Pilot randomized controlled trial of a program to enhance experience and adherence with adjuvant endocrine therapy among women with non-metastatic breast cancer: 12-month quantitative results.

PURPOSE: Adjuvant endocrine therapy (AET) reduces recurrence risk after hormone receptor-positive breast cancer, but non-adherence is common. We pilot-tested SOIE, a program to enhance AET experience and adherence, to assess its acceptability, feasibility, and effects on psychosocial precursors of AET adherence. METHODS: We conducted a 12-month pilot randomized controlled trial among women who had a first AET prescription. Intervention group received SOIE while control group received usual care. Psychosocial factors from the Theory of Planned Behavior (TPB) (intention - primary outcome -, attitude, subjective norm, behavioral control), additional constructs (AET knowledge, social support, coping planning), impact of AET services received, and adherence were measured by questionnaires at baseline, 3-month, and 12-month endpoints. Group patterns were compared using repeated measures analyses with generalized estimating equations. RESULTS: A total of 106 women were randomized (participation = 54.9%; intervention n = 52; control n = 54; retention = 93.8%). Among SOIE women, ≥ 90% received the program components and were satisfied. Both groups scored high on adherence intentions and group patterns over time were not statistically different. In the intervention group, AET knowledge and coping planning with side effects increased (group-by-time p-value = .002 and .016), a higher proportion reported that AET services received helped them take their AET (p < .05) and have a consistent daily intake (p = .01). CONCLUSION: SOIE is feasible and acceptable for survivors with an AET. SOIE did not significantly impact adherence intentions but was beneficial for other program outcomes and daily intake. IMPLICATIONS FOR CANCER SURVIVORS: SOIE may represent an encouraging avenue to enhance supportive care and empower survivors with managing AET.

Shared Lifestyle-Related Risk Factors of Cardiovascular Disease and Cancer: Evidence for Joint Prevention.

Cardiovascular disease (CVD) and cancer are leading causes of mortality and morbidity worldwide and are the major focus of the World Health Organization's joint prevention programs. While, diverse diseases, CVD and cancer, have many similarities. These include common lifestyle-related risk factors and shared environmental, metabolic, cellular, inflammatory, and genetic pathways. In this review, we will discuss the shared lifestyle-related and environmental risk factors central to both diseases and how the strategies commonly used to prevent atherosclerotic vascular disease can be applied to cancer prevention.

Sex Differences in Risk of Severe Adverse Events in Patients Receiving Immunotherapy, Targeted Therapy, or Chemotherapy in Cancer Clinical Trials.

PURPOSE: Women have more adverse events (AEs) from chemotherapy than men, but few studies have investigated sex differences in immune or targeted therapies. We examined AEs by sex across different treatment domains. METHODS: We analyzed treatment-related AEs by sex in SWOG phase II and III clinical trials conducted between 1980 and 2019, excluding sex-specific cancers. AE codes and grade were categorized using the Common Terminology Criteria for Adverse Events. Symptomatic AEs were defined as those aligned with the National Cancer Institute's Patient-Reported Outcome-Common Terminology Criteria for Adverse Events; laboratory-based or observable/measurable AEs were designated as objective (hematologic v nonhematologic). Multivariable logistic regression was used, adjusting for age, race, and disease prognosis. Thirteen symptomatic and 14 objective AE categories were examined. RESULTS: In total, N = 23,296 patients (women, 8,838 [37.9%]; men, 14,458 [62.1%]) from 202 trials experiencing 274,688 AEs were analyzed; 17,417 received chemotherapy, 2,319 received immunotherapy, and 3,560 received targeted therapy. Overall, 64.6% (n = 15,051) experienced one or more severe (grade ≥ 3) AEs. Women had a 34% increased risk of severe AEs compared with men (odds ratio [OR] = 1.34; 95% CI, 1.27 to 1.42; P < .001), including a 49% increased risk among those receiving immunotherapy (OR = 1.49; 95% CI, 1.24 to 1.78; P < .001). Women experienced an increased risk of severe symptomatic AEs among all treatments, especially immunotherapy (OR = 1.66; 95% CI, 1.37 to 2.01; P < .001). Women receiving chemotherapy or immunotherapy experienced increased severe hematologic AE. No statistically significant sex differences in risk of nonhematologic AEs were found. CONCLUSION: The greater severity of both symptomatic AEs and hematologic AEs in women across multiple treatment modalities indicates that broad-based sex differences exist. This could be due to differences in AE reported, pharmacogenomics of drug metabolism/disposition, total dose received, and/or adherence to therapy. Particularly large sex differences were observed for patients receiving immunotherapy, suggesting that studying AEs from these agents is a priority.

