groups (adjusted difference 7.2, 95% CI -2.6 to 16.9) in favour of yoga. However, day 21 cognitive fatigue (adjusted difference 9.0, 95% CI 0.9 to 17.1), cognitive problems (adjusted difference 11.2, 95% CI 3.5 to 19.0) and communication (adjusted difference 10.6, 95% CI 0.8 to 20.4) were significantly better in the yoga compared with the iPad group. There were no significant differences in the other secondary outcomes including PedsQL sleep/rest fatigue (adjusted difference 4.9, 95% CI -3.5 to 13.3). CONCLUSIONS: The effect of individualised yoga on general fatigue is uncertain in paediatric patients receiving intensive chemotherapy. However, yoga significantly improved cognitive fatigue and cognitive problems. TRIAL REGISTRATION NUMBER: NCT02134782.

Exercise Programming Modelling a Standard of Care Approach Improves Physical Health and Patient-Reported Outcomes in Individuals Living with Breast Cancer: A Pilot Study.

Controlled study designs widely report that exercise improves the health of individuals living with breast cancer. Still, many individuals living with breast cancer are not active enough to experience the benefits of exercise. The Activating Cancer Communities through an Exercise Strategy for Survivors study was developed to reach more individuals living with cancer. This report describes the effects of a 12-week individualized exercise program that models a standard-of-care approach on body composition, physical fitness, and patient-reported outcomes in individuals living with breast cancer. Individuals living with breast cancer were recruited for the study and completed an exercise program twice weekly overseen by a Clinical Exercise Physiologist. A total of 43 participants completed the exercise intervention, and 36 withdrew from the study. All participants had significantly improved aerobic fitness, waist circumference, hip circumference, lower body endurance, physical activity behaviour, health-related quality of life, emotional status, and fatigue levels after completing the program. Flexibility, balance, and sleep scores did not change. The results from the 12-week individualized exercise program largely align with the results from more controlled study designs. These results support future initiatives integrating exercise therapy into the standard of care for individuals living with breast cancer.

Feasibility and Implementation of an Oncology Rehabilitation Triage Clinic: Assessing Rehabilitation, Exercise Need, and Triage Pathways within the Alberta Cancer Exercise-Neuro-Oncology Study.

Individuals living with and beyond cancer face physical impairment and inactivity in survivorship. Neuro-oncology populations have especially high rates of sedentary behaviour and functional deficits, including impaired balance, motor skills, and cognition. Our purpose was to assess the rehabilitation and exercise needs of patients with brain tumours while examining the feasibility of a rehabilitation triage clinic as a part of the Alberta Cancer Exercise-Neuro-Oncology study, where patients were referred to a triage clinic, where health, neurologic, and functional status was assessed, followed by a referral to one or multiple resources, including exercise, physiotherapy, occupational therapy, or physiatry. Qualitative perception of the triage clinic was collected. Overall, the triage clinic was feasible and safe for participants, facilitating referral into rehabilitation and exercise resources. Pre-determined enrollment and attendance rates were met, but referral rates to the triage clinic were not met. Oncology clinic staff reported forgetting to refer patients or uncertainty of who was appropriate for rehabilitation as barriers. Oncology clinic-based screening may improve the identification of patients who are sedentary or have a physical impairment. A proposed screening tool, the Cancer Rehabilitation and Exercise Screening Tool (CREST), is presented within our Cancer Rehabilitation and Exercise Pathways Model. The CREST can identify patients who are sedentary or have a functional impairment, facilitating referral to appropriate rehabilitation resources and ultimately improving patient recovery and functioning.

Centering culture in an mHealth adaptation of an alcohol-exposed pregnancy prevention program for American Indian Youth.

Native WYSE CHOICES adapted an Alcohol Exposed Pregnancy (AEP) prevention curriculum for mobile health delivery for young urban American Indian and Alaska Native (AIAN) women. This qualitative study explored the relevance of culture in adapting a health intervention with a national sample of urban AIAN youth. In total, the team conducted 29 interviews across three iterative rounds. Participants expressed interest in receiving culturally informed health interventions, were open to cultural elements from other AIAN tribes, and highlighted the importance of culture in their lives. The study underscores why community voices are central in tailoring health interventions for this population.

