Supportive care organisation in France: an in depth study by the French speaking association for supportive care in cancer (AFSOS).

BACKGROUND: Supportive care in cancer (SCC) was further enhanced in the Second National Cancer Act decreed in December 2009. The aim of our study was to assess current SCC efficacy. PATIENTS AND METHODS: The French speaking association for supportive care in cancer (AFSOS) conducted an observational study to evaluate practices, organisations and information given to patients. A specific 32 point questionnaire was sent to 1621 French physicians (MDs) caring for cancer patients. RESULTS: Three different organisations were evaluated: the individual MDs, the transversal team and its particular structure specialised in global patient care specifically developed at comprehensive cancer centres - CCC. During their disease, 68% of patients received SCC, which was more available during the palliative period (90%) than at the diagnosis (44%). Our results found that 71% of cancer departments had a specific interdisciplinary cross-team to provide SCC, particularly in CCC (62%; p=0.01) while 37% had specific inpatient units. A specific organisation dedicated to home care was greater in CCC than in public or private centres (69%, 45%, 20% respectively; p=0.01). Adverse event information was performed more by an oncologist than other specialists (p=0.01). CONCLUSION: Our results suggest that the specific SCC organisation could be a useful management tool to improve supportive care for cancer patients.

[Practice guidelines of the use of bisphosphonates in solid tumours with bone metastases and in multiple myeloma]. / Guide de recommandations d'utilisation des bisphosphonates dans les lésions osseuses malignes des tumeurs solides et du myélome multiple.

Bisphosphonates are indicated for the treatment of bone lesions in patients with solid tumours or multiple myeloma. Bisphosphonates have proven their effectiveness in reducing the number of bone complications (hypercalcemia, pain, disease-related fractures, spinal cord compression) and delaying their occurrence in patients with bone tumours; they have also been shown to reduce the need for bone surgery and palliative or pain-relieving radiotherapy in these patients. International recommendations for the treatment of bone lesions related to malignant solid tumours and multiple myeloma have been established. We have elaborated clinical practice guidelines on the use of bisphosphonates to assist treatment decision-making in bone oncology. The guide contains decision trees and tables with information to guide pre-treatment evaluation and patient follow-up, as well as indications and conditions of use of bisphosphonates. In 2007, the regional cancer network of Rhône-Alpes, ONCORA, formed a working group (GIP ONCORA) to elaborate the guideline. The final version was then discussed and adopted at a plenary session in July 2009, during a collaborative workshop on supportive care recommendations organized by ONCORA and the regional cancer network of Lorraine.

[Communication around the cancer diagnosis: patient satisfaction and process quality in French Comprehensive Cancer Centers]. / L'annonce de la maladie: satisfaction des patients et démarche qualité dans les Centres de lutte contre le cancer.

BACKGROUND: Our survey was designed to evaluate the satisfaction of patients treated in French Comprehensive Cancer Centers (CCC) with the communication of their cancer diagnosis and treatments, and to use the data obtained to optimize current practices. METHODS: One thousand six hundred (and) six CCC patients participated in a telephone survey. Eligible patients were attending a visit to a CCC for initial care of their disease (i.e. not a relapse). The questionnaire assessed patient satisfaction with the communication of diagnosis and treatment options, globally and with respect to potential individual determinants of satisfaction. FINDINGS: Complete satisfaction was recorded by 77% of patients with their overall care at the CCC and by 63% of patients with the initial consultation when diagnosis was communicated and/or treatment discussed. Overall, 90% of patients were satisfied with the level of their implication in discussions about their care. A model established by Partial Least Squares (PLS) regression analysis, identified four major areas and their relative contributions to patient satisfaction: patient's relationship with their physician (64%); nature of the information provided (14%; influenced strongly by information on type, duration and practical organization of planned treatment); agenda/diary issues (14%; influenced strongly by waiting room delay); accompaniment (8%; influenced equally by support from close family and patient association/self-help groups). INTERPRETATION: Overall satisfaction was high in cancer patients attending visits for initial care in French CCC. The model we devised to understand components of satisfaction could serve as a benchmark for evolution of outcomes in this field.

[Improvement of quality of practices for the preparation of cytotoxic drugs: results of a "before-after" study]. / Optimisation des procédures de manipulation des chimiothérapies anticancéreuses : impact des contrôles de contamination environnementaux.

