Patients as teachers: a within-subjects randomized pilot experiment of patient-led online learning modules for health professionals.

PURPOSE: Many health professions education programs involve people with lived experience as expert speakers. Such presentations may help learners better understand the realities of living with chronic illness or experiencing an acute health problem. However, lectures from only one or a small number of people may not adequately illustrate the perspectives and experiences of a diverse patient cohort. Additionally, logistical constraints such as public health restrictions or travel barriers may impede in-person presentations, particularly among people who have more restrictions on their time. Health professions education programs may benefit from understanding the potential effects of online patient-led presentations with a diverse set of speakers. We aimed to explore whether patient-led online learning modules about diabetes care would influence learners' responses to clinical scenarios and to collect learners' feedback about the modules. METHOD: This within-subjects randomized experiment involved 26 third-year medical students at Université Laval in Quebec, Canada. Participation in the experiment was an optional component within a required course. Prior to the intervention, participating learners responded to three clinical scenarios randomly selected from a set of six such scenarios. Each participant responded to the other three scenarios after the intervention. The intervention consisted of patient-led online learning modules incorporating segments of narratives from 21 patient partners (11 racialized or Indigenous) describing why and how clinicians could provide patient-centered care. Working with clinical teachers and psychometric experts, we developed a scoring grid based on the biopsychosocial model and set 0.6 as a passing score. Independent evaluators, blinded to whether each response was collected before or after the intervention, then scored learners' responses to scenarios using the grid. We used Fisher's Exact test to compare proportions of passing scores before and after the intervention. RESULTS: Learners' overall percentage of passing scores prior to the intervention was 66%. Following the intervention, the percentage of passing scores was 76% (p = 0.002). Overall, learners expressed appreciation and other positive feedback regarding the patient-led online learning modules. DISCUSSION: Findings from this experiment suggest that learners can learn to provide better patient-centered care by watching patient-led online learning modules created in collaboration with a diversity of patient partners.

BRACHY: A Randomized Trial to Evaluate Symptom Improvement in Advanced Non-Small Cell Lung Cancer Treated With External Beam Radiation With or Without High-Dose-Rate Intraluminal Brachytherapy.

PURPOSE: Uncontrolled studies suggest that the addition of high-dose-rate intraluminal brachytherapy (HDRIB) to external beam radiation therapy (EBRT) may improve palliation for patients with advanced non-small cell lung cancer (NSCLC). The purpose of this study was to evaluate the potential clinical benefit of adding HDRIB to EBRT in a multicenter randomized trial. METHODS AND MATERIALS: Patients with symptomatic stage III or IV NSCLC with endobronchial disease were randomized to EBRT (20 Gy in 5 daily fractions over 1 week or 30 Gy in 10 daily fractions over 2 weeks) or the same EBRT plus HDRIB (14 Gy in 2 fractions separated by 1 week). The primary outcome was the proportion of patients who achieved symptomatic improvement in patient-reported overall lung cancer symptoms on the Lung Cancer Symptom Scale (LCSS) at 6 weeks after randomization. Secondary outcomes included improvement in individual symptoms, symptom-progression-free survival, overall survival, and toxicity. The planned sample size was 250 patients based on detection of symptomatic improvement from 40% to 60% with a 2-sided α of .05 and 80% power. RESULTS: A total of 134 patients were randomized over 4.5 years: 67 to each arm. The study closed early owing to slow accrual. The mean age was 69.8 years, and 67% of patients had metastatic disease. At 6 weeks, 19 patients (28.4%) in the EBRT arm and 20 patients (29.9%) in the EBRT plus HDRIB arm experienced an improvement in lung cancer symptoms (P = .84). When limited to patients who completed the LCSS, percentages were 40.4% versus 47.6%, respectively (P = .49). Between group differences in mean change scores (0.3-0.5 standard deviations) in favor of EBRT plus HDRIB were observed for overall symptoms, but only hemoptysis was significantly improved (P = .03). No significant differences were observed in progression-free or overall survival. Grade 3/4 toxicities were similar between groups. CONCLUSIONS: Small to moderate improvements were seen in symptom relief with the combined therapy, but they did not reach statistical significance. Further research is necessary before recommending HDRIB in addition to EBRT for palliation of lung cancer symptoms.

