The efficacy of Life Review Therapy combined with Memory Specificity Training (LRT-MST) targeting cancer patients in palliative care: A randomized controlled trial.
ABSTRACT: BACKGROUND:The aim of this study was to evaluate the efficacy of an intervention combining Life Review Therapy (LRT) and Memory Specificity Training (MST) (LRT-MST) to improve ego-integrity and despair among cancer patients in palliative care. METHODS:In this multicentre randomized controlled trial, cancer patients in palliative care were randomized to the intervention group (LRT-MST; n = 55) or waiting-list control group (n = 52). LRT-MST is a 4-session home-based psychological intervention that aims to retrieve specific positive memories, to re-evaluate life events and to reconstruct the story of a patient's life, including the diagnosis of incurable cancer. Outcome measures were ego-integrity and despair (NEIS), psychological distress, anxiety and depression (HADS), quality of life (EORTC QLQ-C15-PAL), and specificity of the autobiographical memory (AMT). NEIS, HADS and EORTC QLQ-C15-PAL were assessed at baseline (T0), 1 month later (post-treatment; T1), and at 1 month follow-up (T2). AMT was assessed at T0 and T1. Linear mixed models (intention to treat) were used to assess group differences in changes over time. Independent samples t-tests were used to assess group differences at T0, T1, and T2, and effect sizes (ES) were calculated at T1 and T2. RESULTS:The course of ego-integrity (not despair) improved significantly over time (p = .007) in the intervention group compared to the waiting-list control group, with moderate, but insignificant, effect sizes at T1 (ES = .42) and T2 (ES = .48). Compliance rate was 69% and total dropout rate was 28%, both primarily related to disease progression and death. CONCLUSIONS:LRT-MST seems effective among cancer patients in palliative care to improve the course of ego-integrity.
Project description:To evaluate psychometric characteristics of a questionnaire (the Northwestern Ego-integrity Scale (NEIS)) on ego-integrity (the experience of wholeness and meaning in life, even in spite of negative experiences) and despair (the experience of regret about the life one has led, and feelings of sadness, failure and hopelessness) among cancer patients.Cancer patients (n = 164) completed patient reported outcome measures on ego-integrity and despair (NEIS), psychological distress, anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), and quality of life (EORTC QLQ-C30 (cancer survivors, n = 57) or EORTC QLQ-C15-PAL (advanced cancer patients, n = 107)). Confirmatory Factor Analysis was used to assess construct validity. Cronbach's alpha was used to assess internal consistency. Convergent validity was tested based on a priori defined hypotheses: a higher level of ego-integrity was expected to be related to a higher level of quality of life, and lower levels of distress, depression and anxiety; a higher level of despair was expected to be related to a lower level of quality of life, and higher levels of distress, depression and anxiety.The majority of all items (94.5%) of the NEIS were completed by patients and single item missing rate was below 2%. The two subscales, labeled as Ego-integrity (5 items) and Despair (4 items) had acceptable internal consistency (Cronbach's alpha .72 and .61, respectively). The Ego-integrity subscale was not significantly associated with quality of life, distress, anxiety, or depression. The Despair subscale correlated significantly (p <.001) with quality of life (r = -.29), distress (r = .44), anxiety (r = .47) and depression (r = .32).The NEIS has good psychometric characteristics to assess ego-integrity and despair among cancer patients.
