Effects of nonpharmacological interventions on symptom clusters in breast cancer survivors: A systematic review of randomized controlled trials
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SUBMITTER: Li M
PROVIDER: S-EPMC10909965 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundPhysical activity (PA) has been shown to improve total mortality and colorectal-specific mortality risk; however, colorectal cancer (CRC) survivors have lower rates of PA compared with survivors with other types of cancers.ObjectiveTo examine the effect of PA interventions on CRC survivors.MethodsA systematic review and meta-analysis were conducted to identify randomized controlled trials that met the inclusion criteria, which included an intervention designed to increase PA and more than 1 outcome of interest. Random effects of the meta-analyses were performed using Review Manager 5.3.ResultsEight publications representing 7 randomized controlled trials of 803 participants were identified. All studies used a combination of behavioral change methods. Physical activity interventions significantly improved disease-specific quality of life, PA level, and maximum amount of oxygen and did not show significant improvements for fatigue and body mass index among CRC survivors.ConclusionsWe provided evidence that PA interventions were effective in improving disease-specific quality of life, PA level, and maximum amount of oxygen; however, they did not improve fatigue and body mass index. Further randomized controlled trials are needed to determine the optimal mode of delivering PA intervention for CRC survivors.Implications for practiceAs the survival rate of patients with CRC increases, survivors of CRC need to increase PA in a community setting after completing primary treatments. Effective and efficient modes of PA intervention delivery could improve health-related outcomes and address specific barriers for CRC survivors.
| S-EPMC8560161 | biostudies-literature
Project description:This systematic review evaluated the effectiveness of psychological interventions for reducing vaccination pain and related outcomes in children and adolescents.Database searches identified relevant randomized and quasi-randomized controlled trials. Data were extracted and pooled using established methods. Pain, fear, and distress were considered critically important outcomes.Twenty-two studies were included; 2 included adolescents. Findings showed no benefit of false suggestion (n=240) for pain (standardized mean difference [SMD] -0.21 [-0.47, 0.05]) or distress (SMD -0.28 [-0.59, 0.11]), or for use of repeated reassurance (n=82) for pain (SMD -0.18 [-0.92, 0.56]), fear (SMD -0.18 [-0.71, 0.36]), or distress (SMD 0.10 [-0.33, 0.54]). Verbal distraction (n=46) showed reduced distress (SMD -1.22 [-1.87, -0.58]), but not reduced pain (SMD -0.27 [-1.02, 0.47]). Similarly, video distraction (n=328) showed reduced distress (SMD -0.58 [-0.82, -0.34]), but not reduced pain (SMD -0.88 [-1.78, 0.02]) or fear (SMD 0.08 [-0.25, 0.41]). Music distraction demonstrated reduced pain when used with children (n=417) (SMD -0.45 [-0.71, -0.18]), but not with adolescents (n=118) (SMD -0.04 [-0.42, 0.34]). Breathing with a toy (n=368) showed benefit for pain (SMD -0.49 [-0.85, -0.13]), but not fear (SMD -0.60 [-1.22, 0.02]); whereas breathing without a toy (n=136) showed no benefit for pain (SMD -0.27 [-0.61, 0.07]) or fear (SMD -0.36 [-0.86, 0.15]). There was no benefit for a breathing intervention (cough) in children and adolescents (n=136) for pain (SMD -0.17 [-0.41, 0.07]).Psychological interventions with some evidence of benefit in children include: verbal distraction, video distraction, music distraction, and breathing with a toy.