Classification of changes occurring in lung patient during radiotherapy using relative γ analysis and hidden Markov models.

PURPOSE: To present a new automated patient classification method based on relative gamma analysis and hidden Markov models (HMM) to identify patients undergoing important anatomical changes during radiation therapy. METHODS: Daily EPID images of every treatment field were acquired for 52 patients treated for lung cancer. In addition, CBCT were acquired on a regular basis. Gamma analysis was performed relative to the first fraction given that no significant anatomical change was observed on the CBCT of the first fraction compared to the planning CT. Several parameters were extracted from the gamma analysis (e.g., average gamma value, standard deviation, percent above 1). These parameters formed patient-specific time series. Data from the first 24 patients were used as a training set for the HMM. The trained HMM was then applied to the remaining 28 patients and compared to manual clinical evaluation and fixed thresholds. RESULTS: A three-category system was used for patient classification ranging from minor deviations (category 1) to severe deviations (category 3) from the treatment plan. Patient classified using the HMM lead to the same result as the classification made by a human expert 83% of the time. The HMM overestimate the category 10% of the time and underestimate 7% of the time. Both methods never disagree by more than one category. In addition, the information provided by the HMM is richer than the simple threshold-based approach. HMM provides information on the likelihood that a patient will improve or deteriorate as well as the expected time the patient will remain in that state. CONCLUSION: We showed a method to classify patients during the course of radiotherapy based on relative changes in EPID images and a hidden Markov model. Information obtained through this automated classification can complement the clinical information collected during treatment and help identify patients in need of a plan adaptation.

A randomized double-blind controlled trial: impact of probiotics on diarrhea in patients treated with pelvic radiation.

BACKGROUND & AIMS: Radical radiation therapy is commonly used for treatment of pelvic cancer. Up to 80% of patients receiving radiotherapy will develop acute radiation induced diarrhea. The primary aim of this randomized double blind controlled trial is to evaluate the effect of the probiotic Bifilact(®) on moderate and severe treatment-induced diarrhea during pelvic radiation. METHODS: Patients with pelvic cancers were treated between 2006 and 2010 at L'Hôtel-Dieu de Québec, University Health Center. Some patients had surgery before pelvic radiotherapy and some received chemotherapy. A total of 246 Patients were randomized between a placebo and either of two regiments of double strain Bifilact(®) probiotics (Lactobacillus acidophilus LAC-361 and Bifidobacterium longum BB-536): a standard dose twice a day (1.3 billion CFU) or a high dose three times a day (10 billion CFU). Patients were trained to record their digestive symptoms daily with a standardized scale and they met a registered dietician and radiation oncologist every week during treatment. The main analysis compared time to first appearance of grade ≥2-3-4 diarrhea using Kaplan-Meier curves as measured by proportion of patients without moderate and severe diarrhea. RESULTS: 229 patients were analyzed. The difference between the groups for overall grade 2-3-4 diarrhea was not statistically significant (p = 0.13). However at 60 days, the proportion of patients without moderate and severe diarrhea in the standard dose group (35%) was more than twice as high as that of the placebo group (17%) with a hazard ratio of 0.69 (p = 0.04). In patients who had surgery, the standard probiotics dose group had a better proportion of patients without very severe diarrhea than the placebo group, respectively 97% and 74% (p = 0.03). In all groups, the average number of bowel movements per day during treatment was less than 3 soft stools (p = 0.80) and the median abdominal pain less than 1 based on the National Cancer Institute scale (p = 0.23). CONCLUSION: Standard dose of Bifilact(®) may reduce radiation induced grade 2-3-4 diarrhea at the end of the treatment of patients with pelvic cancer. In patients operated on before RT, a standard dose of probiotics may reduce radiation induced grade 4 diarrhea. Nutritional interventions by a registered dietician seemed to reduce global digestive symptoms. TRIAL REGISTRATION: clinicaltrials.gov. Identifier NCT01839721.

Prophylactic irradiation of intervention sites in malignant pleural mesothelioma.

