A catalyst for transforming health systems and person-centred care: Canadian national position statement on patient-reported outcomes.

Background: Patient-reported outcomes (pros) are essential to capture the patient's perspective and to influence care. Although pros and pro measures are known to have many important benefits, they are not consistently being used and there is there no Canadian pros oversight. The Position Statement presented here is the first step toward supporting the implementation of pros in the Canadian health care setting. Methods: The Canadian pros National Steering Committee drafted position statements, which were submitted for stakeholder feedback before, during, and after the first National Canadian Patient Reported Outcomes (canpros) scientific conference, 14-15 November 2019 in Calgary, Alberta. In addition to the stakeholder feedback cycle, a patient advocate group submitted a section to capture the patient voice. Results: The canpros Position Statement is an outcome of the 2019 canpros scientific conference, with an oncology focus. The Position Statement is categorized into 6 sections covering 4 theme areas: Patient and Families, Health Policy, Clinical Implementation, and Research. The patient voice perfectly mirrors the recommendations that the experts reached by consensus and provides an overriding impetus for the use of pros in health care. Conclusions: Although our vision of pros transforming the health care system to be more patient-centred is still aspirational, the Position Statement presented here takes a first step toward providing recommendations in key areas to align Canadian efforts. The Position Statement is directed toward a health policy audience; future iterations will target other audiences, including researchers, clinicians, and patients. Our intent is that future versions will broaden the focus to include chronic diseases beyond cancer.

The Canadian Cancer Research Conference 2019.

The 5th Canadian Cancer Research Conference (ccrc) took place 3-5 November 2019 in Ottawa, Ontario. Nearly 1000 participants-scientists, oncologists, community members, and patients-gathered to share knowledge, foster collaboration, and fuel the future of cancer research in Canada. The scientific program included 3 plenary sessions, 26 concurrent sessions, and 2 poster sessions presenting research described in more than 600 submitted abstracts, giving participants the opportunity to share health research that collectively encompassed the 4 pillars recognized by the Canadian Institutes of Health Research. In addition to the breadth of topics addressed by Canadian and international experts, the highlights of the meeting included the integration of patients and patient advocates, new rapid-fire sessions for abstract presentation, and events that enhanced learning opportunities for trainees.

Medical Oncology Workload in Europe: One Continent, Several Worlds.

AIMS: The workload pressure on medical oncologists will increase in the near future. There are no comprehensive data available about the current workload of medical oncologists in Europe. Here we report the European results of a global survey of the workload of medical oncologists. MATERIALS AND METHODS: An online survey was distributed through a snowball method via national oncology societies to chemotherapy-prescribing physicians in 21 European countries. We compared the workload of medical oncologists in Eastern European countries (EECs) and Western European countries (WECs). The primary measure of workload was the annual number of new cancer patient consults seen per oncologist. RESULTS: In total, 495 oncologists from 16 European countries completed our survey: 100 from seven EECs and 395 from nine WECs. The median number of annual consults per medical oncologist was 225 in EECs compared with 175 in WECs (P < 0.001). The proportion of medical oncologists seeing more than 300 consults/year was 35% (35/100) in EECs compared with 18% (68/395) in WECs. The median number of patients seen in a full day clinic was 25 in EECs and 15 in WECs (P < 0.001). Eastern European medical oncologists reported spending a median of 25 min per new consultation compared with 45 min in WECs (P < 0.001). The top two reported barriers in both EECs and WECs to patient care were high clinical volumes and insufficient time for reading. CONCLUSION: The clinical workload of medical oncologists in EECs was substantially higher than in WECs. European health policymakers and educators need to address existing disparities in the workload of medical oncologist, undertake plans for future workforce supply and consider alternative models of care.

Employment outcomes for recent Canadian radiation oncology graduates.

