Improving anxiety regulation in patients with breast cancer at the beginning of the survivorship period: a randomized clinical trial comparing the benefits of single-component and multiple-component group interventions.

OBJECTIVE: To compare in a multicenter randomized controlled trial the benefits in terms of anxiety regulation of a 15-session single-component group intervention (SGI) based on support with those of a 15-session multiple-component structured manualized group intervention (MGI) combining support with cognitive-behavioral and hypnosis components. METHODS: Patients with nonmetastatic breast cancer were randomly assigned at the beginning of the survivorship period to the SGI (n = 83) or MGI (n = 87). Anxiety regulation was assessed, before and after group interventions, through an anxiety regulation task designed to assess their ability to regulate anxiety psychologically (anxiety levels) and physiologically (heart rates). Questionnaires were used to assess psychological distress, everyday anxiety regulation, and fear of recurrence. Group allocation was computer generated and concealed till baseline completion. RESULTS: Compared with patients in the SGI group (n = 77), patients attending the MGI group (n = 82) showed significantly reduced anxiety after a self-relaxation exercise (P = .006) and after exposure to anxiety triggers (P = .013) and reduced heart rates at different time points throughout the task (P = .001 to P = .047). The MGI participants also reported better everyday anxiety regulation (P = .005), greater use of fear of recurrence-related coping strategies (P = .022), and greater reduction in fear of recurrence-related psychological distress (P = .017) compared with the SGI group. CONCLUSIONS: This study shows that an MGI combining support with cognitive-behavioral techniques and hypnosis is more effective than an SGI based only on support in improving anxiety regulation in patients with breast cancer.

Radiotherapy capacity in European countries: an analysis of the Directory of Radiotherapy Centres (DIRAC) database.

Radiotherapy is used for cure or palliation in around half of patients with cancer. We analysed data on radiotherapy equipment in 33 European countries registered in the Directory of Radiotherapy Centres (DIRAC) database, managed by the International Atomic Energy Agency. As of July, 2012, Europe had 1286 active radiotherapy centres. The average number of teletherapy machines per radiotherapy centre ranged from 1·2 to 7·0 in different countries. Nordic countries, the UK, the Netherlands, and Slovenia all have large centres with four to ten teletherapy machines. Most western and southern European countries have several small centres with one or two machines, with few larger centres. The fragmentation in radiotherapy services that prevails in many European countries might affect the economic burden of radiotherapy and its quality. Eastern and southeastern European countries need to expand and modernise their radiotherapy equipment.

Postoperative radiotherapy after radical prostatectomy for high-risk prostate cancer: long-term results of a randomised controlled trial (EORTC trial 22911).

BACKGROUND: We report the long-term results of a trial of immediate postoperative irradiation versus a wait-and-see policy in patients with prostate cancer extending beyond the prostate, to confirm whether previously reported progression-free survival was sustained. METHODS: This randomised, phase 3, controlled trial recruited patients aged 75 years or younger with untreated cT0-3 prostate cancer (WHO performance status 0 or 1) from 37 institutions across Europe. Eligible patients were randomly assigned centrally (1:1) to postoperative irradiation (60 Gy of conventional irradiation to the surgical bed for 6 weeks) or to a wait-and-see policy until biochemical progression (increase in prostate-specific antigen >0·2 µg/L confirmed twice at least 2 weeks apart). We analysed the primary endpoint, biochemical progression-free survival, by intention to treat (two-sided test for difference at α=0.05, adjusted for one interim analysis) and did exploratory analyses of heterogeneity of effect. This trial is registered with ClinicalTrials.gov, number NCT00002511. FINDINGS: 1005 patients were randomly assigned to a wait-and-see policy (n=503) or postoperative irradiation (n=502) and were followed up for a median of 10·6 years (range 2 months to 16·6 years). Postoperative irradiation significantly improved biochemical progression-free survival compared with the wait-and-see policy (198 [39·4%] of 502 patients in postoperative irradiation group vs 311 [61·8%] of 503 patients in wait-and-see group had biochemical or clinical progression or died; HR 0·49 [95% CI 0·41-0·59]; p<0·0001). Late adverse effects (any type of any grade) were more frequent in the postoperative irradiation group than in the wait-and-see group (10 year cumulative incidence 70·8% [66·6-75·0] vs 59·7% [55·3-64·1]; p=0.001). INTERPRETATION: Results at median follow-up of 10·6 years show that conventional postoperative irradiation significantly improves biochemical progression-free survival and local control compared with a wait-and-see policy, supporting results at 5 year follow-up; however, improvements in clinical progression-free survival were not maintained. Exploratory analyses suggest that postoperative irradiation might improve clinical progression-free survival in patients younger than 70 years and in those with positive surgical margins, but could have a detrimental effect in patients aged 70 years or older. FUNDING: Ligue Nationale contre le Cancer (Comité de l'Isère, Grenoble, France) and the European Organisation for Research and Treatment of Cancer (EORTC) Charitable Trust.