A qualitative study examining newly diagnosed breast cancer patients' experiences of participating in the Alberta Moving Beyond Breast Cancer (AMBER) prospective cohort study.

BACKGROUND: Decisions to participate in cancer trials are associated with uncertainty, distress, wanting to help find a cure, the hope for benefit, and altruism. There is a gap in the literature regarding research examining participation in prospective cohort studies. The aim of this study was to examine the experiences of newly diagnosed women with breast cancer participating in the AMBER Study to identify potential strategies to support patients' recruitment, retention, and motivation. METHODS: Newly diagnosed breast cancer patients were recruited from the Alberta Moving Beyond Breast Cancer (AMBER) cohort study. Data were collected using semi-structured conversational interviews with 21 participants from February to May 2020. Transcripts were imported into NVivo software for management, organization, and coding. Inductive content analysis was undertaken. RESULTS: Five main concepts associated with recruitment, retention, and motivation to participate were identified. These main concepts included: (1) personal interest in exercise and nutrition; (2) investment in individual results; (3) personal and professional interest in research; (4) burden of assessments; (5) importance of research staff. CONCLUSIONS: Breast cancer survivors participating in this prospective cohort study had numerous reasons for participating and these reasons could be considered in future studies to enhance participant recruitment and retention. Improving recruitment and retention in prospective cancer cohort studies could result in more valid and generalizable study findings that could improve the care of cancer survivors.

A virtual randomized controlled trial of an alcohol-exposed pregnancy prevention mobile app with urban American Indian and Alaska Native young women: Native WYSE CHOICES rationale, design, and methods.

BACKGROUND: Fetal Alcohol Spectrum Disorders (FASD) result in lifelong disability and are a leading cause of preventable birth defects in the US, including for American Indian and Alaska Natives (AIANs). Prevention of alcohol exposed pregnancies (AEPs), which can cause FASD, is typically aimed at adult women who are risky drinkers and have unprotected sex. Among AIANs, AEP prevention research has been primarily conducted in reservation communities, even though over 70% of AIANs live in urban areas. Culturally appropriate AEP prevention for urban AIAN young women, regardless of current drinking or sexual behaviors, may maximize the potential for primary prevention at the beginning of the reproductive years for this underserved population. METHODS: We developed a virtual randomized controlled trial (RCT) - fully implemented through technology - to evaluate Native WYSE CHOICES, a culturally tailored mobile app, with urban AIAN young women ages 16-20 nationally. While virtual RCTs are not new, this is the first engaging a solely urban AIAN population, historically excluded from research. Participants are recruited on a rolling basis through the project social media community, organizational partnerships, and in-person events. Eligible participants complete a baseline survey and are randomized to either the app's intervention or comparison arm - each of which provide about 3 h of content. Follow-up data are collected at 1-, 6-, and 12-months post-baseline. RESULTS: Our study offers a template for building trust and extending reach to this underserved population while also providing important lessons and insights on advances in virtual or hybrid research approaches.

Implementing an exercise oncology model to reach rural and remote individuals living with and beyond cancer: a hybrid effectiveness-implementation protocol for project EXCEL (EXercise for Cancer to Enhance Living Well).

INTRODUCTION: Individuals living with and beyond cancer from rural and remote areas lack accessibility to supportive cancer care resources compared with those in urban areas. Exercise is an evidence-based intervention that is a safe and effective supportive cancer care resource, improving physical fitness and function, well-being and quality of life. Thus, it is imperative that exercise oncology programs are accessible for all individuals living with cancer, regardless of geographical location. To improve accessibility to exercise oncology programs, we have designed the EXercise for Cancer to Enhance Living Well (EXCEL) study. METHODS AND ANALYSIS: EXCEL is a hybrid effectiveness-implementation study. Exercise-based oncology knowledge from clinical exercise physiologists supports healthcare professionals and community-based qualified exercise professionals, facilitating exercise oncology education, referrals and programming. Recruitment began in September 2020 and will continue for 5 years with the goal to enroll ~1500 individuals from rural and remote areas. All tumour groups are eligible, and participants must be 18 years or older. Participants take part in a 12-week multimodal progressive exercise intervention currently being delivered online. The reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework is used to determine the impact of EXCEL at participant and institutional levels. Physical activity, functional fitness and patient-reported outcomes are assessed at baseline and 12-week time points of the EXCEL exercise intervention. ETHICS AND DISSEMINATION: The study was approved by the Health Research Ethics Board of Alberta. Our team will disseminate EXCEL information through quarterly newsletters to stakeholders, including participants, qualified exercise professionals, healthcare professionals and community networks. Ongoing outreach includes community presentations (eg, support groups, fitness companies) that provide study updates and exercise resources. Our team will publish manuscripts and present at conferences on EXCEL's ongoing implementation efforts across the 5-year study. TRIAL REGISTRATION NUMBER: NCT04478851.

