scholarly journals External application of liver compresses to reduce fatigue in patients with metastatic cancer undergoing radiation therapy, a randomized clinical trial

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Pirus Ghadjar ◽  
Wiebke Stritter ◽  
Irina von Mackensen ◽  
Felix Mehrhof ◽  
Clara Foucré ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Psychological Distress ◽  
Metastatic Cancer ◽  
Statistical Significance ◽  
Pilot Trial ◽  
Intervention Group ◽  
Control Group ◽  
External Application ◽  
General Fatigue ◽  
End Of Treatment

Abstract Background Liver compresses are frequently used in integrative medicine as supportive therapy during cancer treatment in order to reduce fatigue. We performed a pilot study to test whether the external application of yarrow liver compresses impacts fatigue in patients with metastatic cancer undergoing radiation therapy. Methods A randomized prospective pilot trial was performed including patients with brain metastasis or bone metastasis of solid tumors. Patients underwent either palliative radiation therapy (RT) of the metastatic lesions (control group) over two weeks or the same RT with additional external application of yarrow liver compresses once daily during RT. The primary objective was improvement on the general fatigue subscale of the multidimensional fatigue inventory (MFI-20) at the end of treatment, where a mean difference of two points is considered clinically relevant. Secondary objectives included psychological distress, quality of life and qualitative analysis with self-established visual analogue scales (VAS). Mean differences in general fatigue at the end of treatment compared to baseline were analyzed using the ANCOVA test. Results From 09/2017 to 08/2019 a total of 39 patients were randomized. Due to drop outs 24 patients (12 per group) were available for analysis. Patients in the intervention group received a mean number of 10.5 (range, 7–14) applications of yarrow liver compresses. The mean improvement at the end of therapy on the general fatigue subscale of the MFI-20 was 2 points in favor of the intervention group (p = 0.13), and all other MFI-20 subscales showed at least a trend towards improvement in favor of the intervention group. Likewise, psychological distress and VAS data was improved, the latter reaching statistical significance for the symptoms fatigue, tension and lack of drive. Major toxicities were not observed. Conclusions External application of liver compresses appears to reduce fatigue within a clinical relevant range in patients with metastatic cancer undergoing radiation therapy. Trial registration: ISRCTN, ICTRP DRKS00012999

scholarly journals Alleviating psychological distress associated with a positive cervical cancer screening result: a randomized control trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yukari Isaka ◽  
Ai Hori ◽  
Rie Tanaka ◽  
Masao Ichikawa
Keyword(s):  
Cervical Cancer ◽  
Psychological Distress ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Control Groups ◽  
And Control ◽  
Screening Result

Abstract Background The method of communicating a positive cancer screening result should seek to alleviate psychological distress associated with a positive result. We evaluated whether the provision of information through a leaflet would help reduce psychological distress in a randomized controlled trial. Methods The participants were women aged 20–69 years who were about to undergo cervical cancer screening at health centers. Before the screening, they received hypothetical screening results, with a leaflet (intervention group, n = 493) or without it (control group, n = 479), randomly. Their psychological distress and intention to undergo further examination were then compared between the intervention and control groups. Results After the intervention (providing a leaflet with hypothetical screening results), psychological distress appeared to be higher in the control group than in the intervention group among those who received a hypothetical positive screening result (odds ratio: 2.57, 95% confidence interval: 1.87–3.54), while 95% and 97% of those in the intervention and control groups, respectively, reported that they would undergo further examination. Conclusions Information provision might help reduce psychological distress but not hinder further examination among women who screen positive for cervical cancer. Trial registration: UMIN Clinical Trials Registry UMIN000029894. Date of Registration: November 2017.

scholarly journals Jacobson and Truax Method: evaluation of the clinical effectiveness of a home care program after prostatectomy

2018 ◽  
Vol 26 (0) ◽  
Author(s):  
Luciana Regina Ferreira Pereira da Mata ◽  
Mariana Ferreira Vaz Gontijo Bernardes ◽  
Cissa Azevedo ◽  
Tânia Couto Machado Chianca ◽  
Maria da Graça Pereira ◽  
...  
Keyword(s):  
Radical Prostatectomy ◽  
Home Care ◽  
Clinical Significance ◽  
Statistical Significance ◽  
Intervention Group ◽  
Nursing Intervention ◽  
Telephone Counseling ◽  
Control Group ◽  
Teaching Program ◽  
Knowledge Variable