Introduction: Radiation oncology (ro) is one of several specialties identified by the Royal College of Physicians and Surgeons of Canada with employment difficulties for graduating trainees. The purpose of the present study was to determine the employment status and location of recent Canadian ro trainees within 2 years after graduation, to monitor workforce recruitment trends over time, and to capture the opinions of program directors about employment difficulty for graduates and resident morale. Visa trainee graduates were excluded. Methods: Results of the survey administered to ro program directors in 2016 and again in 2018, both with 100% response rates, are presented here. Results: In both surveys, approximately 57% of ro graduates had attained staff or locum employment in Canada or abroad within 2 years from graduation (p = 0.92). However, graduates with Canadian staff employment increased by 46% to 32 in 2018 from 22 in 2016, while the proportion of graduates with staff positions abroad decreased to 6% from 27% (p = 0.04). Most trainees without staff positions were employed as fellows. The proportion of program directors reporting employment difficulties for graduates in the Canadian labour market declined to 38% from 85% (p = 0.04), and the morale of residents in training programs remained high. Conclusions: Employment challenges for newly certified Canadian-trained radiation oncologists continue. However, compared with the situation 2 years ago, trends in the Canadian ro job market suggest a modest improvement, with more staff employment in Canada and lower emigration rates for jobs abroad.

A pilot evaluation of the expanded prostate cancer index composite for clinical practice (EPIC-CP) tool in Ontario.

PURPOSE: To introduce the EPIC-CP symptom screening tool in routine ambulatory cancer care, and to evaluate its acceptability and perceived usefulness from the perspective of patients and clinicians. METHODS: Eligible prostate cancer patients from four cancer centres were recruited (November 2014-June 2015) from radiation or surgical oncology clinics. A physician and/or health care professional reviewed the EPIC-CP results as part of the clinical encounter. Patient experience with the tool was evaluated using a nine-item Patient Exit Survey (PES). Clinician experience was evaluated through semi-structured qualitative interviews. Patient and clinician results were compared to identify common themes. RESULTS: A total of 333 patients were enrolled, of whom, 287 completed the PES. Most patients had one clinical encounter, although the number of EPIC-CP assessments ranged from 1 to 11 per patient, for a total of 937 EPIC-CP questionnaires completed. Item completion rates were high (91-100%), with items addressing sexual health among the lowest (91-92%). On the PES, most patients (70%) agreed with the item: "Completing this questionnaire helped me tell the clinicians about how I have been feeling". Thematic analysis from clinician interviews revealed that the EPIC-CP captures essential prostate-specific effects that facilitated person-centred communication and customization of interventions. Targeted clinical education and patient resources were seen as necessary for uptake. CONCLUSIONS: EPIC-CP was generally endorsed by clinicians and patients. The implementation of a disease-specific measure in place of a generic symptom screening tool has the potential to improve the quality of the clinical encounter and provide outcome measures for further health services research. Provincial implementation of this tool as a standard of care is recommended.

Medical oncology workload in Canada: infrastructure, supports, and delivery of clinical care.

Background: In 2000, a Canadian task force recommended that medical oncologists (mos) meet a target of 160-175 new patient consultations per year. Here, we report the Canadian results of a global survey of mo workload compared with mo workload in other high-income countries (hics). Methods: Using a snowball method, an online survey was distributed by national oncology societies to chemotherapy-prescribing physicians in 22 hics (World Bank criteria). The survey was distributed within Canada to all members of the Canadian Association of Medical Oncologists. Workload was measured as the annual number of new cancer patient consults per oncologist. Results: The survey was completed by 782 oncologists from hics, including 58 from Canada. Median annual consults per mo were 175 in Canada compared with 125 in other hics. The proportions of mos having 100 or fewer consults or more than 300 consults per year were 3% (2/58) and 5% (3/58) in Canada compared with 31% (222/724) and 16% (116/724) in other hics (p < 0.001 and p = 0.023 respectively). The median number of patients seen in a full-day clinic was 15 in Canada and 25 in other hics (p = 0.220). Canadian mos reported spending a median of 55 minutes per new consultation; new consultations of 35 minutes were reported in other hics (p < 0.001). Median hours worked per week was 55 in Canada and 45 in other hics (p = 0.200). Conclusions: Although the median annual clinical volume for Canadian mos aligns with recommended targets, half the respondents exceeded that level of activity. Health policymakers and educators have to consider mo workforce supply and alternative models of care in preparation for the anticipated surge in cancer incidence in the coming decade.