Centering Native Youths' Needs and Priorities: Findings from the 2020 Native Youth Health Tech Survey.

Health advocates are increasingly using social media and mobile technology to reach American Indian and Alaska Native (AI/AN) youth to address important health topics and enhance protective factors. Public health experts did not know to what extent AI/AN youth used these tools to access health resources during the pandemic. The Native Youth Health Tech Survey was administered online from October to November 2020 with 349 AI/AN youth 15 to 24 years old. Survey results indicated frequent technology use-68.7% sent 1-50 text messages per day, and 65.3% were on social media 3-7 hours per day. Instagram was the most popular channel used, and 53.5% of participants relied heavily on the Internet to access health information. The three most important health topics were Native identity, mental health, and social justice and equality. These findings can inform the design and dissemination of culturally grounded health resources across AI/AN communities to improve their reach and appeal, improving health outcomes, self-esteem, and cultural connectedness.

Exploring Yoga Instructors' Experiences Delivering Yoga to Children and Adolescents Affected by Cancer or Blood Disease.

Yoga may offer benefits for children and adolescents affected by cancer or blood disease, yet there are challenges in translating evidence to practice. Yoga instructors are critical for the delivery of yoga. Understanding yoga instructors' experiences offering yoga to children and adolescents affected by cancer or blood disease could provide information to guide required competencies and training, as well as elucidate factors to consider in future research and programs. Therefore, the present study sought to understand yoga instructors' lived experiences preparing for and facilitating yoga for children and adolescents affected by cancer or blood disease. Fourteen yoga instructors with experience facilitating yoga for this population participated in semi-structured interviews, which were transcribed verbatim and analyzed using principles of interpretive description and thematic analysis. Five unique themes were identified: (1) "I believe in and see the perceived benefits of yoga on and off the mat"; (2) "I feel equipped to deliver yoga but desire further training"; (3) "what I need to deliver a safe yoga program"; (4) "I must be adaptable to successfully facilitate a yoga program"; and (5) "what I need to ensure yoga is widely available." Findings highlight the varied and comprehensive training opportunities yoga instructors sought, while elucidating their training limitations. Yoga instructors shared their perspectives on concerted attention to safety, effectiveness, and access when developing research and programs. This study represents a first step toward defining required competencies for delivering yoga to this population and lays the foundation for future research and programs.

Virtual Research with Urban Native Young Women: Cautionary Tales in the Time of a Pandemic.

BACKGROUND: Community-based participatory research is a particularly powerful approach to research with American Indian and Alaska Native (AIAN) communities who have been subject to a history of mistreatment and unethical research. In person meetings, discussion, and engagement with tribal members and the community have become an essential component of community-based participatory research in AIAN communities. With the advent of the coronavirus disease 2019 pandemic, AIAN communities have moved to close or sharply curtail in-person activities, precluding in-person research methods. Current best practices for research with AIAN communities assumes in-person engagement; little guidance exists on engaging AIAN communities in research using virtual technologies. Our study, Native Women, Young, Strong, Empowered Changing High-risk alcohOl use and Increasing Contraception Effectiveness Study (Native WYSE CHOICES), was intentionally designed before the pandemic to be virtual, including recruitment, enrollment, intervention, and assessment with urban AIAN young women. OBJECTIVES: We present our perspectives on virtual research with AIAN communities, including the critical role of our advisory partners to inform the virtual intervention design and recruitment methods in the formative stages of our project. METHODS: Experiential reflection among research team and community partners. CONCLUSIONS: Virtual technologies, such as videoconferencing, social media, and mobile health apps, offer many tools to reach communities, especially in a pandemic. The virtualization of research with AIAN communities requires a significant investment in time, resources and planning to mitigate disadvantages; it cannot fully replace in-person-based community-based participatory research approaches, but may offer many strengths and unique advantages for research, especially in a pandemic.