Patterns and determinants of adherence to colorectal cancer primary and secondary prevention recommendations in the BC Generations Project. / Tendances et déterminants de l'adhésion aux recommandations en matière de prévention primaire et secondaire du cancer colorectal dans le cadre du BC Generations Project.

INTRODUCTION: Adherence to cancer prevention recommendations can greatly reduce colorectal cancer risk. This study explored patterns and determinants of adherence to these recommendations by participants (n = 26 074) at baseline in a cohort study in British Columbia, Canada. METHODS: Adherence to five colorectal cancer primary prevention behaviours derived from Canadian Cancer Society/World Cancer Research Fund recommendations (nonsmoking, body mass index (BMI), physical activity, alcohol consumption and fruit and vegetable consumption) was measured, and a composite score constructed based on their sum. The definition of secondary prevention adherence was based on the Canadian Task Force on Preventive Health Care recommendations for colorectal cancer screening. RESULTS: Adherence to primary prevention guidelines ranged from 94.8% (nonsmoking) to 44.2% (healthy BMI). Median composite score was 4. Higher composite scores were associated with being female, being married and with a higher educational attainment. Colorectal cancer screening adherence was 62.4%. Older age, chronic conditions, a recent medical examination and higher income were associated with greater odds of adherence to screening. CONCLUSION: Adherence to some colorectal cancer prevention behaviours was high, consistent with findings that British Columbia has low rates of many risky health behaviours. However, there was a clustering of poorer adherence to prevention behaviours with each other and with other risk factors. Screening adherence was high but varied with some sociodemographic and health factors. Future work should evaluate targeted interventions to improve adherence among those in the lowest socioeconomic status and health groups. A better understanding is also needed of the barriers to access and engagement with colorectal cancer screening that persist even in the Canadian public health care system.

Healthcare Provider Perspectives on Adherence to Adjuvant Endocrine Therapy after Breast Cancer.

Adherence to adjuvant endocrine therapy (AET) for breast cancer is suboptimal. The purpose of this study was to: (1) explore the experiences and perspectives of healthcare providers (HCPs) in providing care to breast cancer survivors prescribed AET, (2) identify how social and structural factors influence the provision of AET-related care, and (3) ascertain HCP recommendations for optimizing AET adherence and related care. Individual, in-depth interviews were conducted with 14 HCPs using an interpretive descriptive approach to inquiry and the theoretical lens of relational autonomy. Data was analyzed using thematic and constant comparative techniques. Healthcare providers focused on four main components of AET-related care: (1) the importance of having careful conversations about AET, (2) difficulties in navigating transitions in care, (3) symptom management as a big part of their role, and (4) dealing with AET discontinuation. Recommendations to improve AET adherence focused on developing sustainable and efficient models of delivering high-quality care to women on AET. Healthcare providers play a pivotal role educating women about AET and supporting their adherence to therapy. Sustainable healthcare system innovations and new models of care that address current system gaps are needed to enhance survivorship care, AET adherence, and ultimately, reduce cancer recurrence and mortality.

The Effect of a Complementary Therapy Education Seminar on Support Persons of Individuals with Cancer.

