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1.  Technology-Enabled Remote Monitoring and Self-Management — Vision for Patient Empowerment Following Cardiac and Vascular Surgery: User Testing and Randomized Controlled Trial Protocol 
JMIR Research Protocols  2016;5(3):e149.
Background
Tens of thousands of cardiac and vascular surgeries (CaVS) are performed on seniors in Canada and the United Kingdom each year to improve survival, relieve disease symptoms, and improve health-related quality of life (HRQL). However, chronic postsurgical pain (CPSP), undetected or delayed detection of hemodynamic compromise, complications, and related poor functional status are major problems for substantial numbers of patients during the recovery process. To tackle this problem, we aim to refine and test the effectiveness of an eHealth-enabled service delivery intervention, TecHnology-Enabled remote monitoring and Self-MAnagemenT—VIsion for patient EmpoWerment following Cardiac and VasculaR surgery (THE SMArTVIEW, CoVeRed), which combines remote monitoring, education, and self-management training to optimize recovery outcomes and experience of seniors undergoing CaVS in Canada and the United Kingdom.
Objective
Our objectives are to (1) refine SMArTVIEW via high-fidelity user testing and (2) examine the effectiveness of SMArTVIEW via a randomized controlled trial (RCT).
Methods
CaVS patients and clinicians will engage in two cycles of focus groups and usability testing at each site; feedback will be elicited about expectations and experience of SMArTVIEW, in context. The data will be used to refine the SMArTVIEW eHealth delivery program. Upon transfer to the surgical ward (ie, post-intensive care unit [ICU]), 256 CaVS patients will be reassessed postoperatively and randomly allocated via an interactive Web randomization system to the intervention group or usual care. The SMArTVIEW intervention will run from surgical ward day 2 until 8 weeks following surgery. Outcome assessments will occur on postoperative day 30; at week 8; and at 3, 6, 9, and 12 months. The primary outcome is worst postop pain intensity upon movement in the previous 24 hours (Brief Pain Inventory-Short Form), averaged across the previous 14 days. Secondary outcomes include a composite of postoperative complications related to hemodynamic compromise—death, myocardial infarction, and nonfatal stroke— all-cause mortality and surgical site infections, functional status (Medical Outcomes Study Short Form-12), depressive symptoms (Geriatric Depression Scale), health service utilization-related costs (health service utilization data from the Institute for Clinical Evaluative Sciences data repository), and patient-level cost of recovery (Ambulatory Home Care Record). A linear mixed model will be used to assess the effects of the intervention on the primary outcome, with an a priori contrast of weekly average worst pain intensity upon movement to evaluate the primary endpoint of pain at 8 weeks postoperation. We will also examine the incremental cost of the intervention compared to usual care using a regression model to estimate the difference in expected health care costs between groups.
Results
Study start-up is underway and usability testing is scheduled to begin in the fall of 2016.
Conclusions
Given our experience, dedicated industry partners, and related RCT infrastructure, we are confident we can make a lasting contribution to improving the care of seniors who undergo CaVS.
doi:10.2196/resprot.5763
PMCID: PMC4999307  PMID: 27480247
technology-enabled self-management; remote automated external monitoring; usability testing; randomized controlled trial
2.  The mental health status of ethnocultural minorities in Ontario and their mental health care 
BMC Psychiatry  2016;16:47.
Background
Mental disorders are a leading cause of disability and early mortality. The objective of this study was to describe and compare psychosocial indicators and mental health service use among ethnoculturally-diverse Ontarians.
Methods
This is a cross-sectional analysis of the Ontario Health Study pilot investigation. Residents were mailed an invitation to one of 3 assessment centres (urban, rural and northern sites) from March 2009 to July 2010. Participants had an interview with a nurse and completed a questionnaire on a touchscreen kiosk. The questionnaire included sociodemographic items, and scales assessing symptoms of depressive symptoms (CES-D) and anxiety (GAD-7), social support (Lubben Social Network Scale), stressful life events, and mental health service use.
Results
Eight thousand two hundred thirty-five residents participated, among whom 6652 (82.4 %) self-reported their ethnocultural background as White, 225 (2.8 %) as South Asian, 222 (2.8 %) East Asian, 214 (2.7 %) Southeast Asian, 197 (2.4 %) Black, and 28 (0.3 %) as Aboriginal. Based on their sociodemographic characteristics, participants from these ethnocultural minority groups were matched to White participants. Black participants reported significantly greater stressful life events than White participants (p = .04), particularly death (p < .05), divorce (p = .002) and financial difficulties (p < .001). East Asian participants reported significantly less social support than their White counterparts (p < .001), and this was not confounded by measurement variance. Mental health service use was significantly lower in all ethnocultural minorities except Aboriginals, when compared to White participants (p = .001).
Conclusions
There is a high burden of psychosocial distress in several preponderant ethnocultural minorities in Ontario; many of whom are not accessing available mental health services.
doi:10.1186/s12888-016-0759-z
PMCID: PMC4768406  PMID: 26915910
Mental health; Ethnic groups; Emigrants and immigrants; Ontario
3.  The Toronto General Hospital Transitional Pain Service: development and implementation of a multidisciplinary program to prevent chronic postsurgical pain 
Journal of Pain Research  2015;8:695-702.
