BackgroundCancer cachexia is a syndrome of weight loss (including muscle and fat), anorexia, and decreased physical function. It has been suggested that the optimal treatment for cachexia should be a multimodal intervention. The primary aim of this study was to examine the feasibility and safety of a multimodal intervention (n‐3 polyunsaturated fatty acid nutritional supplements, exercise, and anti‐inflammatory medication: celecoxib) for cancer cachexia in patients with incurable lung or pancreatic cancer, undergoing chemotherapy.MethodsPatients receiving two cycles of standard chemotherapy were randomized to either the multimodal cachexia intervention or standard care. Primary outcome measures were feasibility assessed by recruitment, attrition, and compliance with intervention (>50% of components in >50% of patients). Key secondary outcomes were change in weight, muscle mass, physical activity, safety, and survival.ResultsThree hundred and ninety‐nine were screened resulting in 46 patients recruited (11.5%). Twenty five patients were randomized to the treatment and 21 as controls. Forty‐one completed the study (attrition rate 11%). Compliance to the individual components of the intervention was 76% for celecoxib, 60% for exercise, and 48% for nutritional supplements. As expected from the sample size, there was no statistically significant effect on physical activity or muscle mass. There were no intervention‐related Serious Adverse Events and survival was similar between the groups.ConclusionsA multimodal cachexia intervention is feasible and safe in patients with incurable lung or pancreatic cancer; however, compliance to nutritional supplements was suboptimal. A phase III study is now underway to assess fully the effect of the intervention.
Background Researchers have shown that hospitalisation can decrease older persons’ ability to manage life at home after hospital discharge. Inadequate practices of discharge can be associated with adverse outcomes and an increased risk of readmission. This review systematically summarises qualitative findings portraying older persons’ experiences adapting to daily life at home after hospital discharge. Methods A metasummary of qualitative findings using Sandelowski and Barroso’s method. Data from 13 studies are included, following specific selection criteria, and categorised into four main themes. Results Four main themes emerged from the material: (1) Experiencing an insecure and unsafe transition, (2) settling into a new situation at home, (3) what would I do without my informal caregiver? and (4) experience of a paternalistic medical model. Conclusions The results emphasise the importance of assessment and planning, information and education, preparation of the home environment, the involvement of the older person and caregivers and supporting self-management in the discharge and follow-up care processes at home. Better communication between older persons, hospital providers and home care providers is needed to improve the coordination of care and facilitate recovery at home. The organisational structure may need to be redefined and reorganised to secure continuity of care and the wellbeing of older persons in transitional care situations. Electronic supplementary material The online version of this article (10.1186/s12913-019-4035-z) contains supplementary material, which is available to authorized users.
BackgroundCancer wasting is characterized by muscle loss and may contribute to fatigue and poor quality of life (QoL). Our aim was to investigate associations between skeletal muscle index (SMI) and skeletal muscle radiodensity (SMD) and selected QoL outcomes in advanced non‐small cell lung cancer (NSCLC) at diagnosis.MethodsBaseline data from patients with stage IIIB/IV NSCLC and performance status 0–2 enrolled in three randomized trials of first‐line chemotherapy (n = 1305) were analysed. Associations between SMI (cm2/m2) and SMD (Hounsfield units) based on computed tomography‐images at the third lumbar level and self‐reported physical function (PF), role function (RF), global QoL, fatigue, and dyspnoea were investigated by linear regression using flexible non‐linear modelling.ResultsComplete data were available for 734 patients, mean age 65 years. Mean SMI was 47.7 cm2/m2 in men (n = 420) and 39.6 cm2/m2 in women (n = 314). Low SMI values were non‐linearly associated with low PF and RF (men P = 0.016/0.020, women P = 0.004/0.012) and with low global QoL (P = 0.001) in men. Low SMI was significantly associated with high fatigue (P = 0.002) and more pain (P = 0.015), in both genders, but not with dyspnoea. All regression analyses showed poorer physical outcomes below an SMI breakpoint of about 42–45 cm2/m2 for men and 37–40 cm2/m2 for women. In both genders, poor PF and more dyspnoea were significantly associated with low SMD.ConclusionsLow muscle mass in NSCLC negatively affects the patients' PF, RF, and global QoL, possibly more so in men than in women. However, muscle mass must be below a threshold value before this effect can be detected.
