scholarly journals Smartphone-Based Meditation for Myeloproliferative Neoplasm Patients: Feasibility Study to Inform Future Trials (Preprint)

2018 ◽  
Author(s):  
Jennifer Huberty ◽  
Ryan Eckert ◽  
Linda Larkey ◽  
Jonathan Kurka ◽  
Sue A Rodríguez De Jesús ◽  
...  
Keyword(s):  
Physical Health ◽  
Sleep Disturbance ◽  
Controlled Trial ◽  
Myeloproliferative Neoplasm ◽  
Symptom Burden ◽  
Patient Reported Outcome ◽  
Pharmacologic Therapy ◽  
Control Group ◽  
Limited Efficacy ◽  
Patient Reported

BACKGROUND Myeloproliferative neoplasm (MPN) patients often report high symptom burden that persists despite the best available pharmacologic therapy. Meditation has gained popularity in recent decades as a way to manage cancer patient symptoms. OBJECTIVE The aim of this study was to examine the feasibility of 2 different consumer-based meditation smartphone apps in MPN patients and to examine the limited efficacy of smartphone-based meditation on symptoms compared with an educational control group. METHODS Patients (n=128) were recruited nationally through organizational partners and social media. Eligible and consented patients were enrolled into 1 of 4 groups, 2 of which received varying orders of 2 consumer-based apps (10% Happier and Calm) and 2 that received one of the apps alone for the second 4 weeks of the 8-week intervention after an educational control condition. Participants were asked to perform 10 min of meditation per day irrespective of the app and the order in which they received the apps. Feasibility outcomes were measured at weeks 5 and 9 with a Web-based survey. Feasibility outcomes were acceptability, demand, and limited efficacy for depression, anxiety, pain intensity, sleep disturbance, sexual function, quality of life, global health, and total symptom burden. RESULTS A total of 128 patients were enrolled across all 4 groups, with 73.4% (94/128) patients completing the intervention. Of the participants who completed the 10% Happier app, 61% (46/76) enjoyed it, 66% (50/76) were satisfied with the content, and 77% (59/76) would recommend to others. Of those who completed the Calm app, 83% (56/68) enjoyed it, 84% (57/68) were satisfied with the content, and 97% (66/68) would recommend to others. Of those who completed the educational control, 91% (56/61) read it, 87% (53/61) enjoyed it, and 71% (43/61) learned something. Participants who completed the 10% Happier app averaged 31 (SD 33) min/week; patients completing the Calm app averaged 71 (SD 74) min/week. 10% Happier app participants saw small effects on anxiety (P<.001 d=−0.43), depression (P=.02; d=−0.38), sleep disturbance (P=.01; d=−0.40), total symptom burden (P=.13; d=−0.27), and fatigue (P=.06; d=−0.30), and moderate effects on physical health (P<.001; d=0.52). Calm app participants saw small effects on anxiety (P=.29; d=−0.22), depression (P=.09; d=−0.29), sleep disturbance (P=.002; d=−0.47), physical health (P=.005; d=0.44), total symptom burden (P=.13; d=−0.27), and fatigue (P=.13; d=−0.27). Educational control participants (n=61) did not have effects on any patient-reported outcome except for a moderate effect on physical health (P<.001; d=0.77). CONCLUSIONS Delivering meditation via the Calm app is feasible and scored higher in terms of feasibility when compared with the 10% Happier app. The Calm app will be used to implement a randomized controlled trial, testing the effects of meditation on symptom burden in MPNs. CLINICALTRIAL ClinicalTrials.gov NCT03726944; https://clinicaltrials.gov/ct2/show/NCT03726944 (Archived by WebCite at http://www.webcitation.org/77MVdFJwM)

Treatment with and without stabilizing lumbar spinal orthosis after one- or two-level spondylodesis: A randomized controlled trial

2020 ◽  
Vol 28 (5) ◽  
pp. 541-549
Author(s):  
Yorck Rommelspacher ◽  
Hannah Bode ◽  
Jana Ziob ◽  
Charlotte Struwe ◽  
Adnan Kasapovic ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Control Group ◽  
Patient Reported ◽  
Subjective Pain ◽  
Postoperative Mobility ◽  
Lumbar Spinal ◽  
Spinal Orthosis

BACKGROUND AND OBJECTIVE: Musculature affected during spondylodesis surgery may benefit and recover faster if supported by spine orthosis postoperatively. METHODS: This prospective study included 50 consecutive patients undergoing one- or two-level spondylodesis. The intervention group received a lumbar spine orthosis (n= 23), while the control group remained without orthosis (n= 27). Patients were assessed for pain (Visual Analogue Scale, VAS), Oswestry Disability index (ODI) as well as the use of analgesics. RESULTS: Patients wearing an orthosis postoperatively reported a higher degree of subjective stability. However, both intervention as well as control group did not show any significant differences for each of the follow-up points regarding VAS, ODI or the use of analgesics. CONCLUSION: Wearing an orthosis has neither impact on subjective pain, the need for analgesics nor for postoperative functionality. However, patients reported that they profited from wearing the orthosis by feeling more stable, thereby nicely improving their postoperative mobility. Thus, novel patient reported outcome measures have to be developed to assess these features in future studies.

