Anxiety — Fatigue, Anxiety, Music, and Entertainment (FAME) Study
Citation(s)
Coffman CJ, Edelman D, Woolson RF To condition or not condition? Analysing 'change' in longitudinal randomised controlled trials. BMJ Open. 2016 Dec 30;6(12):e013096. doi: 10.1136/bmjopen-2016-013096.
Cohen J A power primer. Psychol Bull. 1992 Jul;112(1):155-9.
Donaldson GW, Moinpour CM Individual differences in quality-of-life treatment response. Med Care. 2002 Jun;40(6 Suppl):III39-53.
Donaldson GW, Moinpour CM Learning to live with missing quality-of-life data in advanced-stage disease trials. J Clin Oncol. 2005 Oct 20;23(30):7380-4. Epub 2005 Sep 26.
Donaldson GW, Nakamura Y, Moinpour C Mediators, moderators, and modulators of causal effects in clinical trials--Dynamically Modified Outcomes (DYNAMO) in health-related quality of life. Qual Life Res. 2009 Mar;18(2):137-45. doi: 10.1007/s11136-008-9439-
Fairclough, D L., Design and analysis of quality of life studies in clinical trials. 2010: CRC press.
Liang, K -Y. and S.L. Zeger, Longitudinal data analysis of continuous and discrete responses for pre-post designs. Sankhya: The Indian Journal of Statistics, Series B, 2000: p. 134-148.
Liu GF, Lu K, Mogg R, Mallick M, Mehrotra DV Should baseline be a covariate or dependent variable in analyses of change from baseline in clinical trials? Stat Med. 2009 Sep 10;28(20):2509-30. doi: 10.1002/sim.3639.
Moinpour CM, Donaldson GW, Redman MW Do general dimensions of quality of life add clinical value to symptom data? J Natl Cancer Inst Monogr. 2007;(37):31-8.
Singer, J D., J.B. Willett, and J.B. Willett, Applied longitudinal data analysis: Modeling change and event occurrence. 2003: Oxford university press.
Addressing Fatigue, Anxiety, and Cognitive Impairment Through Rhythmic Effects: A Pilot Feasibility Study Using a Group Drumming Intervention With Cancer Patients
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.