Documenting patients' and providers' preferences when proposing a randomized controlled trial: a qualitative exploration.

BACKGROUND: With advances in cancer diagnosis and treatment, women with early-stage breast cancer (ESBC) are living longer, increasing the number of patients receiving post-treatment follow-up care. Best-practice survivorship models recommend transitioning ESBC patients from oncology-provider (OP) care to community-based care. While developing materials for a future randomized controlled trial (RCT) to test the feasibility of a nurse-led Telephone Survivorship Clinic (TSC) for a smooth transition of ESBC survivors to follow-up care, we explored patients' and OPs' reactions to several of our proposed methods. METHODS: We used a qualitative study design with thematic analysis and a two-pronged approach. We interviewed OPs, seeking feedback on ways to recruit their ESBC patients for the trial, and ESBC patients, seeking input on a questionnaire package assessing outcomes and processes in the trial. RESULTS: OPs identified facilitators and barriers and offered suggestions for study design and recruitment process improvement. Facilitators included the novelty and utility of the study and simplicity of methods; barriers included lack of coordination between treating and discharging clinicians, time constraints, language barriers, motivation, and using a paper-based referral letter. OPs suggested using a combination of electronic and paper referral letters and supporting clinicians to help with recruitment. Patient advisors reported satisfaction with the content and length of the assessment package. However, they questioned the relevance of some questions (childhood trauma) while adding questions about trust in physicians and proximity to primary-care providers. CONCLUSIONS: OPs and patient advisors rated our methods for the proposed trial highly for their simplicity and relevance then suggested changes. These findings document processes that could be effective for cancer-patient recruitment in survivorship clinical trials.

Loss of TDP-43 function and rimmed vacuoles persist after T cell depletion in a xenograft model of sporadic inclusion body myositis.

Sporadic inclusion body myositis (IBM) is the most common acquired muscle disease in adults over age 50, yet it remains unclear whether the disease is primarily driven by T cell­mediated autoimmunity. IBM muscle biopsies display nuclear clearance and cytoplasmic aggregation of TDP-43 in muscle cells, a pathologic finding observed initially in neurodegenerative diseases, where nuclear loss of TDP-43 in neurons causes aberrant RNA splicing. Here, we show that loss of TDP-43­mediated splicing repression, as determined by inclusion of cryptic exons, occurs in skeletal muscle of subjects with IBM. Of 119 muscle biopsies tested, RT-PCR­mediated detection of cryptic exon inclusion was able to diagnose IBM with 84% sensitivity and 99% specificity. To determine the role of T cells in pathogenesis, we generated a xenograft model by transplanting human IBM muscle into the hindlimb of immunodeficient mice. Xenografts from subjects with IBM displayed robust regeneration of human myofibers and recapitulated both inflammatory and degenerative features of the disease. Myofibers in IBM xenografts showed invasion by human, oligoclonal CD8+ T cells and exhibited MHC-I up-regulation, rimmed vacuoles, mitochondrial pathology, p62-positive inclusions, and nuclear clearance and cytoplasmic aggregation of TDP-43, associated with cryptic exon inclusion. Reduction of human T cells within IBM xenografts by treating mice intraperitoneally with anti-CD3 (OKT3) suppressed MHC-I up-regulation. However, rimmed vacuoles and loss of TDP-43 function persisted. These data suggest that T cell depletion does not alter muscle degenerative pathology in IBM.

Associations of light physical activity, moderate-to-vigorous physical activity and sedentary behavior with quality of life in men on androgen deprivation therapy for prostate cancer: a quantile regression analysis.

