scholarly journals 45 Cognitive rehabilitation in neuro-oncology: Program development and evaluation

2018 ◽  
Vol 45 (S3) ◽  
pp. S9-S9
Author(s):  
NM Richard ◽  
WP Mason ◽  
D Shultz ◽  
N Laperriere ◽  
BA Millar ◽  
...  
Keyword(s):  
Brain Tumor ◽  
Executive Functions ◽  
Cognitive Rehabilitation ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Management Training ◽  
Strategy Training ◽  
Family Quality Of Life ◽  
Tumor Patients

Background: Brain tumors present unique challenges to patient and family quality of life (QOL). Cognitive dysfunction is common and functionally limiting, with no established treatments. These studies evaluate feasibility and preliminary efficacy of behavioral interventions developed for neuro-oncology patients. Study 1: A randomized controlled trial (N=25 primary brain tumor patients) compared an adapted version of Goal Management Training (GMT, a neuroscience-based integration of mindfulness and strategy training) and a newly-designed supportive psychoeducational intervention (Brain Health Program, BHP) to standard of care. Each intervention comprised 8 individual sessions and at-home practice between sessions. GMT patients’ executive functions improved immediately (p=.077, d=1.13), with maintenance at 4-month follow-up (p=.046, d=1.09). Both intervention groups reported improvements in everyday cognitive functioning immediately (p=.049; d’s GMT=0.43, BHP=0.79) and at follow-up (p=.001; d’s GMT=0.22, BHP=1.01). BHP patients also reported improved mood (p’s=.026 & .012, d’s=0.61 & 0.62). Study 2: Following a needs assessment about cognitive concerns and QOL in brain metastases patients (N=109) and caregivers (N=31), we developed a novel, brief (3 sessions + homework) Cognitive Support Program to provide education and strategy-training in key areas of concern: executive functions, memory, and communication. Options include caregiver co-training, and in-person or web-based delivery. Preliminary data from a pilot trial in progress demonstrate objective and subjective improvements. Conclusions: Cognitive rehabilitation may be a feasible and effective option for primary or metastatic brain tumor patients, addressing a need that is largely unmet in standard cancer care. Further development and larger trials appear warranted, with capacity for remote delivery recommended.

scholarly journals Study Protocol for a Randomized Controlled Trial Evaluating the Efficacy of an Evidence-Based iPad-App for Cognitive Rehabilitation in Patients with Primary Brain Tumors

Neurosurgery ◽  
2018 ◽  
Vol 85 (2) ◽  
pp. 273-279 ◽  
Author(s):  
Sophie Dorothee van der Linden ◽  
Margriet Maria Sitskoorn ◽  
Geert-Jan Maria Rutten ◽  
Karin Gehring
Keyword(s):  
Randomized Controlled Trial ◽  
Brain Tumor ◽  
Brain Tumors ◽  
Cognitive Rehabilitation ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Control Group ◽  
Tumor Patients ◽  
Primary Brain Tumors ◽  
Randomized Controlled

Abstract BACKGROUND Many patients with primary brain tumors suffer from cognitive deficits, which negatively impact their quality of life. However, cognitive rehabilitation programs for these patients are scarce. We developed an iPad-based cognitive rehabilitation program for brain tumor patients, which was based on our effective face-to-face cognitive rehabilitation program. After successful completion of a feasibility study, a randomized controlled trial has been started. OBJECTIVE To evaluate the immediate and long-term effects of the iPad-based program on cognitive performance and patient-reported outcome measures (PROMs) in patients with primary brain tumors in an early stage of the disease. METHODS Prior to surgery, patients with presumed low-grade glioma and meningioma are included. Before surgery and 3 mo after surgery, neuropsychological assessments are conducted. After the second neuropsychological assessment, patients are assigned to the intervention group or waiting-list control group. The intervention consists of psychoeducation, compensation training, and retraining. Patients are advised to spend 3 h per week on the program for 10 wk. Immediately after completion of the program and a half-year thereafter, postintervention assessments take place. Patients in the control group are offered the opportunity to follow the program after all study assessments. EXPECTED OUTCOMES We expect that early cognitive rehabilitation has beneficial effects on cognitive performance and PROMs in brain tumor patients. DISCUSSION The iPad-based program allows brain tumor patients to follow a cognitive rehabilitation program from their homes. Forthcoming results may contribute to further improvement of supportive care for brain tumor patients.

