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Results of the Optimune trial: A randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors.
Holtdirk, F, Mehnert, A, Weiss, M, Mayer, J, Meyer, B, Bröde, P, Claus, M, Watzl, C
PloS one. 2021;(5):e0251276
Abstract
INTRODUCTION After the acute treatment phase, breast cancer patients often experience low quality of life and impaired mental health, which could potentially be improved by offering cognitive behavioural therapy (CBT) and addressing exercise and dietary habits. However, CBT and other behavioural interventions are rarely available beyond the acute treatment phase. Internet-based interventions could bridge such treatment gaps, given their flexibility and scalability. In this randomized controlled trial (RCT), we investigated the effects of such an intervention ("Optimune") over three months. METHODS This RCT included 363 female breast cancer survivors (age range = 30-70), recruited from the community, who had completed the active treatment phase. Inclusion criteria were: breast cancer diagnosis less than 5 years ago and acute treatment completion at least 1 month ago. Participants were randomly assigned to (1) an intervention group (n = 181), in which they received care as usual (CAU) plus 12-month access to Optimune immediately after randomization, or (2) a control group (n = 182), in which they received CAU and Optimune after a delay of 3 months. Primary endpoints were quality of life (QoL), physical activity, and dietary habits at three months. We hypothesized that intervention group participants would report better QoL, more physical activity, and improved dietary habits after 3 months. RESULTS Intention-to-treat (ITT) analyses revealed significant effects on QoL (d = 0.27, 95% CI: 0.07-0.48) and dietary habits (d = 0.36, 95% CI: 0.15-0.56), but the effect on physical exercise was not significant (d = 0.30; 95% CI: 0.10-0.51). DISCUSSION These findings suggest the effectiveness of Optimune, a new CBT-based Internet intervention for breast cancer survivors, in facilitating improvements in quality of life and dietary habits. Efforts to disseminate this intervention more broadly may be warranted. TRIAL REGISTRATION ClinicalTrials.gov, NCT03643640. Registered August 23rd 2018, https://clinicaltrials.gov/ct2/show/NCT03643640.
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Effect of Dietary Coenzyme Q10 Plus NADH Supplementation on Fatigue Perception and Health-Related Quality of Life in Individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.
Castro-Marrero, J, Segundo, MJ, Lacasa, M, Martinez-Martinez, A, Sentañes, RS, Alegre-Martin, J
Nutrients. 2021;(8)
Abstract
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a complex, multisystem, and profoundly debilitating neuroimmune disease, probably of post-viral multifactorial etiology. Unfortunately, no accurate diagnostic or laboratory tests have been established, nor are any universally effective approved drugs currently available for its treatment. This study aimed to examine whether oral coenzyme Q10 and NADH (reduced form of nicotinamide adenine dinucleotide) co-supplementation could improve perceived fatigue, unrefreshing sleep, and health-related quality of life in ME/CFS patients. A 12-week prospective, randomized, double-blind, placebo-controlled trial was conducted in 207 patients with ME/CFS, who were randomly allocated to one of two groups to receive either 200 mg of CoQ10 and 20 mg of NADH (n = 104) or matching placebo (n = 103) once daily. Endpoints were simultaneously evaluated at baseline, and then reassessed at 4- and 8-week treatment visits and four weeks after treatment cessation, using validated patient-reported outcome measures. A significant reduction in cognitive fatigue perception and overall FIS-40 score (p < 0.001 and p = 0.022, respectively) and an improvement in HRQoL (health-related quality of life (SF-36)) (p < 0.05) from baseline were observed within the experimental group over time. Statistically significant differences were also shown for sleep duration at 4 weeks and habitual sleep efficiency at 8 weeks in follow-up visits from baseline within the experimental group (p = 0.018 and p = 0.038, respectively). Overall, these findings support the use of CoQ10 plus NADH supplementation as a potentially safe therapeutic option for reducing perceived cognitive fatigue and improving the health-related quality of life in ME/CFS patients. Future interventions are needed to corroborate these clinical benefits and also explore the underlying pathomechanisms of CoQ10 and NADH administration in ME/CFS.
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A multidisciplinary team-based approach with lifestyle modification and symptom management to address the impact of androgen deprivation therapy in prostate cancer: A randomized phase II study.
