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Effectiveness of Two Web-Based Interventions for Chronic Cancer-Related Fatigue Compared to an Active Control Condition: Results of the "Fitter na kanker" Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Approximately one third of all patients who have been successfully treated for cancer suffer from chronic cancer-related fatigue (CCRF). Effective and easily accessible interventions are needed for these patients. OBJECTIVE:The current paper reports on the results of a 3-armed randomized controlled trial investigating the clinical effectiveness of two different guided Web-based interventions for reducing CCRF compared to an active control condition. METHODS:Severely fatigued cancer survivors were recruited via online and offline channels, and self-registered on an open-access website. After eligibility checks, 167 participants were randomized via an embedded automated randomization function into: (1) physiotherapist-guided Ambulant Activity Feedback (AAF) therapy encompassing the use of an accelerometer (n=62); (2) psychologist-guided Web-based mindfulness-based cognitive therapy (eMBCT; n=55); or (3) an unguided active control condition receiving psycho-educational emails (n=50). All interventions lasted nine weeks. Fatigue severity was self-assessed using the Checklist Individual Strength - Fatigue Severity subscale (primary outcome) six times from baseline (T0b) to six months (T2). Mental health was self-assessed three times using the Hospital Anxiety and Depression Scale and Positive and Negative Affect Schedule (secondary outcome). Treatment dropout was investigated. RESULTS:Multiple group latent growth curve analysis, corrected for individual time between assessments, showed that fatigue severity decreased significantly more in the AAF and eMBCT groups compared to the psycho-educational group. The analyses were checked by a researcher who was blind to allocation. Clinically relevant changes in fatigue severity were observed in 66% (41/62) of patients in AAF, 49% (27/55) of patients in eMBCT, and 12% (6/50) of patients in psycho-education. Dropout was 18% (11/62) in AAF, mainly due to technical problems and poor usability of the accelerometer, and 38% (21/55) in eMBCT, mainly due to the perceived high intensity of the program. CONCLUSIONS:Both the AAF and eMBCT interventions are effective for managing fatigue severity compared to receiving psycho-educational emails. TRIAL REGISTRATION:Trialregister.nl NTR3483; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3483 (Archived by WebCite at http://www.webcitation.org/6NWZqon3o).

SUBMITTER: Bruggeman-Everts FZ

PROVIDER: S-EPMC5668634 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Effectiveness of Two Web-Based Interventions for Chronic Cancer-Related Fatigue Compared to an Active Control Condition: Results of the "Fitter na kanker" Randomized Controlled Trial.

Bruggeman-Everts Fieke Z FZ Wolvers Marije D J MDJ van de Schoot Rens R Vollenbroek-Hutten Miriam M R MMR Vollenbroek-Hutten Miriam M R MMR Van der Lee Marije L ML

Journal of medical Internet research 20171019 10

<h4>Background</h4>Approximately one third of all patients who have been successfully treated for cancer suffer from chronic cancer-related fatigue (CCRF). Effective and easily accessible interventions are needed for these patients.<h4>Objective</h4>The current paper reports on the results of a 3-armed randomized controlled trial investigating the clinical effectiveness of two different guided Web-based interventions for reducing CCRF compared to an active control condition.<h4>Methods</h4>Sever ...[more]