Despite the publication of guidelines for handling antineoplastic agents, measurable amounts of these drugs are still found at various hospital sites. In this context, the French cancer network ONCORA supported the present study to assess the impact of environmental contamination controls on the quality of practices during the preparation of cytotoxic drugs. The first part of the study was conducted at five voluntary hospitals. A total of 65 wipe samples of objects and surfaces were taken in the drug preparation rooms and analyzed for the presence of 5-fluorouracil (5-FU). Measurable amounts of 5-FU were detected in 21 samples (32%). Many surfaces within Biological Safety Cabinets and isolators were found contaminated (36%). The worse results were obtained on gloves and on the outside of infusion bags. The same method was applied during the second part of the study, conducted six months after the end of the first audit. Global contamination was reduced to 17%. This study shows that appropriate handling helps decrease the number of samples contaminated, making it possible to recommend these controls for evaluating and improving the quality of practices. Since 2007, the network's laboratory has extended its activities to all French hospitals interested in this quality assurance programme.

[Best practice guide for radiation therapy of non-small cell bronchial cancers]. / Guide de bonne pratique pour la radiothérapie thoracique exclusive ou postopératoire des carcinomes non à petites cellules.

The objective was the drafting of a practical document intended for radiotherapists and radiophysicists, describing the technique of irradiation of a non small cell bronchial cancer. The good practices concern the care of patients affected by bronchial cancer localized in the thorax and inoperable or patients who must undergo postoperative irradiation. The document has been developed according to a methodology aiming to join the current scientific data from an analysis of the literature on the subject and the assessment of radiotherapists, radiophysicists, lung specialists and methodologists from Rhône-Alpes area. From the stages necessary for the good progress of a radiotherapy, the writers of this document proposed common definitions concerning the centering and the location of the zone to be treated, the calculation of the dose distribution, the preparation of the patient for the treatment, the treatment and the surveillance during the treatment. The recommendations of this guide took into account the peculiarities bound to the nature of the treated region and more particularly the lung heterogeneity, respiratory movements and the radiosensibility of healthy lung tissue. Even if the technical aspect of the radiotherapy was particularly developed, the interest accorded to patient information takes on all its importance for a therapeutic coverage of quality. The authors of the document wished that this Guide of Good Practices, which will be regularly updated, helps the radiotherapists and allows them to harmonize their practices.

[Development of health care networks: ethical and political contexts]. / Le développement des réseaux de soins et de santé: contexte éthique et politique.

The operation of our health care system is in the midst of a major crisis. There is a significantly unacceptable level of health inequities and access to care, high premature mortality rates, lack of a coherent health policy, a weakness in the professional demographic projections, increasing financial deficits, quasi-revolt of professionals, complete disregard for the law (Parliament's vote on the National Insurance's budget)--these are just a few of the symptoms of chaos which have embedded themselves right before our very eyes. This article aims to offer a glimmer of light on this gloomy horizon. It is the first outcome of a new working group which was originally referred to as "les Vignerons d'Uzès", a title which could be seen as lacking substance and has therefore become "The Transdisciplinary Working Group on the Organisation of Health and Care". The group's purpose and objective is to reflect upon the values, practices, regulations, evaluation and what is at stake in the context of our health care system.

A controlled "before-after" study: impact of a clinical guidelines programme and regional cancer network organization on medical practice.

A regional cancer network has been set up in the Rhône-Alpes region in France. The aim of the project is to improve the quality of care and to rationalize prescriptions in the network. In this network, we assessed the impact of the implementation of a clinical practice guidelines project by assessing the conformity of practice with the guidelines and comparing this with the conformity in an external matched control group from another French region without a regional cancer network. Four hospitals (private and public) accepted to assess the impact of the clinical practice guidelines on the management of breast and colon cancer in the experimental group and three hospitals (private and public) in the control group. In 1994 and 1996, women with non-metastatic breast cancer (282 and 346 patients in the experimental group, 194 and 172 patients in the control group, respectively) and all new patients with colon cancer (95 and 94 patients in the experimental group, and 89 and 118 patients in the control group, respectively) were selected. A controlled "before-after" study, using institutional medical records of patients with breast and colon cancer. The medical decisions concerning the patients were analyzed to assess their compliance with the clinical practice guidelines. When medical decisions were judged to be non-compliant, we verified if they were based on scientific evidence in a published article, if they were not, the medical decision was classified as having "no convincing supporting scientific evidence". The compliance rates were significantly higher in 1996 than in 1994 in the experimental group; 36% (126 out of 346) vs 12% (34 out of 282) and 46% (56 out of 123) vs 14% (14 out of 103) (P<0.001) for breast and colon cancer, respectively. Whereas, in the control group the compliance rates were the same for the two periods; 7% (12 out of 173) vs 6% (12 out of 194) (P=0.46) and 39% (49 out of 126) vs 32% (31 out of 96), P=0.19. In the experimental group, in 1994, 101 of the 282 medical decisions (36%) and 27 of the 103 (26%) for breast and colon cancer, respectively, were classified as having "no convincing supporting scientific evidence" compare with 72 out of 346 in 1996 (21%) for breast cancer, and 21 of the 123 (17%) for colon cancer P<0.05. Whereas in the control group these results were 106 out of 194 in 1994 (55%) and 90 out of 172 in 1996 (52%), P=0.65 for breast cancer and 28 out of 96 in 1994 (29%) and 30 out of 126 in 1996 (24%), P=0.36 for colon cancer. The development and implementation strategy of the clinical practice guidelines programme for cancer management results in significant changes in medical practice in our cancer network. These results would suggest that introducing guidelines with specific implementation strategy might also increase the compliance rate with the guideline and "evidence-based medicine".