Objectives: Complementary therapy (CT) use is prevalent among individuals living with cancer, who often consult family and friends (i.e., support persons) in making decisions about CT. This study examines the effect of an education seminar for adult cancer patients and support persons on the support persons' use, knowledge, and decision-making processes related to CT. Design: A patient education seminar that included support persons was developed and evaluated as part of a CT decision support research program. Survey data were collected before and after the education seminar to examine its impact on support persons' knowledge and use of CT, as well as their engagement in the CT decision-making process. Setting: The study was conducted in Western Canada. Subjects: 62 adult support persons. Interventions: Participants attended a 4-h CT education seminar at one in four provincial cancer centers. The seminar provided recommendations regarding how to make informed decisions about CT, where to find credible information, and key issues to consider to avoid potential risks of CT use. The evidence related to popular CT was also reviewed. Outcome Measures: The primary outcome was support persons' CT knowledge. Secondary outcomes included CT use, information-seeking behavior, decision self-efficacy, decision conflict, and distress. Results: A significant increase in support persons' CT knowledge was observed, as well as improved confidence in CT decision making. There was no significant difference in participants' CT use following the education seminar. Most indicated they would continue to locate information about CT using the Internet. A significant decrease in support persons' decisional conflict was reported; however, there were no significant change in distress related to CT decision making. Conclusions: This study demonstrates the importance of including support persons in patient education related to CT and the positive impact on their knowledge and treatment decision-making processes. No significant change in CT use, information seeking behavior and distress related to CT decisions, however, was observed in the study.

A systematic mixed studies review of health behaviour change interventions in colorectal cancer survivors.

AIMS: To explore available health behaviour change interventions in improving key health behaviours in colorectal cancer survivors and patient perspectives about these interventions. DESIGN: A systematic mixed studies review was conducted. DATA SOURCES: Databases searched included Ovid Medline, Ovid Embase, EBSCO PsychoInfo and EBSCO CINAHL. A grey literature search was also completed using Google Scholar and the TRIP database. Identified studies were published between 2003 - 2018. REVIEW METHODS: A parallel-results convergent synthesis design using narrative syntheses was used. Data analysis was conducted following a process of constant comparison. Quality appraisal was conducted using recognized tools appropriate to different study designs. RESULTS: Sixteen unique studies were identified from an initial search of 354 records. There was a pattern of successful physical activity and dietary change associated with behaviour change interventions of varying intensity, modality and length, but sparse description of intervention content was common. Participants preferred clear explanations of health behaviour importance and for interventions to be administered in sessions either with, or led by, other patients. CONCLUSION: The available evidence tentatively suggests that behaviour change interventions can improve the health behaviours of colorectal cancer survivors. However, more research focused on identifying key intervention elements is needed. Patients indicated clear preferences for specific intervention content and delivery, but further research is needed to allow for the appropriate incorporation of patient preferences into the design of such interventions. IMPACT: This review highlights the potential for interventions to improve health behaviours evidenced to influence short and long-term health outcomes in colorectal cancer survivors. However, the examination of the impact of these interventions and patient perspectives indicated a paucity of research. This is an important finding in demonstrating additional research is necessary to improve the support available to a growing group of patients with complex health needs.

International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium.

Patient-reported outcomes (PROs), such as symptoms, function, and other health-related quality-of-life aspects, are increasingly evaluated in cancer randomised controlled trials (RCTs) to provide information about treatment risks, benefits, and tolerability. However, expert opinion and critical review of the literature showed no consensus on optimal methods of PRO analysis in cancer RCTs, hindering interpretation of results. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium was formed to establish PRO analysis recommendations. Four issues were prioritised: developing a taxonomy of research objectives that can be matched with appropriate statistical methods, identifying appropriate statistical methods for PRO analysis, standardising statistical terminology related to missing data, and determining appropriate ways to manage missing data. This Policy Review presents recommendations for PRO analysis developed through critical literature reviews and a structured collaborative process with diverse international stakeholders, which provides a foundation for endorsement; ongoing developments of these recommendations are also discussed.

Prognostic value of patient-reported outcomes from international randomised clinical trials on cancer: a systematic review.

A previous review published in 2008 highlighted the prognostic significance of baseline patient-reported outcomes (PROs) as independent predictors of the overall survival of patients with cancer in clinical studies. In response to the methodological limitations of studies included in the previous review, recommendations were subsequently published in the same year to promote a higher level of methodological rigour in studies of prognostic factors. Our systematic review aimed to provide an update on progress with the implementation of these recommendations and to assess whether the methodological quality of prognostic factor analyses has changed over time. Of the 44 studies published between 2006 and 2018 that were included in our review, more standardisation and rigour of the methods used for prognostic factor analysis was found compared with the previous review. 41 (93%) of the trials reported at least one PRO domain as independently prognostic. The most common significant prognostic factors reported were physical functioning (17 [39%] studies) and global health or quality of life (15 [34%] studies). These findings highlight the value of PROs as prognostic or stratification factors in research across most types of cancer.

