scholarly journals Apixaban, Dalteparin, in Active Cancer Associated Venous Thromboembolism, the ADAM VTE Trial

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 421-421 ◽  
Author(s):  
Robert D. McBane ◽  
Waldemar E. Wysokinski ◽  
Jennifer Le-Rademacher ◽  
Aneel A. Ashrani ◽  
Alfonso J Tafur ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Conflicts Of Interest ◽  
Breast Cancers ◽  
Primary Analysis ◽  
Patients With Cancer ◽  
Cancer Types ◽  
To Receive

Abstract Background: Currently, low molecular weight heparin is the guideline endorsed treatment of patients with cancer associated venous thromboembolism (VTE). While apixaban is approved for the treatment of acute VTE, there are limited data supporting its use in cancer patients. Methods: Patients with cancer associated acute VTE were randomly assigned to receive either apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily or subcutaneous dalteparin (200 IU/kg for 1 month followed by 150 IU/kg once daily) for 6 months. The primary outcome was major bleeding. Secondary outcomes included VTE recurrence and a composite of major plus clinically relevant non-major bleeding. Results: Of the 300 patients who underwent randomization, 287 were included in the primary analysis. Of these, metastatic disease was present in 65.5% of subjects and 74% were receiving concurrent systemic cancer therapy. Colorectal, lung, pancreas, and breast cancers were the four most prevalent cancer types. Major bleeding occurred in 0 of the 142 patients (0%) in the apixaban group as compared with 3 of the 145 patients (2.1%) in the dalteparin group (p=0.9956). Recurrent VTE occurred in 5 patients (3.4%) in the apixaban group and 20 patients (14.1%) in the dalteparin group (difference in risk -10.7 percentage points) with a Hazard Ratio (HR) 0.26, (95% CI, 0.09 - 0.80, p = 0.0182). Major plus clinically relevant non-major bleeding were similar at 9% for both groups. There were no mortality differences comparing apixaban (15.9%) and dalteparin (10.6%) groups at 6 months (HR 1.36, 95% CI 0.79 - 2.35). Monthly quality of life surveys favored apixaban therapy for many measures including: concern for excess bruising, stress, irritation, burden of delivery, and overall satisfaction with anticoagulant therapy (p<0.05). Monthly bruising questionnaire favored apixaban at each interval (p<0.002). Conclusions: Oral apixaban therapy was associated with very low rates of bleeding and significantly lower VTE recurrence with superior quality of life outcome measures compared to parenteral dalteparin in the treatment of cancer associated VTE. These data support the clinical utility of apixaban for the acute treatment of VTE in this patient population. Table. Table. Disclosures No relevant conflicts of interest to declare.

scholarly journals Efficacy and Safety of Direct Oral Anticoagulants for Risk of Cancer-Associated Venous Thromboembolism

2019 ◽  
Vol 25 ◽  
pp. 107602961985362 ◽  
Author(s):  
Jie Zeng ◽  
Xuhui Zhang ◽  
Gregory Y. H. Lip ◽  
Xiaochen Shu ◽  
Lehana Thabane ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Favorable Effect ◽  
Entire Body ◽  
Efficacy And Safety ◽  
Patients With Cancer ◽  
Risk Of Cancer

Efficacy and safety of direct oral anticoagulants (DOACs) for preventing primary and recurrent venous thromboembolism (VTE) in patients with cancer remain unclear. In this study, we conducted a systematic review to summarize the most up-to-date evidence from randomized controlled trials (RCTs). Our primary outcomes included the benefit outcome (VTE) and safety outcome (major bleeding). A random-effects model was used to pool the relative risks (RRs) for data syntheses. The Grading of Recommendations Assessment, Development and Evaluation tool was used to evaluate the quality of the entire body of evidence across studies. We included 11 RCTs with a total of 3741 patients with cancer for analyses. The DOACs were significantly related with a reduced risk of VTE when compared with non-DOACs: RR = 0.77, 95% confidence interval [CI]: 0.61-0.99, P = .04. Nonsignificant trend towards a higher risk of major bleeding was found in DOACs: RR = 1.28 95% CI: 0.81-2.02, P = .29. The quality of the entire body of evidence was graded as moderate for risk of VTE, and low for risk of major bleeding. To summarize, DOACs were found to have a favorable effect on risk of VTE but a nonsignificant higher risk of major bleeding compared with non-DOACs in patients with cancer. The safety effect of DOACs in patients with cancer requires further evaluation in adequately powered and designed studies.