Chronic postsurgical pain (CPSP), an often unanticipated result of necessary and even life-saving procedures, develops in 5–10% of patients one-year after major surgery. Substantial advances have been made in identifying patients at elevated risk of developing CPSP based on perioperative pain, opioid use, and negative affect, including depression, anxiety, pain catastrophizing, and posttraumatic stress disorder-like symptoms. The Transitional Pain Service (TPS) at Toronto General Hospital (TGH) is the first to comprehensively address the problem of CPSP at three stages: 1) preoperatively, 2) postoperatively in hospital, and 3) postoperatively in an outpatient setting for up to 6 months after surgery. Patients at high risk for CPSP are identified early and offered coordinated and comprehensive care by the multidisciplinary team consisting of pain physicians, advanced practice nurses, psychologists, and physiotherapists. Access to expert intervention through the Transitional Pain Service bypasses typically long wait times for surgical patients to be referred and seen in chronic pain clinics. This affords the opportunity to impact patients’ pain trajectories, preventing the transition from acute to chronic pain, and reducing suffering, disability, and health care costs. In this report, we describe the workings of the Transitional Pain Service at Toronto General Hospital, including the clinical algorithm used to identify patients, and clinical services offered to patients as they transition through the stages of surgical recovery. We describe the role of the psychological treatment, which draws on innovations in Acceptance and Commitment Therapy that allow for brief and effective behavioral interventions to be applied transdiagnostically and preventatively. Finally, we describe our vision for future growth.
doi:10.2147/JPR.S91924
PMCID: PMC4610888  PMID: 26508886
Transitional Pain Service; chronic postsurgical pain; transition to chronic pain; opioid use; multidisciplinary treatment
4.  Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial 
Background
Adoptions of health behaviors are crucial for maintaining good health after type 2 diabetes mellitus (T2DM) diagnoses. However, adherence to glucoregulating behaviors like regular exercise and balanced diet can be challenging, especially for people living in lower-socioeconomic status (SES) communities. Providing cost-effective interventions that improve self-management is important for improving quality of life and the sustainability of health care systems.
Objective
To evaluate a health coach intervention with and without the use of mobile phones to support health behavior change in patients with type 2 diabetes.
Methods
In this noninferiority, pragmatic randomized controlled trial (RCT), patients from two primary care health centers in Toronto, Canada, with type 2 diabetes and a glycated hemoglobin/hemoglobin A1c (HbA1c) level of ≥7.3% (56.3 mmol/mol) were randomized to receive 6 months of health coaching with or without mobile phone monitoring support. We hypothesized that both approaches would result in significant HbA1c reductions, although health coaching with mobile phone monitoring would result in significantly larger effects. Participants were evaluated at baseline, 3 months, and 6 months. The primary outcome was the change in HbA1c from baseline to 6 months (difference between and within groups). Other outcomes included weight, waist circumference, body mass index (BMI), satisfaction with life, depression and anxiety (Hospital Anxiety and Depression Scale [HADS]), positive and negative affect (Positive and Negative Affect Schedule [PANAS]), and quality of life (Short Form Health Survey-12 [SF-12]).
Results
A total of 138 patients were randomized and 7 were excluded for a substudy; of the remaining 131, 67 were allocated to the intervention group and 64 to the control group. Primary outcome data were available for 97 participants (74.0%). While both groups reduced their HbA1c levels, there were no significant between-group differences in change of HbA1c at 6 months using intention-to-treat (last observation carried forward [LOCF]) (P=.48) or per-protocol (P=.83) principles. However, the intervention group did achieve an accelerated HbA1c reduction, leading to a significant between-group difference at 3 months (P=.03). This difference was reduced at the 6-month follow-up as the control group continued to improve, achieving a reduction of 0.81% (8.9 mmol/mol) (P=.001) compared with a reduction of 0.84% (9.2 mmol/mol)(P=.001) in the intervention group. Intervention group participants also had significant decreases in weight (P=.006) and waist circumference (P=.01) while controls did not. Both groups reported improvements in mood, satisfaction with life, and quality of life.
Conclusions
Health coaching with and without access to mobile technology appeared to improve glucoregulation and mental health in a lower-SES, T2DM population. The accelerated improvement in the mobile phone group suggests the connectivity provided may more quickly improve adoption and adherence to health behaviors within a clinical diabetes management program. Overall, health coaching in primary care appears to lead to significant benefits for patients from lower-SES communities with poorly controlled type 2 diabetes.
Trial Registration
ClinicalTrials.gov NCT02036892; http://clinicaltrials.gov/ct2/show/NCT02036892 (Archived by WebCite at http://www.webcitation.org/6b3cJYJOD)
doi:10.2196/jmir.4871
PMCID: PMC4642794  PMID: 26441467
diabetes mellitus, type 2; health coaching; mHealth; telehealth; randomized controlled trial; RCT
5.  A pilot randomized trial of conventional versus advanced pelvic floor exercises to treat urinary incontinence after radical prostatectomy: a study protocol 
BMC Urology  2015;15:94.
Background
Radical prostatectomy is the most common and effective treatment for localized prostate cancer. Unfortunately, radical prostatectomy is associated with urinary incontinence and has a significant negative impact on quality of life. Pelvic floor exercises are the most common non-invasive management strategy for urinary incontinence following radical prostatectomy; however, studies provide inconsistent findings regarding their efficacy. One potential reason for sub-optimal efficacy of these interventions is the under-utilization of regional muscles that normally co-activate with the pelvic floor, such as the transverse abdominis, rectus abdominis, and the diaphragm. Two novel approaches to improve urinary continence recovery are ‘Pfilates’ and ‘Hypopressives’ that combine traditional pelvic floor exercises with the activation of additional supportive muscles. Our study will compare an advanced pelvic floor exercise training program that includes Pfilates and Hypopressives, to a conventional pelvic floor exercises regimen for the treatment of post-radical prostatectomy urinary incontinence.
Methods/Design
This is a pilot, randomized controlled trial of advanced pelvic floor muscle training versus conventional pelvic floor exercises for men with localized prostate cancer undergoing radical prostatectomy. Eighty-eight men who will be undergoing radical prostatectomy at hospitals in Toronto, Canada will be recruited. Eligible participants must not have undergone androgen deprivation therapy and/or radiation therapy. Participants will be randomized 1:1 to receive 26 weeks of the advanced or conventional pelvic floor exercise programs. Each program will be progressive and have comparable exercise volume. The primary outcomes are related to feasibility for a large, adequately powered randomized controlled trial to determine efficacy for the treatment of urinary incontinence. Feasibility will be assessed via recruitment success, participant retention, outcome capture, intervention adherence, and prevalence of adverse events. Secondary outcomes of intervention efficacy include measures of pelvic floor strength, urinary incontinence, erectile function, and quality of life. Secondary outcome measures will be collected prior to surgery (baseline), and at 2, 6, 12, 26-weeks post-operatively.