BackgroundNoncommunicable diseases (NCDs) account for 70% of all deaths in a year globally. The four main NCDs are cardiovascular diseases, cancers, chronic pulmonary diseases, and diabetes mellitus. Fifty percent of persons with NCD do not adhere to prescribed treatment; in fact, adherence to lifestyle interventions is especially considered as a major challenge. Smartphone apps permit structured monitoring of health parameters, as well as the opportunity to receive feedback.ObjectiveThe aim of this study was to review and assess the effectiveness of app-based interventions, lasting at least 3 months, to promote lifestyle changes in patients with NCDs.MethodsIn February 2017, a literature search in five databases (EMBASE, MEDLINE, CINAHL, Academic Research Premier, and Cochrane Reviews and Trials) was conducted. Inclusion criteria was quantitative study designs including randomized and nonrandomized controlled trials that included patients aged 18 years and older diagnosed with any of the four main NCDs. Lifestyle outcomes were physical activity, physical fitness, modification of dietary habits, and quality of life. All included studies were assessed for risk of bias using the Cochrane Collaboration`s risk of bias tool. Meta-analyses were conducted for one of the outcomes (glycated hemoglobin, HbA1c) by using the estimate of effect of mean post treatment with SD or CI. Heterogeneity was tested using the I2 test. All studies included in the meta-analyses were graded.ResultsOf the 1588 records examined, 9 met the predefined criteria. Seven studies included diabetes patients only, one study included heart patients only, and another study included both diabetes and heart patients. Statistical significant effect was shown in HbA1c in 5 of 8 studies, as well in body weight in one of 5 studies and in waist circumference in one of 3 studies evaluating these outcomes. Seven of the included studies were included in the meta-analyses and demonstrated significantly overall effect on HbA1c on a short term (3-6 months; P=.02) with low heterogeneity (I2=41%). In the long term (10-12 months), the overall effect on HbA1c was statistical significant (P=.009) and without heterogeneity (I2=0%). The quality of evidence according to Grading of Recommendations Assessment, Development and Evaluation was low for short term and moderate for long term.ConclusionsOur review demonstrated limited research of the use of smartphone apps for NCDs other than diabetes with a follow-up of at least 3 months. For diabetes, the use of apps seems to improve lifestyle factors, especially to decrease HbA1c. More research with long-term follow-up should be performed to assess the effect of smartphone apps for NCDs other than diabetes.
PurposeReference values for patient-reported outcome measures are useful for interpretation of results from clinical trials. The study aims were to collect Norwegian SF-36 reference values and compare with data from 1996 to 2002.MethodsIn 2015, SF-36 was sent by mail to a representative sample of the population (N = 6165). Time trends and associations between background variables and SF-36 scale scores were compared by linear regression models.ResultsThe 2015 response rate was 36% (N = 2118) versus 67% (N = 2323) in 1996 and 56% (N = 5241) in 2002. Only 5% of the youngest (18–29 years) and 27% of the oldest (>70 years) responded in 2015. Age and educational level were significantly higher in 2015 relative to 1996/2002 (p < .001). The oldest age group in 2015 reported better scores on five of eight scales (p < 0.01), the exceptions being bodily pain, vitality, and mental health compared to 1996/2002 (NS). Overall, the SF-36 scores were relatively stable across surveys, controlled for background variables. In general, the most pronounced changes in 2015 were better scores on the role limitations emotional scale (7.4 points, p < .001) and lower scores on the bodily pain scale (4.6 points, p < .001) than in the 1996/2002 survey.ConclusionsThe low response rate in 2015 suggests that the results, especially among the youngest, should be interpreted with caution. The high response rate among the oldest indicates good representativity for those >70 years. Despite societal changes in Norway the past two decades, HRQoL has remained relatively stable.
Cancer cachexia is a multifactorial syndrome characterized by an on-going loss of skeletal muscle mass that cannot be fully reversed by conventional nutritional support alone. Cachexia has a high prevalence in cancer and a major impact on patient physical function, morbidity and mortality. Despite the consequences of cachexia, there is no licensed treatment for cachexia and no accepted standard of care. It has been argued that the multifactorial genesis of cachexia lends itself to therapeutic targeting through a multimodal treatment. Following a successful phase II trial, a phase III randomized controlled trial of a multimodal cachexia intervention is underway.Termed the MENAC trial (Multimodal -Exercise, Nutrition and Anti-inflammatory medication for Cachexia), this intervention is based on evidence to date and consists of Non-steroidal Antiinflammatory Drugs (NSAID) and eicosapentaenoic acid (EPA) to reduce inflammation, a physical exercise programme using resistance and aerobic training to increase anabolism, as well as dietary counselling and oral nutritional supplements to promote energy and protein balance. Herein we describe the development of this trial.
Background Mobile health interventions, especially smartphone applications (apps), have been proposed as promising interventions for supporting adherence to healthy behaviour in patients post cardiac rehabilitation (CR). The overall aim of the study was to examine the effect of individualized follow-up with an app for one year on peak oxygen uptake (VO2peak) in patients completing CR. Design The study was designed as a single-blinded multicentre randomized controlled trial. Methods The intervention group (IG) received individualized follow-up enabled with an app for one year, while the control group (CG) received usual care. The primary outcome was difference in VO2peak. Secondary outcomes included exercise performance (time to exhaustion, peak incline (%) and peak velocity (km/h)), bodyweight, resting blood pressure, lipid profile, triglycerides, exercise habits, health-related quality of life, health status and self-perceived goal achievement. Results In total, 113 patients completing CR (73.4% with coronary artery disease, 16.8% after valve surgery and 9.8% with other heart diseases) were randomly allocated to the IG or CG. Intention to treat analyses showed a statistically significant difference in VO2peak between the groups at follow-up of 2.2 ml/kg/min, 95% confidence interval 0.9–3.5 ( p < 0.001). Statistically significant differences were also observed in exercise performance, exercise habits and in self-perceived goal achievement. Conclusions Individualized follow-up for one year with an app significantly improved VO2peak, exercise performance and exercise habits, as well as self-perceived goal achievement, compared with a CG in patients post-CR. There were no statistically significant differences between the groups at follow-up in the other outcome measures evaluated.
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