Frail old patients as a target population for cancer trials

The recent distinction between co-morbidity and multi-morbidity well stresses the difficulty of managing old patients with cancer whose complexity is not captured by a list of diagnoses or biological burden alone. The most adequate answer found by oncologists and geriatricians was to work together for better evaluating the physiological age and body reserve of the patient. The gold standard tool to assess old patient with cancer is named Comprehensive Geriatric Assessment. Its systematic application needs geriatric competences and time. In this context, a great number of cancer patients are considered as "frail” because they have reduced available physiological reserves. They might not withstand stress when challenged. Oncologists and geriatricians have imagined an innovative process to change the screening procedure of these patients, determine the prognosis, adapt the treatment strategy, to increase the patient's survival and his/her quality of life. The internet website "www.clinicaltrials.com” only lists 8 studies focused on frail elders with cancer. Six of them are focused on specific cancers or specific treatments, one was applied to all kind of cancers and the last was an opinion overview from oncologists and geriatricians. The selection criteria of frail patients are very diverse and probably include cancer patients who are not comparable. It is now time to try to identify new practical, reliable and accurate tools to facilitate the inclusion of the same kind of patients suffering from the same kind of cancer to be able to give more appropriate care and at the same time to constitute a valuable data base. Existing tools are reviewed and analyze

Revie ⊕: the influence of a life review intervention including a positive, patient-centered approach towards enhancing the personal dignity of patients with advanced cancer-a study protocol for a feasibility study using a mixed method investigation.

It is generally recognized that existential concerns must be addressed to promote the dignity of patients with advanced cancer. A number of interventions have been developed in this regard, such as dignity therapy and other life review interventions (LRI). However, so far, none have focused on a positive approach or evaluated its effects on dignity and personal growth. This study aims to explore the feasibility of Revie ⊕, a life review intervention comprising a positive, patient-centered approach, and to determine potential changes of patients' sense of dignity, posttraumatic growth, and satisfaction with life. A mixed method study will be performed, which includes specialized nurses and 40 patients with advanced cancer in an ambulatory and in-patient setting of a Swiss university hospital. Quantitative methods involve a single group, pre- and post-intervention, and outcome measurements include the Patient Dignity Inventory, the Posttraumatic Growth Inventory, and the Satisfaction with Life Scale. Feasibility data relating to process, resource, and scientific elements of the trial will also be collected. A semi-directed interview will be used to collect qualitative data about the process and the participants' experiences of the intervention. In this way, enhanced quantitative-qualitative evidence can be drawn from outcome measures as well as individual, contextualized personal views, to help inform researchers about the plausibility of this complex intervention before testing its effectiveness in a subsequent full trial. Patient dignity is a goal of quality end-of-life care. To our knowledge, this is the first trial to evaluate the role of a life review intervention that is focused on personal growth and on changes relating to the experience of having cancer. This study will evaluate the feasibility of a novel intervention, Revie ⊕, which we hope will contribute to promote the dignity, personal growth, and overall life satisfaction of patients with advanced cancer. ISRCTN, ISRCTN12497093

Sleep disordered breathing in the elderly

Sleep disordered breathing (SDB), i.e., obstructive, central or mixed sleep apneas, has been recognized as a common occurrence in the elderly. Aging is per se associated with a decrease in the quality of sleep; SDB may further disrupt the sleep architecture in older subjects. The prevalence of obstructive sleep apnea (OSA) increases with aging; available studies report prevalence rates of 11-62%. Furthermore, OSA has been associated with increased mortality in older adults. Central apneas and periodic breathing occur with increased frequency either in subjects with neurological disorders such as infarction, tumor, sequelae of infection, diffuse encephalopathies, or in chronic heart failure. Patients with cerebrovascular disease (stroke, or transient ischemic attacks) have a markedly high prevalence of SDB, mainly OSA. In these patients, SDB is associated with a poorer functional prognosis at 3 and 12 months after the acute event, and a higher mortality. The clinical impact of SDB on cognitive function appears to be modest in patients without dementia, although there is a moderate increase in daytime sleepiness. In Alzheimer's disease (AD) however, SDB occurs more frequently than in non-demented older subjects, and its severity is correlated with the degree of cognitive impairment. The hypothesis of a causal relationship between AD and SDB remains a subject of controversy. The possibility of SDB should be considered in the elderly in the differential diagnosis of "reversible dementias”, increased daytime sleepiness, or unexplained right-sided heart failur

Measuring the diffusion of palliative care in long-term care facilities – a death census

