scholarly journals QOLP-33. ACCEPTABILITY RANDOMIZED CONTROLLED TRIAL A COUPLES-BASED MIND-BODY INTERVENTION FOR PATIENTS WITH HIGH GRADE GLIOMA AND THEIR PARTNERS

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi205-vi205
Author(s):  
Kathrin Milbury ◽  
Shiao- Pei Weathers ◽  
Sania Durrani ◽  
Yisheng Li ◽  
Cindy Carmack ◽  
...  
Keyword(s):  
Intervention Study ◽  
Controlled Trial ◽  
Eligible Patient ◽  
Symptom Burden ◽  
High Grade Glioma ◽  
Emotional Disclosure ◽  
Self Report ◽  
High Grade ◽  
Randomized Controlled ◽  
Couples Coping

Abstract BACKGROUND Given the incurable nature, short survival and high symptom burden of high grade glioma (HGG), patients and their partners are at risk of experiencing psychological and existential/spiritual distress. To address these concerns, we developed a dyadic intervention integrating meditation training with emotional disclosure exercises. The primary aim was to examine feasibility and acceptability of the intervention study procedures. METHODS Dyads completed baseline self-report measures and were randomized to a couple-based mind-body (CBMB) or a waitlist control (WLC) group. Couples in the CBMB groups attended 4 weekly (60 min each) therapist-led sessions that were delivered via FaceTime. The CBMB program focused on cultivating mindfulness, compassion, gratitude and purpose. All groups were reassessed, 1 month and 3 months after baseline. RESULTS We approached 60 eligible patient-partner dyads of which 37 (62%) consented and 18 were randomized to the CBMB and 16 to the WLC group. Of those randomized, 23 dyads (67%) completed all assessments (n= 12 in CBMB; n=11 in WLC). Attrition was due to patients’ death (n=3), symptom burden (n=5) or passive withdrawal (n=3). Patients (57% male; mean age=57 years) and partners’ (59% female; mean age=54 years) attended a mean of 3.17 sessions (SD=1.2) with 83% attending at least 2 sessions. All dyads in the CBMB group reported the intervention as beneficial and useful and would recommend this program to other couples. Of note, 60% of couples would have preferred in-person delivery and 95% of patients but only 33% of partners stated that a dyadic intervention is their preference. CONCLUSION It seems to be feasible, acceptable and possibly efficacious to deliver a dyadic intervention via FaceTime to couples coping with HGG. Although both members of the dyad reported to have benefited, dyadic delivery appears to be less desirable for partners.

scholarly journals Effect of Anesthesia on The Outcome of High-Grade Glioma Patients Undergoing Supratentorial Resection: Study Protocol for A Randomized Controlled Trial 

2021 ◽  
Author(s):  
Dexiang Wang ◽  
Jia Dong ◽  
Min Zeng ◽  
Xiaoyuan Liu ◽  
Xiang Yan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Tumor Resection ◽  
High Grade Glioma ◽  
High Grade ◽  
Intravenous Anesthesia ◽  
Inhalation Anesthesia ◽  
Randomized Controlled

Abstract Background High-grade glioma (HGG) is the most malignant brain tumor with poor outcome. Whether anesthetic methods have impact on the outcome of these patients is still unknown. Retrospective study has found that there is no difference between two anesthesia methods on the overall survival (OS), however, intravenous anesthesia with propofol might be beneficial in subgroup patients of KPS<80. Further prospective studies are needed to evaluate the results.Methods This is a single-centered, randomized controlled, parallel group trial. 196 patients with primary HGG for tumor resection will be randomly assigned to receive either the intravenous anesthesia with propofol or inhalation anesthesia with sevoflurane. The primary outcome is the OS within 18 months. Secondary outcomes include progression-free survival (PFS), the numerical rating scale (NRS) of pain intensity and sleep quality, the postoperative encephaloedema volume, complications, the length and cost effectiveness of hospital stay of the patients.Discussion This is a randomized controlled trial to compare the effect of intravenous or inhalation anesthesia maintenance on the outcome of supratentorial HGG patients.The results will help to optimizing the anesthesia methods in these patients.Trial registration: ClinicalTrials.gov (ID: NCT02756312). Registered on 27 April 2020 https://register.clinicaltrials.gov/

Enhancing quality of life and mastery of informal caregivers of high-grade glioma patients: a randomized controlled trial