Radiotherapy-specific quality indicators at national level: How to make it happen.

PURPOSE /OBJECTIVE: To promote best practice and quality of care, the Belgian College of Physicians for Radiotherapy Centers established a set of radiotherapy specific quality indicators for benchmarking on a national level. This paper describes the development, the collected QIs, the observed trends and the departments' evaluation of this initiative. MATERIAL AND METHODS: The Donabedian approach was used, focussing on structural, process and outcome QIs. The criteria for QI selection were availability, required for low-threshold regular collection, and applicability to guidelines and good practice. The QIs were collected yearly and individualized reports were sent out to all RT departments. In 2021, a national survey was held to evaluate the ease of data collection and submission, and the perceived importance and validity of the collected QIs. RESULTS: 18 structural QI and 37 process and outcome parameters (n = 25 patients/pathology/department) were collected. The participation rate amounted to 95 % overall. The analysis gave a national overview of RT activity, resources, clinical practice and reported acute toxicities. The individualized reports allowed departments to benchmark their performance. The 2021 survey indicated that the QIs were overall easy to collect, relevant and reliable. The collection of acute recorded toxicities was deemed a weak point due to inter-observer variabilities and lack of follow-up time. CONCLUSION: QI collection on a national level is a valuable process in steering quality improvement initiatives. The feasibility and relevance was demonstrated with a high level of participation. The national initiative will continue to evolve as a quality monitoring and improvement tool.

Insight on variables leading to burnout in cancer physicians.

Although communication skills training programs have been recommended to reduce physicians' burnout, few studies have investigated their efficacy. This study assessed the impact of two training programs on cancer physicians' burnout. Especially, it identified some variables leading to burnout in order to develop effective interventions. Burnout was assessed with the Maslach Burnout Inventory. No statistically significant impact of training programs on burnout was observed. The amount of clinical workload and the overuse of some facilitative communication skills were associated with cancer physicians' burnout. The content of such programs must be redefined to reduce burnout.

Feasibility and impact of national peer reviewed clinical audits in radiotherapy departments.

PURPOSE/OBJECTIVE: A national incentive brought about the instauration of systematic clinical audits of all Belgian radiotherapy departments (n = 25) from 2011 to 2015 using the International Atomic Energy Agency QUATRO (Quality Improvement Quality Assurance Team for Radiation Oncology) methodology. The impact of these audits was evaluated and the emitted recommendations originating from the audit reports were analysed to identify areas of weakness on a national basis. METHOD: The QUATRO audits performed in each radiotherapy department gave rise to reports in which each department received a list of recommendations that it is free to implement. These audit reports were analyzed to identify common areas for which improvements were recommended. Moreover, questionnaires were sent to all departments in order to evaluate the overall usefulness of the recommendations as well as the relevancy and the actual impact of each individual recommendation. RESULTS: Of the 381 emitted recommendations, 34% concerned process optimization of which a quarter involved process improvement and protocol development. Twenty-seven percent of the recommendations concerned infrastructure of which one-third was related to the quality of the equipment or facility. Nineteen and 20% of recommendations addressed department organisational and staff issues respectively. When analysing the departments' feedback questionnaires, 54% of the departments evaluated the audits' recommendations as being very useful. Furthermore, 42.7% of the recommendations were found to be very relevant and 23.5% were deemed to have an important impact. CONCLUSION: This first round of audits in Belgium allowed for the identification of common areas for improvements of practice in radiation oncology departments, with a focus on process optimization and infrastructure elements. Similarly, the audits' emitted recommendations were globally deemed very relevant. Encouraged, by this analysis, a second cycle of audits has started in Belgium with a modified version of the QUATRO document (B-QUATRO).