Project description:Tannin, an antinutritional component of plant proteins was fed to grass carp (Ctenopharyngodon idellus, 8. 18 ± 0.81 g) for 8 weeks to investigate their tolerance levels. Semi-purified diets (T0, T1, T2, and T3) with varying levels of hydrolysable tannin (0, 0.75, 1.25, and 1.75% respectively) were used. No significant difference was obtained in weight gain, while feed conversion ratio of T0 was significantly lower than T2. Muscle protein content of T0 and T3 were significantly higher than T2, while lipid content of T0 was significantly higher than other groups. Muscle and hepatic glycogen in T0 were significantly lower than other groups. Muscle saturated fatty acids in T3 were significantly higher than T0, and lowest in T1 and T2, while the poly-unsaturated fatty acids in T1 and T2 were higher than T0 and lowest in T3. Significant increases were obtained in trypsin and amylase activities as tannin levels increased, the lipase activity of T0 and T1 was significantly higher than T2 and T3. Activities of hepatic alanine aminotransferase and aspartate aminotransferase decreased with increasing tannin level. The total protein in serum of T2 was significantly higher than T0 and T1 and lowest in T3, whereas globulin of T2 was significantly higher than T0 and T3 and lowest in T1, while albumin of T1 was significantly higher than other groups. Urea nitrogen of T0 was significantly higher than other groups, triglyceride and total cholesterol significantly increased with tannin level and decreased in T3, significant decreases were obtained in low-density lipoprotein cholesterol and high-density lipoprotein cholesterol in T3. mRNA expression of intestinal TOR was significantly upregulated as dietary tannin increased. In hepatopancreas, the expression of glucokinase in T1 was significantly higher than T2, and lowest in T0 and T3, pyruvate kinase in T2 was significantly higher than T0 and T1 and lowest T3. The expression of lipoprotein lipase upregulated as tannin level and downregulated in T3, and fatty acid synthase downregulated as tannin level. In conclusion, grass carp could tolerate 1.75% dietary tannin without influencing growth. However, 1.25% tannin impaired digestion and metabolism of protein, decreased the deposition of lipid and promoted utilization of carbohydrate.
Project description:The management of patients suffering from opioid-refractory cancer pain with a neuropathic component remains an important challenge for healthcare workers. Only one retrospective study specifically reported the use of intravenous (IV) lidocaine amongst the palliative care unit population, the study found that there was a positive response to this therapy. These preliminary uncontrolled results need to be confirmed by randomized controlled trials. The primary objective of this study is to assess the analgesic efficacy of IV lidocaine in patients in palliative care suffering from opioid-refractory cancer pain with a neuropathic component. The secondary objectives are to assess the tolerance of, symptomatology, and patient satisfaction with the therapeutic approach.This will be a multicenter, prospective, randomized, placebo-controlled, double-blind, two-parallel group study. It will take place in eight adult palliative care units across France. The main inclusion criteria are as follows: adult patients suffering from opioid-refractory cancer pain with a neuropathic component, and those receiving palliative care as defined by French Society of Palliative and Support Care. Participants will be randomized (1:1 allocation ratio) to one of two treatment groups: a) lidocaine-experimental group (intravenous lidocaine), or b) placebo-control group (intravenous saline solution). Evaluation assessments will be taken at baseline (T0 randomization), 40 minutes (T1), 120 minutes (T2), 12 hours (T3), 24 hours (T4), 48 hours (T5), and 14 days (T6) after baseline. The primary endpoint is change in the pain level between T0 and T1. The secondary endpoints are: changes in the pain level between T0 and other times, intensity of the neuropathic pain component, daily opioid consumption, symptoms (as classified by the MD Anderson Symptom Inventory), adverse events, and patient's satisfaction (measured using the Pain Treatment Satisfaction Scale). A sample size of 200 individuals will be needed to obtain 90% power to detect a 25% difference in pain success at T1 between the two groups; pain success is classified as a 30% decrease in the pain level between T0 and T1 (10% of patients lost to follow-up expected).The randomized, double-blind, placebo-controlled design is the most appropriate design to demonstrate the efficacy of a new experimental intervention (Evidence-Based Medicine Working Group classification). National and international recommendations could be updated based on the findings of this study.Current controlled trials NCT02137954 (registration date: 7 May 2014).