[Standards, options, and recommendations for the radiotherapy of patients with endometrial cancer. FNCLCC (National Federation of Cancer Campaign Centers) and CRLCC (Regional Cancer Campaign Centers)]. / Standards, Options et Recommandations pour la radiothérapie des patientes atteintes de cancer de l'endomètre.

OBJECTIVES: To develop clinical practice guidelines according to the definitions of the Standards, Options and Recommendations project for the radiotherapy of carcinoma of the endometrium. METHODS: Data were identified by searching Medline and personal reference lists of members of the expert groups. Once the guidelines were defined, the document was submitted for review to independent reviewers, and to the medical committees of the 20 French Cancer Centres. RESULTS: The main recommendations for the radiotherapy of carcinoma of the endometrium are: 1) For grade 1 and 2 stage IA tumours, follow-up alone is standard as additional treatment. For grade 1 and 2 stage IB tumours, vaginal brachytherapy or follow-up alone are options. For grade 3, stage IB tumours and stage IC disease, there are two treatment options: external pelvic radiotherapy with a brachytherapy boost or vaginal brachytherapy. 2) Treatment for stage II disease can be preoperative when stage II disease has been suggested by a positive endometrial curettage. Postoperative vaginal brachytherapy is given for stage IIA tumours if the penetration of the myometrium is less than 50% or if the tumour is grade 1 or 2. In the case of deep penetration, or higher grade disease, or for stage IIB external radiotherapy with brachytherapy boosting must be undertaken routinely. 3) After surgery, for stage IIIA disease, either external pelvic radiotherapy or abdomino-pelvic radiotherapy is indicated, along with medical treatment in certain patients. For stage IIIB tumours, postoperative external radiotherapy with brachytherapy (if possible) should be undertaken. For stage IIIC tumours, standard treatment is external (pelvic or pelvic and para-aortic) radiotherapy followed or not by a brachytherapy boost. In case of extrauterine sites involved abdomino-pelvic irradiation is recommended. 4) Standard treatment for inoperable stage I and II disease is external radiotherapy and brachytherapy. For patients with inoperable stage III or IV disease, treatment is often symptomatic, combining external radiotherapy and medical treatment.

[Standards, Options and Recommendations for the surgical management of carcinoma of the endometrium]. / Standards, Options et Recommandations pour la prise en charge chirurgicale des patientes atteintes de cancer de l'endomètre.

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of the French Cancer Centres (FNCLCC), the 20 French Cancer Centres and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines according to the definitions of the Standards, Options and Recommendations project for the surgical management of carcinoma of the endometrium. METHODS: Data were identified by searching Medline and personal reference lists of members of the expert groups. Once the guidelines were defined, the document was submitted for review to independent reviewers, and to the medical committees of the 20 French Cancer Centres. RESULTS: The main recommendations for the surgical management of carcinoma of the endometrium are: 1) where-ever possible, surgery is the primary treatment of both localised and advanced disease; 2) surgery is performed according to the stage of the cancer and the status of the patient; 3) surgery for stages I and II disease entails total abdominal hysterectomy and bilateral salpingo-oophorectomy. A modified radical hysterectomy is undertaken in cases of macroscopic cervical involvement. An omenectomy is recommended for serous papillary types. Pelvic lymphadenectomy for the purposes of precise staging is undertaken if the patient is of good performance status and without bad pronostic factors. Para-aortic lymphadenectomy can be undertaken to determine involvement of para-aortic nodes; 4) surgery for stages III and IV: radical surgery must be undertaken if at all possible with additional treatment as indicated. In the case of advanced disease, debulking surgery is indicated.

[Standards, options, and recommendations for radiotherapy of kidney cancer]. / Standards, Options et Recommandations pour la radiothérapie du cancer du rein.