BACKGROUND AND PURPOSE: To assess the effectiveness of prophylactic irradiation of intervention track (PIT) to prevent tumor seeding in patients with malignant pleural mesothelioma. MATERIALS AND METHODS: A retrospective review was conducted of 171 patients with a histological diagnosis of pleural mesothelioma with some undergoing prophylactic irradiation of intervention sites. RESULTS: Forty-eight patients (28%) received PIT. A majority of patients were followed until death. Thoracoscopy (88%) was the procedure most often performed. Thirty-three percent of patients received chemotherapy. The median dose of PIT was 21 Gy in 3 fractions with electrons or 6 MV photons. The local progression free survival (LPFS) at the intervention site was significantly higher in the PIT group and was not influenced by chemotherapy. At 6 months, LPFS for the intervention sites was 91% with PIT and 74% without PIT (p=0.002). During the follow-up, 6 patients (13%) in the PIT group had tumor invasion of the subcutaneous tissue compared to 40 patients (33%) in the group without PIT (p=0.008). CONCLUSIONS: This study suggests that PIT in mesothelioma reduces the incidence of procedure tract metastasis. Finally, chemotherapy does not seem to have an influence on the incidence of tract metastasis.

Functional avoidance of lung in plan optimization with an aperture-based inverse planning system.

PURPOSE: To implement SPECT-based optimization in an anatomy-based aperture inverse planning system for the functional avoidance of lung in thoracic irradiation. MATERIAL AND METHODS: SPECT information has been introduced as a voxel-by-voxel modulation of lung importance factors proportionally to the local perfusion count. Fifteen cases of lung cancer have been retrospectively analyzed by generating angle-optimized non-coplanar plans, comparing a purely anatomical approach and our functional approach. Planning target volume coverage and lung sparing have been compared. Statistical significance was assessed by a Wilcoxon matched pairs test. RESULTS: For similar target coverage, perfusion-weighted volume receiving 10 Gy was reduced by a median of 2.2% (p=0.022) and mean perfusion-weighted lung dose, by a median of 0.9 Gy (p=0.001). A separate analysis of patients with localized or non-uniform hypoperfusion could not show which would benefit more from SPECT-based treatment planning. Redirection of dose sometimes created overdosage regions in the target volume. Plans consisted of a similar number of segments and monitor units. CONCLUSIONS: Angle optimization and SPECT-based modulation of importance factors allowed for functional avoidance of the lung while preserving target coverage. The technique could be also applied to implement PET-based modulation inside the target volume, leading to a safer dose escalation.

Safety and feasibility of motexafin gadolinium administration with whole brain radiation therapy and stereotactic radiosurgery boost in the treatment of ≤ 6 brain metastases: a multi-institutional phase II trial.

To determine the safety, tolerability, and report on secondary efficacy endpoints of motexafin gadolinium (MGd) in combination with whole-brain radiotherapy (WBRT) and stereotactic radiosurgery (SRS) for patients with ≤ 6 brain metastases. We conducted an international study of WBRT (37.5 Gy in 15 fractions) and SRS (15-21 Gy) with the addition of MGd (5 mg/kg preceding each fraction beginning week 2). The primary endpoint was to evaluate the rate of irreversible grade 3 or any grade ≥ 4 neurotoxicity and establish feasibility in preparation for a phase III trial. Sixty-five patients were enrolled from 14 institutions, of which 45 (69%) received SRS with MGd as intended and were available for evaluation. Grade ≥ 3 neurotoxicity attributable to radiation therapy within 3 months of SRS was seen in 2 patients (4.4%), including generalized weakness and radionecrosis requiring surgical management. Immediately following the course of MGd plus WBRT, new brain metastases were detected in 11 patients (24.4%) at the time of the SRS treatment planning MRI. The actuarial incidence of neurologic progression at 6 months and 1 year was 17 and 20%, respectively. The median investigator-determined neurologic progression free survival and overall survival times were 8 (95% CI: 5-14) and 9 months (95% CI: 6-not reached), respectively. We observed a low rate of neurotoxicity, demonstrating that the addition of MGd does not increase the incidence or severity of neurologic complications from WBRT with SRS boost.

Patient-specific Monte Carlo-based dose-kernel approach for inverse planning in afterloading brachytherapy.

