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.

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.

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.

Effects of Nutritional Prehabilitation, With and Without Exercise, on Outcomes of Patients Who Undergo Colorectal Surgery: A Systematic Review and Meta-analysis.

BACKGROUND & AIMS: Although there have been meta-analyses of the effects of exercise-only prehabilitation on patients undergoing colorectal surgery, little is known about the effects of nutrition-only (oral nutritional supplements with and without counseling) and multimodal (oral nutritional supplements with and without counseling and with exercise) prehabilitation on clinical outcomes and patient function after surgery. We performed a systemic review and meta-analysis to determine the individual and combined effects of nutrition-only and multimodal prehabilitation compared with no prehabilitation (control) on outcomes of patients undergoing colorectal resection. METHODS: We searched Medline, EMBASE, CINAHL, CENTRAL, and ProQuest for cohort and randomized controlled studies of adults awaiting colorectal surgery who received at least 7 days of nutrition prehabilitation with or without exercise. We performed a random-effects meta-analysis to estimate the pooled risk ratio for categorical data and the weighted mean difference for continuous variables. The primary outcome was length of hospital stay; the secondary outcome was recovery of functional capacity based on results of a 6-minute walk test. RESULTS: We identified 9 studies (5 randomized controlled studies and 4 cohort studies) composed of 914 patients undergoing colorectal surgery (438 received prehabilitation and 476 served as controls). Receipt of any prehabilitation significantly decreased days spent in the hospital compared with controls (weighted mean difference of length of hospital stay = -2.2 days; 95% confidence interval = -3.5 to -0.9). Only 3 studies reported on functional outcomes but could not be pooled owing to methodologic heterogeneity. In the individual studies, multimodal prehabilitation significantly improved results of the 6-minute walk test at 4 and 8 weeks after surgery compared with standard Enhanced Recovery Pathway care and at 8 weeks compared with standard Enhanced Recovery Pathway care with added rehabilitation. The 4 observational studies had a high risk of bias. CONCLUSIONS: In a systematic review and meta-analysis, we found that nutritional prehabilitation alone or combined with an exercise program significantly decreased length of hospital stay by 2 days in patients undergoing colorectal surgery. There is some evidence that multimodal prehabilitation accelerated the return to presurgical functional capacity.

A phase II randomized controlled trial of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy.

BACKGROUND: Existing evidence demonstrates that 1:1 personal training (PT) improves many adverse effects of androgen deprivation therapy (ADT). Whether less resource-intensive exercise delivery models are as effective remains to be established. We determined the feasibility of conducting a multi-center non-inferiority randomized controlled trial comparing PT with supervised group (GROUP) and home-based (HOME) exercise programs, and obtained preliminary efficacy estimates for GROUP and HOME compared to PT on quality of life (QOL) and physical fitness. METHODS: Men with prostate cancer on ADT were recruited from one of two experienced Canadian centres and randomized 1:1:1 to PT, GROUP, or HOME. Randomization was stratified by length of ADT use and site. Participants completed moderate intensity aerobic and resistance exercises 4-5 days per week for 6 months with a target 150 min per week of exercise. Exercise prescriptions were individualized and progressed throughout the trial. Feasibility endpoints included recruitment, retention, adherence, and participant satisfaction. The efficacy endpoints QOL, fatigue, and fitness (VO2 peak, grip strength, and timed chair stands) in GROUP and HOME were compared for non-inferiority to PT. Descriptive analyses were used for feasibility endpoints. Between-group differences for efficacy endpoints were examined using Bayesian linear mixed effects models. RESULTS: Fifty-nine participants (mean age 69.9 years) were enrolled. The recruitment rate was 25.4% and recruitment was slower than projected. Retention was 71.2%. Exercise adherence as measured through attendance was high for supervised sessions but under 50% by self-report and accelerometry. Satisfaction was high and there was no difference in this measure between all three groups. Between-group differences (comparing both GROUP and HOME to PT) were smaller than the minimum clinically important difference on most measures of QOL, fatigue, and fitness. However, two of six outcomes for GROUP and four of six outcomes for HOME had a > 20% probability of being inferior for GROUP. CONCLUSIONS: Feasibility endpoints were generally met. Both GROUP and HOME interventions in men with PC on ADT appeared to be similar to PT for multiple efficacy outcomes, although conclusions are limited by a small sample size and cost considerations have not been incorporated. Efforts need to be targeted to improving recruitment and adherence. A larger trial is warranted. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02046837 . Date of registration: January 20, 2014.