CONTEXT: The "Standards, Options and Recommendations" (SOR), initiated in 1993, is a collaborative project between the Federation of the French Cancer Centres (FNCLCC), the 20 French Cancer Centres and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary expert group, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines for the diagnosis, management and treatment of patients with renal cancer. This review is part of previously published complete guidelines and focuses on the place of radiotherapy in this disease. METHODS: The data was identified by literature search using Medline (up to June 1999) and personal reference lists. The main endpoints considered were survival, risk factors for late effects of radiotherapy, safety and quality of life. RESULTS: The key recommendations are: 1) In localised renal cancer, adjuvant radiotherapy has a limited role: it is not indicated for T1 and T2 tumours and there is no proof of a survival benefit for T3 N1-N2 tumours. Postoperative radiotherapy can be considered in young patients without risk factors for the development of post-radiotherapy complications and without loco-regional invasion (renal capsule, renal pelvis, vena cava, regional lymph nodes); 2) For metastatic tumours, the multidisciplinary team must decide whether palliative radiotherapy is appropriate after consideration of the prognostic factors. An isolated metastasis can be treated by radiosurgery and stereotaxic radiosurgery may be of benefit in the case of one or two cerebral metastasis. The optimal dose for palliative treatment is not known. Radiotherapy followed by immunotherapy can also be considered if the patient has no contraindication to such treatments.

[Standards, Options and Recommendations (SOR) for good practices in dentistry for head and neck cancer patients. Federation of the French Cancer Centres (FNCLCC)]. / Standards, Options et Recommandations pour une bonne pratique odontologiques en cancérologie.

CONTEXT: The Standards, Options and Recommendations (SOR), initiated in 1993, is a collaborative project between the Federation of the French Cancer Centres (FNCLCC), the 20 French Cancer Centres and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcomes for cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary experts group, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines for dentistry and oral hygiene in head and neck cancer patients. METHODS: Data have been identified by literature search using Medline (up to January 1999) and personal reference lists. The main end points considered were risk factors for treatment related late effects, safety and quality of life, efficacy of dental preventative measures and treatment. Once the guidelines were defined, the document was submitted to reviewers for peer review and to the medical committees of the 20 French Cancer Centres for review and agreement. RESULTS: The key recommendations are: 1) before receiving radiotherapy, surgery and chemotherapy for head and neck cancer, patients must benefit from a multidisciplinary approach including dental evaluation; 2) the patients must be informed of precautions and educated about oral hygiene; 3) after radiotherapy, the most important dental late effect to prevent is radionecrosis, in accordance with the oral and dental state, the dentist may propose conservation or extraction of teeth, fluoridation and regular follow-up; 4) during chemotherapy, the principal complications are mucositis, haemorrhage and infection risk; 5) after surgery, the dentist may propose prosthetic measures with the aim functional, aesthetic and psychological benefit; 6) in the particular case of children, treatment and prevention are the same as for adults but the follow-up is specific because of the dental development.

[Standards, options and recommendations (SOR) for diagnosis, treatment and follow-up of osteosarcoma. Groupe de travail SOR]. / Standard, Options et recommandations (SOR) pour le diagnostic, le traitement et la surveillance de l'ostéosarcome.

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of the French Cancer Centres (FNCLCC), the 20 French Cancer Centres and specialists from French Public Universities, General Hospitals and Private Clinics. For pediatric issues, this project is a collaboration between the FNCLCC and the French Society of Pediatric Oncology (SFOP). The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines according to the definitions of Standards, Options and Recommendations for the clinical care of osteosarcoma in children and adult. METHODS: Data have been identified by literature search using Medline (1985-december 1998) and the expert groups personal reference lists. The main criteria considered were incidence, risk factors, prognostic factors and efficacy of treatment. Once the guidelines were defined, the document was submitted for review to 27 national and international independent reviewers, and to the medical committees of the 20 French Cancer Centres and, in particular, the 4 which have particular expertise in pediatric cancer management. RESULTS: The main recommendations for osteosarcoma management are that: 1) the clinical diagnosis is based on appropriate clinical and radiological findings; 2) the final diagnosis is pathological and the biopsy should be performed by the surgeon who will subsequently perform the definitive surgery; 3) surgical biopsy must be of adequate size and performed by an experienced surgeon; 4) the therapeutic strategy for osteosarcoma is based on surgery with neoadjuvant and adjuvant chemotherapy given in experienced centres. Inclusion of high dose methotrexate is recommended for children, and the dose of methotrexate must be adapted for adults. Inclusion of children in SFOP protocols and adults in EORTC and FNCLCC clinical trials is recommended; 5) treatment of metastatic osteosarcoma is based on chemotherapy and surgery to lung metastases which may be curative. Amputation is rarely appropriate. Inclusion of children in SFOP and of adult in EORTC and FNCLCC clinical trials for metastatic osteosarcoma is recommended; 6) at the present time, there are no clear data on which to base guidelines for timing and duration of follow-up studies in this condition.