PURPOSE: Brachytherapy planning software relies on the Task Group report 43 dosimetry formalism. This formalism, based on a water approximation, neglects various heterogeneous materials present during treatment. Various studies have suggested that these heterogeneities should be taken into account to improve the treatment quality. The present study sought to demonstrate the feasibility of incorporating Monte Carlo (MC) dosimetry within an inverse planning algorithm to improve the dose conformity and increase the treatment quality. METHODS AND MATERIALS: The method was based on precalculated dose kernels in full patient geometries, representing the dose distribution of a brachytherapy source at a single dwell position using MC simulations and the Geant4 toolkit. These dose kernels are used by the inverse planning by simulated annealing tool to produce a fast MC-based plan. A test was performed for an interstitial brachytherapy breast treatment using two different high-dose-rate brachytherapy sources: the microSelectron iridium-192 source and the electronic brachytherapy source Axxent operating at 50 kVp. RESULTS: A research version of the inverse planning by simulated annealing algorithm was combined with MC to provide a method to fully account for the heterogeneities in dose optimization, using the MC method. The effect of the water approximation was found to depend on photon energy, with greater dose attenuation for the lower energies of the Axxent source compared with iridium-192. For the latter, an underdosage of 5.1% for the dose received by 90% of the clinical target volume was found. CONCLUSION: A new method to optimize afterloading brachytherapy plans that uses MC dosimetric information was developed. Including computed tomography-based information in MC dosimetry in the inverse planning process was shown to take into account the full range of scatter and heterogeneity conditions. This led to significant dose differences compared with the Task Group report 43 approach for the Axxent source.

Postoperative radiotherapy for lung cancer: improvement in locoregional control using three-dimensional compared with two-dimensional technique.

PURPOSE: To determine whether lung cancer patients treated with three-dimensional (3D) postoperative radiotherapy (PORT) have more favorable outcomes than those treated with two-dimensional (2D) PORT. PATIENTS AND METHODS: We retrospectively analyzed the charts of 153 lung cancer patients who underwent PORT with curative intent at our center between 1995 and 2007. The patients were grouped according to the RT technique; 66 patients were in the 2D group and 87 in the 3D group. The outcomes included locoregional control, survival, and secondary effects. All patients were treated using a linear accelerator at a total dose of approximately 50 Gy and 2 Gy/fraction. A few patients (21%) also received chemotherapy. Most tumors were in the advanced stage, either Stage II (30%) or Stage III (65%). The main clinical indications for PORT were positive resection margins (23%) and Stage pN2 (52%) and pN1 (22%). The patient characteristics were comparable in both groups. RESULTS: Kaplan-Meier analysis showed that the 3D technique significantly improved the locoregional control rate at 5 years compared with the 2D technique (81% vs. 56%, p = .007 [Cox]). The 2D technique was associated with a more than twofold increased risk of locoregional recurrence (hazard ratio, 2.7; 95% confidence interval, 1.3-5.5; p = .006). The overall survival rate did not differ at 5 years (38% vs. 20%, p = .3 [Cox]). The toxicities were also similar and acceptable in both groups. CONCLUSION: The 3D technique for conformal PORT for lung cancer improved the locoregional control rates of patients compared with the 2D technique.

Influence of smoking status on treatment outcomes after post-operative radiation therapy for non-small-cell lung cancer.

BACKGROUND AND PURPOSE: The role of post-operative radiotherapy in patients with resected non-small-cell lung cancer (NSCLC) is unclear. Modifiable factors, like smoking, may help guide therapy. We retrospectively evaluated the impact of smoking on control in patients undergoing post-operative radiation therapy (PORT) for NSCLC. MATERIALS AND METHODS: Between 1995 and 2007, 152 patients who underwent surgery for NSCLC were analyzed (median follow-up 26 months). Non-smokers were defined as patients who never smoked or who had stopped smoking at the time of initial consultation. Sixty seven percent were non-smokers; 5% never smoked, 40% of the non-smokers had ceased smoking for a year or less, while 55% had stopped for more than a year. RESULTS: On univariate analysis, smokers had worse 5-year local control than non-smokers (70% versus 90%, p=0.001) and locoregional control (52% versus 77%, p=0.002). The 5-year survival rate was 21% for smokers and 31% for non-smokers (p=0.2). On multivariate analysis, smokers maintained a detrimental effect on locoregional control (HR 3.6, p=0.0006). CONCLUSIONS: Smokers at initial consultation have poorer local and locoregional control after PORT than non-smokers. In patients being considered for PORT for NSCLC, quitting smoking before treatment confers additional treatment advantage.

