Quality of life after breast-conserving therapy and adjuvant radiotherapy for non-low-risk ductal carcinoma in situ (BIG 3-07/TROG 07.01): 2-year results of a randomised, controlled, phase 3 trial.

BACKGROUND: BIG 3-07/TROG 07.01 is an international, multicentre, randomised, controlled, phase 3 trial evaluating tumour bed boost and hypofractionation in patients with non-low-risk ductal carcinoma in situ following breast-conserving surgery and whole breast radiotherapy. Here, we report the effects of diagnosis and treatment on health-related quality of life (HRQOL) at 2 years. METHODS: The BIG 3-07/TROG 07.01 trial is ongoing at 118 hospitals in 11 countries. Women aged 18 years or older with completely excised non-low-risk ductal carcinoma in situ were randomly assigned, by use of a minimisation algorithm, to tumour bed boost or no tumour bed boost, following conventional whole breast radiotherapy or hypofractionated whole breast radiotherapy using one of three randomisation categories. Category A was a 4-arm randomisation of tumour bed boost versus no boost following conventional whole breast radiotherapy (50 Gy in 25 fractions over 5 weeks) versus hypofractionated whole breast radiotherapy (42·5 Gy in 16 fractions over 3·5 weeks). Category B was a 2-arm randomisation between tumour bed boost versus no boost following conventional whole breast radiotherapy, and category C was a 2-arm randomisation between tumour bed boost versus no boost following hypofractionated whole breast radiotherapy. Stratification factors were age at diagnosis, planned endocrine therapy, and treating centre. The primary endpoint, time to local recurrence, will be reported when participants have completed 5 years of follow-up. The HRQOL statistical analysis plan prespecified eight aspects of HRQOL, assessed by four questionnaires at baseline, end of treatment, and at 6, 12, and 24 months after radiotherapy: fatigue and physical functioning (EORTC QLQ-C30); cosmetic status, breast-specific symptoms, arm and shoulder functional status (Breast Cancer Treatment Outcome Scale); body image and sexuality (Body Image Scale); and perceived risk of invasive breast cancer (Cancer Worry Scale and a study-specific question). For each of these measures, tumour bed boost was compared with no boost, and conventional whole breast radiotherapy compared with hypofractionated whole breast radiotherapy, by use of generalised estimating equation models. Analyses were by intention to treat, with Hochberg adjustment for multiple testing. This trial is registered with ClinicalTrials.gov, NCT00470236. FINDINGS: Between June 1, 2007, and Aug 14, 2013, 1208 women were enrolled and randomly assigned to receive no tumour bed boost (n=605) or tumour bed boost (n=603). 396 of 1208 women were assigned to category A: conventional whole breast radiotherapy with tumour bed boost (n=100) or no boost (n=98), or to hypofractionated whole breast radiotherapy with tumour bed boost (n=98) or no boost (n=100). 447 were assigned to category B: conventional whole breast radiotherapy with tumour bed boost (n=223) or no boost (n=224). 365 were assigned to category C: hypofractionated whole breast radiotherapy with tumour bed boost (n=182) or no boost (n=183). All patients were followed up at 2 years for the HRQOL analysis. 1098 (91%) of 1208 patients received their allocated treatment, and most completed their scheduled HRQOL assessments (1147 [95%] of 1208 at baseline; 988 [87%] of 1141 at 2 years). Cosmetic status was worse with tumour bed boost than with no boost across all timepoints (difference 0·10 [95% CI 0·05-0·15], global p=0·00014, Hochberg-adjusted p=0·0016); at the end of treatment, the estimated difference between tumour bed boost and no boost was 0·13 (95% CI 0·06-0·20; p=0·00021), persisting at 24 months (0·13 [0·06-0·20]; p=0·00021). Arm and shoulder function was also adversely affected by tumour bed boost across all timepoints (0·08 [95% CI 0·03-0·13], global p=0·0033, Hochberg adjusted p=0·045); the difference between tumour bed boost and no boost at the end of treatment was 0·08 (0·01 to 0·15, p=0·021), and did not persist at 24 months (0·04 [-0·03 to 0·11], p=0·29). None of the other six prespecified aspects of HRQOL differed significantly after adjustment for multiple testing. Conventional whole breast radiotherapy was associated with worse body image than hypofractionated whole breast radiotherapy at the end of treatment (difference -1·10 [95% CI -1·79 to -0·42], p=0·0016). No significant differences were reported in the other PROs between conventional whole breast radiotherapy compared with hypofractionated whole breast radiotherapy. INTERPRETATION: Tumour bed boost was associated with persistent adverse effects on cosmetic status and arm and shoulder functional status, which might inform shared decision making while local recurrence analysis is pending. FUNDING: National Health and Medical Research Council, Susan G Komen for the Cure, Breast Cancer Now, OncoSuisse, Dutch Cancer Society.

Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years.

BACKGROUND: Treatment with an aromatase inhibitor for 5 years as up-front monotherapy or after tamoxifen therapy is the treatment of choice for hormone-receptor-positive early breast cancer in postmenopausal women. Extending treatment with an aromatase inhibitor to 10 years may further reduce the risk of breast-cancer recurrence. METHODS: We conducted a double-blind, placebo-controlled trial to assess the effect of the extended use of letrozole for an additional 5 years. Our primary end point was disease-free survival. RESULTS: We enrolled 1918 women. After a median follow-up of 6.3 years, there were 165 events involving disease recurrence or the occurrence of contralateral breast cancer (67 with letrozole and 98 with placebo) and 200 deaths (100 in each group). The 5-year disease-free survival rate was 95% (95% confidence interval [CI], 93 to 96) with letrozole and 91% (95% CI; 89 to 93) with placebo (hazard ratio for disease recurrence or the occurrence of contralateral breast cancer, 0.66; P=0.01 by a two-sided log-rank test stratified according to nodal status, prior adjuvant chemotherapy, the interval from the last dose of aromatase-inhibitor therapy, and the duration of treatment with tamoxifen). The rate of 5-year overall survival was 93% (95% CI, 92 to 95) with letrozole and 94% (95% CI, 92 to 95) with placebo (hazard ratio, 0.97; P=0.83). The annual incidence rate of contralateral breast cancer in the letrozole group was 0.21% (95% CI, 0.10 to 0.32), and the rate in the placebo group was 0.49% (95% CI, 0.32 to 0.67) (hazard ratio, 0.42; P=0.007). Bone-related toxic effects occurred more frequently among patients receiving letrozole than among those receiving placebo, including a higher incidence of bone pain, bone fractures, and new-onset osteoporosis. No significant differences between letrozole and placebo were observed in scores on most subscales measuring quality of life. CONCLUSIONS: The extension of treatment with an adjuvant aromatase inhibitor to 10 years resulted in significantly higher rates of disease-free survival and a lower incidence of contralateral breast cancer than those with placebo, but the rate of overall survival was not higher with the aromatase inhibitor than with placebo. (Funded by the Canadian Cancer Society and others; ClinicalTrials.gov numbers, NCT00003140 and NCT00754845.).

Evaluating health-related quality of life and priority health problems in patients with prostate cancer: a strategy for defining the role of the advanced practice nurse.

A framework for the introduction and evaluation of APN roles emphasizes the importance of a systematic approach to role development based on the assessment of patient health needs. This study determined the health-related quality of life (HRQL) of patients with prostate cancer. The most frequent and severe patient health problems and their perceptions of priority health problems were identified and compared across five patient groups as a strategy to inform the supportive care role of the advanced oncology nurse for patients with advanced prostate cancer. The study found that the majority of men with early stage and advanced hormone sensitive prostate cancer can expect to enjoy good quality of life for several years following diagnosis. These two patient groups have common priority needs for improving their health related to sexual function, urinary frequency, urinary incontinence, and physical activity. Both groups may benefit from an advanced practice nursing (APN) role that can provide episodic supportive care for health problems occurring at different treatment stages. Conversely, it was found that men with advanced hormone refractory prostate cancer experience significantly poorer HRQL and have multiple severe health problems. These patients also have different priority needs including problems related to pain, fatigue, and decreased physical activity. Because of this, the focus of supportive care programs and interventions in advanced prostate cancer will differ for those with hormone refractory disease. They may benefit more from an APN role that can provide ongoing rather than episodic supportive care to assess and manage the multiple, new, and worsening health problems associated with progressive disease.