The role of the radiation oncologist in quality and patient safety: A proposal of indicators and metrics.

This manuscript represents a collaboration from an international group of quality and safety expert radiation oncologists. It is a position/review paper with the specific aim of defining the role of the radiation oncologist in quality and safety management. This manuscript is unique in that we recommend specific quality assurance/control tasks and correlated quality and indicators and safety measures that are the responsibility of the radiation oncologist. The article addresses the role of the radiation oncologist in quality and safety from a strong perspective of multidisciplinarity and teamwork. Our manuscript is "cross-cutting" and applicable to radiation oncologist in any practice setting (i.e. low middle-income countries).

A dosimetric selectivity intercomparison of HDR brachytherapy, IMRT and helical tomotherapy in prostate cancer radiotherapy.

BACKGROUND AND PURPOSE: Dose escalation in order to improve the biochemical control in prostate cancer requires the application of irradiation techniques with high conformality. The dosimetric selectivity of three radiation modalities is compared: high-dose-rate brachytherapy (HDR-BT), intensity-modulated radiation radiotherapy (IMRT), and helical tomotherapy (HT). PATIENTS AND METHODS: Ten patients with prostate adenocarcinoma treated by a 10-Gy HDR-BT boost after external-beam radiotherapy were investigated. For each patient, HDR-BT, IMRT and HT theoretical treatment plans were realized using common contour sets. A 10-Gy dose was prescribed to the planning target volume (PTV). The PTVs and critical organs' dose-volume histograms obtained were compared using Student's t-test. RESULTS: HDR-BT delivers spontaneously higher mean doses to the PTV with smaller cold spots compared to IMRT and HT. 33% of the rectal volume received a mean HDR-BT dose of 3.86 + or - 0.3 Gy in comparison with a mean IMRT dose of 6.57 + or - 0.68 Gy and a mean HT dose of 5.58 + or - 0.71 Gy (p < 0.0001). HDR-BT also enables to better spare the bladder. The hot spots inside the urethra are greater with HDR-BT. The volume of healthy tissue receiving 10% of the prescribed dose is reduced at least by a factor of 8 with HDR-BT (p < 0.0001). CONCLUSION: HDR-BT offers better conformality in comparison with HT and IMRT and reduces the volume of healthy tissue receiving a low dose.

Primary breast lymphoma: patient profile, outcome and prognostic factors. A multicentre Rare Cancer Network study.

BACKGROUND: To asses the clinical profile, treatment outcome and prognostic factors in primary breast lymphoma (PBL). METHODS: Between 1970 and 2000, 84 consecutive patients with PBL were treated in 20 institutions of the Rare Cancer Network. Forty-six patients had Ann Arbor stage IE, 33 stage IIE, 1 stage IIIE, 2 stage IVE and 2 an unknown stage. Twenty-one underwent a mastectomy, 39 conservative surgery and 23 biopsy; 51 received radiotherapy (RT) with (n = 37) or without (n = 14) chemotherapy. Median RT dose was 40 Gy (range 12-55 Gy). RESULTS: Ten (12%) patients progressed locally and 43 (55%) had a systemic relapse. Central nervous system (CNS) was the site of relapse in 12 (14%) cases. The 5-yr overall survival, lymphoma-specific survival, disease-free survival and local control rates were 53%, 59%, 41% and 87% respectively. In the univariate analyses, favorable prognostic factors were early stage, conservative surgery, RT administration and combined modality treatment. Multivariate analysis showed that early stage and the use of RT were favorable prognostic factors. CONCLUSION: The outcome of PBL is fair. Local control is excellent with RT or combined modality treatment but systemic relapses, including that in the CNS, occurs frequently.