Retrospective study of 81 patients treated with brachytherapy for endobronchial primary tumor or metastasis.

PURPOSE: The purpose of this retrospective study is to evaluate the role of endobronchial brachytherapy in the palliation of lung cancer (or metastasis) symptoms and its potential impact on overall survival. METHODS AND MATERIALS: Eighty-one patients were included in this study. Endobronchial brachytherapy catheter was placed under conscious sedation. The projection of the tumor was drawn by the bronchoscopist to help the radiation oncology team to perform the dosimetry. Patients were treated with iridium-192 high-dose rate afterloading unit. Patients were planned to receive 5 Gy in four fractions weekly for a total of 20 Gy. RESULTS: Seventy-three percent of the patients were treated for primary lung cancer. The remaining patients were treated for lung metastasis of other primary. Most patients presented dyspnea, cough, or hemoptysis. These three main symptoms were relieved in 85%, 77%, and 100%, respectively. The median survival was 14.7 months and local progression-free survival at 12 months was 77% and at 24 months 64%, respectively. CONCLUSION: Endobronchial brachytherapy is a very effective palliative treatment for endobronchial lesions.

Breast-conserving therapy after previous irradiation for lymphoma.

There is an increased risk of breast cancer in patients who have undergone radiation treatment for lymphoma. While this usually precludes further radiotherapy (RT), we report five women who received irradiation for lymphoma and who subsequently received breast-conserving therapy between 1995 and 2007 for early-stage breast cancer. There was an overlap between the two treatment fields in all patients. RT for lymphoma ranged between 29.8 and 40 grays (Gy). The interval between lymphoma and the diagnosis of breast cancer was 11-24 years. All five patients had lumpectomy and received subsequent RT (45 Gy in four patients, 50 Gy in the other). All tolerated breast RT well, and toxicity was limited to grade 1 events. All five patients were alive at last follow-up, and there was no local recurrence in the irradiated breast in any patient. We conclude that previous RT for lymphoma is not necessarily an absolute contraindication to breast-conserving therapy.

Use of axillary deodorant and effect on acute skin toxicity during radiotherapy for breast cancer: a prospective randomized noninferiority trial.

PURPOSE: To prospectively determine the effect of deodorant use on acute skin toxicity and quality of life during breast radiotherapy (RT). METHODS AND MATERIALS: Before breast RT, 84 patients were randomly assigned to the deodorant group (n = 40) or the no-deodorant group (n = 44). The patients were stratified by axillary RT and previous chemotherapy. Toxicity evaluations were always performed by the principal investigator, who was unaware of the group assignment, at the end of RT and 2 weeks after completion using the Radiation Therapy Oncology Group acute skin toxicity criteria. Symptoms of acute skin toxicity (i.e., discomfort, pain, pruritus, sweating) and quality of life were self-evaluated. For each criterion, the point estimate of rate difference with the 95% one-sided upper confidence limit was computed. To claim noninferiority owing to deodorant use, the 95% one-sided upper confidence limit had to be lower than the noninferiority margin, fixed to 12.8%. RESULTS: In the deodorant vs. no-deodorant groups, Grade 2 axillary radiodermatitis occurred in 23% vs. 30%, respectively, satisfying the statistical criteria for noninferiority (p = .019). Grade 2 breast radiodermatitis occurred in 30% vs. 34% of the deodorant vs. no-deodorant groups, respectively, also satisfying the statistical criteria for noninferiority (p = .049). Similar results were observed for the self-reported evaluations. The deodorant group reported less sweating (18% vs. 39%, p = .032). No Grade 3 or 4 radiodermatitis was observed. CONCLUSION: According to our noninferiority margin definition, the occurrence of skin toxicity and its related symptoms were statistically equivalent in both groups. No evidence was found to prohibit deodorant use (notwithstanding the use of an antiperspirant with aluminum) during RT for breast cancer.

Dose escalation in the radiotherapy of non-small-cell lung cancer with aperture-based intensity modulation and photon beam energy optimization for non-preselected patients.