Project description:BACKGROUND AND PURPOSE:Cognitive rehabilitation has demonstrated efficacy in producing short-term cognitive and brain changes in patients with Parkinson's disease (PD). To date, no study has assessed the long-term effects of cognitive rehabilitation using neuroimaging techniques in PD. The aim was to assess the longitudinal effects of a 3-month cognitive rehabilitation programme evaluating the cognitive, behavioural and neuroimaging changes after 18 months. METHODS:Fifteen patients with PD underwent a cognitive, behavioural and neuroimaging assessment at pre-treatment (T0 ), post-treatment (T1 ) and after 18 months (T2 ). This study examined the long-term effects (from T0 to T2 ) and the maintenance of the changes (from T1 to T2 ). T1-weighted, diffusion-weighted, functional magnetic resonance imaging during both a resting-state and a memory paradigm were acquired. Voxel-based morphometry and tract-based spatial statistics were used for grey and white matter analyses. A region-of-interest-to-region-of-interest approach was used for resting-state functional connectivity (FC) and a model-based approach was used for brain activation during the memory paradigm. RESULTS:Patients with PD showed increased cognitive performance, decreased functional disability, increased brain FC and activation at T2 compared with T0 (P < 0.05, FDR). Moreover, patients showed maintenance of the improvements in cognition and functionality, and maintenance of the increased brain FC and activation at T2 compared with T1 . However, significant grey matter reduction and alterations of white matter integrity were found at T2 (P < 0.05, FWE). CONCLUSIONS:Findings suggest that the improved cognitive performance and increased brain FC and activation after cognitive rehabilitation were significantly maintained after 18 months in patients with PD, despite the structural brain changes, consistent with a progression of neurodegenerative processes.
Project description:PURPOSE:The aim of the study was to investigate annual structural and functional results, and their correlation with inheritance pattern of retinitis pigmentosa (RP) patients who were treated with Wharton's jelly-derived mesenchymal stem cells (WJ-MSCs). MATERIAL AND METHODS:This prospective, sequential, open-label phase-3 clinical study was conducted at Ankara University Faculty of Medicine, Department of Ophthalmology, between April 2019 and May 2020. The study included 34 eyes from 32 retinitis pigmentosa patients of various genotypes who were enrolled in the stem cells clinical trial. The patients were followed for 12?months after the WJ-MSCs transplantation into subtenon space and evaluated with consecutive examinations. Genetic mutations were investigated using a retinitis pigmentosa panel sequencing method consisting of 90 genes. All patients underwent a complete routine ophthalmic examination with best corrected visual acuity, optical coherence tomography angiography, visual field, and full-field electroretinography. Quantitative data obtained from baseline (T0), 6th month (T1), and 12th month (T2) examinations were compared. RESULTS:According to timepoints at T0, T1, and T2: The mean outer retinal thickness was 100.3??m, 119.1??m, and 118.0??m, respectively (p?=?0.01; T0?<?T1, T2). The mean horizontal ellipsoid zone width were 2.65?mm, 2.70?mm, and 2.69?mm respectively (p?=?0.01; T0?<?T1, T2). The mean best corrected visual acuity (BCVA) were 70.5 letters, 80.6 letters, and 79.9 letters, respectively (p?=?0.01; T0?<?T1, T2). The mean fundus perimetry deviation index (FPDI) was 8.0%, 11.4%, and 11.6%, respectively (p?=?0.01; T0?<?T1, T2). The mean full-field flicker ERG parameters at T0, T1, and T2: amplitudes were 2.4?mV, 5.0?mV, and 4.6?mV, respectively (p?=?0.01; T0?<?T1, T2). Implicit time were 43.3?ms, 37.9?ms, and 38.6?ms, respectively (p?=?0.01; T0?>?T1, T2). According to inheritance pattern, BCVA, FPDI, ERG amplitude, and implicit time data improved significantly in autosomal dominant (AD) and in autosomal recessive (AR) RP at 1?year follow-up (pAD?=?0.01, pAR?=?0.01; pAD?=?pAR?>?pX-linked). No ocular or systemic adverse events related to the surgical methods and/or WJ-MSCs were observed during the 1?year follow-up period. CONCLUSION:Subtenon transplantation of WJ-MSCs was found to be effective and safe in the treatment of RP during the first year, similar to the sixth month's results. In autosomal dominant and autosomal recessive inheritance of RP, regardless of the genetic mutations, subtenon administration of WJ-MSCs can be considered an effective and safe option without any adverse effect for slowing or stopping the disease progression. TRIAL REGISTRATION:ClinicalTrials.gov, NCT04224207 . Registered 8 January 2020.