Factors influencing physicians' detection of cancer patients' and relatives' distress: can a communication skills training program improve physicians' detection?

PURPOSE: This study aimed to assess the impact on physicians' detection of patients' and relatives' distress of six 3-h consolidation workshops (CW) following a 2.5-day communication skills basic training (BT) program and to investigate factors associated with detection of distress. METHODS: Physicians, after BT, were randomized to CW or to a waiting list. Physicians' detection of patients' and relatives' distress was measured through differences between physicians' ratings of patients' and relatives' distress (VAS) and patients' and relatives' self-reported distress (HADS). Communication skills were analysed according to the CRCWEM. RESULTS: Mixed-effects modelling of physicians' detection of patients' distress showed a positive group by time effect in favour of physicians in the CW group. Detection of patients' distress was associated negatively with patients' distress, positively with physicians' concurrent use of psychological assessment and supportive skills, and negatively with general assessment skills. Mixed-effects modelling of physicians' detection of relatives' distress showed no significant group by time effect. Detection of relatives' distress was associated negatively with relatives' distress and with general assessment skills. CONCLUSION: CW following a 2.5-day BT are needed to improve physicians' detection of patients' distress in three-person interviews. Results indicate the need to further improve physicians' detection of relatives' distress.

Factors that influence cancer patients' and relatives' anxiety following a three-person medical consultation: impact of a communication skills training program for physicians.

BACKGROUND: No study has yet assessed the impact of physicians' skills acquisition after a communication skills training program on changes in patients' and relatives' anxiety following a three-person medical consultation. This study aimed at comparing, in a randomized study, the impact, on patients' and relatives' anxiety, of a basic communication skills training program and the same program consolidated by consolidation workshops and at investigating physicians' communication variables associated with patients' and relatives' anxiety. METHODS: Consultations with a cancer patient and a relative were recorded and analyzed by the Cancer Research Campaign Workshop Evaluation Manual. Patients' and relatives' anxiety were assessed with the State-Trait Anxiety Inventory-State. RESULTS: No statistically significant change over time and between groups was observed. Mixed-effects modeling of changes in patients' and relatives' anxiety showed that decreases in both patients' and relatives' anxiety were linked with patients' and relatives' self-reported distress (p = 0.031 and 0.005), and that increases in both patients' and relatives' anxiety were linked with physicians' breaking bad news (p = 0.028 and 0.005). CONCLUSION: No impact of the training program was observed. Results indicate the need to further study communication skills which may help reduce patients' and relatives' anxiety especially when breaking bad news.

Improving the quality of radiation oncology: 10years' experience of QUATRO audits in the IAEA Europe Region.

BACKGROUND AND PURPOSE: The IAEA has developed a methodology for comprehensive quality audits of radiotherapy practices called Quality Assurance Team for Radiation Oncology (QUATRO). This study explores the factors that impacted quality of care among QUATRO audited centres in the IAEA Europe Region. MATERIALS AND METHODS: The 31 QUATRO reports collected over 10years include extensive data describing the quality of radiotherapy at the audited centres. A coding key was developed to aggregate and review these data in terms of recommendations for improvement and positive findings (commendations). RESULTS: Overall 759 recommendations and 600 commendations were given. Eight centres recognized as centres of competence differed from other centres mostly because they operated complete quality management systems and were adequately staffed. Other centres had excessive staff workloads and many gaps in the process of care. Insufficient equipment levels were prevalent. Patient centredness, communication, dosimetry, quality control and radiation protection were frequently commended by QUATRO. CONCLUSIONS: This analysis points to barriers to quality care such as insufficient staffing, education/training, equipment and lack of quality management. It highlights the correlation between the human resources availability and quality of care. It has also identified common action items for enhancing quality of radiotherapy programmes in the Region.

Breast cancer in elderly women: can radiotherapy be omitted?

