Home-based versus supervised group exercise in men with prostate cancer on androgen deprivation therapy: A randomized controlled trial and economic analysis.

INTRODUCTION: Differences between health outcomes, participation/adoption, and cost-effectiveness of home-based (HOME) interventions and supervised group-based training (GROUP) in men with prostate cancer (PC) on androgen deprivation therapy (ADT) are currently unknown. The objective of this study was to assess the clinical efficacy, adherence, and cost-effectiveness of HOME versus GROUP in men on ADT for PC. MATERIALS AND METHODS: This was a multicentre, 2-arm non-inferiority randomized controlled trial and companion cost-effectiveness analysis. Men with PC on ADT were recruited from August 2016 to March 2020 from four Canadian centres and randomized 1:1 to GROUP or HOME. All study participants engaged in aerobic and resistance training four to five days weekly for six months. Fatigue [Functional Assessment of Cancer Therapy-Fatigue (FACT-F)] and functional endurance [6-min walk test (6MWT)] at six months were the co-primary outcomes. Secondary outcomes included quality of life, physical fitness, body composition, blood markers, sedentary behaviour, and adherence. Between-group differences in primary outcomes were compared to margins of 3 points for FACT-F and 40 m for 6MWT using a Bayesian analysis of covariance (ANCOVA). Secondary outcomes were compared with ANCOVA, Costs included Ministry of Health costs, program costs, patient out-of-pocket, and time costs. TRIAL REGISTRATION: #NCT02834416. RESULTS: Thirty-eight participants (mean [standard deviation (SD)] age, 70 [9.0] years) were enrolled (GROUP n = 20; HOME n = 18). There was an 89.8% probability that HOME was non-inferior to GROUP for both fatigue and functional endurance and a 9.5% probability that HOME reduced fatigue compared to GROUP (mean [SD] change, 12.1 [8.1] vs 3.6 [6.1]; p = 0.040) at six months. Adherence was similar among study arms. HOME was cost-saving (mean difference: -$4122) relative to GROUP. DISCUSSION: A HOME exercise intervention appears non-inferior to GROUP for fatigue and functional endurance and requires fewer resources to implement. HOME appears to ameliorate fatigue more than GROUP, but has comparable effects on other clinically relevant outcomes. Although limited by sample size and attrition, these results support further assessment of home-based programs.

A Clinical Consensus Approach to Developing a New Funding Model for Radiation Services in Ontario.

In 2021, Ontario Health (Cancer Care Ontario) introduced a quality-based procedure model for the funding of radiation treatment (RT) in Ontario. This model ties reimbursement to patient care activities, ensuring equity and transparency in funding. Over 200 RT interprofessionals (oncologists, therapists and physicists) participated on 22 expert panels to establish or identify 288 evidence-based RT protocols and 672 quality expectations (QEs) to optimally deliver RT, which eventually led to the micro-costing of all protocols. Iterative review is required to ensure updated techniques and identify evolving standards of care, thereby providing the highest quality of RT care to Ontarians.

Cost of Bladder Cancer Care: A Single-center Comparison of Radical Cystectomy and Trimodal Therapy.

INTRODUCTION: Radical cystectomy and trimodal therapy are both accepted options in the management of muscle-invasive bladder cancer. As such, we sought to evaluate the micro-level costs associated with both modalities. METHODS: All patients undergoing trimodal therapy or radical cystectomy for primary treatment of urothelial muscle-invasive bladder cancer at a single academic center between 2008 and 2012 were included. Direct costs associated with each phase of a patient's clinical course were collected from the hospital's financial department, and physician costs were calculated based on the provincial fee schedule. Costs of radiation treatments were derived from previously published literature. RESULTS: A total of 137 patients were included. The mean (±SD) patient age was 69 (±12) years. Overall, 89 (65%) patients underwent radical cystectomy and 48 (35%) were treated with trimodal therapy. The radical cystectomy group had higher rates of cT3/T4 compared to those in the trimodal therapy group (51% vs 26%, P < .001). The median cost in the treatment phase for radical cystectomy was $30,577 (IQR: $23,908-$38,837) vs $18,979 ($17,271-$23,519) for trimodal therapy (P < .001). There was no significant difference between treatment groups with respect to cost of diagnosis or workup. However, the cost of follow-up care was numerically higher for patients undergoing trimodal therapy compared to radical cystectomy ($3,096/y vs $1,974/y, P = .09). CONCLUSIONS: In appropriately selected patients with muscle-invasive bladder cancer trimodal therapy costs are not prohibitive and are lower than in radical cystectomy. With increasing follow-up time after primary treatment, the cost difference between modalities may be mitigated by the need for bladder surveillance and salvage therapy in the trimodal therapy cohort.