PURPOSE: To verify the potential of aperture-based intensity-modulated radiotherapy (AB-IMRT) to realize dose escalation plans for non-preselected non-small-cell lung cancer (NSCLC) patients, using photon beam energy optimization. METHODS AND MATERIALS: Seven cases of NSCLC were retrospectively studied. Clinical reference plans were made at 60 Gy by an experienced dosimetrist. Dose escalation was applied to PTV2, a subvolume within the main PTV1. Escalation plans were optimized by considering beam angles (table and gantry), energy (6 and 23 MV) and weights, for an increasing dose to the PTV2, starting from 66 Gy and keeping 30 fractions. RESULTS: In five cases, doses over 78 Gy could be achieved before exceeding organs at risk (OARs) standard tolerance. Peripheral overdosages, as well as lung and spinal cord tolerance doses, limited escalation. Means+/-SD V(95%) parameters were (97.3+/-0.9)% for PTV1s and (96.7+/-2.2)% for PTV2s. Doses to OARs were also maintained at acceptable levels. Optimized plans made use of both low- and high-energy beams and had a similar number of monitor units compared to the 60 Gy clinical plans. CONCLUSIONS: The AB-IMRT system can successfully realize dose escalation for a sizeable number of cases. Plans produced contained few large segments, and are applicable to a wide range of tumor volumes and locations.

The impact of the number of excised axillary nodes and of the percentage of involved nodes on regional nodal failure in patients treated by breast-conserving surgery with or without regional irradiation.

PURPOSE: After breast-conserving surgery, recommendations for regional nodal radiotherapy are usually based on the number of positive nodes. This number is dependent on the number of nodes removed during the axillary dissection. This study examines whether the percentage of positive nodes may help to select patients for regional radiotherapy. METHODS AND MATERIALS: A retrospective study was conducted on 1,372 T1-T2 node-positive breast cancer patients treated at L'Hôtel-Dieu de Québec Hospital between 1972 and 1997. RESULTS: Among the patients who did not receive regional radiotherapy, the percentage of involved nodes was significantly associated with axillary failure. Ten-year axillary control rates were 97% and 91% when the percentage of involved nodes was <50% and > or =50%, respectively (p = 0.007). In addition, regional radiotherapy is always significantly associated with a decrease in overall regional failure (axillary and/or supraclavicular), regardless of the percentage of involved nodes. However, regional radiotherapy reduced the axillary failure rate (2% vs. 9%, p = 0.007) only when more than a specific percentage of nodes was involved (> or =40% if N1-3 and > or =50% if N>3 nodes). CONCLUSIONS: The percentage of involved nodes should be taken into consideration in selecting patients for regional radiotherapy. Irradiation of the axilla should be reserved for patients with a specific ratio: >40% involved nodes if N1-3 and > or =50% involved nodes if N>3 nodes.

Impact of locoregional radiotherapy in node-positive patients treated by breast-conservative treatment.

PURPOSE: The aim of this study is to evaluate the impact of locoregional radiation in node-positive patients treated by tumorectomy and radiation therapy. METHODS: A retrospective study including all our 1368 T1-2 node-positive patients was conducted. Conservative surgery was followed by breast irradiation. Axillary and supraclavicular irradiation was left to the discretion of the treating radiation oncologist. RESULTS: In the group receiving locoregional radiation (472 patients), the 10-year regional control was 97% vs. 91% for the group receiving radiation to the breast only (896 patients) (p = 0.004). In a Cox model analysis, locoregional radiation is associated with a better regional control rate (hazard ratio: 0.27; 95% confidence interval: 0.13-0.54, p = 0.0001). Locoregional radiotherapy is associated with a better rate of locoregional control (hazard ratio: 0.56; 95% confidence interval: 0.38-0.8, p = 0.002). In particular, for the N>3 group, the substantial 10-year locoregional failure rate (26% with breast irradiation only) is cut by 50%. Locoregional radiotherapy, however, is not associated with a lower rate of distant metastases. CONCLUSION: Locoregional radiation decreases the rate of locoregional failure by nearly 50%. Locoregional radiotherapy should be considered for node-positive patients, especially if they have more than 3 positive nodes.