Evaluation of a widely available patient decision aid for the treatment of prostate cancer.

BACKGROUND: The effectiveness of patient decision aids (PtDA) is rarely evaluated in the "real world" where patients vary in their preferences related to decision support. PURPOSE: To determine how Canadian patients use and evaluate our widely available PtDA for early-stage prostate cancer treatment with its 8 components. METHODS: Google Analytics and online tracking provided usage information. A Usability Assessment (UA) following the PtDA provided evaluation data; main outcomes [scale: 1 (strongly disagree) to 5 (strongly agree)] were (a) the aid was helpful, and (b) I would recommend it to other patients. RESULTS: Usage data were from 993 users, and UAs from 168 of them. Mean "helpfulness" score was 4.1(5 max); mean "recommend" score was 4.2 (5 max). For each PtDA component, there was no significant difference on each main outcome, between those who used it and those who did not. CONCLUSION: Overall, patients who completed the UA rated the PtDA as helpful and would recommend it to other patients. The widely available PtDA accommodated expected variation in decision support desired, and helpfulness was not associated with variation in components used. PRACTICE IMPLICATION: The internet can be an effective medium for making appropriately designed decision support widely available to prostate cancer patients.

OV21/PETROC: a randomized Gynecologic Cancer Intergroup phase II study of intraperitoneal versus intravenous chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer.

Background: The purpose of this multistage, adaptively, designed randomized phase II study was to evaluate the role of intraperitoneal (i.p.) chemotherapy following neoadjuvant chemotherapy (NACT) and optimal debulking surgery in women with epithelial ovarian cancer (EOC). Patients and methods: We carried out a multicenter, two-stage, phase II trial. Eligible patients with stage IIB-IVA EOC treated with platinum-based intravenous (i.v.) NACT followed by optimal (<1 cm) debulking surgery were randomized to one of the three treatment arms: (i) i.v. carboplatin/paclitaxel, (ii) i.p. cisplatin plus i.v./i.p. paclitaxel, or (iii) i.p. carboplatin plus i.v./i.p. paclitaxel. The primary end point was 9-month progressive disease rate (PD9). Secondary end points included progression-free survival (PFS), overall survival (OS), toxicity, and quality of life (QOL). Results: Between 2009 and 2015, 275 patients were randomized; i.p. cisplatin containing arm did not progress beyond the first stage of the study after failing to meet the pre-set superiority rule. The final analysis compared i.v. carboplatin/paclitaxel (n = 101) with i.p. carboplatin, i.v./i.p. paclitaxel (n = 102). The intention to treat PD9 was lower in the i.p. carboplatin arm compared with the i.v. carboplatin arm: 24.5% (95% CI 16.2% to 32.9%) versus 38.6% (95% CI 29.1% to 48.1%) P = 0.065. The study was underpowered to detect differences in PFS: HR PFS 0.82 (95% CI 0.57-1.17); P = 0.27 and OS HR 0.80 (95% CI 0.47-1.35) P = 0.40. The i.p. carboplatin-based regimen was well tolerated with no reduction in QOL or increase in toxicity compared with i.v. administration alone. Conclusion: In women with stage IIIC or IVA EOC treated with NACT and optimal debulking surgery, i.p. carboplatin-based chemotherapy is well tolerated and associated with an improved PD9 compared with i.v. carboplatin-based chemotherapy. Clinical trial number: clinicaltrials.gov, NCT01622543.

Variation in Radiotherapy Referral and Treatment for High-risk Pathological Features after Radical Prostatectomy: Results from a Population-based Study.

