Evaluation of efficacy and efficiency of a pragmatic intervention by a social worker to support informal caregivers of elderly patients (The ICE Study): study protocol for a randomized controlled trial.

BACKGROUND: Medical progress and the lifestyle modification have prolonged life expectancy, despite the development of chronic diseases. Support and care for older subjects are often provided by a network of informal caregivers composed of family, friends and neighbors, who are essential in helping older persons to continue living at home. It has been shown that the extent and diversity of informal tasks may jeopardize the physical, mental and social wellbeing of caregivers. METHODS/DESIGN: The aim of the Informal Carers of Elderly cohort is to define, through a longitudinal study, profiles of caregivers of older patients with a diagnosis of one of the following diseases: cancer (breast, prostate, colorectal), neurodegenerative diseases (Parkinson's disease, Alzheimer's disease and similar diseases), neurovascular diseases (stroke), sensory diseases (age-related macular degeneration (AMD)) and heart disease (heart failure). Patients must be at least 60 years old and living in the region of Burgundy-Franche-Comte (France). By following the different phases of the caregiving relationship from the announcement of the diagnosis, it will be possible to assess the quality of life of caregivers, coping strategies, levels of anxiety and depression, social support and the extent of their burden. We will also evaluate the efficacy and efficiency of the implementation of a pragmatic intervention by a social worker to help informal caregivers, through a randomized interventional trial nested in the cohort. Qualitative approaches aimed at studying the caregiver/patient relationship, and situations leading to breakdown of the caregiver relationship will be also undertaken. DISCUSSION: Through an analytical and longitudinal definition of profiles of informal caregivers, this study will gather detailed information on their life courses and their health trajectory by identifying consequences associated with the concept of their role as carers. In addition, the randomized interventional trial will explore the relevance of the implementation of a supportive intervention by a social worker to help caregivers. These data will help to identify strategies that could be used to improve the existing sources of aid and to propose new approaches to help caregivers. This study will provide the opportunity to identify the most relevant means of support adapted to caregivers, and provide an impulse for new health care policies. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02626377 . Retrospectively registered on 9 December 2015. Protocol date/version: 23 October 2014/version 2.

Prognostic value of health-related quality of life for death risk stratification in patients with unresectable glioblastoma.

Glioblastoma is the most common malignant brain tumor in adults. Baseline health-related quality of life (HRQoL) is a major subject of concern for these patients. We aimed to assess the independent prognostic value of HRQoL in unresectable glioblastoma (UGB) patients for death risk stratification. One hundred and thirty-four patients with UGB were enrolled from the TEMAVIR trial. HRQoL was evaluated at baseline using the EORTC QLQ-C30 and BN20 brain cancer module. Clinical and HRQoL parameters were evaluated in univariable and multivariable Cox analysis as prognostic factors for overall survival (OS). Performance assessment and internal validation of the final model were evaluated with Harrel's C-index, calibration plot, and bootstrap sample procedure. Two OS independent predictors were identified: future uncertainty and sensitivity deficit. The final model exhibited good calibration and acceptable discrimination (C statistic = 0.63). The internal validity of the model was verified with robust uncertainties around the hazard ratio. The prognostic score identified three groups of patients with distinctly different risk profiles with median OS estimated at 16.2, 9.2, and 4.5 months. We demonstrated the additional prognostic value of HRQoL in UGB for death risk stratification and provided a score that may help to guide clinical management and stratification in future clinical trials.

Assessment of the interest of the geriatric oncology consultation among French general practitioners.

OBJECTIVE: We assessed the interest of the geriatric oncology (GO) consultation (GOC) among general practitioners (GPs). MATERIALS AND METHODS: We conducted a survey among GPs whose patients had had a GOC in 2012. A questionnaire was sent to GPs. The 1st part collected GPs' characteristics including medical education in geriatrics and GO, and knowledge of GOC. The following parts concerned the GOC and included the cancer type, GOC report and care plan. RESULTS: One-hundred twenty-six questionnaires corresponding to 94 GPs were collected. Concerning the GPs' characteristics, age range 50-59 (44.7%), men (62.8%) and urban practice (79.8%) were the most represented, 80.8% had no expertise in geriatrics, 60.6% knew of the existence of GOCs, and 14.9% had received medical education in GO. The most frequent cancer location was gynecological (40.7%) (82.6% were breast cancers). Of the GPs, 69.8% had received a GOC report and 92% were (very) satisfied with the delivery time. A care plan was proposed after the GOC in 83% of cases. It was satisfactory in 96.4% of cases, and applied by 74.7% of GPs. Sixteen percent of GPs were called by the GO team. The less the GP was satisfied with the GOC, the more he or she wanted phone contact (p=0.02); 94% of GPs considered the GOC (very) satisfactory. Sixty-seven percent of GPs wanted to be trained in GO. CONCLUSION: Very few GPs had been trained in geriatrics and/or GO. They were mostly satisfied with GOC and expressed a wish to be trained in GO.