Leveraging system sciences methods in clinical trial evaluation: An example concerning African American women diagnosed with breast cancer via the Patient Navigation in Medically Underserved Areas study

Abstract

Background Systems science methodologies offer a promising assessment approach for clinical trials by: 1) providing an in-silico laboratory to conduct investigations where purely empirical research may be infeasible or unethical; and, 2) offering a more precise measurement of intervention benefits across individual, network, and population levels. We propose to assess the potential of systems sciences methodologies by quantifying the spillover effects of randomized controlled trial via empirical social network analysis and agent-based models (ABM). Design/methods We will evaluate the effects of the Patient Navigation in Medically Underserved Areas (PNMUA) study on adult African American participants diagnosed with breast cancer and their networks through social network analysis and agent-based modeling. First, we will survey 100 original trial participants (50 navigated, 50 non-navigated) and 150 of members of their social networks (75 from navigated, 75 non-navigated) to assess if navigation results in: 1) greater dissemination of breast health information and breast healthcare utilization throughout the trial participants’ networks; and, 2) lower incremental costs, when incorporating navigation effects on trial participants and network members. Second, we will compare cost-effectiveness models, using a provider perspective, incorporating effects on trial participants versus trial participants and network members. Third, we will develop an ABM platform, parameterized using published data sources and PNMUA data, to examine if navigation increases the proportion of early stage breast cancer diagnoses. Discussion Our study results will provide promising venues for leveraging systems science methodologies in clinical trial evaluation.

Healthcare Predictors of Information Dissemination About Genetic Risks

“…[36][37][38][39][40][41][42][43] This pilot study had a target sample size of 100 patients, given our sampling frame (i.e., PNMUA patients who were AA and diagnosed with BC (n = 173), response rates from past research with Chicago-based AA BC survivors (56%), and a priori power analyses regarding the effect of navigation on patient-driven dissemination of breast health information at large. 36,37 Invitation letters and flyers were given to participants who met the eligibility criteria. Institutional Review Boards at each participating institution approved the study, which took place between March 2019 and June 2020.…”

“…Eligibility criteria included: (1) breast cancer patient at least 18 years of age or older, (2) selfidentified as African American female and a breast cancer patient at 1 of the 3 hospitals involved in this study, (3) and participated in the Patient Navigation in Medically Underserved Areas Study, a randomized controlled trial of patient navigation. [36][37][38][39][40][41][42][43] This pilot study had a target sample size of 100 patients, given our sampling frame (i.e., PNMUA patients who were AA and diagnosed with BC (n = 173), response rates from past research with Chicago-based AA BC survivors (56%), and a priori power analyses regarding the effect of navigation on patient-driven dissemination of breast health information at large. 36,37 Invitation letters and flyers were given to participants who met the eligibility criteria.…”

“…Data collection procedures for this study were described in detail previously. 36,37 In brief, hospital staff were trained to review medical records to identify patients who were eligible to participate in this study. Eligibility criteria included: (1) breast cancer patient at least 18 years of age or older, (2) selfidentified as African American female and a breast cancer patient at 1 of the 3 hospitals involved in this study, (3) and participated in the Patient Navigation in Medically Underserved Areas Study, a randomized controlled trial of patient navigation.…”