Pollock, Y, Zhang, L, Kenfield, SA, Van Blarigan, EL, Rodvelt, T, Rabow, M, Macaire, G, Weinberg, R, Topp, K, Friedlander, T, et al
Urologic oncology. 2021;(10):730.e9-730.e15
Abstract
BACKGROUND Androgen deprivation therapy (ADT) is associated with numerous toxicities that are potentially modifiable. We sought to evaluate the impact of participation in a multidisciplinary clinic, STAND (Supportive Therapy in Androgen Deprivation) Clinic, designed to provide individualized lifestyle modification and management of ADT-related side effects. METHODS This phase II study recruited men with prostate cancer who had started ADT <6 months prior to enrollment, and in whom ADT was planned for at least 12 months following enrollment. Patients were randomized in a 1:1 ratio to either the STAND Clinic or usual care. Patients randomized to the STAND Clinic were provided monthly multidisciplinary assessment and counseling on exercise, nutrition, and symptom management for 12 months on a rotating schedule. Primary outcome was change from baseline to 12 months in percent body fat. Feasibility outcomes were also assessed by measuring percentage of completed visits. Secondary outcomes included change from baseline to 12 months in 3 domains: (1) metabolic impact and bone health, (2) quality of life (QOL), and (3) physical activity. RESULTS A total of 25 men were randomized to STAND clinic, and 23 were randomized to usual care. The study did not meet its accrual target of 32 men in each arm and was closed early due to lack of financial support. Overall, 91% (295 of 325) of STAND clinic visits were completed. Eighteen out of the 25 patients in STAND clinic arm (72%) completed all 12 months of STAND clinic visits, and 80% (20 of 25) completed the first 6 months. For all primary and secondary outcomes, there were no statistically significant differences between treatment arms. CONCLUSION Individualized and comprehensive management of ADT toxicities in a multidisciplinary clinic was well attended by patients. However, we did not find any differences in the outcomes assessed between the intervention arm and control.
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Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial.
Díaz-García, A, González-Robles, A, García-Palacios, A, Fernández-Álvarez, J, Castilla, D, Bretón, JM, Baños, RM, Quero, S, Botella, C
Journal of medical Internet research. 2021;(2):e21335
Abstract
BACKGROUND Emotional disorders (EDs) are among the most prevalent mental disorders. Existing evidence-based psychological treatments are not sufficient to reduce the disease burden of mental disorders. It is therefore essential to implement innovative solutions to achieve a successful dissemination of psychological treatment protocols, and in this regard, the use of information and communication technologies such as the internet can be very useful. Furthermore, the literature suggests that not everyone with an ED receives the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which attempts to address the underlying processes common to EDs. Most of these transdiagnostic interventions focus primarily on downregulating negative affectivity (NA), and less attention has been paid to strengths and the upregulation of positive affectivity, despite its importance for well-being and mental health. OBJECTIVE This study aims to evaluate the efficacy of a transdiagnostic internet-based treatment for EDs in a community sample. METHODS A 3-armed randomized controlled trial was conducted. A total of 216 participants were randomly assigned to a transdiagnostic internet-based protocol (TIBP), a TIBP+ positive affect (PA) component, or a waiting list (WL) control group. The treatment protocol contained core components mainly addressed to downregulate NA (ie, present-focused emotional awareness and acceptance, cognitive flexibility, behavioral and emotional avoidance patterns, and interoceptive and situational exposure) as well as a PA regulation component to promote psychological strengths and enhance well-being. Data on depression, anxiety, quality of life, neuroticism and extraversion, and PA/NA before and after treatment were analyzed. Expectations and opinions of treatment were also analyzed. RESULTS Within-group comparisons indicated significant pre-post reductions in the two experimental conditions. In the TIBP+PA condition, the effect sizes were large for all primary outcomes (d=1.42, Beck Depression Inventory [BDI-II]; d=0.91, Beck Anxiety Inventory [BAI]; d=1.27, Positive and Negative Affect Schedule-Positive [PANAS-P]; d=1.26, Positive and Negative Affect Schedule-Negative [PANAS-N]), whereas the TIBP condition yielded large effect sizes for BDI-II (d=1.19) and PANAS-N (d=1.28) and medium effect sizes for BAI (d=0.63) and PANAS-P (d=0.69). Between-group comparisons revealed that participants who received one of the two active treatments scored better at posttreatment than WL participants. Although there were no statistically significant differences between the two intervention groups on the PA measure, effect sizes were consistently larger in the TIBP+PA condition than in the standard transdiagnostic protocol. CONCLUSIONS Overall, the findings indicate that EDs can be effectively treated with a transdiagnostic intervention via the internet, as significant improvements in depression, anxiety, and quality of life measures were observed. Regarding PA measures, promising effects were found, but more research is needed to study the role of PA as a therapeutic component. TRIAL REGISTRATION ClinicalTrials.gov NCT02578758; https://clinicaltrials.gov/ct2/show/NCT02578758. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-017-1297-z.