Coordination of palliative cancer care in the community: "unfinished business".

GOAL: This study assessed the degree to which services in south-central Ontario, Canada, were coordinated to meet the supportive care needs of palliative cancer patients and their families. PARTICIPANTS AND METHOD: Programs within the region that were identified as providing supportive care to palliative cancer patients and their families were eligible to participate in the study. Program administrators participated in a semi-structured interview and direct-care providers completed a survey instrument. MAIN RESULTS: Administrators from 37 (97%) of 38 eligible programs and 109 direct-care providers representing 26 (70%) programs participated in the study. Most administrator and direct-care respondents felt that existing services in the community were responsive to palliative care patients' individual needs. However, at a system level, most respondents in both groups felt that required services were not available and that resources were inadequate. The most frequently reported unmet supportive care need identified by both respondent groups was psychological/social support. Most administrator (69%) and direct-care (64%) respondents felt that palliative care services were not available when needed. The majority of administrator and direct-care respondents were satisfied with the exchange of patient information within and between programs, although direct-care staff identified a deficit in information transferred on palliative care patients' social/psychological status. CONCLUSIONS: The study demonstrated the value of a theory-based approach to evaluate the coordination of palliative cancer care services. The findings revealed that service programs faced significant challenges in their efforts to provide coordinated care.

The statutory duty of physicians to inform patients versus unmet patients' information needs: the case of breast cancer in France.

OBJECTIVES: (1) To explore empirically the extent to which early stage breast cancer patients in France, wish to be informed about their disease and treatments and (2) in view of the statutory duty of physicians to inform patients, to explore, from the patients' point of view, the type of information given by physicians and whether it meets their information needs. METHODS: A retrospective, cross-sectional survey questionnaire using standardized questions was administered by mail to newly diagnosed breast cancer patients and evaluated their relationships with the different physicians involved in their treatment at different points in time. Focus was placed on the relationship between surgeons and patients. RESULTS: Two hundred and thirty-eight patients completed the questionnaire on their relationship with their surgeon. Patients' reported information needs are considerable, though significantly different depending on the item. Patients report that surgeons do not fully respond to their needs. Even though physicians are legally required to provide information to their patients, in routine practice they seem to favour providing information about disease and treatment side effects over treatment consequences, even though patients express a need for information on these latter items. CONCLUSION: More research is needed on the development, use and outcomes of the various strategies and interventions designed to facilitate and improve information transfer in the physician-patient encounter in France.

Improving communication between doctors and breast cancer patients.

PURPOSE: We wanted to assess the effectiveness of intensive education for physicians compared with a traditional session on communicating with breast cancer patients. METHODS: A randomized controlled trial was conducted in practices in London, Hamilton, and Toronto, Canada, with 17 family physicians, 16 surgeons, and 18 oncologists, and with 102 patients of the surgeons and oncologists. Doctors were randomized to 1 of 2 continuing education approaches: a traditional 2-hour version (control group), or a new 6-hour intensive version including exploring the patients' perspectives and reviewing videotapes and receiving feedback (intervention group). Communication behavior of the physicians was measured objectively both before and after the intervention. As well, 4 postintervention patient outcomes were measured, by design only for surgeons and oncologists: patient-centerdness of the visit, satisfaction, psychological distress, and feeling better. RESULTS: No significant differences were found on the communication score of the intervention vs the control physicians when controlling for preintervention communication scores. Intervention family physicians, however, had significantly higher communication subscores than control family physicians. Also, patients of the intervention surgeons and oncologists were significantly more satisfied (scores of 82.06 vs 77.78, P = .03) and felt better (88.2% vs 70.6%, P=.02) than patients of the control surgeons and oncologists when controlling for covariates and adjusting for clustering within doctor. CONCLUSIONS: The continuing medical education intervention was effective in terms of some but not all physician and patient outcomes.

The benefit of deep inspiration breath hold: evaluating cardiac radiation exposure in patients after mastectomy and after breast-conserving surgery.

