Behavioral aspects of clinical trials: An integrated framework from behavior theory

Abstract

A less-than-optimal proportion of patients with cancer are entered into National Cancer Institute-sponsored clinical trials. This article reviews the literature on accrual in oncology clinical trials to characterize the extent of the problem, identify reasons for low accrual, and suggest ways to promote accrual. Four well known theories of health behavior (the Health Belief Model, Subjective Expected Utility Theory, Protection Motivation Theory, and the Theory of Reasoned Action) point to central concepts involved in understanding patient health-related behavior: (1) the probability that an unwelcomed health event will happen to a patient, (2) the severity of that event if it does occur, (3) the effectiveness of a particular behavior (such as taking part in a clinical trial) to modify the severity, and (4) the cost of adopting that behavior. These concepts form a framework for integrating the available information about accrual to clinical oncology trials. Patient and physician factors previously related to clinical trials suggest specific recommendations for increasing accrual to clinical oncology trials. Cancer 1994;742676-82.

Nausea and emesis: evidence for a biobehavioral perspective

“…q Research problem: the challenge to adherence caused by these side effects can pose significant difficulties to the successful completion and scientific interpretation of randomized trials of cancer treatments [48].…”

Preference Assessment of Recruitment into a Randomized Trial for Adolescent Idiopathic Scoliosis

“…The survey was based on previous literature concerning treatment decisions and trial participation 39,[53][54][55][56][57] . The items and scales used to operationalize these concepts are outlined below:…”

Untitled

“…Overfor patienterne anvendes derfor også andre midler, f.eks. begraensninger i forsøgsin-formationen, eller man søger at påvirke den offentlige opinionsdannelse ved at understrege patienternes solidariske forpligtelser på basis af en utilitaristisk etik (Morrow et al 1994, Gillon 1994, Olsen & Olesen 1999.…”

“…2/3 af naegterne i en undersøgelse angav modstand mod randomiseringen som begrundelse for ikke at medvirke. De ønskede selv at have indflydelse på behandlingsbeslutningen (Llewellyn-Thomas et al 1991, Morrow et al 1994).…”