Project description:OBJECTIVE: This prospective study evaluated the density of the midpalatal and transverse sutures as assessed by low-dose CT before rapid maxillary expansion (T0), at the end of active expansion (T1) and after a retention period of 6 months (T2). METHODS: The study sample comprised 17 pre-pubertal subjects (mean age 11.2 years) with constricted maxillary arches. Total amount of expansion was 7 mm in all subjects. Multislice low-dose CT scans were taken at T0, T1 and T2. On the axial CT scanned images six regions of interest (ROIs) were placed along the midpalatal and transverse sutures and two in maxillary and palatal bony areas. Density was measured in Hounsfield units. Mann-Whitney U test and Friedman analysis of variance with post hoc tests were used (p < 0.05). RESULTS: The three ROIs in the midpalatal suture showed a significant decrease in density from T0 to T1, a significant increase from T1 to T2 and a lack of statistically significant differences from T0 to T2. Both ROIs located in the transverse suture showed a significant decrease in density from T0 to T1, followed by a non-significant increase in density from T1 to T2. CONCLUSIONS: At the end of the active phase of expansion a significant reduction in density along the midpalatal and transverse sutures was observed in all subjects. The sutural density of the midpalatal suture at T2 indicated reorganization of the midpalatal suture while the density along the transverse suture increased without reaching the pre-treatment values, possibly due to different morphology between midpalatal and transverse sutures.
Project description:Cognitive and physical activity treatments (CT and PT) are two non-pharmacological approaches frequently used in patients with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD). The aim of this study was to compare CT and PT in these diseases. Eighty-seven patients were randomly assigned to CT (n=30), PT (n=27) or control group (CTRL; n=30) for 6 months. The global cognitive function was measured by Mini Mental State Examination (MMSE). Specific neuropsychological tests explored attention, memory, executive functions, behavioral disorders. Cardiovascular risk factors (CVD) were collected. All measures were performed before (T0), after treatments (T1), and at three-months follow-up (T2). MMSE did not change from T0 to T1 and T2 in patients assigned to PT and CT, while CTRL patients showed a decline MCI: -11.8%, AD: -16.2%). Between group differences (MCI vs AD) were not found at T1 and T2. Significant worsening was found for CTRL in MCI (T0- T1: P=.039; T0-T2: P<.001) and AD (T0-T1: P<.001; T0-T2: P<.001), and amelioration was found for CT in AD (T0-T2: P<.001). Attention, executive functions and behavioral disorders were unaffected by either PT or CT. Memory was increased in patients with MCI assigned to PT (+6.9%) and CT (+8.5%).. CVD were ameliorated in the PT group. CTRL patients of both groups, revealed significant decline in all functions and no between groups differences were detected. PT appear to ameliorate CVD. Although between groups differences were not found, results suggest a major retention in MCI compared with AD, suggesting that the latter might benefit better of constant rather than periodic treatments. This study confirms the positive effects of CT and PT in mitigating the cognitive decline in MCI and AD patients, and it is the first to demonstrate their similar effectiveness on maintaining cognitive function.
Project description:Peatland testate amoebae (TA) are well-established bioindicators for depth to water table (DWT), but effects of hydrological changes on TA communities have never been tested experimentally. We tested this in a field experiment by placing Sphagnum carpets (15 cm diameter) collected in hummock, lawn and pool microsites (origin) at three local conditions (dry, moist and wet) using trenches dug in a peatland. One series of samples was seeded with microorganism extract from all microsites. TA community were analysed at T0: 8-2008, T1: 5-2009 and T2: 8-2009. We analysed the data using conditional inference trees, principal response curves (PRC) and DWT inferred from TA communities using a transfer function used for paleoecological reconstruction. Density declined from T0 to T1 and then increased sharply by T2. Species richness, Simpson diversity and Simpson evenness were lower at T2 than at T0 and T1. Seeded communities had higher species richness in pool samples at T0. Pool samples tended to have higher density, lower species richness, Simpson diversity and Simpson Evenness than hummock and/or lawn samples until T1. In the PRC, the effect of origin was significant at T0 and T1, but the effect faded away by T2. Seeding effect was strongest at T1 and lowest vanished by T2. Local condition effect was strong but not in line with the wetness gradient at T1 but started to reflect it by T2. Likewise, TA-inferred DWT started to match the experimental conditions by T2, but more so in hummock and lawn samples than in pool samples. This study confirmed that TA responds to hydrological changes over a 1-year period. However, sensitivity of TA to hydrological fluctuations, and thus the accuracy of inferred DWT changes, was habitat specific, pool TA communities being least responsive to environmental changes. Lawns and hummocks may be thus better suited than pools for paleoecological reconstructions. This, however, contrasts with the higher prediction error and species' tolerance for DWT with increasing dryness observed in transfer function models.