Implementation of a novel patient-reported outcomes measure for patients with cancer and COVID-19 infection.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 153-153
Author(s):  
Ishwaria Mohan Subbiah ◽  
Tito R. Mendoza ◽  
Xuetao Lu ◽  
Yanhong Zhou ◽  
J. Jack Lee ◽  
...  
Keyword(s):  
Longitudinal Study ◽  
Sleep Disturbance ◽  
Symptom Severity ◽  
Symptom Burden ◽  
Patient Reported Outcome ◽  
Validity And Reliability ◽  
Specific Patient ◽  
Patient Reported ◽  
Health Rating

153 Background: The long-term symptoms from COVID-19 (C19) infection in pts with cancer is not fully known. To monitor the evolution of this symptom burden over time, we designed and implemented a C19-specific patient-reported outcome (PRO) measure that integrated with a known measure of cancer symptom burden. Methods: Within the institutional initiative on C19 and cancer named Data-Driven Determinants for C19 Oncology Discovery Effort (D3CODE), pts with cancer & PCR-pos C19 are invited to participate in this longitudinal study. Pts complete the EQ-5D-5L, the 13 symptom severity & 6 interference items of the core MD Anderson Symptom Inventory (MDASI)+14 COVID-specific items, all scored on a 0-10 scale, 0 = none, 10 = worst imaginable. Pts complete the survey daily x 14 days from positive test date, then weekly x 3months, then monthly x 2yrs. Demographic and disease information was collected. Psychometric procedures determined validity and reliability of the MDASI-COVID. Results: Between 5/15/20 – 02/14/21, 2154 pts w PCR-confirmed C19 were invited to participate in the longitudinal study. 1282 (60%) pts provided consent and began the longitudinal completion of PRO surveys. Pts were 54.5% Female and 45.5% Male, median age 59 years (range 15 – 92). 1021 (80%) are White/Caucasian, 206 (16%) Hispanic, 113 (9%) African American, and 39 (3%) Asian. The validation analysis of MDASI-COVID instrument included the 1st 600 pts where the mean overall health rating on EQ-5D-5L was 78.3 (SD 19.6), best being 100. Highest mean (M) severity symptoms on the MDASI-COVID were fatigue (M 3.45, SD 2.17), drowsiness (M 2.50, SD 2.89), sleep disturbance (M 2.44, SD 2.99), malaise (M 2.37, SD 3.05), and distress (M 2.27, SD 2.90). Most severe (≥ 7) symptoms) reported were fatigue (21.3% of pts), change in taste (14.8%), change in smell (14.4%), malaise (14.3%), sleep disturbance (14.3%), and drowsiness (14%). showed internal consistency (Cronbach α) of the 27 symptom items was 0.957, of the 6 interference items was 0.937. Mean severity of the 27 symptom items was significantly correlated with overall EQ-5D-5L health rating (correlation = -0.45, P < 0.0005), demonstrating concurrent validity. Mean symptom severity and interference showed known-group validity between pts who required hospitalization (symptom M 2.32, SD 2.09; interference M 3.29, SD 3.02) and those who did not (symptom M 1.69, SD 1.85; interference M 2.20, SD 2.64) (symptom P 0.007; interference P 0.004). Conclusions: We successfully deployed a PRO-based long-term symptom monitoring platform for pts with C19 and cancer. The validation analysis of this novel C19 specific PRO, the MDASI-COVID, aids in the quantification of the global symptom burden in pts with both cancer and COVID-19 infection. Deployment of this measure in the ongoing longitudinal observational cohort allows for in-depth understanding of the long-term symptoms related to C19 and cancer.

scholarly journals Optimising symptom management in children with cancer using a novel mobile phone application: protocol for a controlled hybrid effectiveness implementation trial (RESPONSE)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Natalie Bradford ◽  
Paula Condon ◽  
Erin Pitt ◽  
Zephanie Tyack ◽  
Kimberly Alexander
Keyword(s):  
Symptom Management ◽  
Controlled Trial ◽  
Intervention Group ◽  
Symptom Burden ◽  
Control Group ◽  
Children With Cancer ◽  
Randomised Study ◽  
Response System ◽  
Implementation Outcomes ◽  
Patient Reported