AIMS: Guidelines recommend the discussion of adjuvant radiotherapy post-prostatectomy for prostate cancer patients with high-risk pathology to consider all of their treatment options. We determine whether patterns of radiotherapy referral and treatment post-prostatectomy reflect guideline-based use in a contemporary prostatectomy cohort. MATERIALS AND METHODS: Electronic treatment records were linked to Ontario's cancer registry. Multivariable regression was used to evaluate clinical and health systems factors associated with referral and the use of adjuvant radiotherapy within 6 months post-prostatectomy. RESULTS: Among 2663 patients treated with prostatectomy between 1 January 2012 and 30 November 2012, 1261 (47%) were found to have adverse pathology and 492 were referred to radiation oncology ≤6 months post-prostatectomy, of whom 51% received adjuvant radiotherapy. Multivariable analysis showed that patients were more likely to be referred to radiation oncology from a low-volume surgical facility (≤50 versus >50 radical prostatectomy cases, odds ratio 2.50 [1.80-3.48]), if they lived farther from a radiotherapy centre (>50 km versus <10 km, odds ratio 1.73 [1.22-2.46]), if they were seen by radiation oncology preoperatively (odds ratio 1.95 [1.51-2.52]), or if they had adverse pathology: high T-category (pT3b/T4 versus pT2, odds ratio 17.87 [12.14-26.30]; pT3a versus pT2, odds ratio 5.24 [3.95-6.97]), positive margins (non-apex positive versus negative, odds ratio 4.20 [3.19-5.53]; apex only positive versus negative, odds ratio 2.60 [1.71-3.94]) and high Gleason score (8-10 versus ≤6, odds ratio 11.32 [5.37-23.84]; 7 versus ≤6, odds ratio 4.18 [2.16-8.10]). Wide geographic variation in radiotherapy referral rates persisted (range 6-66%; P < 0.0001). After radiotherapy referral, only high T-category (pT3b/T4 versus pT2, odds ratio 5.37 [3.01-9.60]; pT3a versus pT2, odds ratio 2.72 [1.59-4.65]) and non-apex positive margins (odds ratio 2.81 [1.86-4.23]) remained significantly predictive of treatment. CONCLUSIONS: Variations in referral for a discussion of radiotherapy post-prostatectomy are not mainly explained by patient characteristics. After seeing radiation oncology, treatment decisions correlated most strongly with pathological findings. Understanding the reasons for the tremendous non-clinical variations in care is needed to ensure access to potentially curative radiotherapy post-prostatectomy for high-risk prostate cancer patients.

Measuring the Quality of Personal Care in Patients Undergoing Radiotherapy for Prostate Cancer.

AIMS: To describe the quality of the non-technical component of the care (personal care) of patients receiving radical radiotherapy for prostate cancer and to identify elements of personal care that should be priorities for quality improvement. MATERIALS AND METHODS: One hundred and eight patients undergoing radiotherapy for localised prostate cancer completed a self-administered questionnaire that asked them to rate the importance of 143 non-technical elements of care and to rate the quality of their own care with respect to each element. The elements that a patient rated as both 'very important' and less than 'very good' were deemed to be his priorities for improvement. The priorities of the population were established by ranking the elements based on the percentage of patients who identified them as a priority (importance/quality analysis). RESULTS: The response rate was 65%. The percentage of elements rated 'very good' varied from patient to patient: median 79% (interquartile range 69-92%). The percentage of elements rated either 'very good' or 'good' was higher: median 96% (interquartile range 86-98%). Nonetheless, almost every patient rated at least some elements of his care as less than optimal, regardless of the cut-off point used to define optimal quality. Patients assigned their lowest quality ratings to elements relating to the quality of the treatment environment and comprehensiveness of additional services available to them. However, patients rated most of these elements as relatively unimportant, and importance/quality analysis identified elements of care relating to communication of information about the disease and its treatment as the highest priorities for quality improvement. CONCLUSIONS: Most patients rated most elements of their personal care as very good, but almost all were able to identify some elements that were less than optimal. When ratings of quality were integrated with ratings of importance, elements relating to communication emerged as the patients' highest priorities for quality improvement.