Mammographic density parameters and breast cancer tumor characteristics among postmenopausal women.

PURPOSE: Mammographic density is an important breast cancer risk factor, although it is not clear whether the association differs across breast cancer tumor subtypes. We examined the association between indicators of mammographic density and breast cancer risk by tumor subtype among postmenopausal women by investigating heterogeneity across tumor characteristics. METHODS: Mammographic density measures were determined for 477 breast cancer cases and 588 controls, all postmenopausal, in Vancouver, British Columbia, using digitized screening mammograms and Cumulus software. Mammographic dense (DA), non-dense (NDA), and percent dense (PDA) areas were treated as continuous covariates and categorized into quartiles according to the distribution in controls. For cases only, tests for heterogeneity between tumor subtypes were assessed by multinomial logistic regression. Associations between mammographic density and breast cancer risk were modeled for each subtype separately through unconditional logistic regression. RESULTS: Heterogeneity was apparent for the association of PDA with tumor size (p-heterogeneity=0.04). Risk did not differ across the other assessed tumor characteristics (p-heterogeneity values >0.05). CONCLUSION: These findings do not provide strong evidence that mammographic density parameters differentially affect specific breast cancer tumor characteristics.

A preliminary trial examining a 'real world' approach for increasing physical activity among breast cancer survivors: findings from project MOVE.

BACKGROUND: Physical activity (PA) is a safe and effective strategy to help mitigate health challenges associated with breast cancer (BC) survivorship. However, the majority of BC survivors are not meeting the minimum recommended PA (≥150 min of moderate to vigorous intensity). Project MOVE was developed as a model for increasing PA that combined a) Microgrants: funds ($2000) awarded to applicant groups to develop and implement a PA initiative and b) Financial incentives: a reward ($500) for increasing group PA. The purpose of this paper was to provide an exploratory analysis of effectiveness of Project MOVE on PA behavior, PA motivation, and quality of life (QoL) in female BC survivors. The differential outcomes between women meeting and not meeting PA guidelines were also investigated. METHODS: This pre-post test, preliminary trial included groups of adult (18+ years) self-identified female BC survivors, who were post-surgery and primary systemic chemo- and radiation therapy, and living in British Columbia, Canada. PA was assessed by accelerometry. PA motivation and QoL were assessed by self-report. Data were collected at baseline, 6-months, and 12-month time points. Repeated measures mixed ANOVAs were used to test changes in the main outcomes. RESULTS: A total of 10 groups were awarded microgrants between May 2015 and January 2016. Groups comprised of 8 to 12 women with a total of 87 participants. A statistically significant increase was found between time points on weekly moderate to vigorous PA (p = .012). This was mediated by a significant interaction between those meeting PA guidelines and those not meeting guidelines at baseline by time points (p = .004), with those not meeting guidelines at baseline showing the greatest increase in MVPA. A statistically significant difference across time points was found for intrinsic motivation (p = .02), physical functioning (p < .001), physical health limitations (p = .001), emotional health limitations (p = .023), social functioning (p = .001) and general health (p = .004). CONCLUSION: These results provide promising support for a unique approach to increasing PA among BC survivors by empowering women and optimizing PA experiences through the use of microgrants and financial incentives. TRIAL REGISTRATION: ClinicalTrials.gov NCT03548636 , Retrospectively registered June 7, 2018.

Assessment of the burden of diseases and injuries attributable to risk factors in Canada from 1990 to 2016: an analysis of the Global Burden of Disease Study.

BACKGROUND: An understanding of the risk factors contributing to disease burden is critical for determining research priorities and informing national health policy. We aimed to identify the risk factor trends in Canada. METHODS: As part of the Global Burden of Disease (GBD) study (1990-2016), we conducted an analysis of country-level estimates for Canada to assess the burden of diseases and injuries attributable to risk factors. For both 1990 and 2016, metabolic, environmental and behavioural risk factors were ranked according to their contribution to disability-adjusted life years (healthy years of life lost), total deaths and years lived with disability. RESULTS: In 2016, the risk factors accounting for the largest percentage of disability-adjusted life years in Canada were (1) tobacco, (2) diet, (3) high body mass index, (4) high fasting plasma glucose, (5) high systolic blood pressure, (6) alcohol and drug use, (7) occupational risks, (8) high total cholesterol, (9) impaired kidney function and (10) air pollution. Risk factor rankings remained similar from 1990 to 2016 despite some substantial declines in burden, including a 47% (± 3%) decline in the age-standardized disability-adjusted life years rate attributable to tobacco since 1990. Risk factors with an increasing contribution to disability-adjusted life years rates from 1990 to 2016 included high body mass index, high fasting plasma glucose and alcohol and drug use. INTERPRETATION: Metabolic and behavioural risk factors, including modifiable factors such as tobacco use and diet, remain the leading risk factors contributing to the burden of diseases and injuries in Canada. This work identifies priorities and targets for reducing premature death and disability burden in Canada.