BACKGROUND: This study aims to evaluate the reduction of cardiac radiation dose and volume with deep inspiration breath hold (DIBH) technique compared to free breathing (FB) in patients with left-sided breast cancer. The study also aims to evaluate whether the benefits of DIBH vary in patients who had whole breast radiotherapy (RT) after breast-conserving surgery (BCS) and those who had chest wall RT post-mastectomy (M). METHODS: FB and DIBH plans were generated for 15 consecutive post-BCS patients and 17 post-M patients who underwent RT with DIBH using varian real-time position management (RPM) system. Cardiac shields were used in all post-BCS plans, provided that clinical treatment volume coverage was not compromised, while chest wall coverage took priority in post-M plans. The prescribed dose was 50 Gy in 25 fractions for the whole breast or the chest wall. Parameters of interest were cardiac V5, mean LAD dose, maximum LAD dose, and mean heart dose. The impact of DIBH was compared in post-BCS and post-M patients using paired t tests. To gauge clinically meaningful outcome, the proportion of patients with V5 < 5 % and mean cardiac dose <2 Gy were compared using McNemar's test. RESULTS: DIBH decreased V5 by an absolute 4.5 % (2.3 vs. 6.8 %; p < 0.0001) in post-M group, and by an absolute 2.4 % (1.3 vs. 3.7 %; p = 0.0028) in post-BCS group. DIBH decreased the mean heart dose by 107.0 cGy (127.4 vs. 234.4 cGy; p = 0.0002) in post-M group, and by 58.9 cGy (82.2 vs. 141.1 cGy; p = 0.0012) in post-BCS group. DIBH decreased mean LAD by 1201.6 cGy (670 vs. 1872.5 cGy; p = 0.0006) in post-M group, and by 799.0 cGy (425.3 vs. 1224.3 cGy; p = 0.0003) in post-BCS group. DIBH also decreased max LAD dose by 1244.3 cGy (2776.0 vs. 4020.3 cGy; p = 0.0014) in post-M group, and by 1856.3 cGy (1898.7 vs. 3754.9 cGy; p = 0.0005) in post-BCS group. In post-BCS group, cardiac V5 < 5 % was achieved in 10/15 (67 %) FB patients, and in 15/15 (100 %) DIBH patients (p = 0.002), and mean heart dose <2 Gy was achieved in 12/15 (80 %) FB patients and in 15/15 (100 %) DIBH patients (p < 0.001). This compares with post-M group, in which V5 < 5 % was achieved in 6/17 (35 %) FB patients and in 16/17 (94 %) DIBH patients (p = 0.05), and mean heart dose <2 Gy was achieved in 7/17 FB (41 %) an 16/17 DIBH patients (94 %) (p = 0.03). CONCLUSION: The results of this study suggest that there is considerable reduction in cardiac exposure in most patients with DIBH compared to FB, although less reduction is observed in the post-BCS patients. The use of cardiac shields and collimators/gantry adjustments, more readily applicable for post-BCS cases, may limit the additional benefits of DIBH. In an environment where DIBH availability is limited, the result of this study supports the preferential use of DIBH in post-M patients over post-BCS patients.

Radiation therapy quality indicators for invasive breast cancer.

BACKGROUND AND PURPOSE: Radiation therapy (RT) for breast cancer has evolved considerably over the past two decades. A concise list of optimal care indexes is lacking. The purpose of this project was to generate a suite of quality of care indicators for breast cancer RT. MATERIALS AND METHODS: A modified Delphi approach was used including a comprehensive literature and guideline review (1995-2015), an initial review of potential quality indicators (QIs) by a steering committee, a survey of Canadian Radiation Oncologists, and a face-to-face consensus development meeting with breast cancer experts to develop a list of breast RT quality indicators. RESULTS: The literature review identified 163 potential QIs, which was reduced to 73 by the steering committee. After all rounds of the Delphi process the final suite included 33 QIs. Of these, 28 (85%) received at least 80% acceptance from the Radiation Oncologists who participated in the final online survey. CONCLUSIONS: A suite of measureable RT quality indicators to be considered during management of invasive breast cancer was developed. These indicators could be used to assess the quality and consistency of breast cancer RT practices.

Claudin-Low Breast Cancer; Clinical & Pathological Characteristics.