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QOLEC2: a randomized controlled trial on nutritional and respiratory counseling after esophagectomy for cancer.
Pinto, E, Nardi, MT, Marchi, R, Cavallin, F, Alfieri, R, Saadeh, L, Cagol, M, Baldan, I, Saraceni, E, Parotto, M, et al
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2021;(2):1025-1033
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Abstract
BACKGROUND Esophagectomy for cancer strongly impairs quality of life. The aim of this trial was to evaluate the effect of the nutritional and respiratory counseling on postoperative quality of life. METHODS At hospital discharge, patients were randomized into four groups receiving respectively: nutritional and respiratory counseling, nutritional counseling alone, respiratory counseling alone, or standard care. The main endpoint was the impairment in quality of life in the first month after surgery. Linear mixed effect models were estimated to assess mean score differences (MDs) in quality of life scores. RESULTS Patients receiving nutritional counseling reported less appetite loss (MD - 17.7, 95% CI - 32.2 to -3.3) than those not receiving nutritional counseling at 1 month after surgery. Dyspnea was similar between patients receiving vs. those not receiving respiratory counseling (MD - 3.1, 95% CI - 10.8 to 4.6). Global quality of life was clinically similar between patients receiving vs. those not receiving nutritional counseling over time (MD 0.9, 95% CI - 5.5 to 7.3), as well as in patients receiving vs. those not receiving respiratory counseling over time (MD 0.7, 95% CI - 5.9 to 7.2). CONCLUSIONS Intensive postoperative care does not affect global quality of life even if nutritional counseling reduced appetite loss.
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Managing job stress among teachers of children with autism spectrum disorders: A randomized controlled trial of cognitive behavioral therapy with yoga.
Akanaeme, IN, Ekwealor, FN, Ifeluni, CN, Onyishi, CN, Obikwelu, CL, Ohia, NC, Obayi, LN, Nwaoga, CT, Okafor, AE, Victor-Aigbodion, V, et al
Medicine. 2021;(46):e27312
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BACKGROUND Job-related stress undermines occupational, personal, and organizational outcomes. Stress symptoms are common among teachers of children with autism spectrum disorders and affect the academic progress of the children. This study investigated the effectiveness of yoga-based cognitive behavioral therapy in reducing occupational stress among teachers of children with autism in Lagos states, Nigeria. METHODS The current study adopted a group-randomized waitlist control (WLC) trial design with pre-test, posttest, and follow-up assessments. Participants included 58 teachers of children with autism in public and private special schools in Lagos state. Participants were randomly assigned to combined cognitive behavioral therapy and yoga (Y-CBT) (N = 29) and WLC (N = 29) groups. The Y-CBT group participated in a 2 hours Y-CBT program weekly for 12 weeks. Three instruments - Demographic Questionnaire, Single-Item Stress Questionnaire, and Teachers' Stress Inventory (TSI) were used to collect data. Data were collected at baseline; posttest and follow-up evaluations. Data were analyzed using means, standard deviations, t test statistics, repeated measures analysis of variance, and bar charts. RESULTS Results revealed that all dimensions of job stress (perception of stress sources, stress manifestation, and total TSI scores) reduced significantly at posttest and follow up assessments among the Y-CBT group, compared to the WLC. CONCLUSION It was concluded that Y-CBT modalities could help to minimize the perception of stress sources and stress manifestation as well as total TSI scores among teachers of children with autism spectrum disorders.