Economic Evaluation of a Geriatric Oncology Clinic.

Geriatric assessment (GA) is supported by recent trials and guidelines yet rarely implemented due to a lack of resources. We performed an economic evaluation of a geriatric oncology clinic. Pre-GA proposed treatments and post-GA actual treatments were obtained from a detailed chart review of patients seen at a single academic centre. GA-based costs for investigations and referrals were calculated. Unit costs were obtained for surgical, radiation, systemic therapy, laboratory, imaging, physician, nursing, and allied health care (all in 2019 Canadian dollars). A six-month time horizon and government payer perspective were used. Consecutive patients aged 65 years or older (n = 152, mean age 82 y) and referred in the pre-treatment setting between July 2016 and June 2018 were included. Treatment plans were modified for 51% of patients. Costs associated with planned treatment were CAD 3,655,015. Costs associated with GA and related interventions were CAD 95,798. Final treatment costs were CAD 2,436,379. Net savings associated with the clinic were CAD 1,122,837, or CAD 7387 per patient seen. Findings were robust in multiple sensitivity analyses. Combined with mounting trial data demonstrating the clinical benefits of GA, our data can inform a strong business case for geriatric oncology clinics in health care environments similar to ours, but additional studies in diverse health care settings are warranted.

Trimodal therapy vs. radical cystectomy for muscle-invasive bladder cancer: A Markov microsimulation model.

INTRODUCTION: Radical cystectomy (RC) is the historic gold standard treatment for muscle-invasive bladder cancer (MIBC), but trimodal therapy (TMT) has emerged as a valid therapeutic option for select patients. Given that prospective clinical trials have been difficult to perform in this area, our aim was to compare these two primary treatment strategies using decision analytic methods. METHOD: A two-dimensional Markov microsimulation model was constructed using TreeAge Pro to compare RC and TMT for patients with newly diagnosed MIBC. A comprehensive literature search was used to populate model probabilities and utilities. Our primary outcome was quality-adjusted life expectancy (QALE). Secondary outcomes included crude life expectancy (LE) and bladder cancer recurrences. The simulated patient for our model was an adult with MIBC (pT2-4 N0 M0) who was a candidate for either RC or TMT. RESULTS: A total of 500 000 patients were simulated. TMT resulted in an estimated mean QALE of 7.48 vs. 7.41 for RC. However, the average LE for patients treated with TMT was lower compared with RC (10.20 vs. 10.74 years). A sensitivity analysis evaluating the impact of age showed that younger patients treated with RC had greater QALE and longer LE than those treated with TMT; inverse findings were observed for elderly patients. Overall, 39.4% of patients treated with TMT experienced a bladder recurrence. CONCLUSIONS: RC results in a longer LE compared to TMT (0.54 years), but with a lower QALE (-0.07 years). The preferred treatment strategy varied with patient age.

A Cost-Utility Analysis of Magnetic Resonance (MR) Guided Brachytherapy Versus Two-Dimensional and Computed Tomography (CT) Guided Brachytherapy for Locally Advanced Cervical Cancer.