ABSTRACT Objective: to exemplify the applicability of the Jacobson and Truax Method in a nursing intervention study that analyzed the effectiveness of a home care teaching program after radical prostatectomy. Method: this is a descriptive study concerning the applicability of the Jacobson and Truax Method in the data analysis of a clinical trial. The intervention consisted of a teaching program for hospital discharge after radical prostatectomy through oral guidance, writing, and telephonic reinforcement. Thirty-four men participated in the intervention group and 34 men participated in the control group. A reliable index of change and clinical significance was calculated for the knowledge variable in both groups. Scatterplots were presented to demonstrate the effectiveness of the method. Results: for 30 individuals in the intervention group, the intervention presented clinically relevant change than in knowledge. In the control group, none of the 34 individuals presented clinical significance of the results related to this variable, that is, the statistical significance identified by the inferential tests did not have clinically relevant changes in the knowledge variable. Conclusion: the educational intervention carried out through the combination of oral, written and telephone counseling was shown to be clinically effective in improving knowledge about home care.

A Randomized Study to Assess the Impact of Pharmacist Counseling of Employer-Based Health Plan Beneficiaries With Diabetes

2011 ◽  
Vol 25 (2) ◽  
pp. 169-179 ◽  
Author(s):  
Dale F. Kraemer ◽  
Wayne A. Kradjan ◽  
Theresa M. Bianco ◽  
Judi A. Low
Keyword(s):  
Diabetes Management ◽  
Statistical Significance ◽  
Glycosylated Hemoglobin ◽  
Randomized Study ◽  
Intervention Group ◽  
Control Group ◽  
Counseling Intervention ◽  
Care Plans ◽  
Pharmacist Counseling ◽  
The Impact

Objective: To assess the impact of pharmacist counseling on empowering people with diabetes to better self-care. Introduction: Community-based pharmacists can play a key role in educating and empowering people in such programs. Methods: A randomized trial compared the effects of pharmacist counseling (intervention group) with printed materials (control group) in diabetic beneficiaries of several employer-based health care plans. All participants also received waiver of out-of-pocket expenses for diabetic-related medications and supplies. Clinical, humanistic, and claim outcomes were evaluated at baseline and at 1 year follow-up. Results: Sixty-seven beneficiaries participated in this study. The 0.50% decrease from baseline in glycosylated hemoglobin (A1c) was statistically significant ( P = .0008) in the intervention group and the difference between the groups approached statistical significance ( P = .076). Beneficiaries in both groups had greater claim costs for diabetic-related medications and supplies during the study year. Both groups also improved in ability to manage their diabetes with the counseling group showing a significantly better understanding of diabetes ( P = .0024). Conclusion: There was a trend toward improvement in A1c in patients counseled by pharmacist with an increased utilization of diabetes-related medications and supplies. Counseling also improved diabetes knowledge and empowered patients to better diabetes management.

scholarly journals Impact of ascorbic acid in reducing the incidence of vancomycin associated nephrotoxicity in critically ill patients: A preliminary randomized controlled trial

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 929
Author(s):  
Nouran Hesham El-Sherazy ◽  
Naglaa Samir Bazan ◽  
Sara Mahmoud Shaheen ◽  
Nagwa A. Sabri
Keyword(s):  
Ascorbic Acid ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Statistical Significance ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Control Groups ◽  
The Absolute ◽  
And Control

Background Antioxidants show nephroprotective effect against vancomycin associated nephrotoxicity (VAN) in animals. This study aimed to assess the ascorbic acid nephro-protective role against VAN clinically. Methods Forty-one critically ill patients were randomly assigned to one of two groups: intervention group (vancomycin IV plus ascorbic acid, n=21) or control group (vancomycin IV only, n=20). Primary outcomes were the incidence of VAN and the absolute change in creatinine parameters, while mortality rate was the secondary outcome. Nephrotoxicity was defined as an increase in serum creatinine (S.cr) by at least 0.5 mg/dL or 50% of baseline for at least two successive measurements. This study is registered at Clinicaltrials.gov (NCT03921099), April 2019. Results Mean absolute S.cr increase was significant when compared between both groups, P-value = 0.036, where S.cr increased by 0.05(0.12) and 0.34(0.55) mg/dL in the intervention and control groups, respectively. Mean absolute Cr.cl decline was significant when compared between both groups, P-value = 0.04, where Cr.cl was decreased by 5.9(17.8) and 22.3(30.4) ml/min in the intervention and control groups, respectively. Incidence of VAN was 1/21(4.7%) versus 5/20(25%) in the intervention and control groups, respectively (RR: 0.19; CI: 0.024–1.49; P-value = 0.093). Mortality was higher in the control group; however, it was not statistically significant, P-value = 0.141. Conclusion Co-administration of ascorbic acid with vancomycin preserved renal function and reduced the absolute risk of VAN by 20.3%, however, the reduction in VAN incidence didn’t reach statistical significance level. Further large multicenter prospective trials are recommended.