To examine associations of physical activity (PA) and sedentary time (SED) with quality of life (QoL) in men on androgen deprivation therapy (ADT) for prostate cancer. A pooled analysis of 106 men on ADT was conducted. PA and SED were assessed using accelerometers. The Functional Assessment of Cancer Therapy (FACT) was used to assess self-reported QoL. Quantile regression examined the associations of QoL with PA and SED. Total time spent in SED was positively associated with FACT-General at the 50th (p = 0.010) and 75th percentile (p = 0.022). SED in ≥ 30-min bouts was inversely associated with FACT-General at the 50th  (p = 0.025) and 75th percentile (p = 0.029). Breaks in SED were positively associated with physical well-being at the 75th percentile (p = 0.004). Light-intensity PA was positively associated with FACT-Prostate at the 25th percentile (p = 0.020). SED and PA were associated with QoL outcomes, but time in each varied across men reporting the poorest QoL compared to those in the highest QoL distributions.

The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial.

BACKGROUND: Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. We completed an initial feasibility trial of an online self-administered version of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program using the cohort multiple randomized controlled trial (RCT) design. Due to low intervention offer uptake, we will conduct a new feasibility trial with progression to full-scale trial, using a two-arm parallel, partially nested RCT design. The SPIN-SELF Program has also been revised to include facilitator-led videoconference group sessions in addition to online material. We will test the group-based intervention delivery format, then evaluate the effect of the SPIN-SELF Program on disease management self-efficacy (primary) and patient activation, social appearance anxiety, and functional health outcomes (secondary). METHODS: This study is a feasibility trial with progression to full-scale RCT, pending meeting pre-defined criteria, of the SPIN-SELF Program. Participants will be recruited from the ongoing SPIN Cohort ( http://www.spinsclero.com/en/cohort ) and via social media and partner patient organizations. Eligible participants must have SSc and low to moderate disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) Scale score ≤ 7.0). Participants will be randomized (1:1 allocation) to the group-based SPIN-SELF Program or usual care for 3 months. The primary outcome in the full-scale trial will be disease management self-efficacy based on SEMCD Scale scores at 3 months post-randomization. Secondary outcomes include SEMCD scores 6 months post-randomization plus patient activation, social appearance anxiety, and functional health outcomes at 3 and 6 months post-randomization. We will include 40 participants to assess feasibility. At the end of the feasibility portion, stoppage criteria will be used to determine if the trial procedures or SPIN-SELF Program need important modifications, thereby requiring a re-set for the full-scale trial. Otherwise, the full-scale RCT will proceed, and outcome data from the feasibility portion will be utilized in the full-scale trial. In the full-scale RCT, 524 participants will be recruited. DISCUSSION: The SPIN-SELF Program may improve disease management self-efficacy, patient activation, social appearance anxiety, and functional health outcomes in people with SSc. SPIN works with partner patient organizations around the world to disseminate its programs free-of-charge. TRIAL REGISTRATION: ClinicalTrials.gov NCT04246528 . Registered on 27 January 2020.

Effects of a multi-faceted education and support programme on anxiety symptoms among people with systemic sclerosis and anxiety during COVID-19 (SPIN-CHAT): a two-arm parallel, partially nested, randomised, controlled trial.

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 Emergency COVID-19 Research Fund; Scleroderma Canada, made possible by an educational grant for patient support programming from Boehringer Ingelheim; the Scleroderma Society of Ontario; Scleroderma Manitoba; Scleroderma Atlantic; Scleroderma Australia; Scleroderma New South Wales; Scleroderma Victoria; Scleroderma Queensland; Scleroderma SASK; the Scleroderma Association of BC; and Sclérodermie Québec.

A study protocol for a multicenter randomized pilot trial of a dyadic, tailored, web-based, psychosocial, and physical activity self-management program (TEMPO) for men with prostate cancer and their caregivers.

