Mychoice: Testing an Interactive mHealth Tool



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:June 25, 2018
End Date:August 30, 2019
Contact:Linda Fleisher, PhD
Email:Linda.Fleisher@fccc.edu
Phone:267-425-1584

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Mychoice: Testing an Interactive mHealth Tool to Enhance Communication and Informed Decision Making About Clinical Trial Participation in Cancer Patients

Investigators aim to test a culturally diverse and patient guided mHealth decision tool
called mychoice, which allows patients to explore their concerns and questions related to
clinical trial participation, as well as create a customized and personalized set of
questions to enhance patient-provider communication and increase informed decision making.
This study employs a mixed-methods approach using both qualitative and quantitative data to
evaluate the effectiveness of the mychoice intervention for patients and to explore the
provider and organizational factors that impact implementation. A randomized controlled trial
will be performed with 270 participants in order to determine the acceptability and
feasibility of the intervention, as well as its effects on self-efficacy in discussing
clinical trial participation with providers, leading to enhanced informed decision-making. A
secondary aim of the study is to evaluate the implementation of the intervention in clinical
settings. Implementation evaluation will occur using surveys of medical staff whose patients
are participating in the study. These surveys will assess institutional facilitators and
barriers to study implementation. Investigators will also conduct cognitive de-briefing
interviews after the intervention is completed with key stakeholders at the participating
institutions, which will inform a larger implementation study in the future.

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.

Inclusion Criteria:

- 18 years of age or over

- Active diagnosis of invasive cancer (any diagnoses), pre or post
chemo/radiation/surgery

- Able to speak and read English

Exclusion Criteria:

- Participated in a therapeutic trial in the past
We found this trial at
4
sites
1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Principal Investigator: Sarah Bauerle Bass, PhD
Temple University Temple University is many things to many people. A place to pursue life's...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, Pennsylvania 19111
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Philadelphia, Pennsylvania 19140
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