Project description:BACKGROUND:Longitudinal changes in child and adolescent active school transport (AST), and the mediating role of different intensities of daily physical activity (PA) levels in relation to AST and physical fitness and adiposity indicators is unclear. This study aimed to: 1) describe longitudinal changes in AST, light PA (LPA), moderate- to vigorous-intensity PA (MVPA), physical fitness and adiposity indicators over three time-points; and 2) investigate the mediating role of LPA and MVPA levels on associations between AST and physical fitness and adiposity indicators over three time-points among children and adolescents. METHODS:This longitudinal study comprised 1646 Spanish children and adolescents (48.8% girls, mean age 12.5?years ±2.5) at baseline, recruited from schools in Cádiz and Madrid. Mode of commuting to school was self-reported at baseline (T0, 2011-12), 1-year (T1) and 2-year follow-up (T2). PA was assessed using accelerometers. Handgrip strength, standing long jump and cardiorespiratory fitness (CRF) assessed physical fitness. Height, weight, body mass index, waist circumference, and triceps and subscapular skinfold thickness were measured. Multilevel linear regression analyses assessed changes in AST, PA levels, physical fitness and adiposity indicators over three time-points (T0-T1-T2). Additionally, longitudinal path analysis (n?=?453; mean age [years] 12.6?±?2.4) was used to test the mediating effects of LPA and MVPA levels on the association between AST and physical fitness and adiposity indicators. RESULTS:Multilevel analyses observed decreases in LPA between T0-T1 (??=?-?11.27; p?<?0.001) and T0-T2 (??=?-?16.27; p?<?0.001) and decreases in MVPA between T0-T2 (??=?-?4.51; p?=?0.011). Moreover, changes over time showed increases in handgrip between T0-T1 (??=?0.78; p?=?0.028) and T0-T2 (??=?0.81; p?=?0.046). Path analyses showed that AST was directly positively associated with MVPA at T1 (all, ????0.33; p?<?0.001). MVPA at T1 mediated associations between AST and CRF at T2 (??=?0.20; p?=?0.040), but not the other outcomes. LPA did not mediate any associations. CONCLUSIONS:Results from longitudinal path analysis suggest that participation in more AST may help attenuate declines in MVPA that typically occur with age and improve CRF. Therefore, we encourage health authorities to promote AST, as a way to increase MVPA levels and CRF among youth.
Project description:Verticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (ABI) and to be safe in ICU. We evaluated the effectiveness of a very early stepping verticalization protocol on their functional and neurological outcome.Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU on the third day after an ABI. They were randomized to undergo conventional physiotherapy alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with robotic stepping device. Once stabilized, patients were transferred to our Neurorehabilitation unit for an individualized treatment. Outcome measures (Glasgow Coma Scale, Coma Recovery Scale revised -CRSr-, Disability Rating Scale-DRS- and Levels of Cognitive Functioning) were assessed on the third day from the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2). Between- and within-group comparisons were performed by the Mann-Whitney U test and Wilcoxon signed-rank test, respectively.Of the 40 patients enrolled, 31 completed the study without adverse events (15 in the verticalization group and 16 in the conventional physiotherapy). Early verticalization started 12.4±7.3 (mean±SD) days after ABI. The length of stay in ICU was longer for the verticalization group (38.8 ± 15.7 vs 25.1 ± 11.2 days, p = 0.01), while the total length of stay (ICU+Neurorehabilitation) was not significantly different (153.2 ± 59.6 vs 134.0 ± 61.0 days, p = 0.41). All outcome measures significantly improved in both groups after the overall period (T2 vs T0, p<0.001 all), as well as after ICU stay (T1 vs T0, p<0.004 all) and after Neurorehabilitation (T2 vs T1, p<0.004 all). The improvement was significantly better in the experimental group for CRSr (T2-T0 p = 0.033, T1-T0 p = 0.006) and (borderline) for DRS (T2-T0 p = 0.040, T1-T0 p = 0.058).A stepping verticalization protocol, started since the acute stages, improves the short-term and long-term functional and neurological outcome of ABI patients.clinicaltrials.gov NCT02828371.