Impact of Multimodal Cognitive Training on Cognitive Traits of Children: A Multicentric Interventional Study

2021 ◽  
Author(s):  
Manjunatha R ◽  
Praveen Pankajakshan ◽  
Alphonsa Joseph ◽  
Gyan Kashyap ◽  
Usha Manjunath ◽  
...  
Keyword(s):  
Cognitive Training ◽  
Statistical Significance ◽  
Intervention Group ◽  
Control Group ◽  
Sleep State ◽  
Eyes Closed ◽  
Before And After ◽  
Slow Sleep ◽  
Mini Mental Status Examination ◽  
External Behavior

Abstract In this article, we evaluate the hypothesis that a multimodal cognitive training (MCT) program, the Brighter Minds, can enhance certain inherent traits of a child and thus bring changes in the external behavior. For the study, 186 children (randomized to 93 each in intervention and control group) aged 10-15 years were enrolled from three different locations. Psychometric tests, parental/caregiver interviews and EEG (electroencephalography) tests were conducted before and after the program. Intervention group showed strong statistical significance for improvements in Mini Mental Status Examination (MMSE) (P<0.01) but no significance for Raven’s Standard Progrssive Matrices (SPM) or Susan Harter’s test. The parental/caregiver reported satistically significant improvements in focus (P<0.05), empathy (P<0.05), intuition (P<0.05), comprehension (P<0.05) and understanding of abstract concepts (P<0.05) for the intervention group. For the control, Power Spectral Density (PSD) of the baseline eyes-closed (EC) EEG recording, the spectrum below 20Hz exhibited the characteristic “1/f” spectral scaling of the power-law. This signature matches prior reported evidence in literature of those in wakeful state with EC. The intervention group EC PSD, however, exhibited a signature similar to those in a slow sleep state; reflective of the possible transfer effect of the training on other skills like relaxation. We used unsupervised learning methods with dice distance, on the psychometric and interview data, to show the effect of location and the exposure of a few control children to the program.

scholarly journals Sauna Yoga Superiorly Improves Flexibility, Strength, and Balance: A Two-Armed Randomized Controlled Trial in Healthy Older Adults

2019 ◽  
Vol 16 (19) ◽  
pp. 3721 ◽  
Author(s):  
Bucht ◽  
Donath
Keyword(s):  
Large Scale ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Intervention Group ◽  
Control Group ◽  
Minimization Method ◽  
Important Indicator ◽  
Randomized Controlled ◽  
Eyes Closed ◽  
Healthy Elderly

Besides strength and balance, flexibility is an important indicator of health-related physical fitness. Thus, the aim of this two-armed randomized controlled pilot trial was to investigate whether sauna yoga at a moderate temperature (50 °C) beneficially affects flexibility, strength, balance, and quality of life (QOL) in healthy elderly community dwellers. Participants were randomly assigned to an intervention group (INT, n = 11, age: 68.7 ± 5.9) or control group (CON, n = 12, age: 69.3 ± 4.9), using the minimization method. Age, physical activity, gender, and the primary outcome flexibility were used as strata for group allocation. Both groups completed similar exercises in the sauna over eight weeks. Only the INT group was exposed to moderate temperatures of 50 °C. Large and statistically significant improvement in favor of the sauna group (INT) was observed for the chair sit-and-reach test (INT: +83%, CON +3%, p = 0.028, nр² = 0.24). The shoulder and lateral spine flexibility were not relevantly affected. Strength in the lower extremities merely showed a tendency to significant changes (INT: 16%, CON: 3%, p = 0.061, nр² = 0.181). Additionally, balance abilities, with eyes closed, improved (INT: 187%, CON +58%, p = 0.056, nр² = 0.189) in favor of the INT group. QOL only improved in favor of the INT for environmental dimension (INT: +7%, CON: 0%, p = 0.034, nр² = 0.227). These first but preliminary findings indicate that sauna yoga may serve as a promising and feasible means to improve flexibility in elderly people. Strength and balance do not meaningfully benefit from a sauna environment, although strength improved to a slightly higher extent in the sauna group. Future large-scale research is needed to elucidate underlying mechanisms and corroborate these findings