2012 ◽  
Vol 111 (3) ◽  
pp. 303-311 ◽  
Author(s):  
Florien W. Boele ◽  
Wopke Hoeben ◽  
Karen Hilverda ◽  
Jeroen Lenting ◽  
Anne-Lucia Calis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Informal Caregivers ◽  
High Grade Glioma ◽  
High Grade ◽  
Randomized Controlled

Empirical and Theoretical Framework, Intervention Design, and Study Protocol for a Randomized Controlled Trial of LiveWell: A Smartphone-based Self-management Intervention for Individuals with Bipolar Disorder (Preprint)

2021 ◽  
Author(s):  
Evan H Goulding ◽  
Cynthia Dopke ◽  
Rebecca Rossom ◽  
Tania Michaels ◽  
Clair Martin ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Symptom Burden ◽  
Self Report ◽  
Self Management ◽  
Relapse Risk ◽  
Health Technologies ◽  
Randomized Controlled ◽  
Empirically Supported

BACKGROUND Bipolar disorder is a severe mental illness with high levels of morbidity and mortality. Even with pharmacologic treatment, frequent recurrence of episodes, long episode durations, and persistent inter-episode symptoms are common and disruptive. Combining psychotherapy with pharmacotherapy improves outcomes, but access to therapy is limited and many individuals with bipolar disorder do not receive psychotherapy. Mental health technologies can increase access to self-management strategies derived from empirically supported bipolar disorder psychotherapies while also enhancing treatment by delivering real-time assessments, personalized feedback, and provider alerts. In addition, mental health technologies provide a platform for self-report, application use, and behavioral data collection to advance understanding of the longitudinal course of bipolar disorder which can then be utilized to support ongoing improvement of treatment. OBJECTIVE To facilitate the ability to replicate, improve, implement and disseminate effective interventions for bipolar disorder, we provide a description of the theoretical and empirically supported framework, design, and protocol for a randomized controlled trial of LiveWell: a smartphone-based self-management intervention for individuals with bipolar disorder. The goal of this trial is to determine the effectiveness of LiveWell for reducing relapse risk and symptom burden, while simultaneously elucidating behavioral targets of the intervention and better characterizing bipolar disorder course and treatment response. METHODS The study is a single blind randomized controlled trial (N = 205, 2:3 ratio of usual care vs usual care plus LiveWell). The primary outcome is time to relapse. Secondary outcomes are percent time symptomatic, symptom severity, and quality of life. Longitudinal changes in target behaviors proposed to mediate the primary and secondary outcomes will also be determined and their relationships with the outcomes will be assessed. A database of clinical status, symptom severity, real-time self-report, behavioral sensor, application use and personalized content will be created with the aim of better predicting treatment response and relapse risk. RESULTS Recruitment and screening started in March 2017 and ended in April 2019. Follow up ended April 2020. The study results are expected to be published in 2021. CONCLUSIONS This study will examine the potential of LiveWell for reducing relapse risk and symptom burden in individuals with bipolar disorder by increasing access to empirically supported self-management strategies. Simultaneously, a database will be created to initiate development of algorithms to personalize and improve treatment for bipolar disorder. Additionally, we hope that the description of the theoretical and empirically supported framework, intervention design, and study protocol for the randomized controlled trial of LiveWell provided here will facilitate the ability to replicate, improve, implement and disseminate effective interventions for bipolar disorder. CLINICALTRIAL ClinicalTrials.gov NCT03088462

scholarly journals Current FDA-Approved Therapies for High-Grade Malignant Gliomas

Biomedicines ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 324
Author(s):  
Jacob P. Fisher ◽  
David C. Adamson
Keyword(s):  
Controlled Trial ◽  
Malignant Gliomas ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
High Grade ◽  
Tumor Treatment ◽  
Free Survival ◽  
Randomized Controlled ◽  
Significant Survival ◽  
One Year