ABSTRACT: BACKGROUND: The dissemination of palliative care for patients presenting complex chronic diseases at various stages has become an important matter of public health. A death census in Swiss long-term care facilities (LTC) was set up with the aim of monitoring the frequency of selected indicators of palliative care. METHODS: The survey covered 150 LTC facilities (105 nursing homes and 45 home health services), each of which was asked to complete a questionnaire for every non-accidental death over a period of six months. The frequency of 4 selected indicators of palliative care (resort to a specialized palliative care service, the administration of opiates, use of any pain measurement scale or other symptom measurement scale) was monitored in respect of the stages of care and analysed based on gender, age, medical condition and place of residence. RESULTS: Overall, 1200 deaths were reported, 29.1% of which were related to cancer. The frequencies of each indicator varied according to the type of LTC, mostly regarding the administration of opiate. It appeared that the access to palliative care remained associated with cancer, terminal care and partly with age, whereas gender and the presence of mental disorders had no effect on the indicators. In addition, the use of drugs was much more frequent than the other indicators. CONCLUSION: The profile of patients with access to palliative care must become more diversified. Among other recommendations, equal access to opiates in nursing homes and in home health services, palliative care at an earlier stage and the systematic use of symptom management scales when resorting to opiates have to become of prime concern

Cannabinoids for behavioral symptoms in severe dementia: Safety and feasibility in a long-term pilot observational study in nineteen patients.

The management of behavioral symptoms and rigidity in patients with dementia constitutes a significant challenge. Short-term studies suggest an interest in the use of medical cannabis, but long-term data are lacking. The objective of this study was to investigate the feasibility and long-term safety of administering tetrahydrocannabinol/cannabidiol (THC/CBD) treatment as an additional drug to a poly medicated population with severe dementia, evaluate clinical improvements, and collect information on the pharmacokinetics of cannabinoids and possible drug-drug interactions. A prospective observational study of patients with severe dementia living in a long-term care home to whom the physicians had prescribed a medical cannabis treatment. Data were collected over 2 years. We assessed the changes in medical cannabis dosages, safety parameters, variations in neuropsychiatric problems, agitation, rigidity, the most invalidating daily activity, and disabling behavior trouble scores. We evaluated the pharmacokinetics of cannabinoids by measuring plasma levels and analyzing the enzymatic activity. We assessed 19 patients (81.4 years-17 women and two men) receiving an average of 12.4 mg THC/24.8 mg CBD per day for up to 13 months, with no reported problems related to the treatment and limited adverse drug reactions. Clinical scores showed a marked improvement that was stable over time, deprescription of other medications, and care facilitated. The pharmacokinetic evaluation showed an expected slight reduction in the enzymatic activity of CYP1A2 and CYP2C19. A long-term THC/CBD (1:2) medication can be administered safely and with overall positive clinical improvement to poly medicated older adults with severe dementia and associated problems. The results must be confirmed in a randomized trial

No difference in effects of ‘PACE steps to success’ palliative care program for nursing home residents with and without dementia : a pre-planned subgroup analysis of the seven-country PACE trial

Background: 'PACE Steps to Success' is a multicomponent training program aiming to integrate generalist and non-disease-specific palliative care in nursing homes. This program did not improve residents' comfort in the last week of life, but it appeared to improve quality of care and dying in their last month of life. Because this program included only three dementia-specific elements, its effects might differ depending on the presence or stage of dementia. We aimed to investigate whether the program effects differ between residents with advanced, non-advanced, and no dementia. Methods: Pre-planned subgroup analysis of the PACE cluster-randomized controlled trial in 78 nursing homes in seven European countries. Participants included residents who died in the previous 4 months. The nursing home staff or general practitioner assessed the presence of dementia; severity was determined using two highly-discriminatory staff-reported instruments. Using after-death questionnaires, staff assessed comfort in the last week of life (Comfort Assessment in Dying-End-of-Life in Dementia-scale; primary outcome) and quality of care and dying in the last month of life (Quality of Dying in Long-Term Care scale; secondary outcome). Results: At baseline, we included 177 residents with advanced dementia, 126 with non-advanced dementia and 156 without dementia. Post-intervention, respectively in the control and the intervention group, we included 136 and 104 residents with advanced dementia, 167 and 110 with non-advanced dementia and 157 and 137 without dementia. We found no subgroup differences on comfort in the last week of life, comparing advanced versus without dementia (baseline-adjusted mean sub-group difference 2.1; p-value = 0.177), non-advanced versus without dementia (2.7; p = 0.092), and advanced versus non-advanced dementia (- 0.6; p = 0.698); or on quality of care and dying in the last month of life, comparing advanced and without dementia (- 0.6; p = 0.741), non-advanced and without dementia (- 1.5; p = 0.428), and advanced and non-advanced dementia (0.9; p = 0.632). Conclusions: The lack of subgroup difference suggests that while the program did not improve comfort in dying residents with or without dementia, it appeared to equally improve quality of care and dying in the last month of life for residents with dementia (regardless of the stage) and those without dementia. A generalist and non-disease-specific palliative care program, such as PACE Steps to Success, is a useful starting point for future palliative care improvement in nursing homes, but to effectively improve residents' comfort, this program needs further development