Impacting Quality of Life for Patients With Advanced Cancer With a Structured Multidisciplinary Intervention: A Randomized Controlled Trial

2006 ◽  
Vol 24 (4) ◽  
pp. 635-642 ◽  
Author(s):  
Teresa A. Rummans ◽  
Matthew M. Clark ◽  
Jeff A. Sloan ◽  
Marlene H. Frost ◽  
John Michael Bostwick ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Radiation Therapy ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Analog Scale ◽  
Multidisciplinary Intervention ◽  
Linear Analog

Purpose The primary goal of this study was to evaluate the feasibility and effectiveness of a structured, multidisciplinary intervention targeted to maintain the overall quality of life (QOL), which is more comprehensive than psychosocial distress, of patients undergoing radiation therapy for advanced-stage cancer. Patients and Methods Radiation therapy patients with advanced cancer and an estimated 5-year survival rate of 0% to 50% were randomly assigned to either an eight-session structured multidisciplinary intervention arm or a standard care arm. The eight 90-minute sessions addressed the five domains of QOL including cognitive, physical, emotional, spiritual, and social functioning. The primary end point of maintaining overall QOL was assessed by a single-item linear analog scale (Linear Analog Scale of Assessment or modified Spitzer Uniscale). QOL was assessed at baseline, week 4 (end of multidisciplinary intervention), week 8, and week 27. Results Of the 103 participants, overall QOL at week 4 was maintained by the patients in the intervention (n = 49), whereas QOL at week 4 significantly decreased for patients in the control group (n = 54). This change reflected a 3-point increase from baseline in the intervention group and a 9-point decrease from baseline in the control group (P = .009). Intervention participants maintained their QOL, and controls gradually returned to baseline by the end of the 6-month follow-up period. Conclusion Although intervention participants maintained and actually improved their QOL during radiation therapy, control participants experienced a significant decrease in their QOL. Thus, a structured multidisciplinary intervention can help maintain or even improve QOL in patients with advanced cancer who are undergoing cancer treatment.

scholarly journals Early Mobilization in Ischemic Stroke: A Pilot Randomized Trial of Safety and Feasibility in a Public Hospital in Brazil

2015 ◽  
Vol 5 (1) ◽  
pp. 31-40 ◽  
Author(s):  
Simone Rosa Poletto ◽  
Letícia Costa Rebello ◽  
Maria Júlia Monteiro Valença ◽  
Daniele Rossato ◽  
Andrea Garcia Almeida ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Public Hospital ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Intervention Group ◽  
Total Duration ◽  
Early Mobilization ◽  
Functional Independence ◽  
Control Group

Background: The effect of early mobilization after acute stroke is still unclear, although some studies have suggested improvement in outcomes. We conducted a randomized, single-blind, controlled trial seeking to evaluate the feasibility, safety, and benefit of early mobilization for patients with acute ischemic stroke treated in a public teaching hospital in Southern Brazil. This report presents the feasibility and safety findings for the pilot phase of this trial. Methods: The primary outcomes were time to first mobilization, total duration of mobilization, complications during early mobilization, falls within 3 months, mortality within 3 months, and medical complications of immobility. We included adult patients with CT- or MRI-confirmed ischemic stroke within 48 h of symptom onset who were admitted from March to November 2012 to the acute vascular unit or general emergency unit of a large urban emergency department (ED) at the Hospital de Clínicas de Porto Alegre. The severity of the neurological deficit on admission was assessed by the National Institutes of Health Stroke Scale (NIHSS). The NIHSS and modified Rankin Scale (mRS, functional outcome) scores were assessed on day 14 or at discharge as well as at 3 months. Activities of daily living (ADL) were measured with the modified Barthel Index (mBI) at 3 months. Results: Thirty-seven patients (mean age 65 years, mean NIHSS score 11) were randomly allocated to an intervention group (IG) or a control group (CG). The IG received earlier (p = 0.001) and more frequent (p < 0.0001) mobilization than the CG. Of the 19 patients in the CG, only 5 (26%) underwent a physical therapy program during hospitalization. No complications (symptomatic hypotension or worsening of neurological symptoms) were observed in association with early mobilization. The rates of complications of immobility (pneumonia, pulmonary embolism, and deep vein thrombosis) and mortality were similar in the two groups. No statistically significant differences in functional independence, disability, or ADL (mBI ≥85) were observed between the groups at the 3-month follow-up. Conclusions: This pilot trial conducted at a public hospital in Brazil suggests that early mobilization after acute ischemic stroke is safe and feasible. Despite some challenges and limitations, early mobilization was successfully implemented, even in the setting of a large, complex ED, and without complications. Patients from the IG were mobilized much earlier than controls receiving the standard care provided in most Brazilian hospitals.