A Descriptive Systematic Review of Physical Activity Interventions for Caregivers: Effects on Caregivers' and Care Recipients' Psychosocial Outcomes, Physical Activity Levels, and Physical Health.

BACKGROUND: Caregiving can adversely impact individuals' psychosocial and physical well-being. An important task in health research is to find effective ways to enhance caregivers' health and functioning. PURPOSE: To provide a systematic review of the efficacy of physical activity (PA) interventions for caregivers on their and the care recipients' psychosocial outcomes, PA levels, and physical health. METHODS: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist, a descriptive systematic review of studies examining the effects of PA interventions for caregivers on their outcomes and those of the care recipients was conducted. Studies were primarily identified through searching electronic databases. RESULTS: Fourteen studies were reviewed. PA interventions significantly decreased caregivers' distress and increased their well-being, quality of life, sleep quality, PA levels, self-efficacy for caregiving or exercise, and readiness for exercise. Most PA interventions targeted the caregiver alone. Two studies examined the impact of the intervention on the care recipient and found no significant effect. CONCLUSIONS: PA interventions hold promise in improving caregivers' outcomes. However, more high quality trials are needed before definitive conclusions can be drawn.

A phase II RCT and economic analysis of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy.

BACKGROUND: Androgen deprivation therapy is commonly used to treat prostate cancer, the most common visceral cancer in men. However, various side effects often worsen physical functioning and reduce well-being among men on this treatment. Based on existing evidence, both resistance and aerobic training provide benefits for this population yet adherence rates are often low. The method of exercise delivery (supervised in-center or home-based) may be important, yet few studies have compared different models. Additionally, long-term exercise adherence is critical to achieve sustained benefits but long-term adherence data and predictors of adherence are lacking. The primary aim of this phase II, non-inferiority randomized controlled trial is to determine whether three exercise training delivery models are equivalent in terms of benefits in quality of life and physical fitness in this population. Secondary aims include examination of long-term adherence and cost-effectiveness. DESIGN: Men diagnosed with prostate cancer, starting or continuing on androgen deprivation therapy for at least 6 months, fluent in English, and living close to one of two experienced Canadian study centers are eligible. Participants complete five assessments over one year, including a fitness assessment and self-report questionnaires. Socio-demographic and clinical data collection occur at baseline, bone mineral density testing at two time points, and blood work is performed at three time points. Participants are randomized in a 1:1:1 fashion to supervised personal training, supervised group training, or home-based smartphone- and health coach-supported training. Each participant receives a detailed exercise manual, including illustrations of exercises and safety precautions. Participants are asked to complete 4 to 5 exercise sessions per week, incorporating aerobic, resistance and flexibility training. Participant intensity levels will be monitored. The intervention duration is 6 months, with 6 months additional follow-up. Outcomes include: body composition, fitness testing, quality of life and fatigue, biological outcomes, and program adherence. Cost information will be obtained using patient diary-based self-report. DISCUSSION: The goals of this study are to gain a better understanding of health benefits and costs associated with commonly used yet currently not compared exercise delivery models as well as an increased understanding of adherence to exercise. TRIAL REGISTRATION: The trial has been registered at clinicaltrials.gov (Registration # NCT02046837), registered January 20(th), 2014.

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.

Age related changes in skin sensitivity assessed with smartphone vibration testing.

The capacity to perceive tactile input at the fingertips, referred to as tactile sensitivity, is known to diminish with age due to regressive changes to mechanoreceptor density and morphology. Sensitivity is measured as perceptual responses to stimuli of varying intensity. Contrary to traditional sensitivity monitoring instruments, smartphones are uniquely suited for remote assessment and have shown to deliver highly calibrated stimuli along a broad spectrum of intensity, which may improve test reliability. The aim of this study was to evaluate a vibration-emitting smartphone application, the Vibratus App, as a mode of estimating tactile sensory thresholds in the aging adult. The peripheral nerve function of 40 neurologically healthy volunteers (ages 18-71) was measured using monofilaments, a 128-Hz tuning fork, the Vibratus App, and nerve conduction studies (NCS). Between group differences were analyzed to determine each measurement's sensitivity to age. Spearman correlation coefficients depicted the associative strength between hand-held measurements and sensory nerve action potential (SNAP) amplitude. Inter-rater reliability of traditional instruments and the software-operated smartphone were assessed by intraclass correlation coefficient (ICC2,k). Measurements taken with Vibratus App were significantly different between age groups (p < 0.001). The inter-rater reliability of monofilament, smartphone vibration, and tuning fork testing was moderate to good (ICC2,k = 0.65, 0.69, and 0.79, respectively). The findings of this study support further investigation of smartphones as sensitivity monitoring devices for at home monitoring of skin sensitivity.