Validation of the Consensus-Definition for Cancer Cachexia and evaluation of a classification model—a study based on data from an international multicentre project (EPCRC-CSA)

A cancer cachexia classification into stages is warranted in order to guide treatment decisions and clinical trial inclusion. Weight loss and BMI clearly discriminate between non-cachectic and cachectic patients both with regards to all the domains (Intake, Catabolism and Function) and survival. The precachexia stage might be better defined by additional factors in order to be discriminativ

A prospective study of symptoms, function, and medication use during acute illness in nursing home residents: design, rationale and cohort description

<p>Abstract</p> <p>Background</p> <p>Nursing home residents are at high risk for developing acute illnesses. Compared with community dwelling adults, nursing home residents are often more frail, prone to multiple medical problems and symptoms, and are at higher risk for adverse outcomes from acute illnesses. In addition, because of polypharmacy and the high burden of chronic disease, nursing home residents are particularly vulnerable to disruptions in transitions of care such as medication interruptions in the setting of acute illness. In order to better estimate the effect of acute illness on nursing home residents, we have initiated a prospective cohort which will allow us to observe patterns of acute illnesses and the consequence of acute illnesses, including symptoms and function, among nursing home residents. We also aim to examine the patterns of medication interruption, and identify patient, provider and environmental factors that influence continuity of medication prescribing at different points of care transition.</p> <p>Methods</p> <p>This is a prospective cohort of nursing home residents residing in two nursing homes in a metropolitan area. Baseline characteristics including age, gender, race, and comorbid conditions are recorded. Participants are followed longitudinally for a planned period of 3 years. We record acute illness incidence and characteristics, and measure symptoms including depression, pain, withdrawal symptoms, and function using standardized scales.</p> <p>Results</p> <p>76 nursing home residents have been followed for a median of 666 days to date. At baseline, mean age of residents was 74.4 (± 11.9); 32% were female; 59% were white. The most common chronic conditions were dementia (41%), depression (38%), congestive heart failure (25%) and chronic obstructive lung disease (27%). Mean pain score was 4.7 (± 3.6) on a scale of 0 to 10; Geriatric Depression Scale (GDS-15) score was 5.2 (± 4.4). During follow up, 138 acute illness episodes were identified, for an incidence of 1.5 (SD 2.0) episodes per resident per year; 74% were managed in the nursing home and 26% managed in the acute care setting.</p> <p>Conclusion</p> <p>In this report, we describe the conceptual model and methods of designing a longitudinal cohort to measure acute illness patterns and symptoms among nursing home residents, and describe the characteristics of our cohort at baseline. In our planned analysis, we will further estimate the effect of the use and interruption of medications on withdrawal and relapse symptoms and illness outcomes.</p

Study Protocol: The Behaviour and Pain in Dementia Study (BePAID)

<p>Abstract</p> <p>Background</p> <p>People with dementia admitted to the acute hospital often receive poor quality care particularly with regards to management of behavioural and psychiatric symptoms of dementia (BPSD) and of pain. There have been no UK studies on the prevalence and type of pain or BPSD in people with dementia in this setting, or on how these may impact on patients, carers, staff and costs of care.</p> <p>Methods/Design</p> <p>We shall recruit older people with dementia who have unplanned acute medical admissions and measure the prevalence of BPSD using the Behave-AD (Behaviour in Alzheimer's Disease) and the CMAI (Cohen Mansfield Agitation Inventory). Pain prevalence and severity will be assessed by the PAINAD (Pain Assessment in Advanced Dementia) and the FACES pain scale. We will then analyse how these impact on a variety of outcomes and test the hypothesis that poor management of pain is associated with worsening of BPSD.</p> <p>Discussion</p> <p>By demonstrating the costs of BPSD to individuals with dementia and the health service this study will provide important evidence to drive improvements in care. We can then develop effective training for acute hospital staff and alternative treatment strategies for BPSD in this setting.</p