Trace minerals intake: Risks and benefits for cardiovascular health.

Minerals play a major role in regulating cardiovascular function. Imbalances in electrolyte minerals are frequent and potentially hazardous occurrences that may lead to the development of cardiovascular diseases (CVDs). Transition metals, such as iron, zinc, copper and selenium, play a major role in cell metabolism. However, there is controversy over the effects of dietary and supplemental intake of these metals on cardiovascular risk factors and events. Since their pro-oxidant or antioxidant functions can have different effects on cardiovascular health. While deficiency of these trace elements can cause cardiovascular dysfunction, several studies have also shown a positive association between metal serum levels and cardiovascular risk factors and events. Thus, a J- or U-shaped relationship between the transition minerals and cardiovascular events has been proposed. Given the existing controversies, large, well-designed, long-term, randomized clinical trials are required to better examine the effects of trace mineral intake on cardiovascular events and all-cause mortality in the general population. In this review, we discuss the role of dietary and/or supplemental iron, copper, zinc, and selenium on cardiovascular health. We will also clarify their clinical applications, benefits, and harms in CVDs prevention.

Interrelatedness of Distress Among Chinese-Speaking Patients and Family Caregivers.

BACKGROUND: Cancer is a family disease, affecting the individual patient and the family. For Chinese patients and their families in Canada, adjusting to cancer may be particularly distressing when culture and language are not congruent with the mainstream model of care delivery. OBJECTIVE: In view of the limited research on the cancer experience of Chinese families, this study aims to examine the interrelatedness of patients and family caregivers' distress among a Chinese-speaking cancer population in Canada. METHODS: Semi-structured interviews were conducted with a purposive sample of 10 Chinese-speaking cancer patients and 6 family caregivers. Qualitative analysis of the interview data was conducted to construct cross-cutting themes regarding the experiences of distress after a cancer diagnosis. RESULTS: Four overarching themes emerged from the analysis: (1) misconception about cancer, (2) tensions in disclosure, (3) patient and family caregiver distress, and (4) concealing emotion in patient and family caregiver. Notably, the interrelatedness of patients and family caregivers' distress was highlighted, as patients and family caregivers both sought to regulate their own emotions to protect one another's mental well-being. CONCLUSION: The study provides insights into the distress of living with cancer and the impact on family relationships. Understanding the patients and family members' cultural and social contexts also provides the foundation for patient- and family-centered care. IMPLICATIONS FOR PRACTICE: Healthcare professionals can provide culturally appropriate care by recognizing the needs, values, and beliefs of cancer patients and their families. Furthermore, the patient-family-caregiver dyad needs to be considered as the unit of care.

Utilizing RE-AIM to examine the translational potential of Project MOVE, a novel intervention for increasing physical activity levels in breast cancer survivors.

Translating effective research into community practice is critical for improving breast cancer (BC) survivor health. The purpose of this study is to utilize the RE-AIM framework to evaluate the translational potential of Project MOVE, an innovative intervention focused on increasing physical activity (PA) in BC survivors. A mixed-methods design, including a self-report questionnaire, accelerometry, focus groups, and interviews, was used to inform each RE-AIM dimension. Reach was evaluated by the representativeness of participants. Effectiveness was reflected by change in PA levels and perceptions of satisfaction and acceptability. Adoption was examined using participants' perceived barriers/facilitators to program uptake. Implementation was examined by participants' perceived barriers/facilitators to implementing the program. Maintenance was assessed by participant retention. Assessments occurred at baseline and 6-months. Mixed analysis of variance and content analysis were used to analyze the data. A total of 87 participants participated in Project MOVE and were demographically comparable to similar studies (Reach). Participants indicated high levels of program satisfaction (88%) and previously inactive survivors' significantly increased PA levels from baseline to 6-month follow-up (Effectiveness). Participants reported that a program focused on PA rather than disease helped them overcome barriers to PA (Adoption) and having leaders with BC and exercise expertise was essential to accommodate population specific barriers (Implementation). At 6-months, participant retention was 83% (Maintenance). Project MOVE is an acceptable, practical, and effective program for engaging BC survivors in PA and has the potential to be highly transferable to other populations and regions.

