Brief cessation advice, nicotine replacement therapy sampling and active referral (BANSAR) for smoking expectant fathers: Study protocol for a multicentre, pragmatic randomised controlled trial
Pregnancy presents a teachable moment to engage male smokers whose partners are pregnant in smoking cessation. Evidence on how to approach and help these smokers quit smoking in antenatal settings has remained scarce. This paper presents the rationale and study design of a trial which aim to evaluate the effectiveness of a brief intervention model for promoting smoking cessation in expectant fathers. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 18, 2020 Category: Radiology Authors: Tzu Tsun Luk, Chi Ju Hsieh, Wing-cheong Leung, Kwok-yin Leung, Ka Wang Cheung, Carina Kwa, Kar-hung Siong, Kwok-keung Tang, Kai-wan Lee, William Ho-cheung Li, Tai Hing Lam, Man Ping Wang Source Type: research
Determining the effectiveness of early intensive versus escalation approaches for the treatment of relapsing-remitting multiple sclerosis: The DELIVER-MS study protocol
Multiple Sclerosis (MS) is a common cause of neurological disability among young adults and has a high economic burden. Currently there are 18 disease modifying agents for relapsing MS, which were tested in clinical trials versus placebo or an active comparator in a pairwise manner. However, there is currently no consensus on the fundamental principles of treatment approach and initial therapy selection. These factors result in variable use of disease modifying therapies. Here we describe the study protocol for Determining the Effectiveness of earLy Intensive Versus Escalation approaches for the Treatment of Relapsing-remi...
Source: Contemporary Clinical Trials - April 18, 2020 Category: Radiology Authors: Daniel Ontaneda, Emma C. Tallantyre, Praneeta C. Raza, Sarah M. Planchon, Kunio Nakamura, Deborah Miller, Carrie Hersh, Mathew Craner, Clare Bale, Burhan Chaudhry, Douglas D. Gunzler, Thomas E. Love, Stephen Gerry, Alasdair Coles, Jeffrey A. Cohen, Nikos Source Type: research
Hybrid type 1 randomized controlled trial of a tablet-based application to improve quality of care in child mental health treatment
The quality of child mental health care is highly variable in community practice settings. Innovative technology-based solutions may be leveraged to improve quality of care and, in turn, treatment outcomes. This is a protocol paper that describes an innovative study design in which we rigorously evaluate the effectiveness of a tablet-assisted intervention, Supporting Providers and Reaching Kids (SPARK). SPARK consists of a collection of interactive games and activities that are designed to improve provider fidelity and child engagement in evidence-based psychotherapies. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 18, 2020 Category: Radiology Authors: Margaret T. Anton, Leigh E. Ridings, Rochelle Hanson, Tatiana Davidson, Benjamin Saunders, Matthew Price, Carla Kmett Danielson, Brian Chu, Clara E. Dismuke, Zachary W. Adams, Kenneth J. Ruggiero Source Type: research
Translating research into practice: Protocol for a community-engaged, stepped wedge randomized trial to reduce disparities in breast cancer treatment through a regional patient navigation collaborative
Racial and socioeconomic disparities in breast cancer mortality persist. In Boston, MA, Black, Non-Hispanic women and Medicaid-insured individuals are 2 –3 times more likely to have delays in treatment compared to White or privately insured women. While evidence-based care coordination strategies for reducing delays exist, they are not systematically implemented across healthcare settings. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 15, 2020 Category: Radiology Authors: Tracy A. Battaglia, Karen M. Freund, Jennifer S. Haas, Nicole Casanova, Sharon Bak, Howard Cabral, Rachel A. Freedman, Karen Burns White, Stephenie C. Lemon, the TRIP Consortium Source Type: research
Computerized intervention for reducing intimate partner victimization for perinatal women seeking mental health treatment: A multisite randomized clinical trial protocol
