Recruitment

Recruitment Status
Completed
Estimated Enrollment
200

Summary

Conditions
  • Conflict
  • Decisional Conflict
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Evidence shows that although clinical trials are aimed at producing new strategies for reducing cancer morbidity and mortality, participation remains sub-optimal for all populations, especially those from racial and ethnic groups. Although some interventions have been found to be effective at enhanc...

Evidence shows that although clinical trials are aimed at producing new strategies for reducing cancer morbidity and mortality, participation remains sub-optimal for all populations, especially those from racial and ethnic groups. Although some interventions have been found to be effective at enhancing participation, few studies have tested tailored communication activities using innovative communication techniques (perceptual mapping) with aims to address barriers and facilitators for patients and facilitate more engaged discussions with their providers in real world settings. Participation in clinical trials is a serious and complex decision, and many patients of all races and backgrounds have limited knowledge and understanding of clinical trials as a treatment option. Although research has been conducted to explore the barriers to participation, there has been a call for more intervention research to address these barriers. A fundamental aspect of patient focused interventions is an exploration of their personal questions and concerns, without which it is difficult for patients to become empowered to participate in an informed or shared decision making process. However, there remains limited empirical research to suggest which messages are most salient to a diverse range of patients to improve decision making, and how decision tools can be tailored to enhance patient-provider communication. This research will provide insight into that process when the decision is participation in clinical trials. Evidence shows that ethnic and racial minorities are significantly underrepresented in clinical trials, which is critical to producing new strategies for reducing cancer morbidity and mortality for all populations. Recognizing the complexity of barriers to participation in clinical trials, research has focused on potential strategies to enhance participation. Interventions have shown that provider referrals of minority patients, community outreach, acknowledging and addressing issues of trust, flexibility in intervention methods, and population targeted materials are effective. Few studies, however, have tested tailored communication activities to address barriers and facilitators for patients using innovative communication techniques in real world settings - meaning ways these activities can be integrated into the healthcare workflow - or addressed the unique needs of racial and ethnic minorities. The mychoice communication tool begins to prepare patients to participate in a personal and tailored discussion with their provider about clinical trials as a potential treatment option. The tool is also customized to address the concerns of those least likely to participate, instead of providing a more general look at clinical trials- a common trait of other available tools. Previous research has shown that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials and integrating these tools into the clinical encounter is critical. In addition, using innovative communication techniques (perceptual mapping and vector modeling) to validate and explore notable messages across diverse cancer patients provided new insights into tailoring messages and personalizing patient/provider communication. Insight gained from validation of the intervention will improve the decision making process and inform a large scale integration of mychoice to affect patient perceptions and increase willingness to participate in clinical trials, especially in minority patients. In addition, Investigators will assess barriers to implementation when introducing the tool in diverse cancer centers, each with different protocols and patient populations, to inform a future proposal. Using the Consolidated Framework for Implementation Science (CFIR), one of the predominant implementation science research frameworks, we will focus on five domains: intervention characteristics, outer settings, inner setting, characteristics of individuals (patients and providers), and process. Implementation science is becoming an important component of intervention implementation and we aim to use this framework to ensure success.

Tracking Information

NCT #
NCT03427177
Collaborators
  • Merck Sharp & Dohme Corp.
  • University of Pennsylvania
  • Temple University
  • Thomas Jefferson University
Investigators
Principal Investigator: Linda Fleisher, PhD Fox Chase Cancer Center Principal Investigator: Sarah Bass, PhD Temple