Cognitive rehabilitation for executive dysfunction in brain tumor patients: a pilot randomized controlled trial

2019 ◽  
Vol 142 (3) ◽  
pp. 565-575 ◽  
Author(s):  
Nadine M. Richard ◽  
Lori J. Bernstein ◽  
Warren P. Mason ◽  
Normand Laperriere ◽  
Catherine Maurice ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Brain Tumor ◽  
Cognitive Rehabilitation ◽  
Controlled Trial ◽  
Executive Dysfunction ◽  
Tumor Patients ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Cognitive rehabilitation for brain tumor survivors: A pilot study.

2016 ◽  
Vol 34 (3_suppl) ◽  
pp. 140-140
Author(s):  
Nadine M. Richard ◽  
Lori J. Bernstein ◽  
Warren P. Mason ◽  
Normand Laperriere ◽  
Caroline Chung ◽  
...  
Keyword(s):  
Brain Tumor ◽  
Pilot Study ◽  
Cognitive Dysfunction ◽  
Cognitive Rehabilitation ◽  
Statistical Significance ◽  
Executive Dysfunction ◽  
Management Training ◽  
Strategy Training ◽  
Individual Treatment ◽  
Behavioral Regulation

140 Background: Brain tumor survivors often face unique challenges from chronic cognitive deficits such as memory problems or executive dysfunction. Cognitive rehabilitation is a relatively new field. With few well-controlled studies in cancer patients, oncology and supportive care teams lack accessible, reliable tools to address cognitive dysfunction. This pilot study evaluated the feasibility and potential efficacy of two behavioral interventions for brain tumor survivors. Methods: We compared two programs, each with 8 individual treatment sessions and daily homework. Goal Management Training (GMT) is a neuroscience-based integration of mindfulness and strategy training. The Brain Health Workshop (BHW) offers supportive psychoeducation about living with a brain tumor. Using a prospective randomized design, 6 brain tumor patients (with chronic cognitive dysfunction, ≥ 3 months post-radiation or surgery) were enrolled in GMT or BHW and completed a battery of measures at baseline and post-training. Composite scores were calculated by domain, with objective tests of attention, processing speed, memory, and executive functioning, and subjective measures of coping, mood, behavioral regulation and cognitive symptoms. Patient feedback was obtained in post-training qualitative interviews. Results: All patients (Table 1) completed all study activities. Analyses of group differences in composite change scores showed greater improvement in executive functions and greater attainment of pre-training functional goals in the GMT group (p's < .05). The BHW group showed a trend toward greater improvement in mood and behavioral regulation that did not reach statistical significance. Patients in both groups reported satisfaction with their program and continued, frequent (daily to every other day) use of their new knowledge following training. Conclusions: This pilot study demonstrated the feasibility of cognitive rehabilitation for brain tumor survivors between 1 and 8 years post-diagnosis. Results suggest unique benefits of each intervention that will be further explored in a larger clinical trial. [Table: see text]

scholarly journals eHealth cognitive rehabilitation for brain tumor patients: results of a randomized controlled trial

2021 ◽  
Author(s):  
Sophie D. van der Linden ◽  
Geert-Jan M. Rutten ◽  
Linda Dirven ◽  
Martin J. B. Taphoorn ◽  
Djaina D. Satoer ◽  
...  
Keyword(s):  
Brain Tumor ◽  
Cognitive Rehabilitation ◽  
Patient Reported Outcomes ◽  
Intervention Group ◽  
Cognitive Outcomes ◽  
Strategy Training ◽  
Control Group ◽  
Low Grade ◽  
Tumor Patients ◽  
Patient Reported