[Standards, options and recommendations (SOR) for clinical care of rhabdomyosarcoma (RMS) and other soft tissue sarcoma in children. Federation of the French Cancer Centers. French Society of Pediatric Oncology]. / Standards, options et recommandations pour la prise en charge des patients atteints de rhabdomyosarcome et autres tumeurs mésenchymateuses malignes de l'enfant.

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of the French Cancer Centres (FNCLCC), the 20 French Cancer Centres and specialists from French Public Universities, General Hospitals and Private Clinics. For pediatric issues, this project is a collaboration between the FNCLCC and the French Society of Pediatric Oncology (SFOP). The main objective is the development of clinical practice guidelines to improve the quality of health care and outcomes for cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop a clinical practice guideline according to the definitions of Standards, Options and Recommendations for the clinical care of rhabdomyosarcoma and other soft tissue sarcoma in children and adolescents. METHODS: Data have been identified by literature search using Medline (1985-may 1997) and experts group personal references lists. The main criteria considered were incidence, risk factors, prognostic factors and efficacy of cancer treatment. Once the guideline was defined, the document was submitted for review to 14 national and international independent reviewers, and to the medical committees of the 20 French Cancer Centres and, in particular the 4 which have expertise in pediatric cancer management, for agreement. RESULTS: The main recommendations for rhabdomyosarcoma management are: 1/ diagnosis is based on appropriate clinical and radiological findings; 2/ pathological and immunohistochemical studies are essential to confirm the diagnosis; 3/ surgery must be performed by an experienced surgeon. Surgery and radiotherapy must be as conservative as possible; 4/ therapeutic strategies for rhabdomyosarcoma depend on location and extends and are based on chemotherapy, surgery and radiotherapy. Inclusion of patients in SFOP, SIOP and IRS clinical trials is recommended; 5/ treatment of metastatic rhabdomyosarcoma is based on intensive chemotherapy, and surgery with or without radiotherapy; 6/ the management of non-rhabdomyosarcoma is based on the likelihood of sensitivity to chemotherapy; 7/ at the present time, there are no clear data on which to base guidelines for timing and duration of follow-up studies in these conditions.

Impact of a clinical guidelines program for breast and colon cancer in a French cancer center.

CONTEXT: Between 1993 and 1994, the 80 physicians in the French comprehensive cancer center, Léon Bérard, developed and implemented a Clinical Practice Guidelines (CPGs) project based on an analysis of the literature and a consensus of intrainstitutional experts. OBJECTIVE: The aims of this project are to assist community-based oncologists in their decision making and to minimize inappropriate variation in practices. A study was designed to assess the impact of CPGs on management of breast and colon cancer. DESIGN: A "before-after" study, using institutional computerized records of patients with breast or colon cancer. SETTING: Records for 100 women with localized breast cancer were randomly selected from those available in 1993 and 1995, and those for all patients newly referred with colon cancer in 1993 and 1995 (77 and 81 patients, respectively). Medical decisions on these records were analyzed to assess their compliance with the CPGs. (A systematic search of the literature was performed to determine the scientific evidence for noncompliant decisions.) RESULTS: Of 375 available medical decisions, 350 were assessable. The compliance rate with CPGs for breast cancer was significantly higher in 1995 compared with 1993, 54% (54/99; 95% confidence interval [CI], 44%-64%) vs 19% (18/95; 95% CI, 11%-27%) (P<.001). The compliance rate for colon cancer was also significantly higher in 1995 than in 1993, 70% (62/88; 95% CI, 60%-80%) vs 50% (34/ 68; 95% CI, 38%-62%) (P=.009). In 1993, 42% (40/95; 95% CI, 32%-52%) of medical decisions for breast cancer and in 1995, 68% (67/99; 95% CI, 59%-77%) conformed with the CPGs or were judged to be based on "scientific evidence." In 1993, 71% (48/68; 95% CI, 60%-81%) of medical decisions for colon cancer, and in 1995 81% (71/88; 95% CI, 73%-89%) conformed with the CPGs or were judged to be based on scientific evidence. CONCLUSIONS: Compliance rates were significantly higher in 1995 for both cancers. The development and implementation of CPGs for cancer management seem to result in significant changes in medical practice, although a causal relationship between changes and CPGs is not demonstrated in this study.