PURPOSE: The standard treatment for locally advanced cervical cancer is external beam radiation therapy and concurrent cisplatin followed by brachytherapy. Traditionally, 2-dimensional brachytherapy (2DBT) or computed tomography guided brachytherapy (CTgBT) has been used, but magnetic resonance guided brachytherapy (MRgBT) improves clinical outcomes and has become the new standard of care. This cost-utility analysis was undertaken to compare MRgBT to CTgBT and 2DBT. METHODS AND MATERIALS: A Markov model was constructed to evaluate the cost-utility from the perspective of the public health care payer in Ontario. Treatment effectiveness, expressed as quality-adjusted life years, and costs, expressed in 2016 Canadian dollars, were evaluated for MRgBT, CTgBT, and 2DBT. Results were reported as incremental cost-effectiveness ratios for all patients and separately for low and high-risk subgroups. Sensitivity analyses were performed to assess the impact of uncertainty in model parameters. RESULTS: MRgBT improved tumor control, reduced side effects, and was less costly compared with either CTgBT or 2DBT for all patients and in low- and high-risk prognostic subgroups separately. Sensitivity analysis supported the robustness of the findings and identified the cost of treating cancer recurrence to be the single most influential model parameter. CONCLUSIONS: MRgBT is more effective and less costly than CTgBT or 2DBT by avoiding downstream costs of treating cancer recurrence and managing side effects. These findings will assist health care providers and policymakers with future infrastructure and human resource planning to ensure optimal care of women with this disease.

Protocol for a phase III RCT and economic analysis of two exercise delivery methods in men with PC on ADT.

BACKGROUND: Androgen deprivation therapy (ADT) is commonly used to treat prostate cancer. However, side effects of ADT often lead to reduced quality of life and physical function. Existing evidence demonstrates that exercise can ameliorate multiple treatment-related side effects for men on ADT, yet adherence rates are often low. The method of exercise delivery (e.g., supervised group in-centre vs. individual home-based) may be important from clinical and economic perspectives; however, few studies have compared different delivery models. Additionally, long-term exercise adherence and an understanding of predictors of adherence are critical to achieving sustained benefits, but such data are lacking. The primary aim of this multi-centre phase III non-inferiority randomized controlled trial is to determine whether a home-based delivery model is non-inferior to a group-based delivery model in terms of benefits in fatigue and fitness in this population. Two other key aims include examining cost-effectiveness and long-term adherence. METHODS: Men diagnosed with prostate cancer of any stage, starting or continuing on ADT for at least 6 months, fluent in English, and living close to a study centre are eligible. Participants complete five assessments over 12 months (baseline and every 3 months during the 6-month intervention and 6-month follow-up phases), including a fitness assessment and self-report questionnaires. Biological outcomes are collected at baseline, 6, and 12 months. A total of 200 participants will be randomized in a 1:1 fashion to supervised group training or home-based training supported by smartphones, health coaches, and Fitbit technology. Participants are asked to complete 4 to 5 exercise sessions per week, incorporating aerobic, resistance and flexibility training. Outcomes include fatigue, quality of life, fitness measures, body composition, biological outcomes, and program adherence. Cost information will be obtained using patient diary-based self-report and utilities via the EQ-5D. DISCUSSION: To disseminate publicly funded exercise programs widely, clinical efficacy and cost-effectiveness have to be demonstrated. The goals of this trial are to provide these data along with an increased understanding of adherence to exercise among men with prostate cancer receiving ADT. TRIAL REGISTRATION: The trial has been registered at clinicaltrials.gov (Registration # NCT02834416 ). Registration date was June 2, 2016.

Do radiation oncology outreach clinics affect the use of radiotherapy?

BACKGROUND AND PURPOSE: The scope and effect of radiation oncology (RO) outreach activities within centralized radiotherapy (RT) systems is poorly defined. The purpose of this study was to describe the outreach activities of Ontario's regional cancer centres, and to explore the relationship between radiation oncology (RO) outreach clinics and rates of radiotherapy (RT) utilization at hospitals without RT on site (HWOS-RT). MATERIALS AND METHODS: Ontario RO centres' outreach activities were identified by semi-structured interview. A multivariate analysis determined the association between on-site RT facilities, or presence of RO clinic at HWOS-RT, and RT utilization within one year of diagnosis (RT1Y), for all patients diagnosed with cancer in Ontario in 2011-2012. RESULTS: RO outreach varied widely by region. Of the largest 58 diagnosing hospitals, 14 had RT on-site, 19 had no RT but RO outreach clinic(s) and 25 had no RT or RO clinic. RT was used more frequently for patients diagnosed at hospitals with on-site RT compared to those at HWOS-RT (RT1Y = 35% vs. 29%, RR = 1.32 [95% CI 1.27-1.38]). For HWOS-RT, RT was used more frequently if there was an RO clinic (RT1Y = 31% vs. 29%, RR = 1.06 [95% CI 1.02-1.10]). CONCLUSIONS: RO outreach clinics were associated with a small but significant increase in RT utilization. There is opportunity to improve access to RT by optimizing the effectiveness of RO outreach.

