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PurposeOral anticancer therapies have an important place in the therapeutic arsenal, but factors influencing adherence to oral treatment are poorly documented in oncology. The objective of this study was to assess the impact of anxio-depressive symptoms and cognitive functioning on oral medication adherence.MethodsThis prospective study included cancer patients initiating a first oral therapy. Before initiation of treatment, an assessment of depression, anxiety, and cognition was performed. Using self-report questionnaires, we collected information on socio-demographic conditions and the non-adherence at 1 (M1) and 3 months (M3) after the beginning of treatment.ResultsAmong 129 patients enrolled, median age was 70 years and 81% of patients were treated for metastatic cancer. Before initiating treatment, 16% and 8% of patients presented respectively depression and anxiety symptoms. Global cognitive impairment was observed in 51% of patients. Ten percent of the patients were non-adherent at M1 and 13% at M3. Depression was strongly associated with non-adherence at M1 (P = 0.046) and M3 (P = 0.014), but not anxiety. Non-adherence was associated with lower working memory (P = 0.037) and digit memory (P = 0.018) at M1 and short-term memory (P = 0.04) at M3. Patients with more than eight co-medications were more often non-adherents (P = 0.055).ConclusionsNon-adherence to oral anticancer therapies was mainly associated to depression. Focusing on depressive symptoms before initiation of oral anticancer therapy could help to identify patient profiles more likely to fail self-management. Working memory, digit memory, and short-term memory also seem to play a role in non-adherence. Further studies should include a more specific population, especially according to age.

Background: The aim of the study was to analyse efficacy, safety, and health-related quality of life (HRQoL) for sorafenib treatment in patients with metastatic uveal melanoma. Methods: A multicentre, single-arm phase II trial was conducted. The primary objective was to determine the non-progression rate (RECIST) at 24 weeks for patients receiving sorafenib at a dose of 800 mg per day. Secondary endpoints included progression-free survival (PFS), overall survival (OS), toxicity, and HRQoL. Results: Thirty-two patients were included. Ten patients showed non-progression at 24 weeks (31.2%) without objective tumour responses. The estimated 24-week PFS was 31.2% (95% CI: 14.8%–47.6%) and the estimated 24-week OS was 62.5% (95% CI: 45.4%–79.6%). Ten patients (34.3%) had at least one grade 3 or 4 adverse reaction and 12 patients (41.4%) required dose modifications due to toxicity. At 24 weeks, no patient had an improvement in global HRQoL and 87.5% experienced a permanent increase in physical fatigue. Conclusions: Sorafenib demonstrated non-progression at 24 weeks in 31.2% of patients. However, 41.4% of patients required dose modifications due to toxicity and no improvement in HRQoL was demonstrated.

Résumé Les soins de support (SS) [médicamenteux ou non médicamenteux] ont une place de plus en plus importante dans l’arsenal de prise en charge holistique des patients ayant un cancer. À ce titre, l’évaluation de l’efficacité de ces interventions médicamenteuses ou non doit reposer sur des études cliniques développées selon une méthodologie optimale à l’instar des traitements dits curatifs. L’un des freins au développement de SS non médicamenteux consiste en l’évaluation méthodologique de leur efficacité, mais de façon similaire à ce que l’on observe dans le processus du développement du médicament: de la phase I à la phase III. La question de l’évaluation conjointe des SS et des traitements potentiellement curatifs est également une approche méthodologique à investiguer afin d’étudier les interactions et proposer, si besoin, une prise en charge adaptée propre à optimiser l’efficacité des traitements. À ce jour, il n’existe pas de guidelines spécifiques en cancérologie pour l’évaluation des SS. La complexité de la méthodologie requise pour mener à bien des études d’évaluation nécessite une réflexion et l’élaboration d’un cadre structuré de type CONSORT stands for Consolidated Standards of Reporting Trials ainsi qu’une collaboration multidisciplinaire impliquant également les patients.

Short and easy questionnaires have been developed to assess the health-related quality of life (HRQoL) in patients with chronic obstructive pulmonary disease (COPD), such as the Maugeri Foundation Respiratory Failure Questionnaire (MRF-28) and the COPD-specific HRQoL Questionnaire (VQ11). Both are valid, reliable, and sensitive, but their minimal clinically important differences (MCID) are unknown. Consequently, this study aimed to confirm the convergent validities of the MRF-28 and VQ11 and establish their MCID. A retrospective design was used to evaluate the effect of individual home-based pulmonary rehabilitation (PR) in 400 COPD patients. Exercise tolerance, anxiety and depression based on the Hospital Anxiety and Depression Scale (HADS), and HRQoL using three questionnaires (MRF-28, VQ11, and the Visual Simplified Respiratory Questionnaire: VSRQ) were assessed before and after an individualized home-based PR program (5 sessions of 30-45 mins/week for 8 weeks, including a weekly session supervised by a team member). PR improved all measured variables ( < 0.0001). The correlations were significant ( < 0.0001) between VSRQ and MRF-28 (r = -0.685 at baseline and r = -0.686 after the PR program), and between VSRQ and VQ11 (r = -0.691 at baseline and r = -0.753 after the PR program). Moreover, changes in score (delta between after and before PR program) of VSRQ were also significantly correlated ( < 0.0001) to changes in score of MRF-28 (r = -0.372) and VQ11 (r = -0.423). Last, we calculated MCID of -5.2 and -2.0 units for MRF-28 and VQ11, respectively. The MRF-28 and VQ11 can be used in routine practice to evaluate the effects of PR on the HRQoL of COPD patients, with MCID of -5.2 and -2.0, respectively.