| S-EPMC4900411 | biostudies-other
Project description:BackgroundThis systematic review evaluated the effectiveness of process interventions (education for clinicians, parent presence, education of parents [before and on day of vaccination], and education of patients on day of vaccination) on reducing vaccination pain, fear, and distress and increasing the use of interventions during vaccination.Design/methodsDatabases were searched using a broad search strategy to identify relevant randomized and quasi-randomized controlled trials. Critical outcomes were pain, fear, distress (when applicable), and use of pain management interventions. Data were extracted according to procedure phase (preprocedure, acute, recovery, combinations of these) and pooled using established methods. Analyses were conducted using standardized mean differences (SMD) and risk ratios (RR).ResultsThirteen studies were included. Results were generally mixed. On the basis of low to very low-quality evidence, the following specific critical outcomes showed significant effects suggesting: (1) clinicians should be educated about vaccine injection pain management (use of interventions: SMD 0.66; 95% confidence interval [CI]: 0.47, 0.85); (2) parents should be present (distress preprocedure: SMD -0.85; 95% CI: -1.35, -0.35); (3) parents should be educated before the vaccination day (use of intervention preprocedure: SMD 0.83; 95% CI: 0.25, 1.41 and RR, 2.08; 95% CI: 1.51, 2.86; distress acute: SMD, -0.35; 95% CI: -0.57, -0.13); (4) parents should be educated on the vaccination day (use of interventions: SMD 1.02; 95% CI: 0.22, 1.83 and RR, 2.42; 95% CI: 1.47, 3.99; distress preprocedure+acute+recovery: SMD -0.48; 95% CI: -0.82, -0.15); and (5) individuals 3 years of age and above should be educated on the day of vaccination (fear preprocedure: SMD -0.67; 95% CI: -1.28, -0.07).ConclusionsEducating individuals involved in the vaccination procedure (clinicians, parents of children being vaccinated; individuals above 3 y of age) is beneficial to increase use of pain management strategies, reduce distress surrounding with vaccination, and to reduce fear. When possible, parent presence is also recommended for children undergoing vaccination.
| S-EPMC4900433 | biostudies-literature
Project description:Patient-centered decision making about hot flash treatments often incorporates a balance of efficacy and side effects in addition to patient preference. This systematic review examines randomized controlled trials (RCTs) comparing at least two non-hormonal hot flash treatments in breast cancer survivors. In July 2015, PubMed, SCOPUS, CINAHL, Cochrane, and Web of Science databases were searched for RCTs comparing active, non-hormonal hot flash treatments in female breast cancer survivors. Thirteen trials were included after identifying 906 potential studies. Four trials were dose comparison studies of pharmacologic treatments citalopram, venlafaxine, gabapentin, and paroxetine. Hot flash reduction did not differ by tamoxifen or aromatase inhibitor use. Citalopram 10, 20, and 30 mg daily had comparable outcomes. Venlafaxine 75 mg daily improved hot flashes without additional side effects from higher dosing. Gabapentin 900 mg daily improved hot flashes more than 300 mg. Paroxetine 10 mg daily had fewer side effects than 20 mg. Among four trials comparing different pharmacologic treatments, venlafaxine alleviated hot flash symptoms faster than clonidine; participants preferred venlafaxine over gabapentin. Five trials compared pharmacologic to non-pharmacologic treatments. Acupuncture had similar efficacy to venlafaxine and gabapentin but may have longer durability after completing treatment and fewer side effects. We could not perform a pooled meta-analysis because outcomes were not reported in comparable formats. Clinical trial data on non-hormonal hot flash treatments provide comparisons of hot flash efficacy and other patient important outcomes to guide clinical management. Clinicians can use the information to help patients select hot flash interventions.
| S-EPMC4838539 | biostudies-literature
Project description:ObjectiveTo evaluate the effects of mobile health (mHealth) diet interventions on cancer survivors' diet intake, weight change, waist circumference, hip circumference, and quality of life (QoL).MethodsThe PubMed, Embase, Web of Science, Cochrane Library, Scopus, ProQuest, China National Knowledge Infrastructure, Wanfang, and SinoMed databases were searched from their inception to September 25, 2022. Randomized controlled trials (RCTs) on the effects of mHealth diet interventions in cancer survivors were identified. Two researchers independently selected the included studies and appraised their quality. The methodological quality of the included studies was assessed using the Revised Cochrane risk-of-bias tool for RCTs (RoB2).ResultsA total of 15 RCTs involving 2363 cancer survivors were included. MHealth diet interventions significantly improved fruit and vegetable intake (standardized mean difference [SMD] = 0.19, 95% confidence interval [CI] [0.05, 0.33], P < 0.01), and QoL (SMD = 0.13, 95% CI [0.01, 0.26], P = 0.04) and reduced fat intake (SMD = -0.22, 95% CI [-0.34, -0.11], P < 0.01), weight (SMD = -0.35, 95% CI [-0.48, -0.22], P < 0.01), waist circumference (MD = -1.43, 95% CI [-2.33, -0.53], P < 0.01), and hip circumference (MD = -3.54, 95% CI [-4.88, -2.19], P < 0.01) in cancer survivors. No significant differences were observed in energy intake (P = 0.46) or whole grain intake (P = 0.14).ConclusionsMHealth diet interventions may be an effective strategy for cancer survivors. Large-scale RCTs with rigorous study designs are needed to examine the effect of diet intervention delivered via mHealth.