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.

IMRT utilization in Ontario: qualitative deployment evaluation.

PURPOSE: The purpose of this paper is to describe a jurisdiction-wide implementation and evaluation of intensity-modulated radiation therapy (IMRT) in Ontario, Canada, highlighting innovative strategies and lessons learned. DESIGN/METHODOLOGY/APPROACH: To obtain an accurate provincial representation, six cancer centres were chosen (based on their IMRT utilization, geography, population, academic affiliation and size) for an in-depth evaluation. At each cancer centre semi-structured, key informant interviews were conducted with senior administrators. An electronic survey, consisting of 40 questions, was also developed and distributed to all cancer centres in Ontario. FINDINGS: In total, 21 respondents participated in the interviews and a total of 266 electronic surveys were returned. Funding allocation, guidelines and utilization targets, expert coaching and educational activities were identified as effective implementation strategies. The implementation allowed for hands-on training, an exchange of knowledge and expertise and the sharing of responsibility. Future implementation initiatives could be improved by creating stronger avenues for clear, continuing and comprehensive communication at all stages to increase awareness, garner support and encourage participation and encouraging expert-based coaching. IMRT utilization for has increased without affecting wait times or safety (from fiscal year 2008/2009 to 2012/2013 absolute increased change: prostate 46, thyroid 36, head and neck 29, sarcoma 30, and CNS 32 per cent). ORIGINALITY/VALUE: This multifaceted, jurisdiction-wide approach has been successful in implementing guideline recommended IMRT into standard practice. The expert based coaching initiative, in particular presents a novel training approach for those who are implementing complex techniques. This paper will be of interest to those exploring ways to fund, implement and sustain complex and evolving technologies.

Testicular cancer survivors' supportive care needs and use of online support: a cross-sectional survey.

INTRODUCTION: The supportive care needs of testicular cancer survivors have not been comprehensively studied. Likewise, there is limited research on their use of the Internet or social media applications--tools that are popular among young adults and which could be used to address their needs. METHODS: Two hundred and four testicular cancer patients receiving care at an urban cancer center completed a questionnaire assessing supportive care needs and the use and preferences for online support. We examined the associations between patient characteristics and met or unmet supportive care needs and the use of testicular cancer online communities. RESULTS: Respondents had more met (median 8.0, interquartile range (IQR) 10.0) than unmet (median 2.0, IQR 7.0) needs. The majority (62.5%) reported at least one unmet need, most commonly (25%) concerning financial support, body image, stress, being a cancer survivor, and fear of recurrence. Patients who were younger, had nonseminoma testicular cancer, or received treatment beyond surgery had more needs, and those who were unemployed had more unmet needs. The majority of respondents (71.5%) were social media users (e.g., Facebook), and 26% had used a testicular cancer online support community. Reasons for nonuse were lack of awareness (34.3%), interest (30.9%), trust (4.9%), and comfort using computers (2.5%). Users were more likely to speak English as a first language and have more needs. CONCLUSIONS: At least one in four testicular cancer survivors has unmet needs related to financial support, body image, stress, being a cancer survivor, and fear of recurrence. A web-based resource may be a useful strategy to consider given the high prevalence of social media use in this sample and their desire for online support. Efforts are needed to raise awareness about online peer support resources and to overcome barriers to their use.

Healthcare costs associated with prostate cancer: estimates from a population-based study.