Abstract Background Intense and aggressive treatment regimens for most children’s cancer have achieved vast improvements in survival but are also responsible for both a high number and burden of symptoms. The use of Patient Reported Outcome Measures (PROMs) demonstrates a range of benefits for improved symptom management in adults with cancer. There are, however, multiple barriers to integrating PROMs into routine care in children and adolescents with cancer. This study aims to evaluate: (1) the effectiveness of electronic PROMs to generate stratified alerts, symptom management recommendations and graphical summaries (the RESPONSE system) to improve health outcomes and (2) the implementation of the RESPONSE system by assessing feasibility, acceptability, satisfaction, and sustainability. Methods A pragmatic hybrid II effectiveness-implementation controlled trial, using mixed methods, will be undertaken, advancing both knowledge of the effectiveness of the intervention and implementation factors. One-hundred and sixty children with cancer receiving active treatment will be recruited 1:1 to a non-randomised study involving two groups with an equal number of participants in each group. The intervention group (n = 80) will be prospectively recruited to receive the RESPONSE system intervention over eight weeks, versus the historical matched control group (n = 80) who will complete the ePROMs without access to the RESPONSE system. The primary outcome of the effectiveness trial is change between groups in total symptom burden. Secondary outcomes include child health-related quality-of-life and implementation outcomes. Trial data will be analysed using linear mixed-effects models. Formative implementation evaluation is informed by CFIR and ERIC frameworks and implementation outcomes will be mapped to the RE-AIM framework and include interviews, field notes, as well as administrative data to evaluate feasibility, acceptability, satisfaction and sustainability. Trial registration number ACTRN12621001084875. Retrospectively Registered 16 August 2021.

scholarly journals Enhancing Patient-Provider Communication With the Electronic Self-Report Assessment for Cancer: A Randomized Trial

2011 ◽  
Vol 29 (8) ◽  
pp. 1029-1035 ◽  
Author(s):  
Donna L. Berry ◽  
Brent A. Blumenstein ◽  
Barbara Halpenny ◽  
Seth Wolpin ◽  
Jesse R. Fann ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Clinic Visit ◽  
Self Report ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Control Group ◽  
Cancer Symptoms ◽  
Patient Reported ◽  
Life Issues ◽  
Clinic Visits

Purpose Although patient-reported cancer symptoms and quality-of-life issues (SQLIs) have been promoted as essential to a comprehensive assessment, efficient and efficacious methods have not been widely tested in clinical settings. The purpose of this trial was to determine the effect of the Electronic Self-Report Assessment–Cancer (ESRA-C) on the likelihood of SQLIs discussed between clinicians and patients with cancer in ambulatory clinic visits. Secondary objectives included comparison of visit duration between groups and usefulness of the ESRA-C as reported by clinicians. Patients and Methods This randomized controlled trial was conducted in 660 patients with various cancer diagnoses and stages at two institutions of a comprehensive cancer center. Patient-reported SQLIs were automatically displayed on a graphical summary and provided to the clinical team before an on-treatment visit (n = 327); in the control group, no summary was provided (n = 333). SQLIs were scored for level of severity or distress. One on-treatment clinic visit was audio recorded for each participant and then scored for discussion of each SQLI. We hypothesized that problematic SQLIs would be discussed more often when the intervention was delivered to the clinicians. Results The likelihood of SQLIs being discussed differed by randomized group and depended on whether an SQLI was first reported as problematic (P = .032). Clinic visits were similar with regard to duration between groups, and clinicians reported the summary as useful. Conclusion The ESRA-C is the first electronic self-report application to increase discussion of SQLIs in a US randomized clinical trial.

scholarly journals Longitudinal study of symptom burden in outpatients with advanced cancers based on electronic Patient-Reported Outcome (ePRO) platform: a single institution, prospective study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e038223
Author(s):  
Lili Tang ◽  
Ying Pang ◽  
Yi He ◽  
Qiuling Shi ◽  
Xinkun Han ◽  
...  
Keyword(s):  
Study Protocol ◽  
Symptom Management ◽  
Depression Scale ◽  
Symptom Burden ◽  
Patient Reported Outcome ◽  
Critical Parameters ◽  
Advanced Lung Cancer ◽  
Optimal Time ◽  
Patient Reported