Apixaban and dalteparin in active malignancy associated venous thromboembolism

2017 ◽  
Vol 117 (10) ◽  
pp. 1952-1961 ◽  
Author(s):  
Charles Loprinzi ◽  
Aneel Ashrani ◽  
Juliana Perez Botero ◽  
Roberto Leon Ferre ◽  
Stanislav Henkin ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Major Bleeding ◽  
The United States ◽  
Limited Data ◽  
Open Label ◽  
Safety Outcome ◽  
Patients With Cancer ◽  
Superiority Trial ◽  
To Receive

SummaryCurrently, low molecular weight heparin (LMWH) is the guideline endorsed treatment of patients with cancer associated venous thromboembolism (VTE). While apixaban is approved for the treatment of acute VTE, there are limited data supporting its use in cancer patients. The rationale and design of this investigator initiated Phase IV, multicenter, randomized, open label, superiority trial assessing the safety of apixaban versus dalteparin for cancer associated VTE is provided (ADAM-VTE; NCT02585713). The main aim of the ADAM-VTE trial is to test the hypothesis that apixaban is associated with a significantly lower rate of major bleeding compared to dalteparin in the treatment of cancer patients with acute VTE. The primary safety outcome is rate of major bleeding. Secondary efficacy objective is to assess the rates of recurrent VTE or arterial thromboembolism. Cancer patients with acute VTE (n=300) are randomized to receive apixaban (10 mg twice daily for 7 days followed by 5 mg twice daily thereafter) or dalteparin (200 IU/Kg daily for 30 days followed by 150 IU/kg daily thereafter) for 6 months. Stratification factors used for randomization include cancer stage and cancer specific risk of venous thromboembolism using the Khorana score. Participating centers are chosen from the Academic and Community Cancer Research United (ACCRU) consortium comprised of 90 oncology practices in the United States and Canada. Based on the hypothesis to be tested, we anticipate that these trial results will provide evidence supporting apixaban as an effective treatment of cancer associated VTE at lower rates of major bleeding compared to LMWH.

A randomized controlled trial of the effect of intercessory prayer on the spiritual wellbeing and quality of life of patients with cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20708-e20708
Author(s):  
I. N. Olver ◽  
H. S. Whitford
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Intercessory Prayer ◽  
Spiritual Wellbeing ◽  
Patients With Cancer ◽  
Randomized Controlled ◽  
To Receive

e20708 Background: A number of scientific trials assessing the positive impact of intercessory prayer attest to centuries of anecdotal evidence, despite debate of its mechanism. However, little attention has been afforded to patients with cancer and the effect such intervention has on quality of life, including spiritual wellbeing. This study aimed to assess the effect of remote, Christian intercessory prayer on cancer patients’ quality of life, specifically their spiritual wellbeing, including their search for meaning, peace, and faith. Methods: New, consecutive patients with cancer attending an Australian cancer centre, aged 18 years or above, able to read English, and give consent were recruited. With Ethics Committee approval, this prospective, double blinded randomized controlled trial only partially divulged the nature of the study to patients who were informed of the measurements but not the inclusion of randomization to an intervention. Specifically, patients were blindly, randomly allocated to receive distant, intercessory prayer from an established Christian prayer chain (intervention) or not to receive prayer (control). All patients completed the Mental Adjustment to Cancer (MAC) scale and the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) at baseline. The FACIT-Sp was re-administered six months later to assess the primary endpoint, a change in spiritual wellbeing. It was anticipated that 1000 patients were needed (allowing for 20% drop out) to achieve 80% power to detect hypothesized small differences (Cohen's d .20-.50) between groups (alpha = .05). Results: A total of 1003 eligible, consenting patients were accrued between June 2003 and May 2008. Intervention (n = 509) and control (n = 494) groups will be compared across baseline characteristics to identify any pre-existing differences. Between-within subject analyses of covariance (ANCOVAs) will be used to assess whether any differences were evident between groups across measures of spiritual wellbeing and other facets of quality of life. Conclusions: The results of these analyses will be presented. It is hoped this research will provide further empirical support for the biopsychosocialspiritual model of health. No significant financial relationships to disclose.

scholarly journals Virtual reality-based relaxation for enhancement of perioperative well-being and quality of life: protocol for a randomised pilot trial

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e044193
Author(s):  
Matthias Christian Schrempf ◽  
Julian Quirin Petzold ◽  
Hugo Vachon ◽  
Morten Aagaard Petersen ◽  
Johanna Gutschon ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Virtual Reality ◽  
Sample Size ◽  
Stress Reduction ◽  
Pilot Trial ◽  
Well Being ◽  
Coping Resources ◽  
Patients With Cancer ◽  
Sample Size Calculations