Use of low-value radiotherapy practices in Canada: an analysis of provincial cancer registry data.

BACKGROUND: As part of Choosing Wisely Canada (a national campaign to encourage patient-provider conversations about unnecessary medical tests, treatments, and procedures), a list of ten oncology practices that could be low-value in some instances was developed. Of those practices, two were specific to radiation therapy (rt): conventional fractionation as part of breast-conserving therapy (bct) for women with early-stage breast cancer, and multifraction radiation for palliation of uncomplicated painful bone metastases. Here, we report baseline findings for the current utilization rates of those two rt practices in Canada. RESULTS: The use of conventional fractionation as part of bct varied substantially from province to province. Of women 50 years of age and older, between 8.8% (Alberta) and 36.5% (Saskatchewan) received radiation in 25 fractions (excluding boost irradiation) as part of bct. The use of hypofractionated rt (that is, 16 fractions excluding boost irradiation)-a preferred approach for many patients-was more common in all 6 reporting provinces, ranging from 43.2% in Saskatchewan to 94.7% in Prince Edward Island. The use of multifraction rt for palliation of bone metastases also varied from province to province, ranging from 40.3% in British Columbia to 69.0% in Saskatchewan. The most common number of fractions delivered to bone metastases was 1, at 50.2%; the second most common numbers were 2-5 fractions, at 41.7%. CONCLUSIONS: Understanding variation in the use of potentially low-value rt practices can help to inform future strategies to promote higher-value care, which balances high-quality care with the efficient use of limited system resources. Further work is needed to understand the factors contributing to the interprovincial variation observed and to develop benchmarks for the appropriate rate of use of these rt practices.

Significance of baseline and change in quality of life scores in predicting clinical outcomes in an international phase III trial of advanced pancreatic cancer: NCIC CTG PA.3.

BACKGROUND: There is insufficient information regarding the prognostic significance of baseline and change in quality of life (QoL) scores on overall survival (OS) in advanced pancreatic cancer. METHODS: QoL was assessed prospectively using the EORTC QLQ-C30 as part of the PA.3 trial of gemcitabine + erlotinib (G + E) vs. gemcitabine + placebo (G + P). Relevant variables and QoL scores at baseline and change at 8 weeks were analyzed by Cox stepwise regression to determine predictors of OS. RESULTS: 222 of 285 patients (pts) treated with G + E and 220 of 284 pts treated with G + P completed baseline QoL assessments. In a multivariable Cox analysis combining all pts, better QoL physical functioning (PF) score independently predicted longer OS (HR 0.86; CI: 0.80-0.93), as did non-white race (HR 0.64; CI: 0.44-0.95), PS 0-1 (HR 0.65; CI: 0.50-0.85), locally advanced disease (HR 0.55; CI: 0.43-0.71) and G + E (HR 0.78; CI: 0.64-0.96). Improvement in physical function at week 8 also predicted for improved survival (HR 0.89; CI: 0.81-0.97 for 10 point increase in score, p = 0.02). CONCLUSION: In addition to clinical variables, patient reported QoL scores at baseline and change from baseline to week 8 added incremental predictive information regarding survival for advanced pancreatic cancer patients.

Quality of Radiation Therapy Referral and Utilisation Post-prostatectomy: A Population-based Study of Time Trends.