Emotion and Symptom-focused Engagement (EASE): A randomized pilot trial of an integrated psychosocial and palliative care intervention for individuals with acute leukemia (AL).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 7041-7041 ◽  
Author(s):  
Gary Rodin ◽  
Carmine Malfitano ◽  
Anne Rydall ◽  
Christopher Lo ◽  
Aaron David Schimmer ◽  
...  
Keyword(s):  
Palliative Care ◽  
Psychological Distress ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Pilot Trial ◽  
Physical Symptoms ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Symptom Screening ◽  
Physical Distress

7041 Background: Individuals diagnosed with AL may experience severe physical and psychological distress due to the illness and its treatment, the threat of relapse and treatment failure, and a high risk of mortality. To alleviate psychological and physical distress in this population, we developed a novel, 8-week, manualized intervention called EASE. This includes: 1) EASE-psy- a tailored psychotherapeutic component to reduce psychological distress; and 2) EASE-phys-symptom screening, with moderate to severe physical symptoms triggering early palliative care. Methods: To assess the feasibility and preliminary efficacy of EASE, patients were recruited within 2 weeks of admission to a comprehensive cancer center and randomized to receive either EASE or usual care (UC). Physical and psychological symptoms were assessed at baseline, 4, 8 (primary endpoint), and 12 weeks. Intervention patients received 6-10 psychotherapy sessions over 8 weeks, weekly assessment of physical symptoms, and consultation and follow-up by palliative care, when needed. One-way ANOVA was performed to assess mean change scores over time between groups. Results: Forty-two patients were randomized to EASE (n = 22) or UC (n = 20). Predefined feasibility outcomes were all met: > 86% (19/22) of EASE participants (goal > 64%) completed > 50% of proposed EASE-psy sessions; 64% (14/22) completed symptom screenings (goal > 50%); and 100% of those with moderate to severe symptoms had > 1 meeting with the EASE-phys team (goal 100%). There were statistically significant findings favoring EASE vs. UC for satisfaction with care at 8 and 12 weeks (Δ: -3.12 vs 7.39, p < 0.04; -6.1910 vs 0.0125 p < 0.03). There were trends favoring EASE vs. UC for traumatic stress symptoms, depressive symptoms, quality of life, attachment security, and number, severity, and distress related to physical symptoms at 4, 8, and 12 weeks. Conclusions: Although not powered for statistical significance, this randomized pilot trial of EASE for AL showed promising reductions in psychological and physical distress and supports the feasibility and need for a larger randomized controlled trial. Clinical trial information: NCT02353559.

scholarly journals The Effect of Baduanjin on Promoting the Physical Fitness and Health of Adults

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Ran Li ◽  
Li Jin ◽  
Ping Hong ◽  
Zi-Hong He ◽  
Chuan-Ye Huang ◽  
...  
Keyword(s):  
Physical Fitness ◽  
Statistical Significance ◽  
Intervention Group ◽  
Blood Lipid ◽  
The Body ◽  
Control Group ◽  
Triceps Brachii ◽  
Fitness And Health ◽  
Subcutaneous Adipose ◽  
Lower Corner

The purpose of study was to assess the efficacy of a 16-week Baduanjin qigong training intervention in promoting physical fitness and health for adults. An experimental design was adopted, and subjects were assigned randomly into an experimental group (n=55) and a control group (n=55). In the intervention group comprised of adults, there were no significant variations in blood glucose, blood lipid, blood pressure, heart rate variability, and vital capacity indices. The body weight and body mass index (BMI) dropped in the intervention group. Compared with the control group, the skinfold thicknesses decreased at lower corner of scapula, triceps brachii, and abdomen, with a statistical significance (P<0.001;P=0.005;P=0.003). By comparing the physical fitness indices, it was found that the increase of the results of sit-and-reach test in the intervention group had statistical significance (P=0.001). In conclusion, it was found by our trial that Baduanjin exercise could significantly improve the physical flexibility and subcutaneous adipose accumulation in the healthy adults.

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