Abstract:
BACKGROUND:Despite evidence that palliative care increases quality and length of life, many patients and families remain uninformed about its nature and benefits. The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care: A Personal Guide (MCC), intended to improve breast cancer patients' knowledge of palliative care and to facilitate its timely integration into cancer self-management. METHODS:Aims are to: 1) evaluate the effects of MCC on patients' knowledge of palliative care; 2) examine preliminary effects of MCC on patients' behaviors (role in self-management, engagement in goals of care conversations, medical communication, management of transitions, health care utilization), and feelings (self-efficacy, anxiety, depression, uncertainty); and 3) evaluate protocol feasibility and acceptability. An exploratory aim is to investigate how demographic and clinical factors may moderate intervention effects, with emphasis on differences in use and outcomes among minority participants. We plan to enroll 60 patients and their family caregivers with 50% minority participation. The intervention group receives MCC; the attention-control group receives a Symptom Management Toolkit. We collect data at baseline, one, and three months. DISCUSSION:This study will inform a large scale trial of MCC. It is challenging for patients with breast cancer, their family caregivers, and providers to make choices that include palliation alone or in combination with potentially curative treatment. MCC may help address this challenge by giving patients the information, skills, and confidence to better self-manage breast cancer. Results may help to establish palliative care as a mainstay of self-management interventions targeting serious illness. TRIAL REGISTRATION:ClinicalTrials.gov Identifier NCT02148575 (date registered: 5.21.14; date first patient enrolled: 7.15.14).
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Schulman-Green D,Linsky S,Jeon S,Kapo J,Blatt L,Chagpar Adoi
10.1016/j.cct.2016.04.009subject
Has Abstractpub_date
2016-05-01 00:00:00pages
133-8eissn
1551-7144issn
1559-2030pii
S1551-7144(16)30056-8journal_volume
48pub_type
杂志文章,随机对照试验abstract::Although the Diabetes Prevention Program (DPP) developed a lifestyle weight loss intervention that has been demonstrated to prevent type 2 diabetes in high-risk individuals, it has yet to be widely adopted at the community level. The Healthy Living Partnership to Prevent Diabetes study (HELP PD) was designed to transl...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2009.09.002
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND:Medicaid recipients with serious mental illness die 25-30 years earlier than people in the general population due to health conditions that are modifiable through lifestyle changes. Cardiovascular diseases from excess weight, smoking, and sedentary lifestyle contribute substantially to this life expectancy d...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2019.04.005
更新日期:2019-06-01 00:00:00
abstract::While investigators designing clinical trials face the important issue of endpoint selection, an equally troublesome concern can be the a priori selection of the endpoint analysis. In this latter circumstance, there may be only one endpoint of interest in the clinical trial, but several competing endpoint analyses are...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2006.05.010
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND:Research demonstrates a link between migraine and obesity. Obesity increases the risk of frequent migraines and is associated with migraine prevalence among reproductive-aged women. These findings are substantiated by several plausible mechanisms and emerging evidence of migraine improvements after surgical ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2013.03.004
更新日期:2013-05-01 00:00:00
abstract:BACKGROUND:Atrial fibrillation (AF) increases the risk of thromboembolic stroke. An oral anticoagulant should be administrated to prevent stroke in patients with moderate stroke risk (ie, CHA2DS2-VASc score>2). If the stroke risk is low (i.e. the score=1), however, antiplatelet agent such as aspirin is widely used. Asp...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2017.06.011
更新日期:2017-09-01 00:00:00
abstract::Identifying effective strategies for treating obesity is a clinical challenge and a public health priority. The present study is an innovative test of the relative effectiveness of lottery-based financial incentives and environmental strategies on weight loss and maintenance. The Healthy Weigh study is evaluating the ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.10.013
更新日期:2019-01-01 00:00:00
abstract::Managing chronic pain effectively is often challenging for health care providers and patients. Telehealth technologies can bridge geographic distance and improve patients' quality of care in communities where access to pain specialists has previously been unavailable. This paper describes the development and evaluatio...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2014.05.005
更新日期:2014-07-01 00:00:00
abstract::The ability to recruit qualified subjects who are willing to adhere to the study protocol in clinical trials is an essential component of translational research. Such tasks can be particularly challenging for chemoprevention studies when the targeted study population is healthy, at risk individuals who do not have sig...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2009.05.004
更新日期:2009-09-01 00:00:00
abstract::Hepatitis C virus (HCV) is a leading cause of chronic liver disease. The natural history of HCV infection is heterogeneous, and a person infected with HCV can clear the virus or progress to a chronic infection. The chronic infection can remain asymptomatic for decades before the development of liver cirrhosis and/or c...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2008.03.006
更新日期:2008-09-01 00:00:00
abstract:BACKGROUND:Many of the health behaviors known to contribute to cardiometabolic risk and disease (CMRD), including physical activity, diet, sleep, and screen time, begin during childhood. Given the population-wide burden of CMRD, novel ways of assessing risk and providing feedback to support behavior change are needed. ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.07.012
更新日期:2016-07-01 00:00:00
abstract:BACKGROUND:Multiple sclerosis is a chronic progressive neurological disease. Evidence attests to the benefits of exercise, guidelines for exercise in multiple sclerosis are available. Remote-delivery of exercise adherence programmes based on the exercise guidelines require urgent testing. AIMS:The design, and outcomes...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2021.106281
更新日期:2021-01-12 00:00:00
abstract::The COVID-19 pandemic has substantially impacted the conduct of clinical trials. While initially preparing for a period of time, where it would likely be impossible to supervise trials in the usual way and precautionary measures had to be implemented to care for medication supply and general safety of study participan...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106155
更新日期:2020-11-01 00:00:00