Intimate partner victimization (IPV) is a significant social and public health problem among perinatal women. Research suggests that 21% to 33% of perinatal women report IPV and there is an enormous amount of morbidity associated with IPV. Moreover, IPV places women at high risk for several psychiatric disorders, which transforms the perinatal period from an already challenging process into a potentially overwhelming one. Further, IPV and untreated mental illness during the perinatal period pose a dual risk of adverse physical and emotional outcomes for women and their developing fetus/infant. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 15, 2020 Category: Radiology Authors: Dawn M. Johnson, Golfo Tzilos Wernette, Ted R. Miller, Maria Muzik, Christina A. Raker, Caron Zlotnick Source Type: research
IMPROVE, a community-based exercise intervention versus support group to improve functional and health outcomes among older African American and non-Hispanic White breast cancer survivors from diverse socioeconomic backgrounds: Rationale, design and methods
African Americans (AA) and socioeconomic status (SES) disadvantaged older breast cancer survivors (BCS) are more likely to experience poor functional and health outcomes. However, few studies have evaluated the putative beneficial effects of exercise on these outcomes in older racial minority and SES-disadvantaged BCS. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 14, 2020 Category: Radiology Authors: Cynthia Owusu, Nora L. Nock, Paul Hergenroeder, Kristina Austin, Elizabeth Bennet, Stephen Cerne, Halle Moore, Jean Petkac, Mark Schluchter, Kathryn H. Schmitz, Monica Webb-Hooper, Lindsay Atkins, Oghenerukeme Asagba, Leonard Wimbley, Nathan A. Berger Source Type: research
Study Protocol: A randomized controlled trial of suicide risk reduction in the year following jail release (the SPIRIT Trial)
This article describes the protocol for a randomized effectiveness and cost-effectiveness trial of Stanley and Brown's Safety Planning Intervention (SPI) during pretrial jail detention to reduce post-release suicide events (suicide attempts, suicide behaviors, and suicide-related hospitalizations). (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 14, 2020 Category: Radiology Authors: Jennifer E. Johnson, Richard Jones, Ted Miller, Ivan Miller, Barbara Stanley, Greg Brown, Sarah A. Arias, Louis Cerbo, Julie Rexroth, Holly Fitting, Danis Russell, Sheryl Kubiak, Michael Stein, Christopher Matkovic, Lauren M. Weinstock, Brandon Gaudiano, Source Type: research
Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (IP4-CHRONOS): A prospective, multi-centre therapeutic phase II parallel Randomised Control Trial
Focal therapy (FT) targets individual areas of cancer within the prostate, providing oncological control with minimal side-effects. Early evidence demonstrates encouraging short-medium-term outcomes. With no randomized controlled trials (RCT) comparing FT to radical therapies, Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (CHRONOS) will compare the cancer control of these two strategies. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 13, 2020 Category: Radiology Authors: Deepika Reddy, Taimur T. Shah, Tim Dudderidge, Stuart McCracken, Manit Arya, Chris Dobbs, Mark Emberton, Francesca Fiorentino, Emily Day, A.T. Prevost, John Staffurth, Matthew Sydes, Mathias Winkler, Hashim U. Ahmed Source Type: research
A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol
This randomized trial will evaluate the mechanisms of three chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS). We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level. The shared versus specific role of these mechanisms across the three treatments will be evaluated during treatment (Primary Aim), and immediately post-treatment to examine relapse mechanisms (Secondary Aim). (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 13, 2020 Category: Radiology Authors: M.A. Day, D.M. Ehde, J. Burns, L.C. Ward, J.L. Friedly, B.E. Thorn, M.A. Ciol, E. Mendoza, J.F. Chan, S. Battalio, J. Borckardt, M.P. Jensen Source Type: research
Improving health engagement and lifestyle management for breast cancer survivors with diabetes
Breast cancer survivors with type 2 diabetes are at high risk for cancer recurrence, serious health complications, more severe symptoms, psychological distress, and premature death relative to breast cancer survivors without diabetes. Maintaining glycemic control is critical for decreasing symptoms and preventing serious health problems. Many breast cancer survivors with type 2 diabetes have difficulty maintaining diabetes self-management behaviors and achieving glycemic control. Both cancer and diabetes-related symptoms (e.g., physical symptoms and psychological distress) are often barriers to engaging in diabetes self-ma...