Claudin-low breast cancer is a molecular type of breast cancer originally identified by gene expression profiling and reportedly associated with poor survival. Claudin-low tumors have been recognised to preferentially display a triple-negative phenotype, however only a minority of triple-negative breast cancers are claudin-low. We sought to identify an immunohistochemical profile for claudin-low tumors that could facilitate their identification in formalin fixed paraffin embedded tumor material. First, an in silico collection of ~1600 human breast cancer expression profiles was assembled and all claudin-low tumors identified. Second, genes differentially expressed between claudin-low tumors and all other molecular subtypes of breast cancer were identified. Third, a number of these top differentially expressed genes were tested using immunohistochemistry for expression in a diverse panel of breast cancer cell lines to determine their specificity for claudin-low tumors. Finally, the immunohistochemical panel found to be most characteristic of claudin-low tumors was examined in a cohort of 942 formalin fixed paraffin embedded human breast cancers with >10 years clinical follow-up to evaluate the clinico-pathologic and survival characteristics of this tumor subtype. Using this approach we determined that claudin-low breast cancer is typically negative for ER, PR, HER2, claudin 3, claudin 4, claudin 7 and E-cadherin. Claudin-low tumors identified with this immunohistochemical panel, were associated with young age of onset, higher tumor grade, larger tumor size, extensive lymphocytic infiltrate and a circumscribed tumor margin. Patients with claudin-low tumors had a worse overall survival when compared to patients with luminal A type breast cancer. Interestingly, claudin-low tumors were associated with a low local recurrence rate following breast conserving therapy. In conclusion, a limited panel of antibodies can facilitate the identification of claudin-low tumors. Furthermore, claudin-low tumors identified in this manner display similar clinical, pathologic and survival characteristics to claudin-low tumors identified from fresh frozen tumor material using gene expression profiling.

Estimating the Risks of Breast Cancer Radiotherapy: Evidence From Modern Radiation Doses to the Lungs and Heart and From Previous Randomized Trials.

Purpose Radiotherapy reduces the absolute risk of breast cancer mortality by a few percentage points in suitable women but can cause a second cancer or heart disease decades later. We estimated the absolute long-term risks of modern breast cancer radiotherapy. Methods First, a systematic literature review was performed of lung and heart doses in breast cancer regimens published during 2010 to 2015. Second, individual patient data meta-analyses of 40,781 women randomly assigned to breast cancer radiotherapy versus no radiotherapy in 75 trials yielded rate ratios (RRs) for second primary cancers and cause-specific mortality and excess RRs (ERRs) per Gy for incident lung cancer and cardiac mortality. Smoking status was unavailable. Third, the lung or heart ERRs per Gy in the trials and the 2010 to 2015 doses were combined and applied to current smoker and nonsmoker lung cancer and cardiac mortality rates in population-based data. Results Average doses from 647 regimens published during 2010 to 2015 were 5.7 Gy for whole lung and 4.4 Gy for whole heart. The median year of irradiation was 2010 (interquartile range [IQR], 2008 to 2011). Meta-analyses yielded lung cancer incidence ≥ 10 years after radiotherapy RR of 2.10 (95% CI, 1.48 to 2.98; P < .001) on the basis of 134 cancers, indicating 0.11 (95% CI, 0.05 to 0.20) ERR per Gy whole-lung dose. For cardiac mortality, RR was 1.30 (95% CI, 1.15 to 1.46; P < .001) on the basis of 1,253 cardiac deaths. Detailed analyses indicated 0.04 (95% CI, 0.02 to 0.06) ERR per Gy whole-heart dose. Estimated absolute risks from modern radiotherapy were as follows: lung cancer, approximately 4% for long-term continuing smokers and 0.3% for nonsmokers; and cardiac mortality, approximately 1% for smokers and 0.3% for nonsmokers. Conclusion For long-term smokers, the absolute risks of modern radiotherapy may outweigh the benefits, yet for most nonsmokers (and ex-smokers), the benefits of radiotherapy far outweigh the risks. Hence, smoking can determine the net effect of radiotherapy on mortality, but smoking cessation substantially reduces radiotherapy risk.