STUDY TYPE: Health Economic (multiway sensitivity analyses). LEVEL OF EVIDENCE: 2b. OBJECTIVE: To estimate the total healthcare costs and costs attributable to prostate cancer across all stages of disease, and to determine the predictors of those costs, as describing the cost of care for patients with prostate cancer is useful to understand the economic burden of illness, explore patterns of care, and provide reliable cost data for economic evaluations. METHODS: We estimated direct medical costs for 42 484 men diagnosed with prostate cancer in Ontario, Canada between 1995 and 2002 using linked administrative data. The observation time was divided into five phases: (I) before diagnosis (6 months before); (II) initial care (12 months after diagnosis); (III) continuing care; (IV) pre-terminal care (from 18 to 6 months before death); and (V) terminal care (6 months before death). Attributable costs were estimated by comparing costs in cases to matched controls. RESULTS: The total direct costs per 100 days (in $Canadian, 2004) were: Phase I $1297; II $3289; III $1495; IV $5629; and V $16 020. Prostate cancer-attributable costs accounted for 72% of total costs in the 12-month period after diagnosis (II, $2366), but <35% of total costs in phases III to V ($398, $1977 and $3140, respectively). An advanced stage at diagnosis, being older at diagnosis, and higher comorbidity were associated with increased costs. CONCLUSION: Prostate cancer is associated with increased direct healthcare costs over the natural history of the disease. Costs are highest around two events, cancer diagnosis and cancer death. Future research should evaluate costs borne by private insurers and patients, evaluate the effects of patient and system variables on lifetime costs, and explore differences in end-of-life healthcare costs across countries.

Management and outcome differences in supraglottic cancer between Ontario, Canada, and the Surveillance, Epidemiology, and End Results areas of the United States.

PURPOSE: We compared the management and outcome of supraglottic cancer in Ontario, Canada, with that in the Surveillance, Epidemiology, and End Results (SEER) Program areas in the United States. METHODS: Electronic, clinical, and hospital data were linked to cancer registry data and supplemented by chart review where necessary. Stage-stratified analyses compared initial treatment and survival in the SEER areas (n = 1,643) with a random sample from Ontario (n = 265). We also compared laryngectomy rates at 3 years in those patients 65 years and older at diagnosis. RESULTS: Radical surgery was more commonly used in SEER, with absolute differences increasing with increasing stage: I/II, 17%; III, 36%; and IV, 45%. The 5-year survival rates were 74% in Ontario and 56% in SEER for stage I/II disease (P =.01), 55.7% in Ontario and 46.8% in SEER for stage III disease (P =.40), and 28.5% in Ontario and 29.1% in SEER for stage IV disease (P =.28). Cancer-specific survival results mirrored the overall survival results with the exception of stage IV disease, for which 34.6% of Ontario patients survived their cancer compared with 38.1% in SEER (P =.10). This stage IV difference was more pronounced when we further controlled for possible cause of death errors by restricting the comparison to patients with a single primary cancer (P =.01). Three-year actuarial laryngectomy rates differed. In stage I/II, these rates were 3% in Ontario compared with 35% in SEER (P < 10(-3)). In stage III disease, the rates were 30% and 54%, respectively (P =.03), and in stage IV disease they were 33% and 64% (P =.002). CONCLUSION: There are large differences in the management of supraglottic cancer between the SEER areas of the United States and Ontario. Long-term larynx retention was higher in Ontario, where radiotherapy is widely regarded as the treatment of choice and surgery is reserved for salvage. In stages I to III, survival was similar in the two regions despite the differences in treatment policy. In stage IV, there may be a small survival advantage in the U.S. SEER areas related to the higher use of primary surgery.

The ten-year rule revisited: accuracy of clinicians' estimates of life expectancy in patients with localized prostate cancer.

OBJECTIVES: To determine the accuracy of clinicians' predictions of life expectancy in patients with localized prostate cancer, when provided with information about age and comorbidity, and to determine whether life expectancy estimates predict the choice of initial treatment. METHODS: A survey was sent by facsimile to 191 Canadian urologists and radiation oncologists asking them to estimate the life expectancy and choose the initial therapy (radical prostatectomy, radiation, or watchful waiting) for 18 patient scenarios: two prostate cancer scenarios, each with three ages and three levels of comorbidity. RESULTS: Life expectancy estimates were accurate within 1 year of the projections of a Markov model for 31% of the clinicians' responses and accurate within 3 years for 67% of the responses. The average prediction error ranged from 2.4 to 5.2 years. The life expectancy was correctly estimated as being greater than or less than 10 years in 82% of responses. Ten years was the minimal life expectancy for recommending surgery and within the range (5 to 15 years) in which radiation was recommended. CONCLUSIONS: Clinicians can use age and comorbidity to predict the life expectancy of patients with localized prostate cancer with a modest degree of overall accuracy, but with sufficient accuracy to use the "10-year rule." Life expectancy estimates are strongly associated with treatment choice. The appropriateness of the 10-year rule remains to be determined.