Discussion
Pfilates and Hypopressives are novel approaches to optimizing urinary function after radical prostatectomy. This trial will provide the foundation of data for future, large-scale trials to definitively describe the effect of these advanced pelvic floor exercise modalities compared to conventional pelvic floor exercise regimes for men with prostate cancer undergoing radical prostatectomy
Trial registration
Clinicalstrials.gov Identifier: NCT02233608.
doi:10.1186/s12894-015-0088-4
PMCID: PMC4574075  PMID: 26377550
6.  Does perceived risk predict breast cancer screening use? Findings from a prospective cohort study of female relatives from the Ontario site of the Breast Cancer Family Registry 
Breast (Edinburgh, Scotland)  2014;23(4):482-488.
Summary
Objective
While the relationship between perceived risk and adherence to breast cancer screening guidelines has been studied extensively, the majority of studies are cross-sectional. We prospectively examined this relationship among women with familial risk.
Materials and Methods
The prospective association between perceived risk and screening behaviors was examined in 913 women aged 25 to 72, with varying levels of familial breast cancer risk from the Ontario site of the Breast Cancer Family Registry. Associations between perceived lifetime breast cancer risk and subsequent use of screening mammography, clinical breast examination (CBE) and genetic testing were assessed using logistic regression.
Results
Overall, perceived risk did not predict subsequent use of screening mammography, CBE or genetic testing. Women at moderate/high familial risk who perceived their risk as greater than 50% were significantly less likely to have a CBE (odds ratio (OR) = 0.52, 95% confidence interval (CI): 0.30–0.91, p=0.04), and less likely to have a mammogram (OR = 0.70, 95% CI: 0.40–1.20, p=0.70) or genetic test (OR = 0.61, 95% CI: 0.34–1.10, p=0.09) compared to women who perceive their risk as 50%. In contrast, women at low familial risk who perceived their risk as greater than 50% were non-significantly more likely to have a mammogram (OR = 1.13, 95% CI: 0.59–2.16, p=0.78), CBE (OR = 1.11, 95% CI: 0.63–1.95, p=0.74) or genetic test (OR = 1.29, 95% CI: 0.50– 3.33, p=0.35) compared to women who perceive their risk as 50%.
Conclusion
Perceived risk did not significantly predict subsequent screening use overall, however this relationship may be moderated by level of familial risk. Results may inform risk education and management strategies among women with varying levels of familial breast cancer risk.
doi:10.1016/j.breast.2014.04.001
PMCID: PMC4317252  PMID: 24821458
breast cancer; perceived risk; breast cancer screening; familial risk
7.  Functional capacity and heart rate response: associations with nocturnal hypertension 
Background
Absences of normative, 10–20 % declines in blood pressure (BP) at night, termed nocturnal non-dipping, are linked to increased cardiovascular mortality risks. Current literature has linked these absences to psychological states, hormonal imbalance, and disorders involving hyper-arousal. This study focuses on evaluating associations between nocturnal non-dipping and indices of functional cardiac capacity and fitness.
Methods
The current study was a cross-sectional evaluation of the associations between physical capacity variables e.g. Metabolic Equivalent (MET) and Maximum Heart Rate (MHR), Heart rate reserve (HRR), and degree of reduction in nocturnal systolic blood pressure (SBP) or diastolic blood pressure (DBP), also known as ‘dipping’. The study sample included 96 cardiac patient participants assessed for physical capacity and ambulatory blood pressure monitoring. In addition to evaluating differences between groups on nocturnal BP ‘dipping’, physical capacity, diagnoses, and medications, linear regression analyses were used to evaluate potential associations between nocturnal SBP and DBP ‘dipping’, and physical capacity indices.
Results
45 males and 14 females or 61.5 % of 96 consented participants met criteria as non-dippers (<10 % drop in nocturnal BP). Although non-dippers were older (p = .01) and had a lower maximum heart rate during the Bruce stress test (p = .05), dipping was only significantly associated with Type 2 Diabetes co-morbidity and was not associated with type of medication. Within separate linear regression models controlling for participant sex, MHR (β = 0.26, p = .01, R2 = .06), HRR (β = 0. 19, p = .05, R2 = .05), and METs (β = 0.21, p = .04, R2 = .04) emerged as significant but small predictors of degree of nighttime SBP dipping. Similar relationships were not observed for DBP.
Conclusions
Since the variables reflecting basic heart function and fitness (MHR and METs), did not account for appreciable variances in nighttime BP, nocturnal hypertension appears to be a complex, multi-faceted phenomena.
doi:10.1186/s12872-015-0064-7
PMCID: PMC4511245  PMID: 26197812
Ambulatory blood pressure monitoring; Abnormal nocturnal blood pressure; Nocturnal non-dipping
8.  A phase II RCT and economic analysis of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy 
BMC Cancer  2015;15:312.
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 20th, 2014.
doi:10.1186/s12885-015-1316-8
PMCID: PMC4415317  PMID: 25908311
Prostate cancer; Androgen deprivation therapy; Exercise; Randomized controlled trial; Quality of life; Fatigue; Physical fitness; Cost-effectiveness; Patient adherence
9.  Prehabilitation for men undergoing radical prostatectomy: a multi-centre, pilot randomized controlled trial 
BMC Surgery  2014;14:89.
Background
An emerging field of research describes the role of preoperative health behaviours, known as prehabilitation. The preoperative period may be a more physically and emotionally salient time to introduce and foster chronic adherence to health behaviours, such as exercise, in patients compared to post-treatment during recovery. Moreover, physical and psychosocial improvements during the preoperative period may translate into an enhanced recovery trajectory with reduced operative complications and postoperative adverse effects. No studies have assessed prehabilitation for men with prostate cancer undergoing radical prostatectomy.