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Effects of quercetin supplementation on inflammatory factors and quality of life in post-myocardial infarction patients: A double blind, placebo-controlled, randomized clinical trial.
Dehghani, F, Sezavar Seyedi Jandaghi, SH, Janani, L, Sarebanhassanabadi, M, Emamat, H, Vafa, M
Phytotherapy research : PTR. 2021;(4):2085-2098
Abstract
Myocardial infarction (MI) is one of the leading causes of death in the world. Epidemiological studies have shown that dietary flavonoids are inversely related to cardiovascular morbidity and mortality. The study aimed to determine whether quercetin supplementation can improve inflammatory factors, total antioxidant capacity (TAC) and quality of life (QOL) in patients following MI. This randomized double-blind, placebo-controlled trial was conducted on 88 post-MI patients. Participants were randomly assigned into quercetin (n = 44) and placebo groups (n = 44) receiving 500 mg/day quercetin or placebo tablets for 8 weeks. Quercetin supplementation significantly increased serum TAC compared to placebo (Difference: 0.24 (0.01) mmol/L and 0.00 (0.00) mmol/L respectively; p < .001). TNF-α levels significantly decreased in the quercetin group (p = .009); this was not, however, significant compared to the placebo group. As for QOL dimensions, quercetin significantly lowered the scores of insecurity (Difference: -0.66 (12.5) and 0.00 (5.55) respectively; p < .001). No significant changes in IL-6, hs-CRP, blood pressure and other QOL dimensions were observed between the two groups. Quercetin supplementation (500 mg/day) in post-MI patients for 8 weeks significantly elevated TAC and improved the insecurity dimension of QOL, but failed to show any significant effect on inflammatory factors, blood pressure and other QOL dimensions.
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Cost-effectiveness analysis of a multiple health behaviour change intervention in people aged between 45 and 75 years: a cluster randomized controlled trial in primary care (EIRA study).
Aznar-Lou, I, Zabaleta-Del-Olmo, E, Casajuana-Closas, M, Sánchez-Viñas, A, Parody-Rúa, E, Bolíbar, B, Iracheta-Todó, M, Bulilete, O, López-Jiménez, T, Pombo-Ramos, H, et al
The international journal of behavioral nutrition and physical activity. 2021;(1):88
Abstract
BACKGROUND Multiple health behaviour change (MHBC) interventions that promote healthy lifestyles may be an efficient approach in the prevention or treatment of chronic diseases in primary care. This study aims to evaluate the cost-utility and cost-effectiveness of the health promotion EIRA intervention in terms of MHBC and cardiovascular reduction. METHODS An economic evaluation alongside a 12-month cluster-randomised (1:1) controlled trial conducted between 2017 and 2018 in 25 primary healthcare centres from seven Spanish regions. The study took societal and healthcare provider perspectives. Patients included were between 45 and 75 years old and had any two of these three behaviours: smoking, insufficient physical activity or low adherence to Mediterranean dietary pattern. Intervention duration was 12 months and combined three action levels (individual, group and community). MHBC, defined as a change in at least two health risk behaviours, and cardiovascular risk (expressed in % points) were the outcomes used to calculate incremental cost-effectiveness ratios (ICER). Quality-adjusted life-years (QALYs) were estimated and used to calculate incremental cost-utility ratios (ICUR). Missing data was imputed and bootstrapping with 1000 replications was used to handle uncertainty in the modelling results. RESULTS The study included 3062 participants. Intervention costs were €295 higher than usual care costs. Five per-cent additional patients in the intervention group did a MHBC compared to usual care patients. Differences in QALYS or cardiovascular risk between-group were close to 0 (- 0.01 and 0.04 respectively). The ICER was €5598 per extra health behaviour change in one patient and €6926 per one-point reduction in cardiovascular risk from a societal perspective. The cost-utility analysis showed that the intervention increased costs and has no effect, in terms of QALYs, compared to usual care from a societal perspective. Cost-utility planes showed high uncertainty surrounding the ICUR. Sensitivity analysis showed results in line with the main analysis. CONCLUSION The efficiency of EIRA intervention cannot be fully established and its recommendation should be conditioned by results on medium-long term effects. TRIAL REGISTRATION Clinicaltrials.gov NCT03136211 . Registered 02 May 2017 - Retrospectively registered.