It is tempting to spare elderly women the burden of adjuvant radiotherapy after breast cancer surgery, even if such a treatment would be justified in light of the available clinical evidence. The reason is that evidence-based radiotherapy derives from clinical trials that excluded elderly women, and that breast cancer is often believed to be more indolent at advanced ages. Unfortunately, the epidemiological evidence, and the few clinical trials recruiting patients over 65 or 70 year of age, all point to the need for postoperative irradiation in a similar set-up as in younger patients. So far, there is no evidence that a subgroup exists in which radiotherapy can be safely omitted. Therefore, the decision to treat or not to treat should be openly discussed with the patient, addressing risks and benefits of both attitudes. Only in frail patients, with an obviously limited life expectancy (months or at most a few years), can omission of radiotherapy be considered, as the burden of local recurrence is likely not to appear before the patient dies from an other cause.

Anatomical bases for the radiological delineation of lymph node areas. Upper limbs, chest and abdomen.

Cancer spreads locally through direct infiltration into soft tissues, or at distance by invading vascular structures, then migrating through the lymphatic or blood flow. Although cancer cells carried in the blood can end in virtually any corner of the body, lymphatic migration is usually stepwise, through successive nodal stops, which can temporarily delay further progression. In radiotherapy, irradiation of lymphatic paths relevant to the localisation of the primary has been common practice for decades. Similarly, excision of cancer is often completed by lymphatic dissection. Both in radiotherapy and in surgery, advanced knowledge of the lymphatic pathways relevant to any tumour location is an important information for treatment preparation and execution. This second part describes the lymphatics of the upper limb, of the thorax and of the upper abdomen. Providing anatomical bases for the radiological delineation of lymph nodes areas in the axilla, in the chest and in the abdomen, it also offers a simplified classification for labeling the mediastinal and intra-abdominal nodal levels, grouped in each location inside three major functional areas (called I, II and III) which are all divided into three sublevels (named a, b or c).

Anatomical bases for the radiological delineation of lymph node areas. Major collecting trunks, head and neck.

Cancer spreads locally through direct infiltration into soft tissues or at distance by invading vascular structures, then migrating through the lymphatic or blood flow. Although cancer cells carried in the blood can end in virtually any corner of the body, lymphatic migration is usually stepwise, through successive nodal stops, which can temporarily delay further progression. In radiotherapy, irradiation of lymphatic paths relevant to the localisation of the primary has been common practice for decades. Similarly, excision of cancer is often completed by lymphatic dissection. Both in radiotherapy and in surgery, advanced knowledge of the lymphatic pathways relevant to any tumor location is an important information for treatment preparation and execution. This first part describes the major collecting trunks of the lymphatic system and then the lymphatics of the head and neck providing anatomical bases for the radiological delineation of lymph node areas in the cervical region, it adds to the existing nomenclature of six nodal levels (I-VI), three new areas listed as parotid, buccal and external jugular levels.

A federal audit of the Belgian radiotherapy departments in breast cancer treatment.