Methods/Design
This is a multi-centre, pilot randomized control trial conducted at two Canadian urban teaching hospitals. 100 men undergoing radical prostatectomy for prostate cancer with no contraindications to exercise will be recruited and randomized to the prehabiliation program or usual care. Prehabilitation participants will engage in a preoperative, individualized exercise program including pelvic floor muscle strengthening instructions and a healthy lifestyle guide for men with prostate cancer. These participants will be asked to engage in 60 minutes of home-based, unsupervised, moderate-intensity exercise on 3–4 days per week. Usual care participants will receive the same pelvic floor muscle strengthening instructions and healthy lifestyle guide only. We will assess the feasibility of conducting an adequately powered trial of the same design via recruitment rate, programmatic adherence/contamination, attrition, and safety. Estimates of intervention efficacy will be captured through measurements at baseline (4–8 weeks preoperatively), within 1 week prior to surgery, and postoperatively at 4, 12, and 26 weeks. Efficacy outcomes include: fatigue, quality of life, urinary incontinence, physical fitness, body composition, aerobic fitness, pain, and physical activity volume.
Discussion
The primary outcome of this study is to determine the feasibility of conducting a full-scale, randomized controlled trial of prehabilitation versus usual care and to estimate effect sizes that will inform sample size determinations for subsequent trials in this field. To our knowledge, this is the first study to examine a structured presurgical exercise program for men undergoing radical prostatectomy for prostate cancer. This trial will advance our understanding of strategies to efficiently and effectively use the preoperative period to optimize postoperative recovery.
Trial registration
Clinicaltrials.gov Identifier: NCT02036684
doi:10.1186/1471-2482-14-89
PMCID: PMC4246547  PMID: 25394949
Prehabilitation; Prostate cancer; Exercise; Randomized controlled trial; Rehabilitation
10.  The MOBI-Kids Study Protocol: Challenges in Assessing Childhood and Adolescent Exposure to Electromagnetic Fields from Wireless Telecommunication Technologies and Possible Association with Brain Tumor Risk 
The rapid increase in mobile phone use in young people has generated concern about possible health effects of exposure to radiofrequency (RF) and extremely low frequency (ELF) electromagnetic fields (EMF). MOBI-Kids, a multinational case–control study, investigates the potential effects of childhood and adolescent exposure to EMF from mobile communications technologies on brain tumor risk in 14 countries. The study, which aims to include approximately 1,000 brain tumor cases aged 10–24 years and two individually matched controls for each case, follows a common protocol and builds upon the methodological experience of the INTERPHONE study. The design and conduct of a study on EMF exposure and brain tumor risk in young people in a large number of countries is complex and poses methodological challenges. This manuscript discusses the design of MOBI-Kids and describes the challenges and approaches chosen to address them, including: (1) the choice of controls operated for suspected appendicitis, to reduce potential selection bias related to low response rates among population controls; (2) investigating a young study population spanning a relatively wide age range; (3) conducting a large, multinational epidemiological study, while adhering to increasingly stricter ethics requirements; (4) investigating a rare and potentially fatal disease; and (5) assessing exposure to EMF from communication technologies. Our experience in thus far developing and implementing the study protocol indicates that MOBI-Kids is feasible and will generate results that will contribute to the understanding of potential brain tumor risks associated with use of mobile phones and other wireless communications technologies among young people.
doi:10.3389/fpubh.2014.00124
PMCID: PMC4172002  PMID: 25295243
children; adolescents; brain tumors; ELF–EMF; mobile phones; RF-EMF
11.  Smartphone-Enabled Health Coach Intervention for People With Diabetes From a Modest Socioeconomic Strata Community: Single-Arm Longitudinal Feasibility Study 
Background
Lower socioeconomic strata (SES) populations have higher chronic disease risks. Smartphone-based interventions can support adoption of health behaviors that may, in turn, reduce the risks of type 2 diabetes-related complications, overcoming the obstacles that some patients may have with regular clinical contact (eg, shiftwork, travel difficulties, miscommunication).
Objective
The intent of the study was to develop and test a smartphone-assisted intervention that improves behavioral management of type 2 diabetes in an ethnically diverse, lower SES population within an urban community health setting.
Methods
This single-arm pilot study assessed a smartphone application developed with investigator assistance and delivered by health coaches. Participants were recruited from the Black Creek Community Health Centre in Toronto and had minimal prior experience with smartphones.
Results
A total of 21 subjects consented and 19 participants completed the 6-month trial; 12 had baseline glycosylated hemoglobin (HbA1c) levels >7.0% and these subjects demonstrated a mean reduction of 0.43% (SD 0.63) (P<.05) with minimal changes in medication.
Conclusions
This project supported the feasibility of smartphone-based health coaching for individuals from lower SES with minimal prior smartphone experience.
doi:10.2196/jmir.3180
PMCID: PMC4071226  PMID: 24907918
diabetes mellitus; type 2; health coaching; telehealth
12.  Who are the under- and never- screened for cancer in Ontario: a qualitative investigation 
BMC Public Health  2014;14:495.
Background
Observed breast, cervical and colon cancer screening rates are below provincial targets for the province of Ontario, Canada. The populations who are under- or never-screened for these cancers have not been described at the Ontario provincial level. Our objective was to use qualitative methods of inquiry to explore who are the never- or under-screened populations of Ontario.
Methods
Qualitative data were collected from two rounds of focus group discussions conducted in four communities selected using maps of screening rates by dissemination area. The communities selected were archetypical of the Ontario context: urban, suburban, small city and rural. The first phase of focus groups was with health service providers. The second phase of focus groups was with community members from the under- and never- screened population. Guided by a grounded theory methodology, data were collected and analyzed simultaneously to enable the core and related concepts about the under- and never-screened to emerge.
Results
The core concept that emerged from the data is that the under- and never-screened populations of Ontario are characterized by diversity. Group level characteristics of the under- and never- screened included: 1) the uninsured (e.g., Old Order Mennonites and illegal immigrants); 2) sexual abuse survivors; 3) people in crisis; 4) immigrants; 5) men; and 6) individuals accessing traditional, alternative and complementary medicine for health and wellness. Under- and never-screened could have one or multiple group characteristics.