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Smart wearable devices as a psychological intervention for healthy lifestyle and quality of life: a randomized controlled trial.
Yen, HY
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. 2021;(3):791-802
Abstract
PURPOSE Creating a healthy lifestyle is important across different life stages. Commercial smart wearable devices are an innovative and interesting approach as an early psychological intervention for modifying health-related behaviors. Therefore, the purpose of this study was to explore the effects of smart wearable devices on health-promoting lifestyles and quality of life. METHODS The study design was a three-parallel randomized controlled trial with a 3-month intervention. Two commercial smart wearable devices (smartwatches and smart bracelets) with different levels of complicated functions were applied as a psychological intervention in comparison with a smartphone app as the control group. Participants were healthy young adults with a median age of 26 years. Outcome measurements were conducted by self-administered questionnaires. Chi-square tests and ANOVA were performed for testing the difference of participants at baseline, and generalized estimating equations were performed for testing the effect of the intervention. RESULTS At the beginning, 81 participants were recruited and 73 participants completed the study. Results of a healthy lifestyle demonstrated significant group effects of exercise and a significant effect of the interaction for self-actualization and stress management in the experimental group with a smartwatch (Self-actualization: MD = 0.35[- 0.10,0.80]; Exercise: MD = 0.21[- 0.33 0.75]; Stress management: MD = 0.36[- 0.04,0.76]) by comparing with only using mobile app (Self-actualization: MD = - 0.03[- 0.25,0.18]; Exercise: MD = - 0.12[- 0.38,0.14]; Stress management, MD = - 0.28[- 0.55,0.00]). The significant effect of group-by-time interaction for self-actualization was found in the experimental group with a smart bracelet (MD = 0.05[- 0.30,0.20]) by comparing with the control group. The GEE-adjusted model indicated significant effects of the interaction on the comprehensive, physical, and mental quality of life in the experimental group with the smartwatch (Comprehensive: MD = 0.24[- 0.04,0.52]; Physical: MD = 0.67[0.26,1.09]; Mental: MD = 0.72[0.29,1.16]) by comparing with the control group (Comprehensive: MD = - 1.57[- 2.55, - 0.59]; Physical: MD = 0.25[0.00,0.50]; Mental: MD = 0.08[- 0.11,0.27]). CONCLUSION From a psychological perspective, smart wearable devices have potential benefits of shaping a healthy lifestyle and improving the quality of life. Enhancing the utility of commercial well-designed smart wearable devices is an innovative and effective strategy for promoting public health.
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Protein intake, weight loss, dietary intervention, and worsening of quality of life in older patients during chemotherapy for cancer.
Regueme, SC, Echeverria, I, Monéger, N, Durrieu, J, Becerro-Hallard, M, Duc, S, Lafargue, A, Mertens, C, Laksir, H, Ceccaldi, J, et al
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2021;(2):687-696
Abstract
Decreased health-related quality of life (HRQoL) is common in patients with cancer. We investigated the effects of dietary intervention and baseline nutritional status on worsening of HRQoL in older patients during chemotherapy. In this randomized control trial assessing the effect on mortality of dietary advice to increase dietary intake during chemotherapy, this post hoc analysis included 155 patients with cancer at risk of malnutrition. The effects of dietary intervention, baseline Mini Nutritional Assessment item scores, weight loss, and protein and energy intake before treatment on the worsening of HRQoL (physical functioning, fatigue) and secondary outcomes (Timed Up and Go test, one-leg stance time, depressive symptoms, basic (ADL), or instrumental (IADL) activities of daily living) were analyzed by multinomial regressions. Dietary intervention increased total energy and protein intake but had no effect on any examined outcomes. Worsening of fatigue and ADL was predicted by very low protein intake (< 0.8 g kg-1 day-1) before chemotherapy (OR 3.02, 95% CI 1.22-7.46, p = 0.018 and OR 5.21, 95% CI 1.18-22.73, p = 0.029 respectively). Increase in depressive symptomatology was predicted by 5.0-9.9% weight loss before chemotherapy (OR 2.68, 95% CI 1.10-6.80, p = 0.038). Nutritional intervention to prevent HRQoL decline during chemotherapy should focus on patients with very low protein intake along with those with weight loss.