| S-EPMC10140457 | biostudies-literature
Project description:The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs) of patient education.On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health) and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers.We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%). The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47%) or active treatment (47%). A minority of records (17%, 95% CI 11 to 23%) reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention). Further, for most reports (59%), important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63%. Information about the caregivers was missing for 70% of trials. Most trials (73%) took place in the United States or United Kingdom, 64% involved only one centre, and participating centers were mainly tertiary-care, academic or university hospitals (51%).Educational interventions assessed in ongoing RCTs of educational interventions are poorly described in trial registries. The lack of adequate description raises doubts about the ability of trial registration to help patients and researchers know about the treatment evaluated in trials of education.
| S-EPMC3503701 | biostudies-other
Project description:BackgroundThis systematic review evaluated the effectiveness of physical and procedural interventions for reducing pain and related outcomes during vaccination.Design/methodsDatabases were searched using a broad search strategy to identify relevant randomized and quasi-randomized controlled trials. Data were extracted according to procedure phase (preprocedure, acute, recovery, and combinations of these) and pooled using established methods.ResultsA total of 31 studies were included. Acute infant distress was diminished during intramuscular injection without aspiration (n=313): standardized mean difference (SMD) -0.82 (95% confidence interval [CI]: -1.18, -0.46). Injecting the most painful vaccine last during vaccinations reduced acute infant distress (n=196): SMD -0.69 (95% CI: -0.98, -0.4). Simultaneous injections reduced acute infant distress compared with sequential injections (n=172): SMD -0.56 (95% CI: -0.87, -0.25). There was no benefit of simultaneous injections in children. Less infant distress during the acute and recovery phases combined occurred with vastus lateralis (vs. deltoid) injections (n=185): SMD -0.70 (95% CI: -1.00, -0.41). Skin-to-skin contact in neonates (n=736) reduced acute distress: SMD -0.65 (95% CI: -1.05, -0.25). Holding infants reduced acute distress after removal of the data from 1 methodologically diverse study (n=107): SMD -1.25 (95% CI: -2.05, -0.46). Holding after vaccination (n=417) reduced infant distress during the acute and recovery phases combined: SMD -0.65 (95% CI: -1.08, -0.22). Self-reported fear was reduced for children positioned upright (n=107): SMD -0.39 (95% CI: -0.77, -0.01). Non-nutritive sucking (n=186) reduced acute distress in infants: SMD -1.88 (95% CI: -2.57, -1.18). Manual tactile stimulation did not reduce pain across the lifespan. An external vibrating device and cold reduced pain in children (n=145): SMD -1.23 (95% CI: -1.58, -0.87). There was no benefit of warming the vaccine in adults. Muscle tension was beneficial in selected indices of fainting in adolescents and adults.ConclusionsInterventions with evidence of benefit in select populations include: no aspiration, injecting most painful vaccine last, simultaneous injections, vastus lateralis injection, positioning interventions, non-nutritive sucking, external vibrating device with cold, and muscle tension.
| S-EPMC4900423 | biostudies-literature
Project description:This systematic review and meta-analysis was designed to determine the efficacy of mindfulness-based interventions (MBIs) in improving fatigue-related outcomes in adult cancer survivors. Randomized controlled trials (RCTs) were identified from PubMed, MEDLINE, PsycINFO, CINAHL, Web of Science, and EMBASE databases and reference lists of included studies. Separate random-effects meta-analyses were conducted for fatigue and vitality/vigor. Twenty-three studies reporting on 21 RCTs (N = 2239) met inclusion criteria. MBIs significantly reduced fatigue compared to controls at post-intervention (g = 0.60, 95 % CI [0.36, 0.83]) and first follow-up (g = 0.42, 95 % CI [0.20, 0.64]). Likewise, MBIs significantly improved vitality/vigor at post-intervention (g = 0.39, 95 % CI [0.25, 0.52]) and first follow-up (g = 0.35, 95 % CI [0.03, 0.67]). The evidence grade was low due to risk of bias, substantial heterogeneity, and publication bias among studies. MBIs show promise in improving fatigue and vitality/vigor in cancer survivors. More rigorous trials are needed to address current gaps in the evidence base.