Abstract Background Evidence-based cognitive rehabilitation programs for brain tumor patients are not widely available, despite the high need. We aimed to evaluate the effects of a tablet-based cognitive rehabilitation program on cognitive performance, cognitive complaints, fatigue, and psychological distress in primary brain tumor patients following neurosurgery. Also, attrition, adherence and patient satisfaction with the program were evaluated. Methods Adults with presumed low-grade glioma and meningioma were recruited before surgery. Three months thereafter, participants were allocated to the intervention group or waiting-list control group using minimization. The 10-week eHealth app ReMind, based on the effective face-to-face intervention, consisted of psychoeducation, strategy-training and attention retraining. Performance-based cognitive outcomes and patient-reported outcomes were assessed before surgery and 3, 6 and 12 months thereafter. Mean scores, percentages of cognitively impaired individuals and reliable change indices (RCIs) were compared between groups. Results Sixty-two out of 183 eligible patients were randomized. Of the people who declined, 56% reported that participation would to be too burdensome. All participants found a tablet-app suitable for delivery of cognitive rehabilitation and 90% rated the program as “good” or “excellent”. Performance-based cognitive outcomes and patient-reported outcomes did not significantly differ in group means over time nor RCIs between the intervention (final n = 20) and control group (final n = 25). Conclusions Recruitment at this early stage was difficult, resulting in limited statistical power. No significant effects were demonstrated, while adherence and satisfaction with the eHealth program were good. In clinical practice, ReMind may be helpful, if timing would be adapted to patients’ needs.

Development of a Program based on Goal Management Training for Adolescents with Executive Dysfunctions Complaints

2021 ◽  
Vol 24 ◽  
Author(s):  
Liana Garcia Nunes ◽  
Alessandra Gotuzo Seabra
Keyword(s):  
Working Memory ◽  
Executive Functions ◽  
Execution Time ◽  
Management Training ◽  
Intellectual Ability ◽  
Control Group ◽  
Goal Management ◽  
Executive Dysfunctions ◽  
Goal Management Training

Abstract This study aimed to develop a program based on Goal Management Training (GMT) and to investigate its effectiveness on executive functions, through formal instruments and an ecological task. Participants were 25 adolescents with complaints of executive dysfunctions. They underwent neuropsychological assessment of working memory, inhibitory control, cognitive flexibility, planning, and intellectual ability. Participants also took part in a cooking activity and were evaluated for errors per action, of omission, activity performance time, recipe consultation. After, they were randomly allocated to an active control group (CG), which underwent psychoeducation sessions, and an experimental group (EG), stimulated through GMT in eight sessions. Then participants underwent another assessment and follow-up after 4 weeks. In post-intervention analyses, results showed an improvement in executive functions in EG, in the working memory measurement and time of the ecological activity (g = 1.78 and .93, respectively), IQ (g = −1.01), reasoning (g = −.89), flexibility (g = −1.21), and inhibition (g = −3.11). In follow-up evaluation, large-size effects were observed on flexibility (g = −2.95), inhibition (g = −5.78) and execution time of the ecological activity (g = .98). Significant interactions between assessment Time x Group revealed EG gains in IQ, scores in reasoning and flexibility. EG also had longer execution time in flexibility and inhibition tests. That is, EG had greater scores and probably was less impulsive in these tests. Furthermore, EG decreased the number of verifications and the time in the ecological task, that is, had a more efficient performance. Results suggest the intervention can be as instrument to promote executive function.

Benefit of Static FET PET in Pretreated Pediatric Brain Tumor Patients with Equivocal Conventional MRI Results

2021 ◽  
Author(s):  
Frederik Grosse ◽  
Florian Wedel ◽  
Ulrich-Wilhelm Thomale ◽  
Ingo Steffen ◽  
Arend Koch ◽  
...  
Keyword(s):  
Brain Tumor ◽  
Tumor Tissue ◽  
Pediatric Brain Tumor ◽  
Ct Scans ◽  
Tumor Patients ◽  
Fet Pet ◽  
Conventional Mri ◽  
Pet Ct ◽  
Pediatric Brain