PMID: 29051138

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Project description:BackgroundPostpartum fatigue is the most common issue among postnatal women and it could not only seriously affect the health of mothers but also bring about adverse impacts on their offspring. This meta-analysis aims to synthesize nonpharmacological evidence and evaluate the effectiveness of interventions for reducing postpartum fatigue among puerperae.MethodsThe Cochrane Library, PubMed, Embase, Web of Science, PsycINFO, CINAHL and ProQuest databases were searched for papers published from inception until June 2021. Grey literature was searched using OpenGrey. Randomized controlled trials (RCTs) or controlled clinical trials (CCTs) evaluating nonpharmacological interventions conducted during 0 ~ 78 weeks postpartum for fatigue reduction were eligible for inclusion. The methodological quality of the included studies was independently assessed by two reviewers using the Cochrane risk-of-bias tool and the risk of bias in nonrandomized studies of interventions. Cohen's kappa coefficient was used to measure inter-rater agreement. The meta-analysis was conducted using Review Manager 5.3.ResultsSeventeen published clinical trials matched the eligibility criteria and ten studies involving 1194 participants were included in this meta-analysis. The intervention start time varied from immediately postpartum care to 1 year after delivery, and duration ranged from 1 day to 3 months. The results revealed that exercise (SMD = - 1.74, 95% CI = -2.61 to - 0.88) and drinking tea (MD = - 3.12, 95% CI = -5.44 to - 0.80) resulted in significant improvements in women's postpartum fatigue at postintervention. Drinking tea may have beneficial effects on depression (MD = - 2.89, 95% CI = -4.30 to - 1.49). Positive effects of psychoeducational interventions on postpartum fatigue or depression were not observed. Physical therapies including mother-infant skin-to-skin contact, taking warm showers and breathing lavender oil aroma were used for reducing postpartum fatigue. No significant risk of publication bias was found. Small number of included studies and sample sizes, not time-matched conditions of control groups, high heterogeneity and the risk of bias within the included studies were the main limitations of our review.ConclusionsThis review provides evidence that exercise and drinking tea may be effective nonpharmacological interventions for relieving postpartum fatigue. More effective and targeted exercise programs need to be further studied. Rigorous RCTs of drinking tea are needed. Caution is required when interpreting the findings due to the limitations of our study. Further studies are still needed to validate our findings and increase confidence in the results.

Project description:IntroductionPostpartum fatigue is a common symptom among new mothers after their pregnancy. It has a considerable negative impact on women's functional and mental status as well as the development of babies. Identifying effective interventions to prevent or reduce postpartum fatigue is meaningful to improve the quality of life and avoid adverse outcomes of this vulnerable population. This systematic review aims to synthesise non-pharmacological evidence and evaluate the effectiveness of interventions for reducing postpartum fatigue among puerperas.Methods and analysisThis review will be conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. We will systematically search the Cochrane Library, PubMed, Embase, Web of Science, PsycINFO, CINAHL and ProQuest databases to identify clinical trials implementing non-pharmacological interventions conducted during 0-78 weeks postpartum for fatigue reduction. An additional search of OpenGrey will be conducted to identify grey literature. The search will be performed on 30 March 2021 without restrictions on time and language. Two independent reviewers will be responsible for study selection, data extraction and study quality assessment. The Cochrane risk-of-bias tool will be adopted to evaluate the risk biases of the included randomised controlled trials, and the Risk of Bias in Non-randomised Studies of Interventions will be applied to evaluate non-randomised controlled trials. Any disagreements will be referred to a third reviewer to reach a consensus. Findings will be qualitatively synthesised, and a meta-analysis will be conducted for the statistical combination if outcome data are sufficient and available.Ethics and disseminationThis systematic review will not involve the collection of primary data and will be based on published data. Therefore, ethics approval is not required. The final findings will be disseminated through peer-reviewed journals and academic conferences.Prospero registration numberCRD42021234869.

Project description:BackgroundActive school transport (AST) is a promising strategy to increase children's physical activity. A systematic review published in 2011 found large heterogeneity in the effectiveness of interventions in increasing AST and highlighted several limitations of previous research. We provide a comprehensive update of that review.MethodsReplicating the search of the previous review, we screened the PubMed, Web of Science, Cochrane, Sport Discus and National Transportation Library databases for articles published between February 1, 2010 and October 15, 2016. To be eligible, studies had to focus on school-aged children and adolescents, include an intervention related to school travel, and report a measure of travel behaviors. We assessed quality of individual studies with the Effective Public Health Practice Project quality assessment tool, and overall quality of evidence with the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach. We calculated Cohen's d as a measure of effect size.ResultsOut of 6318 potentially relevant articles, 27 articles reporting 30 interventions met our inclusion criteria. Thirteen interventions resulted in an increase in AST, 8 found no changes, 4 reported inconsistent results, and 5 did not report inferential statistics. Cohen's d ranged from -0.61 to 0.75, with most studies reporting "trivial-to-small" positive effect sizes. Three studies reported greater increases in AST over longer follow-up periods and two Safe Routes to School studies noted that multi-level interventions were more effective. Study quality was rated as weak for 27/30 interventions (due notably to lack of blinding of outcome assessors, unknown psychometric properties of measurement tools, and limited control for confounders), and overall quality of evidence was rated as low. Evaluations of implementation suggested that interventions were limited by insufficient follow-up duration, incomplete implementation of planned interventions, and limited access to resources for low-income communities.ConclusionsInterventions may increase AST among children; however, there was substantial heterogeneity across studies and quality of evidence remains low. Future studies should include longer follow-ups, use standardized outcome measures (to allow for meta-analyses), and examine potential moderators and mediators of travel behavior change to help refine current interventions.Trial registrationRegistered in PROSPERO: CRD42016033252.