| S-EPMC8200642 | biostudies-literature
Project description:ObjectiveAs the population with multiple chronic conditions (MCC) increases, it is essential that randomized controlled trials (RCTs) consider MCC. Behavioral interventions have the potential to positively impact MCC patient outcomes; however, a comprehensive review of consideration of MCC in these trials has not been conducted. The purpose of this systematic review is to determine the frequency with which participants with MCC are represented in behavioral intervention RCTs targeting chronic illness published 2000-2014.MethodMEDLINE and EMBASE were searched from 2000 to 2014 to identify RCTs testing behavioral interventions among adults with chronic illness. A random sampling selection process was performed to identify 600 eligible studies representative of the literature. Two reviewers independently extracted information on consideration of MCC in eligibility criteria and evaluated the reporting and consideration of MCC in trial analyses. Risk of bias was assessed using the Cochrane Collaboration Risk of Bias Tool.ResultsIn 600 behavioral intervention RCTs, targeting MCC was rare (4.3%). Exclusion of MCC was common (68.3%) and was done through general, specific, or vague exclusion criteria. 218 (36.3%) trials reported presence of MCCs through general or condition-specific measures. Comorbidities were only considered in 4.8% of all trial analyses.ConclusionsIn this comprehensive systematic review of 600 studies published from 2000-2014, RCTs testing behavioral interventions rarely consider individuals with MCC, limiting generalizability. Given the public health relevance and limited evidence base, this work highlights the urgent need to improve the consideration of MCC in clinical trial research. (PsycINFO Database Record (c) 2019 APA, all rights reserved).
| S-EPMC6983953 | biostudies-literature
Project description:BackgroundThis systematic review evaluated the effectiveness of exposure-based psychological and physical interventions for the management of high levels of needle fear and/or phobia and fainting in children and adults.Design/methodsA systematic review identified relevant randomized and quasi-randomized controlled trials of children, adults, or both with high levels of needle fear, including phobia (if not available, then populations with other specific phobias were included). Critically important outcomes were self-reported fear specific to the feared situation and stimulus (psychological interventions) or fainting (applied muscle tension). Data were pooled using standardized mean difference (SMD) or relative risk with 95% confidence intervals.ResultsThe systematic review included 11 trials. In vivo exposure-based therapy for children 7 years and above showed benefit on specific fear (n=234; SMD: -1.71 [95% CI: -2.72, -0.7]). In vivo exposure-based therapy with adults reduced fear of needles posttreatment (n=20; SMD: -1.09 [-2.04, -0.14]) but not at 1-year follow-up (n=20; SMD: -0.28 [-1.16, 0.6]). Compared with single session, a benefit was observed for multiple sessions of exposure-based therapy posttreatment (n=93; SMD: -0.66 [-1.08, -0.24]) but not after 1 year (n=83; SMD: -0.37 [-0.87, 0.13]). Non in vivo e.g., imaginal exposure-based therapy in children reduced specific fear posttreatment (n=41; SMD: -0.88 [-1.7, -0.05]) and at 3 months (n=24; SMD: -0.89 [-1.73, -0.04]). Non in vivo exposure-based therapy for adults showed benefit on specific fear (n=68; SMD: -0.62 [-1.11, -0.14]) but not procedural fear (n=17; SMD: 0.18 [-0.87, 1.23]). Applied tension showed benefit on fainting posttreatment (n=20; SMD: -1.16 [-2.12, -0.19]) and after 1 year (n=20; SMD: -0.97 [-1.91, -0.03]) compared with exposure alone.ConclusionsExposure-based psychological interventions and applied muscle tension show evidence of benefit in the reduction of fear in pediatric and adult populations.
| S-EPMC4900415 | biostudies-literature