Conclusion
The under- and never-screened in Ontario comprise a diversity of groups. Heterogeneity within and intersectionality among under- and never-screened groups adds complexity to cancer screening participation and program planning.
doi:10.1186/1471-2458-14-495
PMCID: PMC4229738  PMID: 24885998
Cancer screening; Qualitative methods; Sexual abuse; Mennonites; Ethics
13.  The acute effects of exercise on cortical excitation and psychosocial outcomes in men treated for prostate cancer: a randomized controlled trial 
Purpose: Regular exercise improves psychological well-being in men treated for prostate cancer (PCa). For this population and among cancer survivors in general, the effect of a single bout of exercise on self-report or objective measures of psychological well-being has not been examined. We examined the acute effect of a single bout of exercise on the cortical silent period (CSP) and on self-reported mood in men that have received treatment for PCa.
Methods: Thirty-six PCa survivors were randomly assigned to 60 min of low to moderate intensity exercise or to a control condition. Outcomes were assessed immediately before and after either the exercise or the control condition.
Results: No significant between-group differences were observed in CSP or mood were observed following the exercise session or control conditions. Participants with higher scores of trait anxiety had significantly shorter CSP at baseline, as well as those receiving androgen deprivation therapy. Age and baseline CSP had a low-moderate, but significant negative correlation. Changes in CSP following the exercise condition were strongly negatively correlated with changes in self-reported vigor.
Conclusion: While we did not observe any acute effect of exercise on the CSP in this population, the associations between CSP and trait anxiety, age, and vigor are novel findings requiring further examination.
Implications for Cancer Survivors: Exercise did not acutely affect our participants in measures of psychological well-being. Additional mechanisms to explain the chronic psychosocial benefits of exercise previously observed in men with PCa require further exploration.
Clinicaltrials.gov Identifier: NCT01715064 (http://clinicaltrials.gov/show/NCT01715064).
doi:10.3389/fnagi.2014.00332
PMCID: PMC4244640  PMID: 25505413
cortical silent period; anxiety; depression; physical activity; prostate cancer; randomized controlled trial
14.  ColonCancerCheck Primary Care Invitation Pilot project 
Canadian Family Physician  2013;59(12):e541-e549.
Abstract
Objective
To describe the perceptions of those who received invitations to the ColonCancerCheck Primary Care Invitation Pilot (the Pilot) about the mailed invitation, colorectal cancer (CRC) screening in general, and their specific screening experiences.
Design
Qualitative study with 6 focus group sessions, each 1.5 hours in length.
Setting
Hamilton, Ont; Ottawa, Ont; and Thunder Bay, Ont.
Participants
Screening-eligible adults, aged 50 years and older, who received a Pilot invitation for CRC screening.
Methods
The focus groups were conducted by a trained moderator and were audiorecorded and transcribed verbatim. The transcripts were analyzed using grounded-theory techniques facilitated by the use of electronic software.
Main findings
Key themes related to the invitation letter, the role of the family physician, direct mailing of the fecal occult blood testing (FOBT) kit, and alternate CRC screening promotion strategies were identified. Specifically, participants suggested the letter content should use stronger, more powerful language to capture the reader’s attention. The importance of the family physician was endorsed, although participants favoured clarification of the physician and program roles in the actual mailed invitation. Participants expressed support for directly mailing FOBT kits to individuals, particularly those with successful previous test completion, and for communication of both negative and positive screening results.
Conclusion
This study yielded a number of important findings including strategies to optimize letter content, support for directly mailed FOBT kits, and strategies to report results that might be highly relevant to other health programs where population-based CRC screening is being considered.
PMCID: PMC3860944  PMID: 24336559
15.  Exercise effects on adipokines and the IGF axis in men with prostate cancer treated with androgen deprivation: A randomized study 
Canadian Urological Association Journal  2013;7(11-12):E692-E698.
Background
Androgen deprivation therapy (ADT) has significant deleterious effects on body composition that may be accompanied by unfavourable changes in adipokine levels. While exercise has been shown to improve a number of side effects associated with ADT for prostate cancer, no studies have assessed the effect of exercise on adiponectin and leptin levels, which have been shown to alter the mitogenic environment.
Methods:
Twenty-six men with prostate cancer treated with ADT were randomized to home-based aerobic exercise training or resistance exercise training for 24 weeks. Adiponectin, leptin, insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 3 (IGFBP-3) were analyzed by ELISA (enzyme-linked immunosorbent assay), in addition to physical activity volume, peak aerobic capacity, and anthropometric measurements, at baseline, 3 months and 6 months.
Results:
Resistance exercise significantly reduced IGF-1 after 3 months (p = 0.019); however, this change was not maintained at 6 months. At 6 months, IGFBP-3 was significantly increased compared to baseline for the resistance training group (p = 0.044). In an exploratory analysis of all exercisers, favourable changes in body composition and aerobic fitness were correlated with favourable levels of leptin, and favourable leptin:adiponectin and IGF-1:IGFBP-3 ratios at 3 and 6 months.
Conclusions:
Home-based exercise is correlated with positive changes in adipokine levels and the IGF-axis that may be related to healthy changes in physical fitness and body composition. While the improvements of adipokine markers appear to be more apparent with resistance training compared to aerobic exercise, these findings must be considered cautiously and require replication from larger randomized controlled trials to clarify the role of exercise on adipokines and IGF-axis proteins for men with prostate cancer.
doi:10.5489/cuaj.235
PMCID: PMC3840521  PMID: 24282459
16.  Accuracy of Self-Reported Screening Mammography Use: Examining Recall among Female Relatives from the Ontario Site of the Breast Cancer Family Registry 
ISRN Oncology  2013;2013:810573.