Project description:IntroductionChronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) has profound quality of life and economic consequences for individuals, their family, formal services and wider society. Little is known about which therapeutic interventions are more cost-effective.ObjectiveA systematic review was carried out to identify and critically appraise the evidence on the cost-effectiveness of CFS/ME interventions.MethodsThe review protocol was prespecified (PROSPERO: CRD42018118731). Searches were carried out across two databases-MEDLINE (1946-2020) and EMBASE (1974-2020). Additional studies were identified by searching reference lists. Only peer-reviewed journal articles of full economic evaluations examining CFS/ME interventions were included. Trial- and/or model-based economic evaluations were eligible. Data extraction and screening were carried out independently by two reviewers. The methodological quality of the economic evaluation and trial were assessed using the Consensus Health Economic Criteria checklist (CHEC-list) and Risk of Bias-2 (RoB-2) tool, respectively. A narrative synthesis was used to summarise the economic evidence for interventions for adults and children in primary and secondary care settings.ResultsTen economic evaluations, all based on data derived from randomised controlled trials, met our eligibility criteria. Cognitive behavioural therapy (CBT) was evaluated across five studies, making it the most commonly evaluated intervention. There was evidence from three trials to support CBT as a cost-effective treatment option for adults; however, findings on CBT were not uniform, suggesting that cost-effectiveness may be context-specific. A wide array of other interventions were evaluated in adults, including limited evidence from two trials supporting the cost effectiveness of graded exercise therapy (GET). Just one study assessed intervention options for children. Our review highlighted the importance of informal care costs and productivity losses in the evaluation of CFS/ME interventions.ConclusionsWe identified a limited patchwork of evidence on the cost-effectiveness of interventions for CFS/ME. Evidence supports CBT as a cost-effective treatment option for adults; however, cost-effectiveness may depend on the duration and frequency of sessions. Limited evidence supports the cost effectiveness of GET. Key weaknesses in the literature included small sample sizes and short duration of follow-up. Further research is needed on pharmacological interventions and therapies for children.