Source: Contemporary Clinical Trials - April 10, 2020 Category: Radiology Authors: Rebecca A. Shelby, Caroline S. Dorfman, Sarah S. Arthur, Hayden B. Bosworth, Leonor Corsino, Linda Sutton, Lynda Owen, Alaattin Erkanli, Francis Keefe, Cheyenne Corbett, Gretchen Kimmick Source Type: research
Does the COVID-19 outbreak identify a broader need for an urgent transformation of cancer clinical trials research?
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 5, 2020 Category: Radiology Authors: Hala T. Borno, Eric J. Small Source Type: research
Use of real-world data for HPV vaccine trial follow-up in the Nordic region
Post-marketing studies are commonly performed to follow-up on the safety and effectiveness of a drug or vaccine after approval has been obtained. These post-marketing studies may involve the collection of real-world data from registries and clinical biobanks in order to obtain real-world evidence. As this approach can monitor the effects of pharmaceutical products over decades, it is particularly necessary for the development of safe and effective vaccines. A long-term follow-up (LTFU) study was initiated as an extension of a phase 3 clinical study (V501 –015; NCT00092534) to assess the effectiveness, immunogenicity and ...
Source: Contemporary Clinical Trials - March 31, 2020 Category: Radiology Authors: Espen Enerly, Sophie Berger, Susanne K. Kj ær, Karin Sundström, Suzanne Campbell, Laufey Tryggvadóttir, Christian Munk, Maria Hortlund, Thomas Group, Amita Joshi, Alfred J. Saah, Mari Nygård Source Type: research
Impacting child health outcomes in congenital heart disease: Cluster randomized controlled trial protocol of in-clinic physical activity counselling
Most (>90%) children with congenital health defects are not active enough for optimal health. Proactively promoting physical activity during every clinic visit is recommended, but rarely implemented due to a lack of appropriate resources. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 24, 2020 Category: Radiology Authors: Olivia Lemire, Jenna Yaraskavitch, Jane Lougheed, Andrew S. Mackie, Kambiz Norozi, Patricia E. Longmuir Source Type: research
The South Asian Healthy Lifestyle Intervention (SAHELI) trial: Protocol for a mixed-methods, hybrid effectiveness implementation trial for reducing cardiovascular risk in South Asians in the United States
Intensive lifestyle interventions targeting diet and physical activity are recommended for reducing atherosclerotic cardiovascular disease (ASCVD) risk in adults. However, existing interventions often do not reach immigrant populations because of a mismatch between the social, cultural, and environmental context of immigrants and Western bio behavioral models which underpin evidence-based lifestyle interventions. The South Asian Healthy Lifestyle Intervention (SAHELI) study is a type 1 hybrid design randomized controlled trial aimed at reducing ASCVD risk in South Asian Americans, a group at higher ASCVD risk than whites a...
Source: Contemporary Clinical Trials - March 23, 2020 Category: Radiology Authors: Namratha R. Kandula, Veronica Bernard, Swapna Dave, Linda Ehrlich-Jones, Catherine Counard, Nirav Shah, Santosh Kumar, Goutham Rao, Ronald Ackermann, Bonnie Spring, Juned Siddique Source Type: research
Dynamic treatment regimens in small n, sequential, multiple assignment, randomized trials: An application in focal segmental glomerulosclerosis
Focal segmental glomerulosclerosis (FSGS) is a rare kidney disease with an annual incidence of 0.2 –1.8 cases per 100,000 individuals. Most rare diseases like FSGS lack effective treatments, and it is difficult to implement clinical trials to study rare diseases because of the small sample sizes and difficulty in recruitment. A novel clinical trial design, a small sample, sequential, multiple a ssignment, randomized trial (snSMART) has been proposed to efficiently identify effective treatments for rare diseases. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 17, 2020 Category: Radiology Authors: Yan-Cheng Chao, Howard Trachtman, Debbie S. Gipson, Cathie Spino, Thomas M. Braun, Kelley M. Kidwell Source Type: research