Cultural influences on the physician-patient encounter: The case of shared treatment decision-making.

OBJECTIVE: In this paper we discuss the influence of culture on the process of treatment decision-making, and in particular, shared treatment decision-making in the physician-patient encounter. We explore two key issues: (1) the meaning of culture and the ways that it can affect treatment decision-making; (2) cultural issues and assumptions underlying the development and use of treatment decision aids. METHODS: This is a conceptual paper. Based on our knowledge and reading of the key literature in the treatment decision-making field, we looked for written examples where cultural influences were taken into account when discussing the physician-patient encounter and when designing instruments (decision aids) to help patients participate in making decisions. RESULTS: Our assessment of the situation is that to date, and with some recent exceptions, research in the above areas has not been culturally sensitive. CONCLUSION: We suggest that more research attention should be focused on exploring potential cultural variations in the meaning of and preferences for shared decision-making as well as on the applicability across cultural groups of decision aids developed to facilitate patient participation in treatment decision-making with physicians. PRACTICE IMPLICATIONS: Both patients and physicians need to be aware of the cultural assumptions underlying the development and use of decision aids and assess their cultural sensitivity to the needs and preferences of patients in diverse cultural groups.

Shared treatment decision making: what does it mean to physicians?

PURPOSE: Physicians are urged to practice shared treatment decision making (STDM), yet this concept is poorly understood. We developed a conceptual framework describing essential characteristics of a shared approach. This study assessed the degree of congruence in the meanings of STDM as described in the framework and as perceived by practicing physicians. METHODS: A cross-sectional survey questionnaire was mailed to eligible Ontario medical and radiation oncologists and surgeons treating women with early-stage breast cancer. Open-ended and structured questions elicited physicians' perceptions of shared decision making. RESULTS: Most study physicians spontaneously described STDM using characteristics identified in the framework as essential to this concept. When presented with clinical examples in which the decision-making roles of physicians and patients were systematically varied, study physicians overwhelmingly identified example 4 as illustrating a shared approach. This example was deliberately constructed to depict STDM as defined in the framework. In addition, more than 85.0% of physicians identified as important to STDM specific patient and physician roles derived from the framework. These included the following: the physician gives information to the patient on treatment benefits and risks; the patient gives information to the physician about her values; the patient and physician discuss treatment options; both agree on the treatment to implement. CONCLUSION: Substantial congruence was found between the meaning of STDM as described in the framework and as perceived by study physicians. This supports use of the framework as a conceptual tool to guide research, compare different treatment decision-making approaches, clarify the meaning of STDM, and enhance its translation into practice.

Clinical trial update: National Cancer Institute of Canada.

The Breast Cancer Site Group (BCSG) of the National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) has conducted a wide variety of clinical trials focussing on large phase III trials of adjuvant chemotherapy, adjuvant hormonal therapy, and optimal delivery of adjuvant radiation therapy. The Group has also fostered, together with the NCIC CTG Investigational New Drug (IND) Program, a series of phase II and phase I/II studies which will be carried through if possible, into the phase III setting.

A Phase I-II study in the use of acupuncture-like transcutaneous nerve stimulation in the treatment of radiation-induced xerostomia in head-and-neck cancer patients treated with radical radiotherapy.

PURPOSE: Recent studies have suggested that acupuncture may improve radiation-induced xerostomia with an increase in the median salivary flow rate and sustained symptom relief. An acupuncture-like transcutaneous nerve stimulation method (Codetron) without invasive needles was developed to mimic acupuncture treatment. This Phase I-II study examined the effectiveness of Codetron in treating radiation-induced xerostomia. METHODS AND MATERIALS: Patients with symptomatic xerostomia after radical radiotherapy for head-and-neck cancer but with evidence of residual salivary function were recruited into the study. Two 6-week courses of Codetron treatment of acupuncture points preselected according to traditional Chinese medicine principles were given with a 2-week break between each course. Basal and citric acid-primed whole saliva production were measured at baseline and up to 1 year after treatment completion. Xerostomia symptoms were assessed by a five-item xerostomia symptom questionnaire with a visual analog scale and quality of life was evaluated using the Head and Neck Radiotherapy Questionnaire. RESULTS: We enrolled 46 patients in the study. All patients had received radiotherapy doses of >or=50 Gy to bilateral head-and-neck fields, including the parotid glands. Of the 46 patients, 37 completed the follow-up assessments at 3 and 6 months after treatment completion. No Codetron treatment-related complications occurred. Improvement in xerostomia symptoms was noted, with a mean increase in the visual analog scale score of 86 (p < 0.0005) and 77 (p < 0.0001) at 3 and 6 months after treatment completion, respectively. For all patients, the increase in the mean basal and citric acid-primed whole saliva production at 3 and 6 months after treatment completion was also statistically significant (p < 0.001 and p < 0.0001, respectively). No statistically significant change in the quality-of-life evaluation compared with baseline was observed. CONCLUSION: The results suggest that Codetron treatment improves whole saliva production and related symptoms in patients with radiation-induced xerostomia. The treatment effects were sustained for at least 6 months after Codetron treatment completion. A prospective randomized Phase III trial with appropriate controls is being planned.