IntroductionPatients with cancer undergoing surgery often suffer from reduced quality of life and various forms of distress. Untreated distress can negatively affect coping resources as well as surgical and oncological outcomes. A virtual reality-based stress reduction intervention may increase quality of life and well-being and reduce distress in the perioperative phase for patients with cancer. This pilot trial aims to explore the feasibility of the proposed intervention, assess patient acceptability and obtain estimates of effect to provide data for sample size calculations.Methods and analysisPatients with colorectal cancer and liver metastasis undergoing elective surgery will be recruited for this single-centre, randomised pilot trial with a three-arm design. A total of 54 participants will be randomised at 1:1:1 ratio to one of two intervention groups or a control receiving standard treatment. Those randomised to an intervention group will either receive perioperative virtual reality-based stress reduction exercises twice daily or listen to classical music twice daily. Primary feasibility outcomes are number and proportions of participants recruited, screened, consented and randomised. Furthermore, adherence to the intervention, compliance with the completion of the quality of life questionnaires and feasibility of implementing the trial procedures will be assessed. Secondary clinical outcomes are measurements of the effectiveness of the interventions to inform sample size calculations.Ethics and disseminationThe study protocol, the patient information and the informed consent form have been approved by the ethics committee of the Ludwigs-Maximilians-University, Munich, Germany (Reference Number: 19–915). Study findings will be submitted for publication in peer-reviewed journals.Trial registration numberDRKS00020909.

scholarly journals Correction to: The relationship between comorbidity medication adherence and health related quality of life among patients with cancer

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Dana Drzayich Antol ◽  
Adrianne Waldman Casebeer ◽  
Raya Khoury ◽  
Todd Michael ◽  
Andrew Renda ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Medication Adherence ◽  
Health Related Quality ◽  
Patients With Cancer ◽  
Related Quality ◽  
Health Related ◽  
The Relationship

An amendment to this paper has been published and can be accessed via the original article.

Current measures of distress may not account for what's most important in existential care interventions: Results of the outlook trial

2020 ◽  
Vol 18 (6) ◽  
pp. 648-657
Author(s):  
Karen E. Steinhauser ◽  
Karen M. Stechuchak ◽  
Katherine Ramos ◽  
Joseph Winger ◽  
James A. Tulsky ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Early Stage ◽  
Well Being ◽  
Primary Analysis ◽  
Significant Difference ◽  
Spiritual Well Being ◽  
Screening For Distress ◽  
Secondary Outcomes ◽  
Stage Renal Disease

AbstractObjectiveCompare the efficacy of two interventions addressing emotional and existential well-being in early life-limiting illness.MethodPrimary trial analysis (n = 135) included patients with advanced cancer, congestive heart failure, or end-stage renal disease; Arm 1 received the Outlook intervention, addressing issues of life completion and preparation, and Arm 2 received relaxation meditation (RM). Primary outcomes at five weeks (primary endpoint) and seven weeks (secondary): completion and preparation (QUAL-E); secondary outcomes: anxiety (POMS) quality of life (FACT-G) and spiritual well-being (FACIT-Sp) subscales of faith, meaning, and peace.ResultsAverage age was 62; 56% were post-high school-educated, 54% were married, 52% white, 44% female, and 70% had a cancer diagnosis. At baseline, participants demonstrated low levels of anxiety (<5 on POMS subscale) and depression (<10 on CESD) relative to population norms. Results of the primary analysis revealed no significant differences in mean Preparation by treatment arm at five weeks (14.4 Outlook vs. 14.8 RM; between-group difference −0.4 [95% CI, −1.6, 0.8], p = 0.49) or seven weeks (15.2 vs.15.4; between-group difference −0.2 [95% CI, −1.5, 1.0], p = 0.73). There were also no significant differences in mean Life Completion by treatment arm between five weeks (26.6 Outlook vs. 26.3 RM; between-group difference 0.2 [95% CI, −1.2, 1.7], p = 0.76) or seven weeks (26.5 vs. 27.5; between-group difference −1.0 [95% CI, −2.7, 0.7], p = 0.23). Compared to RM, Outlook participants did not have significant differences over time in the secondary outcomes of overall quality of life, anxiety, depression, FACT-G subscales, and FACIT-Sp subscales.DiscussionIn early-stage life-limiting illness, Outlook did not demonstrate a significant difference in primary or secondary outcomes relative to RM. Results underscore the importance of pre-screening for distress. Qualitatively, Outlook participants were able to express suppressed emotions, place illness context, reflect on adaptations, and strengthen identity. Screening for distress and identifying specified measures of distress, beyond anxiety and depression, is essential in our ability to adequately assess the multi-dimensional mechanisms that decrease existential suffering.

