Enhancing Recruitment and Retention in Randomized Clinical Trials of Cancer Symptom Management

2007 ◽  
Vol 34 (2) ◽  
pp. E17-E22 ◽  
Author(s):  
Ann M. Berger ◽  
Donna Edwards Neumark ◽  
Julie Chamberlain
Keyword(s):  
Clinical Trials ◽  
Symptom Management ◽  
Randomized Clinical Trials ◽  
Recruitment And Retention ◽  
Cancer Symptom Management

scholarly journals Improving recruitment and retention of adolescents and young adults with cancer in randomized controlled clinical trials

2019 ◽  
Vol 0 (0) ◽  
Author(s):  
Sharron L. Docherty ◽  
Stacey Crane ◽  
Joan E. Haase ◽  
Sheri L. Robb
Keyword(s):  
Clinical Trials ◽  
Young Adults ◽  
Randomized Clinical Trials ◽  
Adolescents And Young Adults ◽  
Adolescent And Young Adult ◽  
Recruitment And Retention ◽  
Randomized Controlled Clinical Trials ◽  
Pros And Cons ◽  
Adult Resilience ◽  
Psychosocial Programs

Abstract Participation of adolescents and young adults (AYAs) with cancer in randomized clinical trials (RCTs) is necessary to advance treatments and psychosocial programs. Exploring AYAs experiences in an RCT will inform strategies to support recruitment and retention. A qualitative design was used to study the experiences of 13 AYAs in the Stories and Music for Adolescent and Young Adult Resilience during Transplant I (SMART I) trial. Key themes included: Weighing the Pros and Cons; Randomization Preferences; Completing Measures; and Worthwhile Experience. The experiences of AYAs during RCTs can bring insights that inform the design and management of AYA trials. Strategies include improving assent/consent processes, design of electronic interfaces and encouraging researcher flexibility.

Integrating Patient-Reported Outcomes Into Cancer Symptom Management Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks

2007 ◽  
Vol 25 (32) ◽  
pp. 5070-5077 ◽  
Author(s):  
Jeff A. Sloan ◽  
Lawrence Berk ◽  
Joseph Roscoe ◽  
Michael J. Fisch ◽  
Edward G. Shaw ◽  
...  
Keyword(s):  
Clinical Trials ◽  
National Cancer Institute ◽  
Symptom Management ◽  
Patient Reported Outcomes ◽  
Draft Guidance ◽  
End Point ◽  
Patient Reported ◽  
The Us ◽  
Cancer Symptom Management ◽  
Made In

Patient-reported outcomes (PROs) are often the primary end point in symptom management trials. The scientific field of PROs is evolving, as evidenced by the US Food and Drug Administration's February 2007 release of a draft guidance for using PROs in effectiveness claims for drug labeling. This article presents issues encountered during use of PROs in National Cancer Institute–sponsored symptom management trials. Selected trials are presented that exemplify the challenges often seen in symptom management trials, and solutions are described. The examples presented include defining the appropriate end point, selecting and validating assessments, and answering the research questions through statistical analysis and interpretation. Progress has been made in addressing some of the unique challenges of PRO-based symptom management research. Many challenges still remain, but a foundational body of work now exists for more consistent and rigorous application of PROs into symptom management trials. There remains a need for more research in several methodologic aspects of design, analysis, and interpretation of symptom management trials.

Research-Design Issues in Cancer-Symptom–Management Trials Using Complementary and Alternative Medicine: Lessons From the National Cancer Institute Community Clinical Oncology Program Experience

2005 ◽  
Vol 23 (27) ◽  
pp. 6682-6689 ◽  
Author(s):  
David R. Buchanan ◽  
Jeffrey D. White ◽  
Ann M. O'Mara ◽  
Joseph W. Kelaghan ◽  
Wendy B. Smith ◽  
...  
Keyword(s):  
Quality Control ◽  
Clinical Trials ◽  
Alternative Medicine ◽  
Complementary And Alternative Medicine ◽  
Research Design ◽  
Symptom Management ◽  
Design Issues ◽  
Community Clinical Oncology Program ◽  
Cancer Symptom Management ◽  
Complementary And Alternative

Purpose To identify major research-design issues in proposals submitted by investigators in the Community Clinical Oncology Program (CCOP) for clinical trials of complementary and alternative medicine (CAM) for cancer-symptom management. Methods We conducted content analysis of all scientific reviews of concepts and protocols submitted by the CCOP to the National Cancer Institute (NCI) to identify research challenges in conducting clinical trials designed to evaluate CAM interventions for cancer-symptom management. Results Since the inception of the NCI Office of Cancer Complementary and Alternative Medicine in 1998, a total of 46 symptom-management studies using CAM interventions have been proposed by CCOP investigators, with 20 studies now in progress comprising 22% of the current total CCOP symptom-management portfolio. Proposals fell into four categories: complex natural products; nutritional therapeutics; mind-body interventions; and alternative medical systems. The most significant research-design issues arose as a consequence of the lack of preclinical data for CAM interventions and the lack of quality-control standards comparable with those used in regulating new pharmaceutical agents. Conclusion Across the different types of CAM interventions, the most common problems found in proposed research designs are related to unwarranted assumptions about the consistency and standardization of CAM interventions, the need for data-based justifications for the study hypotheses, and the need to implement appropriate quality control and monitoring procedures during the course of the trial. To advance the state of the science, future research must address these critical issues if CAM interventions are to be evaluated rigorously and have a consequent impact on clinical practice and general public awareness.

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Inflammatory Mediators ◽  
Randomized Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Patients With Cancer ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Human Adults ◽  
Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

Ongoing randomized clinical trials for the treatment of thrombosis in the antiphospholipid syndrome

2001 ◽  
Vol 21 (02) ◽  
pp. 77-81 ◽  
Author(s):  
G. Finazzi
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Low Dose ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Collaborative Study ◽  
Clinical Problem ◽  
Vascular Events ◽  
Dose Oral ◽  
Adverse Pregnancy

SummaryThrombotic events are a major clinical problem for patients with antiphospholipid antibodies (APA). However, current recommendations for their prevention and treatment are still based on retrospective studies. Data from large scale, prospective clinical trials are required to ultimately identify the optimal management of these patients. To date, at least four randomized studies are underway. The WAPS and PAPRE clinical trials are aimed to establish the correct duration and intensity of oral anticoagulation in APA patients with major arterial or venous thrombosis. The WARSS-APASS is a collaborative study to evaluate the efficacy and safety of aspirin or low-dose oral anticoagulants in preventing the recurrence of ischemic stroke. The recently announced UK Trial compares low-dose aspirin with or without low-intensity anticoagulation for the primary prevention of vascular events in APA-positive patients with SLE or adverse pregnancy history, but still thrombosis-free. It is hoped that the results of these trials will be available soon since clinicians urgently need more powerful data to treat their patients with the APA syndrome.

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