Evidence of the accuracy of self-reported mammography use among women with familial breast cancer risk is limited. This study examined the accuracy of self-reported screening mammography dates in a cohort of 1,114 female relatives of breast cancer cases, aged 26 to 73 from the Ontario site of the Breast Cancer Family Registry. Self-reported dates were compared to dates abstracted from imaging reports. Associations between inaccurate recall and subject characteristics were assessed using multinomial regression. Almost all women (95.2% at baseline, 98.5% at year 1, 99.8% at year 2) accurately reported their mammogram use within the previous 12 months. Women at low familial risk (OR = 1.77, 95% CI: 1.00–3.13), who reported 1 or fewer annual visits to a health professional (OR = 1.97, 95% CI: 1.15, 3.39), exhibited a lower perceived breast cancer risk (OR = 1.90, 95% CI: 1.15, 3.15), and reported a mammogram date more than 12 months previous (OR = 5.22, 95% CI: 3.10, 8.80), were significantly more likely to inaccurately recall their mammogram date. Women with varying levels of familial risk are accurate reporters of their mammogram use. These results present the first evidence of self-reported mammography recall accuracy among women with varying levels of familial risk.
doi:10.1155/2013/810573
PMCID: PMC3747415  PMID: 23984098
17.  Gender differences in attitudes impeding colorectal cancer screening 
BMC Public Health  2013;13:500.
Background
Colorectal cancer screening (CRCS) is the only type of cancer screening where both genders reduce risks by similar proportions with identical procedures. It is an important context for examining gender differences in disease-prevention, as CRCS significantly reduces mortality via early detection and prevention. In efforts to increase screening adherence, there is increasing acknowledgment that obstructive attitudes prevent CRCS uptake. Precise identification of the gender differences in obstructive attitudes is necessary to improve uptake promotion. This study randomly sampled unscreened, screening - eligible individuals in Ontario, employing semi-structured interviews to elicit key differences in attitudinal obstructions towards colorectal cancer screening with the aim of deriving informative differences useful in planning promotions of screening uptake.
Methods
N = 81 participants (49 females, 32 males), 50 years and above, with no prior CRCS, were contacted via random-digit telephone dialing, and consented via phone-mail contact. Altogether, N = 4,459 calls were made to yield N = 85 participants (1.9% response rate) of which N = 4 participants did not complete interviews. All subjects were eligible for free-of-charge CRCS in Ontario, and each was classified, via standard interview by CRCS screening decision-stage. Telephone-based, semi-structured interviews (SSIs) were employed to investigate gender differences in CRCS attitudes, using questions focused on 5 attitudinal domains: 1) Screening experience at the time of interview; 2) Barriers to adherence; 3) Predictors of Adherence; 4) Pain-anxiety experiences related to CRCS; 5) Gender-specific experiences re: CRCS, addressing all three modalities accessible through Ontario’s program: a) fecal occult blood testing; b) flexible sigmoidoscopy; c) colonoscopy.
Results
Interview transcript analyses indicated divergent themes related to CRCS for each gender: 1) bodily intrusion, 2) perforation anxiety, and 3) embarrassment for females and; 1) avoidant procrastination with underlying fatalism, 2) unnecessary health care and 3) uncomfortable vulnerability for males. Respondents adopted similar attitudes towards fecal occult blood testing, flexible sigmoidoscopy and colonoscopy, and were comparable in decision stage across tests. Gender differences were neither closely tied to screening stage nor modality. Women had more consistent physician relationships, were more screening-knowledgeable and better able to articulate views on screening. Men reported less consistent physician relationships, were less knowledgeable and kept decision-making processes vague and emotionally distanced (i.e. at ‘arm’s length’).
Conclusions
Marked differences were observed in obstructive CRCS attitudes per gender. Females articulated reservations about CRCS-associated distress and males suppressed negative views while ambiguously procrastinating about the task of completing screening. Future interventions could seek to reduce CRCS-related stress (females) and address the need to overcome procrastination (males).
doi:10.1186/1471-2458-13-500
PMCID: PMC3672022  PMID: 23706029
18.  A pilot study of an exercise & cognitive behavioral therapy intervention for epithelial ovarian cancer patients 
Background
Ovarian cancer has the highest mortality rate of all gynaecologic cancers. Faced with poor prognoses, stressful treatment effects and a high likelihood of recurrence, survivors must confront significant physical and psychological morbidities that negatively impact health-related quality of life. Frequently reported side effects include cancer-related fatigue, peripheral neuropathy, and psychological distress. Exercise and cognitive behavioral therapy interventions have counteracted such adverse effects in other cancer populations.
Objective
To investigate the feasibility and benefits of a 24-week home-based exercise intervention, coordinated with 12 weeks of cognitive behavioral therapy (two sessions per month), developed for two types of patients diagnosed with epithelial ovarian cancer: 1) those undergoing primary treatment with adjuvant chemotherapy after primary surgery; 2) those on surveillance after completing treatment within the last 2 years.
Methods
Participants were recruited from the Gynaecologic Oncology Clinic. Eligible participants completed baseline assessments and were provided with home-based exercise equipment. Cognitive behavioral therapy was provided every other week for patients via telephone. Assessments were completed at baseline (T1), 3 months (T2) and 6 months (T3).
Results
19 of the 46 eligible patients approached were enrolled, with 7 patients in the treatment group and 12 in the surveillance group. There was a significant within group increase in peak VO2 from baseline to 6 months: F(2,16) = 5.531, p = 0.015, partial η2 = 0.409.
Conclusion
The combined 6-month exercise-cognitive behavioral therapy intervention was associated with significant increases in aerobic fitness in epithelial ovarian cancer patients assessed. These improvements were similar regardless of whether the patient was receiving chemotherapy or under surveillance.
doi:10.1186/1757-2215-6-21
PMCID: PMC3623735  PMID: 23557323
Ovarian cancer; Exercise; Cognitive behavioral therapy; Chemotherapy; Health-related quality of life; Epithelial ovarian cancer
19.  Canadian national surveys on pandemic influenza preparations: pre-pandemic and peri-pandemic findings 
BMC Public Health  2013;13:271.