AIMS: Adjuvant radiotherapy post-prostatectomy has been shown to benefit patients with adverse pathology. It remains unclear whether salvage radiotherapy confers equivalent outcomes. Practice guidelines recommend referral to radiation oncology within 6 months after prostatectomy to discuss adjuvant and salvage radiotherapy. The study objectives were to assess, at a population level: (i) post-prostatectomy referral patterns for radiotherapy; (ii) adjuvant and salvage radiotherapy utilisation; and (iii) time trends in relation to clinical trials and guidelines. These findings provide indications of access to quality care. MATERIALS AND METHODS: This was a retrospective cohort study. Electronic radiotherapy consultation and treatment records were linked to the population-based Ontario Cancer Registry. The population included prostate cancer cases treated with prostatectomy in Ontario between 2003 and 2012. Radiotherapy referral and treatment rates over time were analysed using the chi-squared trend test. RESULTS: Over the study period, 30 447 prostate cancer patients received prostatectomy. The proportion seen by radiation oncology within 6 months after prostatectomy doubled from 10.7% in 2003-2004 to 21.7% in 2011-2012 (P < 0.0001 for trend), with the largest annual percentage difference in 2009-2011 (3.4%). Among 4641 patients seen within 6 months, adjuvant radiotherapy rates remained at 51.0% ± 3.0%. Contemporaneous with radiation oncology referral trends, overall adjuvant radiotherapy use increased from 6.2% in 2003-2004 to 11.0% in 2011-2012 (P < 0.001), while salvage radiotherapy remained at 8.4% ± 0.4%. Consequently, the total proportion receiving radiotherapy within 24 months increased from 14.1% in 2003-2004 to 17.7% in 2009-2010 (P < 0.0001). CONCLUSIONS: There was an increase in access to early radiation oncology referral post-prostatectomy and adjuvant radiotherapy in Ontario between 2003 and 2012, following guideline publication.

MAF mediates crosstalk between Ras-MAPK and mTOR signaling in NF1.

Mutations in the neurofibromatosis type 1 (NF1) tumor suppressor gene are common in cancer and can cause resistance to therapy. Using transcriptome analysis we identified MAF as an NF1- regulated transcription factor and verified MAF regulation through RAS/MAPK/AP-1 signaling in malignant peripheral nerve sheath tumor (MPNST) cell lines. MAF was also downregulated in human MPNST. Acute re-expression of MAF promoted expression of glial differentiation markers in MPNST cells in vitro, decreased self-renewal of embryonic precursors and transiently affected tumor cell phenotypes in vitro by increasing MPNST cell death and reducing metabolic activity and anchorage-independent growth. Paradoxically, chronic MAF overexpression enhanced MPNST cell tumor growth in vivo, correlating with elevated pS6 in vitro and in vivo. RAD001 blocked MAF-mediated tumor growth, and MAF regulated the mTOR pathway through DEPTOR. MAPK inhibition with NF1 loss of function is predicted to show limited efficacy due to reactivation of mTOR signaling via MAF.

Health-related quality of life in recurrent platinum-sensitive ovarian cancer--results from the CALYPSO trial.

BACKGROUND: In the CALYPSO trial, carboplatin-pegylated liposomal doxorubicin (CD) demonstrated superior therapeutic index versus carboplatin-paclitaxel (CP) in patients with recurrent ovarian cancer. This paper reports the health-related quality of life (HRQoL) findings. MATERIALS AND METHODS: HRQoL was measured with the EORTC QoL-QC30 questionnaire and OV28 ovarian cancer module. Mean change scores from baseline in HRQoL subscales (five functional scales and global health status) in each arm and the proportion of patients improved or worsened were calculated every 3 months until 12 months. RESULTS: Compliance was 90% at baseline and 76%, 64%, 57% at 3, 6, and 9 months, respectively. Baseline HRQoL showed already impaired global scores (mean 62/100) and considerable symptom burden (90% of patients reporting nonzero scores). Global QoL and abdominal symptom scores improved over time in both arms; at 6 months, 36% of patients met criteria for improved symptoms. Treatment with CD resulted in less peripheral neuropathy (9.8 versus 24.2), fewer other chemotherapy side-effects (9.5 versus 16.2), and less impact on body image (3.8 versus 10.4) versus CP (all P<0.02) at 6 months. CONCLUSIONS: These patient-reported outcomes confirm the overall lower toxicity of CD versus CP. The improved disease-related outcomes achieved with CD were not at the expense of QoL.

Social support and quality of life of prostate cancer patients after radiotherapy treatment.