Project description:BackgroundFactors contributing to subjective fatigue in people with idiopathic Parkinson's disease (PD) are not well known. This makes it difficult to manage fatigue effectively in PD.ObjectivesTo evaluate the effects of pharmacological and non-pharmacological interventions, compared to an inactive control intervention, on subjective fatigue in people with PD.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); MEDLINE (via PubMed); Ovid EMBASE; EBSCO CINAHL; Ovid PsycINFO; PEDro; and the WHO International Clinical Trials Registry Platform Search Portal up to April 2015. References of included studies and identified review articles were screened for additional studies. There were no restrictions based on language, date of publication or study setting.Selection criteriaRandomised controlled trials (RCTs) that report on subjective fatigue in people with PD.Data collection and analysisTwo review authors independently performed study selection, data collection and risk of bias assessments.Main resultsEleven studies were eligible for this systematic review, with a total of 1817 people. Three studies included only people who experienced clinically relevant fatigue (Fatigue Severity Scale score ≥ 4 out of 7 or Multidimensional Fatigue Inventory total score > 48 out of 100), whereas all other studies did not select participants on the basis of experienced fatigue. Nine studies investigated the effects of medication (i.e. levodopa-carbidopa, memantine, rasagiline, caffeine, methylphenidate, modafinil or doxepin) on subjective fatigue. All studies were placebo controlled. There was insufficient evidence to determine the effect of doxepin on the impact of fatigue on activities in daily life (ADL) or fatigue severity (one study, N = 12, standardised mean difference (SMD) = -1.50, 95% confidence interval (CI) -2.84 to -0.15; low quality evidence). We found high quality evidence that rasagiline reduced or slowed down the progression of physical aspects of fatigue (one study, N = 1176, SMD = -0.27, 95% CI -0.39 to -0.16, I(2) = 0%). None of the other pharmacological interventions affected subjective fatigue in PD. With regard to adverse effects, only levodopa-carbidopa showed an increase for the risk of nausea (one study, N = 361, risk ratio (RR) = 1.85, 95% CI 1.05 to 3.27; high quality evidence). Two studies investigated the effect of exercise on fatigue compared with usual care. We found low quality evidence for the effect of exercise on reducing the impact of fatigue on ADL or fatigue severity (two studies, N = 57, SMD = -0.45, 95% CI -1.21 to 0.32, I(2) = 44%).Authors' conclusionsBased on the current evidence, no clear recommendations for the treatment of subjective fatigue in PD can be provided. Doxepin may reduce the impact of fatigue on ADL and fatigue severity; however, this finding has to be confirmed in high quality studies. Rasagiline may be effective in reducing levels of physical fatigue in PD. No evidence was found for the effectiveness of levodopa-carbidopa, memantine, caffeine, methylphenidate, modafinil or exercise. Studies are needed to investigate the effect of exercise intensity on exercise capacity and subjective fatigue. Future studies should focus on interventions that address the maladaptive behavioural or cognitive aspects of fatigue in people with PD. Characteristics, such as severity and nature of perceived fatigue and underlying mood disorders should be considered to identify responders and non-responders when studying interventions for fatigue. The development of a core-set of self-report fatigue questionnaires with established responsiveness and known minimal important difference values will facilitate the interpretation of change in fatigue scores.

Project description:BackgroundBest outpatient treatment of nonspecific chronic low back pain is high-dosed exercise that is maintained after therapy. Primary care biopsychosocial intervention (PCBI) is an outpatient multicomponent intervention that includes an active component (exercise, physical activity, or physiotherapy) and at least one psychological, social, or occupational component. Research has shown that PCBI can reduce pain intensity and disability. While scattered studies support low-dosed (<15 treatment hours) PCBI, there is no systematic review comparing the effectiveness of low-dosed PCBI treatment with traditional physical activity interventions in adults with nonspecific chronic low back pain (CLBP).Inclusion criteriaRandomised controlled trials that evaluate low-dosed outpatient biopsychosocial interventions compared to physical treatment with an active component such as exercise, physical activity or usual physiotherapy treatment for adult participants (18 years or older) who suffer from nonspecific CLBP will be included.MethodsA comprehensive search of multiple databases will be used to find relevant studies. The databases will be searched from inception to December 2021, with English or German language restrictions imposed. Keywords and derivatives of "chronic back pain", "exercise intervention", "cognitive-behavioral therapy", "primary care" and "randomized controlled trials" will be used. Sources will include CINAHL, Cochrane Central Register of Controlled Trials (CENTRAL), Ovid Medline, Physiotherapy Evidence Database (PEDro), PubMed and Web of Science.DiscussionTo our knowledge, this will be the first systematic review and meta-analysis of narrowly defined low- dosed PCBI across populations with nonspecific chronic low back pain. The objective of this review is to evaluate the effectiveness of low-dosed outpatient biopsychosocial interventions versus physical active interventions on pain intensity and disability in adults with CLBP. This study will provide evidence that could improve treatment options for patients with nonspecific CLBP.Trail registrationSystematic review registration number: PROSPERO 2022 CRD42022302771. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022302771.

Dataset Information

Effectiveness of Two Web-Based Interventions for Chronic Cancer-Related Fatigue Compared to an Active Control Condition: Results of the "Fitter na kanker" Randomized Controlled Trial.

Publications

Effectiveness of Two Web-Based Interventions for Chronic Cancer-Related Fatigue Compared to an Active Control Condition: Results of the "Fitter na kanker" Randomized Controlled Trial.

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