Randomized clinical trials are the gold standard for evaluation of medical interventions. However, recruitment of patients, particularly minorities, into trials is often difficult. Slow and non-representative trial accrual delays the assessment and introduction of new treatments, increases the cost, and reduces the generalizability of trials. Despite a growing number of programs and websites are providing information on clinical trials (two examples are the National Institutes of Health Clinical Trials Education Series website, and the National Medical Association's Project I.M.P.A.C.T. (Increase Minority Participation and Awareness of Clinical Trials)), there has been little progress in improving minority participation. Thus, we believe that a novel approach, which targets the specific concerns and knowledge needs of minorities, and which empowers them to personally consider and then discuss with their physician participation in trials, is needed. In the proposed research, we directly address the problem of low minority participation rates in clinical trials through a development of a decision aid (DA) for participation in clinical trials that is targeted to minority individuals. Decision aids (DAs) have been widely and successfully used in treatment and screening situations. A systematic review of DA trials has shown that patients receiving DAs have a higher knowledge of options and outcomes, more realistic expectations, less difficulty in reaching a decision, and more active participation in decision making than individuals who do not receive the DA. However, despite the fact that decision to participate in clinical trials is one of the most difficult and complex health care decisions for individuals, almost no previous work as been done on decision aid for clinical trials participation. We believe that participation in clinical trials, particularly for minorities, will be increased by the availability of a well-design, culturally sensitive decision aid. Thus, our goal for this research is to develop and test for effectiveness a minority targeted DA for participation in clinical trials. Specifically our aims are:
Aim 1 : Assemble a comprehensive database on attitudes, barriers and facilitators of participation in trials through integration of information from qualitative interviews with African American cancer survivors and/or family members, a systematic literature review, and a recently completed study of cancer clinical trials participation.
Aim 2 : Develop a targeted web-based decision aid in English and Spanish that has as its goals: a) providing information about clinical trials in a comprehensible way, b) improving patient self-efficacy for discussing trials with health care providers, and c) helping patients clarify their beliefs/values regarding the benefits and risks of participating in a trial.
Aim 3 : Explore the efficacy, usefulness, and effects of the decision aid a population of Hispanic and African American cancer survivors and family members. The proposed research will develop a targeted decision aid that aims to improve participation and particularly improve minority participation in a wide range of clinical trials. More efficient and representative recruitment means that clinical trials can accrue participants in a more timely fashion, and thus results about the effectiveness of new treatments and therapies can be obtained more efficiently. Thus, the proposed research will have a wide reaching effect on the clinical trials research community, and consequently on entire populations of patients who will benefit from the newly developed treatments and therapies.
The proposed research will develop a targeted decision aid that aims to improve participation and particularly improve minority participation in a wide range of clinical trials. More efficient and representative recruitment means that clinical trials can accrue participants in a more timely fashion, and thus results about the effectiveness of new treatments and therapies can be obtained more efficiently. Thus, the proposed research will have a wide reaching effect on the clinical trials research community, and consequently on entire populations of patients who will benefit from the newly developed treatments and therapies.