scholarly journals Observational non-randomised controlled evaluation of the effectiveness of cancer counselling centres: a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032889
Author(s):  
Solveigh Paola Lingens ◽  
Georgia Schilling ◽  
Julia Harms ◽  
Holger Schulz ◽  
Christiane Bleich
Keyword(s):  
Quality Of Life ◽  
Short Form ◽  
Control Group ◽  
Life Questionnaire ◽  
Psychosocial Variables ◽  
European Organization ◽  
Psychological Burden ◽  
Patients With Cancer ◽  
Small Effect Size

IntroductionIn recent years, medical treatment for cancer has improved, thereby increasing the life expectancy of patients with cancer. Hence, the focus in healthcare shifted towards analysing treatments that offer to decrease distress and improve the quality of life of patients with cancer. The psychological burden of patients with cancer originates from all kinds of psychosocial challenges related to diagnosis and treatment. Cancer counselling centres (CCounCs) try to address these concerns. However, the current literature lacks research on the effectiveness of CCounCs. This study aims to assess the effectiveness of CCounCs with regard to distress and other relevant psychosocial variables (quality of life, anxietyand so on).Methods and analysisThis prospective observational study with a non-randomised control group has three measurement points: before the first counselling session (baseline, t0) and at 2 weeks and 3 months after baseline (t1, t2). Patients and their relatives who seek counselling between December 2018 and November 2020 and have sufficient German language skills will be included. The control group will be recruited at clinics and oncological outpatient centres in Hamburg. Propensity scoring will be applied to adjust for differences between the control and intervention groups at baseline. Sociodemographic data, medical data and counselling concerns are measured at baseline. Distress (distress thermometer), quality of life (Short Form-8 Health Survey, European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30), anxiety (Generalized AnxietyDisorder-7), depression (Patient HealthQuestionnaire-9) and further psychosocial variables are assessed at all time points. With a total of 787 participants, differences between the intervention and control groups of a small effect size (f=0.10) can be detected with a power of 80%.Ethics and disseminationThe study was registered prior to data collection with the German Registration of Clinical Trials in September 2018. Ethical approval was received by the local psychological ethical committee of the Center for Psychosocial Medicine at the University Medical Centre Hamburg-Eppendorf in August 2018. The results will be published in peer-reviewed journals.Trial registration numberDRKS00015516; Pre-results.

scholarly journals Fears, beliefs, and quality of life of patients with cancer vs the general population during the coronavirus disease 2019 (COVID-19) pandemic in Lombardy

2021 ◽  
pp. 030089162110228
Author(s):  
Carla Ida Ripamonti ◽  
Giacomo Massa ◽  
Daniela Insolvibile ◽  
Mauro Guglielmo ◽  
Guido Miccinesi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
General Population ◽  
Perceived Risk ◽  
Well Being ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Psychological Consequences ◽  
Patients With Cancer ◽  
Fear Of Cancer

Aim: To understand how patients with cancer reacted to the coronavirus disease 2019 (COVID-19) pandemic and whether their quality of life (QoL) was affected. Methods: In June 2020, 111 patients with cancer treated in the supportive care unit of a Comprehensive Cancer Center in Milan and 201 healthy controls from the general population were enrolled and assessed both quantitatively and qualitatively for fears and COVID-19–related beliefs as well as for QoL. Results: Fear of COVID-19 was significantly lower among patients (41% vs 57.6%; p = 0.007), as was fear of cancer (61.5% vs 85.6%; p < 0.001) and other diseases. The perceived risk of getting COVID-19 was lower among patients (25.2% vs 52.7%; p < 0.001), as was the belief of having been exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (18.1% vs 40.8%; p < 0.001). The physical component of QoL was better among the population (54.5 vs 43.8; p < 0.001); the reverse was true for patients’ psychological well-being (44.6 vs 39.6; p < 0.001). The qualitative data supported such results, showing a reduced psychological effect on the patients with cancer compared to the controls. Various reasons explain this result, including the awareness of being treated for cancer and nevertheless protected against getting infected in a cancer center of public health reorganized to continue treating patients by protecting them and personnel from the risk of infection. Conclusions: The experience of a cancer diagnosis, together with proper hospital reorganization, may act as protective factors from fears and psychological consequences of the COVID-19 outbreak.

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