BACKGROUND: The Belgian Federal College of Radiotherapy carried out an external audit of breast cancer patient documentation in the 26 Belgian radiotherapy centres. The objective was to assess compliance with the recommendations regarding minimal requirements for documentation of radiotherapy prescription and administration. All centres volunteered to take part in this audit. METHODS: Two experienced radiation oncologists site-visited the departments over a 6 month period (Sept. 2003-Feb. 2004), with a list of items to be verified, including details on the surgery, the pathological report, details on systemic treatments, details on the radiotherapy prescription (and consistency with therapeutic guidelines) and delay surgery/radiotherapy. FINDINGS: Three hundred and eighty-nine patients files were reviewed, for a total of 399 breast cancers (10 patients with bilateral cancer). Mean age was 57.8 y (range 29-96). Breast conservative surgery (BCS) was used in 71%; radical mastectomy in 29%. A complete pathological report was present in all files but 2 (99.5% conformity). 5.2% were treated for DCIS, 61.6% for pT1, 28.2% for pT2 and 5% for pT3-4. Data regarding resection margins were specified to be free in 76.2%, tangential in 12% (within 2 mm) and positive for DCIS in 3.8% or invasive cancer in 1.5% (no information, on margins in 6.5%). The pT stage was always specified, and consistent with the macroscopic and microscopic findings. Hormonal receptors were routinely assessed (94.7%), as well as Her2neu (87.4%). Axillary surgery was carried out in 92%, either by sentinel node biopsy or by complete clearance, in which case the median number of nodes analysed was 12 for all centres together (7-17). All radiotherapy prescriptions were in line with evidence-based standards of therapy (i.e., irradiation of breast after BCS or after mamectomy (in case of pN+), but one. The mean delay between surgery and radiotherapy was 5.5 weeks (SD 11 days). CONCLUSION: There was a high degree of conformity of the various centres with the minimal requirements for documentation of radiotherapy prescription and administration of the Federal College of Radiotherapy. In addition, the quality of surgery (assessed by margin clearance) and of pathological reports was excellent, whatever the institution of origin (teaching vs. non-teaching, private vs. public). Belgian patients referred for radiotherapy are treated with great care. Prescriptions are based on pathological evidence, gathered through appropriate surgery. All indications were evidence-based; there was no overuse of radiotherapy in early breast cancer treatment.

Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911).

BACKGROUND: Local failure after prostatectomy can arise in patients with cancer extending beyond the capsule. We did a randomised controlled trial to compare radical prostatectomy followed by immediate external irradiation with prostatectomy alone for patients with positive surgical margin or pT3 prostate cancer. METHODS: After undergoing radical retropubic prostatectomy, 503 patients were randomly assigned to a wait-and-see policy, and 502 to immediate postoperative radiotherapy (60 Gy conventional irradiation delivered over 6 weeks). Eligible patients had pN0M0 tumours and one or more pathological risk factors: capsule perforation, positive surgical margins, invasion of seminal vesicles. Our revised primary endpoint was biochemical progression-free survival. Analysis was by intention to treat. FINDINGS: The median age was 65 years (IQR 61-69). After a median follow-up of 5 years, biochemical progression-free survival was significantly improved in the irradiated group (74.0%, 98% CI 68.7-79.3 vs 52.6%, 46.6-58.5; p<0.0001). Clinical progression-free survival was also significantly improved (p=0.0009). The cumulative rate of locoregional failure was significantly lower in the irradiated group (p<0.0001). Grade 2 or 3 late effects were significantly more frequent in the postoperative irradiation group (p=0.0005), but severe toxic toxicity (grade 3 or higher) were rare, with a 5-year rate of 2.6% in the wait-and-see group and 4.2% in the postoperative irradiation group (p=0.0726). INTERPRETATION: Immediate external irradiation after radical prostatectomy improves biochemical progression-free survival and local control in patients with positive surgical margins or pT3 prostate cancer who are at high risk of progression. Further follow-up is needed to assess the effect on overall survival.

Risk, society and system failure.

Modern societies are risk societies. Together with the formidable development of complex technologies (chemical industry, energy production, mass transportation, etc), new hazards have emerged. Sharing danger is the hallmark of modernity, as large industrial accidents can now have countrywide, or even, worldwide consequences. The Chernobyl explosion for example, has smeared large European surfaces with radioactive materials, across borders and nations, without any regard for who was responsible and who was the victim. Complex technologies should therefore be managed with great foresightness, particularly focusing on preventive management. A sound understanding of the (minor) role of human errors of operators and the (major) role of process design is a pre-requisite for appropriate management. This also applies to the complex business of radiotherapy, as the same organisational principles apply than in the heavy industry: restrict the role of operators, expect their mistakes, design in a mistake-proof way, accept the burden of preventive maintenances, supervise maintenance carefully and, above all, invest in safety.

Do refined consensus guidelines improve the uniformity of clinical target volume delineation for rectal cancer? Results of a national review project.

In a previous national central review project, 74% of the rectal cancer clinical target volumes (CTVs) needed a modification. In a follow-up initiative, we evaluated whether the use of refined international consensus guidelines improves the uniformity of CTV delineation in clinical practice.