Defining patient-based minimal clinically important effect sizes: a study in palliative radiotherapy for painful unresectable pelvic recurrences from rectal cancer.

PURPOSE: To measure patient-based minimal clinically important effect sizes (minimal incremental benefit that an individual would require to accept one treatment option over another) for pain relief between two contrasting palliative radiotherapy regimens for painful pelvic recurrences from rectal cancer. METHODS AND MATERIALS: Forty-three patients with a history of cancer pain without prior pelvic radiotherapy participated in decision aid-facilitated trade-off exercises. The clinical scenario and treatment options of a 5-day vs. a 20-day course of radiotherapy were described. The duration of pain relief for the 20-day regimen was increased until the respondents' preferences switched to the 20-day regimen. The exercises were repeated for different probabilities of benefit and pain intensity at the time of decision making. RESULTS: When the probability of pain relief was unchanged, the median switch point for the duration of pain relief was 6.7 and 7.2 months for severe and mild pain, respectively. The cumulative percentage frequency curve for the switch points approximated a sigmoid distribution. CONCLUSION: Determining the minimal clinically important effect sizes for symptom relief for palliative therapies is feasible. This type of information can be used to incorporate patient values into clinical trial designs. Modification of this method can be used to improve our understanding of shared (physician and patient) decision making.

Lessons learned from the Decision Board: a unique and evolving decision aid.

One session of the conference was devoted to the presentation of different types of decision aids. This paper reports the experience and lessons learned through the development and use of the Decision Board. This is a uniquely interactive decision aid administered by the clinician during the medical consultation. The instrument has been developed in a number of clinical contexts, primarily regarding treatment options for cancer patients. Studies have shown the instrument to improve patient understanding and facilitate the shared decision-making process. Randomized trials are ongoing, evaluating the addition of the Decision Board to the traditional medical consultation. The instrument continues to evolve to meet patients' need for information and flexibility in presentation. Computer-based versions of the Decision Board are currently being developed.

Towards improving the co-ordination of supportive cancer care services in the community.

In this paper an evaluation approach to assess the co-ordination of supportive community cancer care is presented. The aim of the study was to identify current gaps in co-ordination of services in a selected region in the province of Ontario, Canada, determine how consistent these gaps were across the province of Ontario, and develop service design considerations for improving the co-ordination of supportive cancer care services in the province of Ontario. The study addressed services required by two populations -clients who had been recently diagnosed and those in the palliative stages of cancer. The evaluation was theory-driven and incorporated evidence from three methods: a systematic literature review, a community case study and a provincial scan. The results revealed the absence of a formal supportive cancer care system and a complex community care system. Supportive cancer care was shown to be delivered by a range of generalist programs that lacked specialisation in addressing the unique needs of cancer clients. In addition, there was no clear evidence of leadership for co-ordinating supportive cancer care, where client care was most often provided by multiple programs at any given point in time. The study generated recommendations to improve co-ordination of supportive cancer care at both the administrative as well as direct care level.

Treatment decision-making in the medical encounter: comparing the attitudes of French surgeons and their patients in breast cancer care.