IntroductionAn electronic Patient-Reported Outcome (ePRO) platform is needed for implementing evidence-based symptom management in outpatients with advanced cancer. We describe the overall protocol and the methodology for measuring symptom burden, to provide critical parameters needed to implement symptom management on the ePRO platform.Methods and analysisThe study focusses on patients with advanced lung cancer, stomach cancer, oesophagus cancer, liver cancer, colorectal cancer or breast cancer. The primary outcome is the change of symptom burden. MD Anderson Symptom Inventory, and other PRO instruments (Insomnia Severity Index, Hospital Anxiety and Depression Scale, 9-item Patient Health Questionnaire and EuroQol-5 dimensions-5 levels version) were used. The secondary outcomes include feasibility of using ePRO, symptom-related quality of life, reasons for no improvement of symptoms, defining frequency of PRO assessments and cut-points, items for screening and management of comorbidity and satisfaction with ePRO platform in patients and health providers. After initial outpatient visit for baseline assessment, ePRO system will automatically send follow-up notification seven times over 4 weeks to patients. The characteristics and changing trajectory of symptoms of patients will be described. Parameters for using PROs, such as optimal time points for follow-up and cut-off point for alert will be determined. The feasibility of ePRO platform to track the changes of target symptoms in outpatients will be evaluated.Ethics and disseminationThe study protocol and related documents were approved by the Institutional Research Board (IRB) of Peking University Cancer Hospital on 13 February 2019 (2019YJZ07). The results of this study will be disseminated through academic workshops, peer-reviewed publications and conferences.Trial registration numberChiCTR1900023560.

scholarly journals Quality of Life and Symptom Burden 1 Month After Concussion in Children and Adolescents

2018 ◽  
Vol 58 (1) ◽  
pp. 42-49 ◽  
Author(s):  
David R. Howell ◽  
Julie C. Wilson ◽  
Michael W. Kirkwood ◽  
Joseph A. Grubenhoff
Keyword(s):  
Quality Of Life ◽  
Physical Health ◽  
Children And Adolescents ◽  
Symptom Burden ◽  
Psychosocial Health ◽  
Post Injury ◽  
Persistent Symptoms ◽  
Patient Reported ◽  
A Prospective Study

We conducted a prospective study of children and adolescents (n = 176; mean age = 13.0 ±2.7 years; 38% female) assessed acutely post-concussion and again 30 days later. We investigated the association between symptom burden and quality of life (QOL) outcomes, as well as the effect of age on QOL. We assessed QOL using patient-reported Pediatric Quality of Life Inventory 4.0, and symptoms using the Health and Behavior Inventory (HBI). Acute (<2 days post-injury) HBI ratings demonstrated a low correlation ( R2 = 0.08) with physical health QOL and a moderate correlation with psychosocial health QOL ( R2 = 0.21) 30 days post-concussion. HBI ratings 30 days post-concussion demonstrated a moderately high correlation with physical health QOL ( R2 = 0.35) and psychosocial health QOL ( R2 = 0.57). Age was not significantly associated with physical or psychosocial QOL ratings. Impairments in QOL following concussion may identify children and adolescents who need additional referral to address persistent symptoms at this time.

scholarly journals Treatment of osteoarthritis with autologous, micro-fragmented adipose tissue: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rasmus Kramer Mikkelsen ◽  
Lars Blønd ◽  
Lisbeth Rosenkrantz Hölmich ◽  
Cecilie Mølgaard ◽  
Anders Troelsen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adipose Tissue ◽  
Knee Injury ◽  
Primary Outcome ◽  
Morphological Changes ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Outcome Score ◽  
Patient Reported

Abstract Background Osteoarthritis is a destructive joint disease that leads to degeneration of cartilage and other morphological changes in the joint. No medical treatment currently exists that can reverse these morphological changes. Intra-articular injection with autologous, micro-fragmented adipose tissue has been suggested to relieve symptoms. Methods/Design The study is a blinded randomized controlled trial with patients allocated in a 1:1 ratio to 2 parallel groups. Patients suffering from pain and functional impairment due to osteoarthritis Kellgren-Lawrence grades 2–3 in the tibiofemoral joint are eligible for inclusion. The intervention group is treated with an intra-articular injection with autologous, micro-fragmented adipose tissue prepared using the Lipogems® system. The control group receives an intra-articular injection with isotonic saline. In total, 120 patients are to be included. The primary outcome is The Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months. Secondary outcomes are KOOS at 3, 12 and 24 months; the Tegner activity score; treatment failure; and work status of the patient. The analysis will be conducted both as intention-to-treat and per-protocol analysis. Discussion This trial is the first to investigate the efficacy of autologous, micro-fragmented adipose tissue in a randomized controlled trial. The study uses the patient-reported outcome measure Knee Injury and Osteoarthritis Outcome Score (KOOS4) after 6 months as the primary outcome, as it is believed to be a valid measure to assess the patient’s opinion about their knee and associated problems when suffering from osteoarthritis.

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