The standard of care (SOC) for high-grade gliomas (HGG) is maximally safe surgical resection, followed by concurrent radiation therapy (RT) and temozolomide (TMZ) for 6 weeks, then adjuvant TMZ for 6 months. Before this SOC was established, glioblastoma (GBM) patients typically lived for less than one year after diagnosis, and no adjuvant chemotherapy had demonstrated significant survival benefits compared with radiation alone. In 2005, the Stupp et al. randomized controlled trial (RCT) on newly diagnosed GBM patients concluded that RT plus TMZ compared to RT alone significantly improved overall survival (OS) (14.6 vs. 12.1 months) and progression-free survival (PFS) at 6 months (PFS6) (53.9% vs. 36.4%). Outside of TMZ, there are four drugs and one device FDA-approved for the treatment of HGGs: lomustine, intravenous carmustine, carmustine wafer implants, bevacizumab (BVZ), and tumor treatment fields (TTFields). These treatments are now mainly used to treat recurrent HGGs and symptoms. TTFields is the only treatment that has been shown to improve OS (20.5 vs. 15.6 months) and PFS6 (56% vs. 37%) in comparison to the current SOC. TTFields is the newest addition to this list of FDA-approved treatments, but has not been universally accepted yet as part of SOC.

scholarly journals Effect of a Multidomain Lifestyle Intervention on Estimated Dementia Risk

2021 ◽  
pp. 1-6
Author(s):  
Alina Solomon ◽  
Ron Handels ◽  
Anders Wimo ◽  
Riitta Antikainen ◽  
Tiina Laatikainen ◽  
...  
Keyword(s):  
Lifestyle Intervention ◽  
Intervention Study ◽  
Controlled Trial ◽  
Control Group ◽  
Post Hoc Analysis ◽  
Randomized Controlled ◽  
Dementia Risk ◽  
Geriatric Intervention ◽  
Prevention Potential ◽  
Post Hoc

We investigated the effect of a multidomain lifestyle intervention on the risk of dementia estimated using the validated CAIDE risk score (post-hoc analysis). The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) is a 2-year randomized controlled trial among 1,260 at-risk older adults (60–77 years). Difference in the estimated mean change in CAIDE score at 2 years in the intervention compared to the control group was –0.16 (95 %CI –0.31 to 0.00) (p = 0.013), corresponding to a relative dementia risk reduction between 6.04–6.50%. This could be interpreted as a reflection of the prevention potential of the intervention.

scholarly journals Health Effects of Written Emotional Disclosure in Adolescents with Asthma: A Randomized, Controlled Trial

2005 ◽  
Vol 31 (6) ◽  
pp. 557-568 ◽  
Author(s):  
Lori J. Warner ◽  
Mark A. Lumley ◽  
Rita J. Casey ◽  
Wayne Pierantoni ◽  
Reina Salazar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Health Effects ◽  
Controlled Trial ◽  
Emotional Disclosure ◽  
Written Emotional Disclosure ◽  
Randomized Controlled

scholarly journals Foam Rolling Elicits Neuronal Relaxation Patterns Distinct from Manual Massage: A Randomized Controlled Trial

2021 ◽  
Vol 11 (6) ◽  
pp. 818
Author(s):  
Yann Kerautret ◽  
Aymeric Guillot ◽  
Sébastien Daligault ◽  
Franck Di Rienzo
Keyword(s):  
Skin Conductance ◽  
Muscle Pain ◽  
Controlled Trial ◽  
Muscle Relaxation ◽  
Well Being ◽  
Self Report ◽  
Controlled Study ◽  
Control Group ◽  
Foam Rolling ◽  
Randomized Controlled

The present double-blinded, randomized controlled study sought to compare the effects of a full-body manual massage (MM) and a foam rolling (FR) intervention on subjective and objective indexes of performance and well-being. A total of 65 healthy individuals were randomly allocated to an FR, MM, or a control group who received a cognitively oriented relaxation routine. Self-report ratings of perceived anxiety, muscle relaxation, and muscle pain were used to index changes in affect and physical sensations. The sit-and-reach and toe-touch tests, as well as a mental calculation task, were used to index motor and cognitive performances, respectively. We also conducted resting-state electroencephalography and continuous skin conductance recordings before and after the experimental intervention. Both FR and MM groups exhibited neural synchronization of alpha and beta oscillations during the posttest. Skin conductance increased from the pretest to the posttest in the relaxation group, but decreased in the FR group. All interventions improved range of motion, although only the MM group outperformed the relaxation group for the toe-touch performance. MM was associated with reduced muscle pain and increased muscle relaxation. Reduced perceived anxiety after the intervention was observed in the FR group only. Overall, MM and FR both improved objective and subjective indexes of performance and well-being. Differences between the two massage interventions are discussed in relation to the effects of pressure stimulation on autonomic regulations and the proactive vs. retroactive nature of FR, compared to MM.

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