Patient education constitutes a relevant strategy to improve pain management. In the field of therapeutic patient education (TPE), we aimed 1) to assess pain impact in cancer patients, 2) to identify patients' educative needs in pain management, and 3) to refine research criteria for its future evaluation. Pain intensity, relief and interference were assessed in 75 cancer patients with unbalanced background pain. Self-assessment questionnaire evaluated i) patients' pain management and ii) their knowledge and needs in TPE. Most patients experienced pain for more than 6 months and 41.6% reported adequate pain relief. Understanding pain and pain management were major patients' preferences (>58%). Most patients declared they knew their pain treatments, but fewer than half of them were able to name them. However, education concerning pain treatment was considered as essential in <30% of patients. Almost all patients (97.1%) stated pain education as beneficial, with a preference for individualized sessions (41.2%). In addition, the assessment criteria for its future evaluation were refined. Targeted population mainly concerned patients with persistent pain. Only half of patients reported pain relief despite antalgics. Patient education was declared as beneficial for almost all participants. Tailoring a pain TPE on patients' needs has the potential to help them to optimally manage their pain daily.

Purpose Acute radiodermatitis (ARD) is a frequent side effect of radiotherapy, a therapeutic option for head and neck squamous cell carcinoma (HNSCC). It is responsible for pain, quality of life (QoL) impairment, and increased risk of treatment discontinuation, which may compromise the prognosis for patients. Local therapies to prevent or alleviate ARD have been proposed without providing any high level of evidence to establish recommendations. Methods We implemented a prospective multicenter randomized study on patients with HNSCC treated with definitive radiotherapy to assess the impact on ear, nose, and throat (ENT) pain of the application of a hydrogel-based skin dressing (HydroTac®) compared with the application of hyaluronic acid (Ialuset®) during radiotherapy. Results Out of 130 enrolled patients, 48 patients per group were assessable for the main endpoint. No difference between groups was found: a worsening of ENT pain of 3 points or more on a visual analog scale from the initiation to 1 month after the end of the radiotherapy was observed for 8 patients (16.7%) who received HydroTac® compared to 13 patients (27%) who received Ialuset® ( p  = 0.342). The proportion of patients who experienced ARD and grades of ARD (CTCAE v4.0 criteria) were similar between groups. Patient compliance with radiodermatitis treatment was poor, with 56.1% of patients in the HydroTac® group having their treatment temporarily stopped. Conclusion The application of a hydrogel dressing to prevent ARD during radiotherapy for HNSCC patients has failed to demonstrate a benefit. These results may be limited by the difficulties of applying the dressing.

Background Despite numerous guidelines, nearly one of two patients with cancer pain remains undertreated, thereby affecting their quality of life. Active patient involvement through Therapeutic Patient Education (TPE) is considered as a relevant strategy to overcoming hurdles in pain management. The aim of the EFFADOL study is to assess the effectiveness of a TPE program in improving cancer pain management. Methods/design The EFFADOL study is a stepped-wedge randomised controlled trial. A total of 260 cancer patients with unbalanced background pain will be randomised over the institutional level, i.e. stepped-wedge cluster design. Six clusters will be formed, one at the regional level of “Basse-Normandie” for patients receiving the educational approach by health providers already trained to TPE. Then, five additional centers will be gradually included at the national level, making it possible to compare the “conventional” management of pain (before medical staff training to TPE) with the educational approach (after being trained). The main study parameter is pain interference on daily life assessed with the self-administrated and validated Brief Pain Inventory questionnaire. Secondary objectives comprised the evaluation of patients’ adherence to pain education program, the description of pain intensity, pain relief, analgesic adherence and pain emotional impact. Educational dimension of the program will be evaluated through the patients’ acquisition of knowledge and skills about their pain and treatment as well as their self-efficacy to participate actively in pain management. The patient’s feeling of pain changes will be measured. Finally, the satisfaction of participants and educators will be reported. We hypothetise active involvement of patients in TPE will lead to an improved pain management compared to standard care. Discussion Analyzing the impact of a TPE program in cancer pain patients will improve their pain management and quality of life. We expect that the dissemination of our project educational approach through the French territory will be accompanied by long term change in clinical practices with mutual benefit to patients and caregiver-educators. Trial registration NCT03297723 , registered: 09/28/2017. Protocol version: Version n°1.1 dated from 2016/09/08.

The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology. Total laryngectomy is a mutilating surgical procedure having a major impact on the patient’s life, due to its physical and functional sequelae. Its psychosocial consequences are also important and alter the quality of life of patients and their close relations. Currently, care for laryngectomised patients consists essentially in informing and educating them on some technical procedures during hospital admission. The intervention of a speech therapist, often serves as the link between the patient and the hospital care team. These healthcare modalities often insufficiently account for the social, environmental and personal factors that interact in health-related problems. This report presents the therapeutic education programme protocol “PETAL” for laryngectomised patients and their close relations to improve their quality of life. The trial will be conducted over three phases: (1) the “pilot” phase aims at developing knowledge on the consequences of laryngectomy on the quality of life of patients and their close relations and developed a pluridisciplinary therapeutic education program, (2) the prospective intervention “replication” phase aims at evaluating the programme’s transferability in three centres and (3) the cluster-randomised multicentric comparative intervention phase, will assess the benefits of the developed programme. Phase I identified nine themes of workshops related to therapeutic education, training and coordination of care. The developed programme should reinforce town-hospital links to improve help, follow-up and support for patients and their close relations.