Background
Prior to the 2009 H1N1 Influenza pandemic, public health authorities in Canada and elsewhere prepared for the future outbreak, partly guided by an ethical framework developed within the Canadian Program of Research on Ethics in a Pandemic (CanPREP). We developed a telephone-based survey based on that framework, which was delivered across Canada in late 2008. In June, 2009, the WHO declared pandemic Phase 6 status and from the subsequent October (2009) until May 2010, the CanPREP team fielded a second (revised) survey, collecting another 1,000 opinions from Canadians during a period of pre-pandemic anticipation and peri-pandemic experience.
Methods
Surveys were administered by telephone with random sampling achieved via random digit dialing. Eligible participants were adults, 18 years or older, with per province stratification approximating provincial percentages of national population. Descriptive results were tabulated and logistic regression analyses used to assess whether demographic factors were significantly associated with outcomes, and to identify divergences (between the pre-pandemic and intra-pandemic surveys).
Results
N = 1,029 interviews were completed from 1,986 households, yielding a gross response rate of 52% (AAPOR Standard Definition 3). Over 90% of subjects indicated the most important goal of pandemic influenza preparations was saving lives, with 41% indicating that saving lives solely in Canada was the highest priority and 50% indicating saving lives globally was the highest priority. About 90% of respondents supported the obligation of health care workers to report to work and face influenza pandemic risks excepting those with serious health conditions which that increased risks. Strong majorities favoured stocking adequate protective antiviral dosages for all Canadians (92%) and, if effective, influenza vaccinations (95%). Over 70% agreed Canada should provide international assistance to poorer countries for pandemic preparation, even if resources for Canadians were reduced.
Conclusions
Results suggest Canadians trust public health officials to make difficult decisions, providing emphasis is maintained on reciprocity and respect for individual rights. Canadians also support international obligations to help poorer countries and associated efforts to save lives outside the country, even if intra-national efforts are reduced.
doi:10.1186/1471-2458-13-271
PMCID: PMC3627899  PMID: 23530550
Pandemic influenza; Canada; Survey research; Public health ethics; Bioethics; H1N1
20.  Adherence to breast and ovarian cancer screening recommendations for female relatives from the Ontario Site of the Breast Cancer Family Registry 
Objective
This study compares adherence to breast and ovarian cancer screening recommendations among a population cohort of women at familial risk to breast and/or ovarian cancer.
Methods
This cross-sectional study included 1039 first-degree female relatives without breast cancer identified from the Ontario site of the Breast Cancer Family Registry. We compared breast and ovarian cancer screening behaviours, using a telephone-administered questionnaire, among three groups of women defined by their familial risk (high; moderate; low) to breast and/or ovarian cancer. Associations between screening behaviours and familial risk were assessed using multinomial regression models adjusted by familial clustering.
Results
Women 40 to 49 years of age at moderate or high familial risk were significantly more likely to have had a screening mammogram within the past 12 months (OR: 2.80; 95% CI: 1.40-5.58), and women less than 50 years of age were more likely to have a clinical breast examination (OR: 1.84; 95% CI: 1.02-3.31) compared to women at low familial risk. Compared to women at low or moderate familial risk, women at high familial risk were significantly more likely to have ever had a genetic test for the BRCA 1/2 genes (OR: 2.67; 95% CI: 1.76-4.05).
Conclusions
Although the overall level of adherence among higher risk women is sub-optimal in the community, women at a higher familial risk are adhering more often to cancer screening recommendations than women at a lower familial risk.
doi:10.1097/CEJ.0b013e3283476217
PMCID: PMC3179806  PMID: 21691207
breast cancer; ovarian cancer; cancer screening; family history
21.  Predictors of Patient Self-Ratings of Quality of Life in Alzheimer’s Disease: Cross-Sectional Results from the Canadian Alzheimer’s Disease Quality of Life (CADQOL) Study 
Objectives
To assess whether the core symptoms of Alzheimer’s disease (AD) consistently predict patient self-rated quality of life (QOL) as assessed by a variety of QOL measures in a large national sample of AD patients.
Design
Cross-sectional.
Setting
Fifteen dementia and geriatric clinics across Canada.
Participants
Community-living patients with AD (n = 370) with Mini-Mental State Examination (MMSE) scores > 10.
Measurements
Patients rated their QOL using two utility indexes, the EQ-5D, the Quality of Well-Being Scale, a global QOL visual analogue scale, and the disease-specific QOL-AD instrument. Cognition was assessed with the AD Assessment Scale-Cognitive subscale and MMSE, function with the Disability Assessment for Dementia, and behavioral and psychological symptoms with the Neuropsychiatric Inventory (NPI) and the Geriatric Depression Scale (GDS). One-way analysis of variance and fully adjusted multiple linear regression were used to assess the relationship between core dementia symptoms and QOL ratings.
Results
The QOL measures had only small to moderate correlations with each other. For all QOL measures, patient ratings were significantly lower among patients with more depressive symptoms. In multivariable analyses, the GDS score was the only significant independent predictor of patient self-ratings for all four QOL measures.
Conclusions
Self-rated symptoms of depression were a consistent independent predictor of patient-rated QOL across diverse QOL measures, while performance-based measures of cognition and informant-based functional status were not. These findings confirm the importance of identifying and treating depression in patients with AD and endorse the use of measures of self-rated depressive symptoms and QOL as outcomes in AD clinical trials.
doi:10.1097/JGP.0b013e3182006a67
PMCID: PMC3267777  PMID: 21946804 CAMSID: cams2069
Alzheimer’s disease; dementia; quality of life; utility; depression
22.  Predictors of Family Caregiver Ratings of Patient Quality of Life in Alzheimer’s Disease: Cross-Sectional Results from the Canadian Alzheimer’s Disease Quality of Life (CADQOL) Study 
Objectives
To assess whether the core symptoms of Alzheimer’s disease (AD) and caregiver factors consistently predict family caregiver ratings of patient quality of life (QOL) as assessed by a variety of QOL measures in a large national sample.
Design
Cross-sectional.
Setting
Fifteen dementia and geriatric clinics across Canada.
Participants
Family caregivers (n = 412) of community-living patients with AD of all severities.