OBJECTIVES: To explore attitudes of French surgeons and their patients towards treatment decision-making (TDM) in the medical encounter. METHODS: Surgeons involved in early stage breast cancer and their patients treated in a French cancer care network received a cross-sectional survey questionnaire containing examples of four different approaches to TDM: paternalistic, "some sharing", informed TDM and, shared TDM. RESULTS: Surgeons' interaction styles were clearly distributed among paternalistic, shared and mixed. The paternalistic approach seemed to be associated with private rather than public practice and with less professional experience. Patients reported a rather low level of participation in TDM, varying by socio-demographic characteristics. One third of patients were dissatisfied with the way their treatment decision had been made. CONCLUSION: Most surgeons reported adopting the "some sharing" approach. However, one patient out of three reported that they would have liked to participate more in the TDM process. PRACTICE IMPLICATIONS: Surgeons need to ask patients what their preferences for involvement in TDM are and then think about ways to accommodate both their own and patients' preferences regarding the TDM process to be used in each encounter. In addition, decision aids could be offered to surgeons to help them discuss treatment options with their patients.

Enablers and barriers to using patient decision aids in early stage breast cancer consultations: a qualitative study of surgeons' views.

BACKGROUND: For early stage breast cancer, randomized controlled trials (RCTs) have shown that patient decision aids (PtDAs), when used by surgeons, result in increased patient knowledge about options and different patient treatment choices as compared to standard care. Yet, recent data suggests that PtDAs are used by less than 25% of Canadian cancer physicians. We conducted a study to explore breast cancer surgeons' views on enablers and barriers to the use of PtDAs in their practice. METHODS: Purposeful sampling was used to select breast cancer surgeons in three Ontario health regions to participate in semi-structured interviews. Inductive coding and the constant comparative method were used to identify the main themes. RESULTS: Twenty-two surgeons (79%) agreed to participate (median age, 50 years; 9 (40%) female). Surgeons practiced in academic (n = 7, 32%) or community (n = 15, 68%) hospitals. Fourteen surgeons were aware of PtDAs, nine had used a PtDA with patients as part of an RCT, and six had developed their own informal PtDA for use in their practice. Enablers of informal PtDA use included surgeon exposure during training and surgeon perceived need for a systematic approach when communicating risks and benefits of surgical treatments with patients. Barriers to formal PtDA use included high surgeon confidence in their verbal communication skills, surgeon belief that patients understood conveyed information, and difficulties embedding such tools in practice routines. CONCLUSIONS: Surgeons in this study valued systematic communication with patients. Several surgeons changed their practice to include formal or informal PtDAs provided they perceived there was a clear benefit to themselves or to patients. However, high surgeon confidence in their personal communications skills coupled with beliefs that patients understand conveyed information may be key barriers to PtDA uptake once surgeons have established communication routines.

Randomized trial of decongestive lymphatic therapy for the treatment of lymphedema in women with breast cancer.

PURPOSE: Because of its morbidity and chronicity, arm lymphedema remains a concerning complication of breast cancer treatment. Although massage-based decongestive therapy is often recommended, randomized trials have not consistently demonstrated benefit over more conservative measures. PATIENTS AND METHODS: Women previously treated for breast cancer with lymphedema were enrolled from six institutions. Volumes were calculated from circumference measurements. Patients with a minimum of 10% volume difference between their arms were randomly assigned to either compression garments (control) or daily manual lymphatic drainage and bandaging followed by compression garments (experimental). The primary outcome was percent reduction in excess arm volume from baseline to 6 weeks. RESULTS: A total of 103 women were randomly assigned, and 95 were evaluable. Mean reduction of excess arm volume was 29.0% in the experimental group and 22.6% in the control group (difference, 6.4%; 95% CI, -6.8% to 20.5%; P = .34). Absolute volume loss was 250 mL and 143 mL in the experimental and control groups, respectively (difference, 107 mL; 95% CI, 13 to 203 mL; P = .03). There was no difference between groups in the proportion of patients losing 50% or greater excess arm volume. Quality of life (Short Form-36 Health Survey) and arm function were not different between groups. CONCLUSION: This trial was unable to demonstrate a significant improvement in lymphedema with decongestive therapy compared with a more conservative approach. The failure to detect a difference may have been a result of the relatively small size of our trial.