Abstract Background MRI has shortcomings in differentiation between tumor tissue and post-therapeutic changes in pretreated brain tumor patients. Patients We assessed 22 static FET-PET/CT-scans of 17 pediatric patients (median age 12 years, range 2–16 years, ependymoma n=4, medulloblastoma n=4, low-grade glioma n=6, high-grade glioma n=3, germ cell tumor n=1, choroid plexus tumor n=1, median follow-up: 112 months) with multimodal treatment. Method FET-PET/CT-scans were analyzed visually by 3 independent nuclear medicine physicians. Additionally quantitative FET-Uptake for each lesion was determined by calculating standardized uptake values (SUVmaxT/SUVmeanB, SUVmeanT/SUVmeanB). Histology or clinical follow-up served as reference. Results Static FET-PET/CT reliably distinguished between tumor tissue and post-therapeutic changes in 16 out of 17 patients. It identified correctly vital tumor tissue in 13 patients and post-therapeutic changes in 3 patients. SUV-based analyses were less sensitive than visual analyses. Except from a choroid plexus carcinoma, all tumor entities showed increased FET-uptake. Discussion Our study comprises a limited number of patients but results corroborate the ability of FET to detect different brain tumor entities in pediatric patients and discriminate between residual/recurrent tumor and post-therapeutic changes. Conclusions We observed a clear benefit from additional static FET-PET/CT-scans when conventional MRI identified equivocal lesions in pretreated pediatric brain tumor patients. These results warrant prospective studies that should include dynamic scans.

scholarly journals Oral dexamethasone for the prevention of acute migraine recurrence in pediatric patients presenting to the emergency department with migraine

2018 ◽  
Vol 1 ◽  
pp. 251581631880415
Author(s):  
Serena L Orr ◽  
Lawrence Richer ◽  
Nick Barrowman ◽  
Roger Zemek
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Recruitment Rate ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Oral Dexamethasone ◽  
Safety Outcomes

Objective: To assess the feasibility of a randomized controlled trial protocol that aims to determine the efficacy and safety of oral dexamethasone compared to placebo for the prevention of migraine recurrence in children and adolescents visiting the pediatric emergency department (ED) with migraine. Methods: This study was a two-arm, parallel-group, randomized, placebo-controlled, double-blind pilot trial of patients presenting to the pediatric ED with migraine. Eligible participants were randomized at 1:1 ratio to receive either oral dexamethasone 0.6 mg/kg (maximum 15 mg) or matched placebo as a single dose. Efficacy and safety outcomes were assessed at discharge, 48 h and 7 days after discharge. The primary outcome of the trial was feasibility and was assessed through participant recruitment rate, follow-up completion rates, participant satisfaction ratings and comparison of enrolled versus non-enrolled participants. Efficacy and safety outcomes were not analyzed given that this was a pilot study. Results: Twelve participants were enrolled over the 6-month recruitment period. This represents 60% of the planned sample size and a 10.5% recruitment rate. No other feasibility issues were identified and patients expressed high satisfaction rates with their treatment: 90.9% were satisfied with their treatment at discharge and at 48-h follow-up and 81.8% were satisfied with their treatment at 7-day follow-up (81.8%). There were no significant differences observed when comparing enrolled participants to those not enrolled. Conclusion: This pilot randomized controlled trial is the first to assess dexamethasone in the pediatric ED for the prevention of migraine recurrence. The protocol is feasible but recruitment in a single center was lower than expected. Future pediatric ED migraine studies may use innovative or pragmatic trial designs to maximize feasibility from a recruitment standpoint.

scholarly journals Cognitive Behavioural Therapy for Nightmares for Patients with Persecutory Delusions (Nites): An Assessor-Blind, Pilot Randomized Controlled Trial

2019 ◽  
pp. 070674371984742 ◽  
Author(s):  
Bryony Sheaves ◽  
Emily A. Holmes ◽  
Stephanie Rek ◽  
Kathryn M. Taylor ◽  
Alecia Nickless ◽  
...  
Keyword(s):  
Suicidal Ideation ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Behavioural Therapy ◽  
Serious Adverse Events ◽  
Persecutory Delusions ◽  
Treatment As Usual ◽  
Cognitive Behavioural