Measurements
Caregiver ratings of patient QOL using three utility indexes, the EQ-5D, Quality of Well-Being Scale and Health Utilities Index, a global QOL visual analogue scale, a disease-specific measure, the QOL-AD, and a generic health status measure, the Short Form-36. Patient cognition was assessed with the AD Assessment Scale-Cognitive Subscale and Mini-Mental State Examination, function with the Disability Assessment for Dementia, and behavioral and psychological symptoms with the Neuropsychiatric Inventory and the Geriatric Depression Scale. Caregiver burden was assessed with the Zarit Burden Interview and caregiver depression with the Center for Epidemiologic Studies-Depression scale. One-way analysis of variance and fully adjusted multiple linear regression were used to assess the relationship between patient dementia symptom and caregiver variables with QOL ratings.
Results
In multivariable analyses, caregiver ratings of patient function and depressive symptoms were the only consistent independent predictors of caregiver-rated QOL across the QOL measures.
Conclusions
Caregiver ratings of patient function and depression were consistent independent predictors of caregiver-rated QOL using a spectrum of QOL measures, while measures of patient cognition and caregiver burden and depression were not. These findings support the continued use of caregiver ratings as an important source of information about patient QOL and endorse the inclusion in AD clinical trials of caregiver-rated measures of patient function, depression and QOL.
doi:10.1097/JGP.0b013e3182006a7f
PMCID: PMC3267778  PMID: 21946805 CAMSID: cams2070
Alzheimer’s disease; dementia; quality of life; utility; family caregiver; depression; function
23.  ColonCancerCheck Primary Care Invitation Pilot project 
Canadian Family Physician  2012;58(10):e570-e577.
Abstract
Objective
To determine family physician perspectives regarding the acceptability and effectiveness of 2 interventions—a targeted, mailed invitation for screening to patients, and family physician audit-feedback reports—and on the colorectal cancer (CRC) screening program generally. This information will be used to guide program strategies for increasing screening uptake.
Design
Qualitative study.
Setting
Ontario.
Participants
Family physicians (n = 65).
Methods
Seven 1-hour focus groups were conducted with family physicians using teleconferencing and Web-based technologies. Responses were elicited regarding family physicians’ perspectives on the mailing of invitations to patients, the content and design of the audit-feedback reports, the effect of participation in the pilot project on daily practice, and overall CRC screening program function.
Main findings
Key themes included strong support for both interventions and for the CRC screening program generally. Moderate support was found for direct mailing of fecal occult blood testing (FOBT) kits. Participants identified potential pitfalls if interventions were implemented outside of patient enrolment model practices. Participants expressed relatively strong support for colonoscopy as a CRC screening test but relatively weak support for FOBT.
Conclusion
Although the proposed interventions to increase the uptake of CRC screening were highly endorsed, concerns about their applicability to non–patient enrolment model practices and the current lack of physician support for FOBT will need to be addressed to optimize intervention and program effectiveness. Our study is highly relevant to other public health programs planning organized CRC screening programs.
PMCID: PMC3470535  PMID: 23064936
24.  Beliefs about optimal age and screening frequency predict breast screening adherence in a prospective study of female relatives from the Ontario Site of the Breast Cancer Family Registry 
BMC Public Health  2012;12:518.
Background
Although few studies have linked cognitive variables with adherence to mammography screening in women with family histories of breast and/or ovarian cancer, research studies suggest cognitive phenomena can be powerful adherence predictors.
Methods
This prospective study included 858 women aged 30 to 71 years from the Ontario site of the Breast Cancer Family Registry with at least one first-degree relative diagnosed with breast and/or ovarian cancer. Data on beliefs about breast cancer screening and use of mammography were obtained from annual telephone interviews spanning three consecutive years. Self-reported mammogram dates were confirmed with medical imaging reports. Associations between beliefs about breast cancer screening and adherence with annual mammography were estimated using polytomous logistic regression models corrected for familial correlation. Models compared adherers (N = 329) with late-screeners (N = 382) and never-screeners (N = 147).
Results
Women who believed mammography screening should occur annually were more likely to adhere to annual screening recommendations than women who believed it should happen less often (OR: 5.02; 95% CI: 2.97-8.49 for adherers versus late-screeners; OR: 6.82; 95% CI: 3.29-14.16 for adherers versus never-screeners). Women who believed mammography screening should start at or before age 50 (rather than after) (OR: 9.72; 95% CI: 3.26-29.02) were significantly more likely to adhere when compared with never-screeners.
Conclusions
Study results suggest that women with a family history of breast cancer should be strongly communicated recommendations about initial age of screening and screening intervals as related beliefs significantly predict adequate adherence.
doi:10.1186/1471-2458-12-518
PMCID: PMC3432622  PMID: 22788119
Breast cancer; Breast screening; Family history; Beliefs; Adherence
25.  Influence of perceived breast cancer risk on screening behaviors of female relatives from the Ontario Site of the Breast Cancer Family Registry 
Background
Few studies have examined the influence of perceived risk on breast screening behaviors among women with an increased familial breast cancer risk.
Methods
This study included 1019 women aged 20 to 71 years from the Ontario site of the Breast Cancer Family Registry who had at least one first-degree relative diagnosed with breast and/or ovarian cancer. Information was obtained from a self-administered questionnaire completed at the time of recruitment and a follow-up telephone questionnaire. The associations between breast screening behaviors and perceived risk of developing breast cancer, measured on both a numerical and Likert-type verbal scale, were estimated using logistic regression analyses.
Results
Women who rated their risk of developing breast cancer as greater than 50% compared to less than 50% were significantly more likely to have a screening mammogram within the last 12 months (OR: 1.91, 95% CI: 1.15 – 3.16). Women were significantly more likely to have a screening mammogram (OR: 1.82, 95% CI: 1.17 – 2.81) in the past 12 months if they rated their risk as above or much above average compared to same as average or below.
Conclusion
These findings may inform educational messages for improving risk communication of women at elevated familial breast cancer risk.
doi:10.1097/CEJ.0b013e3283447467
PMCID: PMC3104111  PMID: 21467941
Breast cancer; breast screening; family history; perceived risk

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