BACKGROUND: Prostate cancer predisposes patients and caregivers to a wide range of complex physical and psychosocial challenges, and interventions must incorporate a wide range of self-management strategies to help patients and their caregivers effectively cope with cancer challenges. To palliate this need, our team recently developed and evaluated the initial acceptability of a dyadic, Tailored, wEb-based, psychosocial, and physical activity self-Management PrOgram (TEMPO). TEMPO is a 10-week, interactive, web-based intervention consisting of five modules designed to help dyads manage their physical and psychosocial needs. It aims to teach dyads new self-management strategies and encourages them to increase their physical activity (PA) levels, mainly through walking and strength-based exercises. Initial acceptability evaluation of TEMPO revealed high user satisfaction, in addition to having a number of potential benefits for participants. After integrating suggested changes to TEMPO, the proposed pilot study aims to further test the acceptability and feasibility of TEMPO. METHODS: This study is a multicenter, stratified, parallel, two-group, pilot randomized control trial (RCT), where patient-caregiver dyads are randomized (stratified by anxiety level) to receive (a) TEMPO or (b) usual care. Participants (n goal = 40) are recruited across Canada at participating cancer centers and through self-referral (e.g., online recruitment). Patient inclusion criteria are (a) having received prostate cancer treatment within the past 2 years or scheduled to receive treatment, (b) identified a primary caregiver willing to participate in the study, and (c) has access to the Internet. Eligible caregivers are those identified by the patient as his primary source of support. Dyads complete a baseline questionnaire (T1) and another one 3 months later (T2) assessing various aspects of physical and emotional functioning (e.g., the Medical Outcomes Study (MOS) 12-item Short Form Health Survey (SF-12), the Hospital Anxiety and Depression Scale (HADS), and the Perceived Stress Scale (PSS)), self-management behaviors (e.g., the Health Education Impact Questionnaire (heiQ)), physical activity (the International Physical Activity Questionnaires (IPAQ) and the Multidimensional Self-efficacy for Exercise Scale (MSES)), and dyadic coping (the Dyadic Coping Inventory (DCI)). Dyads that used TEMPO are also asked to participate in a semi-structured exit interview exploring their overall experience with the program. DISCUSSION: This feasibility analysis will begin to develop the knowledge base on TEMPO's value for men with prostate cancer and their caregivers to inform a larger trial. TRIAL REGISTRATION: NCT04304196.

Cisplatin induced neurotoxicity is mediated by Sarm1 and calpain activation.

Cisplatin is a commonly used chemotherapy agent with significant dose-limiting neurotoxicity resulting in peripheral neuropathy. Although it is postulated that formation of DNA-platinum adducts is responsible for both its cytotoxicity in cancer cells and side effects in neurons, downstream mechanisms that lead to distal axonal degeneration are unknown. Here we show that activation of calpains is required for both neurotoxicity and formation of DNA-platinum adduct formation in neurons but not in cancer cells. Furthermore, we show that neurotoxicity of cisplatin requires activation of Sarm1, a key regulator of Wallerian degeneration, as mice lacking the Sarm1 gene do not develop peripheral neuropathy as evaluated by both behavioral or pathological measures. These findings indicate that Sarm1 and/or specific calpain inhibitors could be developed to prevent cisplatin induced peripheral neuropathy.

The Effect of Yoga Interventions on Cancer-Related Fatigue and Quality of Life for Women with Breast Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Women with breast cancer (BC) are living longer with debilitating side effects such as cancer-related fatigue (CRF) that affect overall well-being. Yoga promotes health, well-being and may be beneficial in reducing CRF. Although there have been previous systematic reviews and meta-analyses, the effects of yoga on CRF and quality of life (QOL) remain unclear, particularly in comparison with other types of physical activity (PA). Our objective is to carry out a systematic review and meta-analysis of the effects of yoga on CRF and QOL in women with BC. METHODS: Electronic databases were searched (MEDLINE, Embase Classic+Embase and EMB Reviews, Cochrane Central CT) from inception to May 2018. Randomized controlled trials were included if they were full text, in English, included a yoga intervention, a comparator (including non-PA usual care or alternate PA intervention), and reported on CRF or QOL. Effects of yoga were pooled using standardized mean difference (SMD) via a random effects model. RESULTS: Of the 2468 records retrieved, 24 trials were included; 18 studies compared yoga to a non-PA comparator and 6 to a PA comparator. Yoga demonstrated statistically significant improvements in CRF over non-PA (SMD -0.30 [-0.51; -0.08]) but not PA (SMD -0.17 [-0.50; 0.17]) comparators. Additionally, yoga demonstrated statistically significant improvements in QOL over non-PA (SMD -0.27 [-0.46; -0.07]) but not PA (SMD 0.04 [-0.22; +0.31]) comparators. DISCUSSION: This meta-analysis found that yoga provides small to medium improvements in CRF and QOL compared to non-PA, but not in comparison to other PA interventions.