Research suggests that social support can have an impact on health-related quality of life (HRQOL). Social support can be structural support (SSS) or functional support (FSS). Our study was designed to clarify the relationships between HRQOL, FSS and SSS. We conducted a cross-sectional survey and a detailed chart review. The study population was men attending a follow-up clinic after receiving radiotherapy for prostate cancer. Functional social support was measured by using the MOS Social Support Survey. Structural social support was measured by using questions adapted from the 1994-1995 National Population Health Survey conducted by Statistics Canada. Health-related quality of life was measured by using the European Organization for Research and Treatment of Cancer's QLQ-C30. We found a statistically significant positive correlation between FSS and HRQOL but no association between overall SSS and HRQOL. Worsening urinary symptoms were significantly associated with lower levels of FSS and with lower HRQOL. This study underscores that the perception of support (functional) is more important than the amount or size of support (structural). We also identified a subgroup of men who have lower FSS and lower HRQOL that suffer from urinary side effects of their treatment. Further research to clarify the relationship between FSS and urinary symptoms will also clarify how an intervention could improve the HRQOL of these men.

A conceptual framework for patient-provider communication: a tool in the PRO research tool box.

PURPOSE: To demonstrate how a previously described conceptual framework of physician-patient communication can inform the application of existing theory and the extension of new theory regarding the impact of patient-reported outcomes (PROs) in clinical practice. METHOD: We used a communication framework to guide interpretation of empirical results relating to three situations: Collecting PROs from individual patients, providing individual patient's PROs to his/her physician, and providing PROs from clinical trials to individual patients. RESULTS: For each of the selected situations, results of empirical studies of PROs are discussed in terms of the elements of the communication framework. These influences are developed into testable hypotheses regarding the impact of PROs and alternative hypotheses explaining empirical research results. We further illustrate how the conceptual framework can be knitted to other theories of communication to enhance understanding of the use of PROs in clinical practice. CONCLUSION: Guidance of a conceptual framework of communication can enhance understanding of PRO study results and lead to testable hypotheses about how to further improve the clinical use of PROs.

The Colon Health and Life-Long Exercise Change trial: a randomized trial of the National Cancer Institute of Canada Clinical Trials Group.

BACKGROUND: Observational studies indicate that physical activity (PA) is strongly associated with improved disease outcomes in colon cancer survivors, but a randomized controlled trial is needed to determine whether the association is causal and whether new policies to promote exercise are justified. PURPOSE: The co.21 Colon Health and Life-Long Exercise Change (challenge) trial undertaken by the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) is designed to determine the effects of a structured pa intervention on outcomes for survivors of high-risk stage II or III colon cancer who have completed adjuvant therapy within the previous 2-6 months. METHODS: Trial participants (n = 962) will be stratified by centre, disease stage, body mass index, and performance status, and will be randomly assigned to a structured pa intervention or to general health education materials. The pa intervention will consist of a behavioural support program and supervised pa sessions delivered over a 3-year period, beginning with regular face-to-face sessions and tapering to less frequent face-to-face or telephone sessions. The primary endpoint is disease-free survival. Important secondary endpoints include multiple patient-reported outcomes, objective physical functioning, biologic correlative markers, and an economic analysis. SUMMARY: Cancer survivors and cancer care professionals are interested in the potential role of PA to improve multiple disease-related outcomes, but a randomized controlled trial is needed to provide compelling evidence to justify changes in health care policies and practice.

Defining the optimal treatment strategy for localized prostate cancer patients: a survey of ongoing studies at the National Cancer Institute of Canada Clinical Trials Group.

The designation "clinically localized prostate cancer" comprises a group of biologically heterogeneous tumours with different growth rates and risks of relapse. Because prostate cancer is primarily a disease of older men, treatment selection must take into account the prognosis of the tumour, patient age, comorbidities, side effects of treatment, and patient preferences. Clinical trials must identify the various prognostic groups and test the appropriate treatment strategies within these subgroups.