Objective:Nightmares are relatively common in patients experiencing psychosis but rarely assessed or treated. Nightmares may maintain persecutory delusions by portraying fears in sensory-rich detail. We tested the potential benefits of imagery-focused cognitive behavioural therapy (CBT) for nightmares on nightmare severity and persecutory delusions.Method:This assessor-blind parallel-group pilot trial randomized 24 participants with nightmares and persecutory delusions to receive CBT for nightmares delivered over 4 weeks in addition to treatment as usual (TAU) or TAU alone. Assessments were at 0, 4 (end of treatment), and 8 weeks (follow-up). Feasibility outcomes assessed therapy uptake, techniques used, satisfaction, and attrition. The primary efficacy outcome assessed nightmare severity at week 4. Analyses were intention to treat, estimating treatment effect with 95% confidence intervals (CIs).Results:All participants offered CBT completed therapy (mean [SD], 4.8 [0.6] sessions) with high satisfaction, and 20 (83%) participants completed all assessments. Compared with TAU, CBT led to large improvements in nightmares (adjusted mean difference = −7.0; 95% CI, –12.6 to –1.3; d = –1.1) and insomnia (6.3; 95% CI, 2.6 to 10.0; d = 1.4) at week 4. Gains were maintained at follow-up. Suicidal ideation was not exacerbated by CBT but remained stable to follow-up, compared with TAU, which reduced at follow-up (6.8; 95% CI, 0.3 to 3.3; d = 0.7). CBT led to reductions in paranoia (–20.8; 95% CI, –43.2 to 1.7; d = –0.6), although CIs were wide. Three serious adverse events were deemed unrelated to participation (CBT = 2, TAU = 1).Conclusions:CBT for nightmares is feasible and may be efficacious for treating nightmares and comorbid insomnia for patients with persecutory delusions. It shows promise on paranoia but potentially not on suicidal ideation.

scholarly journals Sanfu herbal patch applied at acupoints in patients with bronchial asthma: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Xie Xiaoyan ◽  
Danghan Xu ◽  
Lixing Zhuang ◽  
Hui Liu ◽  
Sui Tan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bronchial Asthma ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Blood Analysis ◽  
Quality Data ◽  
Controlled Clinical Trial ◽  
Life Questionnaire ◽  
Asthma Control Test

Abstract Background Bronchial asthma (BA) is one of the most common inflammatory airway disorders. As one of the main non-drug therapies, the Sanfu herbal patch (SHP) has been widely used to treat BA, although the evidence and mechanism are inconclusive. The objective of this pilot trial is to clarify the clinical efficacy and safety of the SHP in the treatment of BA in the chronic persistent or clinical remission stage and to provide high-quality data for further research.Methods: We propose a multicenter, double-blinded, parallel, randomized, placebo-controlled clinical trial involving 4 study hospitals in China. A total of 72 eligible participants will be randomized into an SHP group and a placebo group. They will receive SHP for 3 treatment sessions(TSs). The primary outcome will be changes in forced expiratory volume in one second after 3 TSs. Secondary outcomes will include: (1) the Asthma Quality of Life Questionnaire, Asthma Control Test, and Asthma Long-term Follow-up Scale; (2) levels of Metallothionein-2 and Transgelin-2 in blood and urine; and (3) levels of IL-5, IL-13, IL-23, IL-25, and thymic stromal lymphopoietin in blood. Analysis of the data will be performed at baseline, at the end of the 2nd and 3rd TSs and at 24-week follow-up. The safety of the SHP will be evaluated at each TS.Discussion: The aim of this trial is to determine whether SHP is more effective than placebo in the treatment of patients with BA, and whether SHP works by reducing airway inflammation and reversing bronchoconstriction.Trial registration: Chinese Clinical Trial Registry(http://www.chictr.org.cn), ChiCTR1900024616. Registered on 19 July 2019.

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