Leisure Time Physical Activity Levels in Immigrants by Ethnicity and Time Since Immigration to Canada: Findings from the 2011-2012 Canadian Community Health Survey.

New immigrants to Canada are mostly from Asian/South Asian countries currently experiencing low levels of physical activity (PA) and high rates of overweight/obesity. Little is known about the leisure time PA (LTPA) patterns of recent immigrants. Study sample was extracted from Canadian Community Health Survey (2011-2012). Based on reported daily energy expenditure on LTPAs over past 3 months, participants were categorized as physically active, moderately active, and inactive. Likelihood of being physically inactive was estimated for recent immigrants versus established immigrants. Higher proportion of recent immigrants were inactive (60%) compared to established immigrants (53%). Adjusted models estimated a higher likelihood of inactivity among recent immigrants (OR 1.40, 95% CI 1.13, 1.72) versus established immigrants. Inactivity was higher among immigrants of visible minorities, 58.8 versus 46.7% of white immigrants. Recent immigrants of visible minorities are at higher risk of being inactive. This highlights importance of developing programs to increase PA in specific groups of new immigrants.

Electrolyte minerals intake and cardiovascular health.

Appropriate intake of micronutrient, such as electrolyte minerals is critical for the well-being of the cardiovascular health system. However, there are some debates regarding the impacts of dietary and/or supplemental intake of these minerals, on the risk of cardiovascular events and associated risk factors. High sodium intake is adversely associated with the risk of hypertension. Although many reports refered to the positive association of Na intake and cardiovascular events and all-cause mortality, however, other studies indicated that low Na intake is related to higher risk of all-cause mortality and HF-related events. By contrast, dietary potassium, magnesium and calcium have an inverse correlation with cardiovascular events and risk factors, especially with blood pressure. There are some controversies about cardiovascular effects and all-cause mortality of high Ca intake, including no effect, preventive or adverse effect with or without vitamin D. Calcium supplementation might be beneficial for prevention of cardiovascular events and all-cause mortality only in individuals with low intake. Moreover, calcium intake showed a J- or U-shaped association with the risk of cardiovascular diseases. Due to the controversies of the effect of electrolyte minerals especially sodium and calcium intake on cardiovascular events, large scale, well-designed long-term randomized clinical trials are required to evaluate the effect of minerals intake on cardiovascular events and all-cause mortality. In this review, we discuss the role of dietary and or supplemental sodium, potassium, magnesium, calcium, in cardiovascular health, as well as their clinical applications, benefits, and risks for the primary prevention of cardiovascular disease, in general population.

Toward equitably high-quality cancer survivorship care.

Although models of cancer survivorship care are rapidly evolving, there is increasing evidence of health disparities among cancer survivors. In the current context, Canada's survivorship care systems privilege some and not others to receive high-quality care and optimize their health outcomes. The aim of this study was to improve survivorship care systems by helping clinicians and decision makers to a better understanding of how various psychosocial/political factors, survivors' health experiences and health management strategies might shape the development of and access to high-quality survivorship care for Canadians with cancer. Using a nursing epistemological approach informed by critical and intersectional perspectives, we conducted a three-phased Interpretive Description study. We engaged in critical textual analysis of documentary sources, a secondary analysis of interview transcripts from an existing database, and qualitative interviews with 34 survivors and 12 system stakeholders. On the basis of these data, we identified individual, group, and system factors that contributed to gaps between survivors' expected and actual survivorship care experiences. By understanding what shapes survivorship care systems and resources, we help illuminate and unravel the complex nature of the issue, supporting clinicians and decision makers to find multi-layered approaches for equitably high-quality survivorship care.