abstract::Traditionally, children presenting with appendicitis are referred for urgent appendectomy. Recent improvements in the quality and availability of diagnostic imaging allow for better pre-operative characterization of appendicitis, including severity of inflammation; size of the appendix; and presence of extra-luminal i...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2019.06.013
更新日期:2019-08-01 00:00:00
abstract::Cancer related cognitive impairments (CRCI) are frequently reported by patients prior to, during and after medical treatment. Although this cognitive decline severely affects patients' quality of life, little is known about effective treatments. Exercise programs represent a promising supportive strategy in this field...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.05.007
更新日期:2016-07-01 00:00:00
abstract:BACKGROUND:Flaxseed is an important source of alpha-linolenic acid an essential omega-3 fatty acid. The possibility that a supplementation of the diet with foods rich in alpha-linolenic acid, antioxidants and fiber (like flaxseed) has not been investigated. METHODS/DESIGN:The primary objective is to determine whether ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2011.05.005
更新日期:2011-09-01 00:00:00
abstract::Determining the quality of a randomized clinical trial (RCT) is necessary for decision-makers to determine the believability and applicability of the trial findings. Issues that are likely to affect the utility of RCT evidence include issues of bias, random error and applicability. In this article we focus primarily o...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,评审
doi:10.1016/j.cct.2015.07.019
更新日期:2015-11-01 00:00:00
abstract:BACKGROUND:We evaluated the association of demographic and clinical characteristics with participation in an epidemiologic study of diabetes mellitus among youth. METHODS:SEARCH for Diabetes in Youth is a multicenter study of physician-diagnosed diabetes in youth under the age of 20 comprising a surveillance and a coh...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1016/j.cct.2008.05.008
更新日期:2008-11-01 00:00:00
abstract:BACKGROUND:Atorvastatin and metformin are known energy restricting mimetic agents that act synergistically to produce molecular and metabolic changes in advanced prostate cancer (PCa). This trial seeks to determine whether these drugs favourably alter selected parameters in men with clinically-localized, aggressive PCa...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.06.014
更新日期:2016-09-01 00:00:00
abstract::Although colorectal cancer (CRC) is largely preventable through identification of pre-cancerous polyps through various screening modalities, morbidity and mortality rates remain a challenge, especially in African-American, Latino, low-income and uninsured/underinsured patients. Barriers to screening include cost, acce...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2016.11.009
更新日期:2017-01-01 00:00:00
abstract:PURPOSE:To describe the strategies-based on the social triad concept of a partnership of researchers, school personnel and community-employed to recruit low-income, minority parent/caregivers of kindergarten children into a school-based tooth decay prevention trial in the United States. METHODS:The study site was an u...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2011.09.012
更新日期:2012-01-01 00:00:00
abstract::Modified Zelen's approach is a randomization technique useful in multi-center trials where balance in treatment assignments within a center is desired. It has great balancing properties in a study with equal allocation to several treatment arms. This technique can also be used in studies with unequal allocation, where...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,评审
doi:10.1016/j.cct.2011.08.006
更新日期:2011-11-01 00:00:00
abstract:BACKGROUND:Extended-release naltrexone (XR-NTX, Vivitrol; Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist. XR-NTX is a potentially effective intervention for opioid use disorders and as relapse prevention among criminal justice system (CJS) populations. METHODS:This 5-site open-...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2015.01.005
更新日期:2015-03-01 00:00:00
abstract::Researchers have long sought to find combinations of cancer drugs that might achieve synergy. However, while observed in some preclinical tumor models, synergistic effects are rarely seen in clinical trials. In fact, growing evidence in clinical trial data shows that the treatment effect of most approved combination t...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106126
更新日期:2020-11-01 00:00:00
abstract::Although progress has been made to elucidate the effects of exercise as a strategy for reducing obesity and related cardiometabolic risk factors, the specific exercise exposures required to achieve optimal benefit continue to be the source of considerable uncertainty and debate. Despite the inference of a dose-depende...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.10.010
更新日期:2013-01-01 00:00:00
abstract::Clinical trial is considered a breakthrough method in medicine and essential to the development of new drugs. Clinical trials that comply with international and national regulations require an appropriate infrastructure and team qualification. The goal of this study was to evaluate clinical trial groups in Brazil: pro...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2010.06.002
更新日期:2010-09-01 00:00:00
abstract:INTRODUCTION:Breast cancer survivors face dual challenges: long term sequelae of treatment, and risk of recurrent disease. Obesity and a sedentary lifestyle complicate both challenges. The WISER Survivor trial assessed the effects of exercise and/or weight-loss on lymphedema, biomarkers of breast cancer recurrence, and...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.07.017
更新日期:2017-10-01 00:00:00
abstract::Obesity prevalence is higher in rural compared to urban residents. Rural health clinics offer a potential venue for delivery of weight management. However, traditional programs require travel to attend on-site meetings which is impractical or inconvenient for rural residents. Clinic staff in most rural settings are un...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.02.006
更新日期:2018-04-01 00:00:00
abstract::Illustrated is the use of a patient enrichment adaptive design in a randomized phase II trial which allows the evaluation of treatment benefits by the biomarker expression level and makes interim adjustment according to the pre-specified rules. The design was applied to an actual phase II metastatic hepatocellular car...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2013.12.001
更新日期:2014-01-01 00:00:00
abstract::Behavioral weight loss programs help people achieve clinically meaningful weight losses (8-10% of starting body weight). Despite data showing that only half of participants achieve this goal, a "one size fits all" approach is normative. This weight loss intervention science gap calls for adaptive interventions that pr...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.01.011
更新日期:2016-03-01 00:00:00
abstract:BACKGROUND:Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured muc...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106177
更新日期:2020-12-01 00:00:00