Rural and small town breast cancer survivors' preferences for physical activity.

BACKGROUND: Recent data suggests that only 35 % of rural and small town breast cancer survivors are achieving physical activity (PA) guidelines after treatment. PURPOSE: The purpose of this study was to determine preferences for PA counseling and programming and barriers to program participation in a sample of rural and small town breast cancer survivors. METHODS: Survivors (n = 524) residing in rural and small town areas of Alberta, Canada completed a mailed self-report survey that assessed demographic variables, PA, and PA counseling and programming preferences. RESULTS: Seventy-eight percent of survivors indicated they would have possibly (i.e., yes or maybe) been interested in being counseled about PA at the time of diagnosis, while 70 % would possibly be interested in being counseled about PA at this current time. Overall, 85 % felt they would possibly be able to participate in a PA program. Receiving chemotherapy was negatively associated with wanting to receive PA counseling (odds ratio [OR] = 0.58; 95 % confidence interval [CI], 0.39 to 0.86), PA program interest (OR = 0.43; 95 % CI, 0.28 to 0.67), and PA program ability (OR = 0.44; 95 % CI, 0.26 to 0.75). Preferred activities involved walking (51 %), flexibility and related activities (e.g., yoga, stretching) (36 %), and strength training (27 %). CONCLUSIONS: Rural and small town survivors appear to be interested in and able to participate in PA counseling and programs. PA initiatives targeted to the preferences of breast cancer survivors living in nonurban areas may be more likely to facilitate and maintain PA behavior.

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.

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.

Physical activity is associated with clinically important differences in health-related quality of life among rural and small-town breast cancer survivors.

PURPOSE: The primary purpose of this study was to examine differences in health-related quality of life and fatigue between rural and small-town (RST) breast cancer survivors meeting and not meeting public health physical activity (PA) recommendations. METHODS: Using a retrospective survey design, RST breast cancer survivors (N = 524) residing in Southern Alberta, Canada completed a mailed questionnaire assessing self-reported prediagnosis, on treatment, and current PA behavior, and current health-related quality of life and fatigue. RESULTS: Analyses indicated 44.1%, 13.7%, and 34.7% of RST breast cancer survivors met public health PA recommendations during prediagnosis, on treatment, and post-treatment (i.e., current) time periods, respectively. Multivariate analyses of variance suggested indicated survivors currently meeting PA recommendations reported clinically advantageous differences in health-related quality of life and fatigue symptoms than survivors not currently meeting PA recommendations. Repeated measures analyses also indicated significant differences in PA behavior across the three cancer-related time periods (all p < 0.01). CONCLUSIONS: The results of this study provide evidence that RST breast cancer survivors have similar PA behavior estimates across the cancer trajectory to urban survivors. Being physically active was associated with clinically important advantages with respect to health-related quality of life and fatigue. Strategies designed to facilitate PA behavior in the RST breast cancer survivor population are warranted.

Predictors of physical activity among rural and small town breast cancer survivors: an application of the theory of planned behaviour.

The primary objective of this study was to investigate the utility of the two-component theory of planned behaviour (TPB) in understanding physical activity intentions and behaviour in rural and small town breast cancer survivors. The secondary objective was to elicit the most common behavioural, normative and control beliefs of rural and small town survivors regarding physical activity. Using a cross-sectional survey design, 524 rural and small town breast cancer survivors completed a mailed survey that assessed physical activity and TPB variables. Physical activity intention explained 12% of the variance in physical activity behaviour (p < 0.01) while the TPB constructs together explained 43% of the variance in physical activity intention (p < 0.01). Unique behavioural, normative and control beliefs were elicited from the sample. The two-component TPB framework appears to be a suitable model to initiate an understanding of physical activity determinants among rural and small town breast cancer survivors. These data can be used in the development and establishment of physical activity behaviour interventions and health promotion materials designed to facilitate physical activity behaviour among rural and small town breast cancer survivors.

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.

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.

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.

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.

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.