Design of Chatbot Persona for Breast Cancer Screening Outreach Among Black Women

May 13, 2023 updated by: Leah Marcotte, University of Washington

Human Centered Design Approach to Eliminating Disparities in Breast Cancer Screening

Breast cancer screening disparities among Black women persist despite health system recognition and outreach. However, current evidence on how to tailor and optimize implementation strategies for breast cancer screening outreach is limited. The proposed study is part of a larger project to design a chatbot for breast cancer screening outreach to Black women and will focus on optimizing the chatbot persona. Using the Multiphase Optimization Strategy (MOST) framework, the investigators will conduct a randomized factorial experiment to assess the individual components of chatbot persona for breast cancer screening and identify which components have the greatest effect on trust and engagement for Black women. This information will guide the design of an optimized chatbot intervention that achieves the primary outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this study is to determine the optimal delivery of initial chatbot messages for culturally tailored breast cancer screening outreach. Mistrust of the medical system has been identified as a significant barrier to mammography screening among Black women. Yet, while tailored interventions for breast cancer screening exist, the optimal design of a tailored intervention to engender trust is unknown. Chatbots have been shown to increase levels of trust in web-based information, though adoption of chatbots may depend on chatbot characteristics. The investigators propose to use the Multiphase Optimization Strategy (MOST), a framework for developing efficacious, efficient, scalable and cost-effective interventions, to assess the performance of chatbot intervention components and their interactions.

The chatbot message delivery will be systematically varied across two components, each of which is represented by a separate factor in the 2x2x1 factorial study design with a control arm. Specifically, each participant will be randomly assigned to one of five separate experimental conditions. Conditions include: (1) chatbot with a primary care doctor persona and direct communication style; (2) chatbot with a breast cancer survivor persona and direct communication style; (3) chatbot with a primary care doctor persona and indirect communication style; and (4) chatbot with a breast cancer survivor persona and indirect communication style. All participants will complete a survey regarding their perceptions about the initial outreach messages from the chatbot.

The main effects will be estimated of the two experimental factors and their interactions on the study's primary outcomes - trust in the chatbot system to use for breast cancer screening education and scheduling, and intention to use. This information will guide the design of an optimized chatbot persona that achieves the primary outcomes.

Participants will be enrolled if they are Black individuals who qualify for breast cancer screening residing in the United States who are between the ages of 40-74. Recruitment will be conducted on Prolific, an online participant pooling platform, and Amazon Mechanical Turk (MTurk), a crowdsourcing platform used for research recruitment. Prolific will be used given the platform's ability for selecting the participant population. However, due to the limited number of individuals within the inclusion criteria on Prolific, and if needed participants will also be recruited on MTurk. Participants will be asked to view the chatbot messages and respond to questions to assess trust, engagement, and directness of the chatbot.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
550

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Black or African American women between the ages of 40-74 years old and residing in the United States.

Description

Inclusion Criteria:

All women who are 40-74 years old:

  • who identify as Black

Exclusion Criteria:

  • Participants who do not complete the survey
  • Participants who complete the survey in less than half the normal average time
  • Participants who do not pass the attention check

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1
Primary care doctor persona with direct messages
Other: Persona: Primary care doctor
The chatbot persona is a Black woman who is a primary care doctor.
Other: Communication Style: Direct
The chatbot messages are characterized by commands and direct addresses (''you'').
Group 2
Breast cancer survivor persona with direct messages
Other: Communication Style: Direct
The chatbot messages are characterized by commands and direct addresses (''you'').
Other: Persona: Breast cancer survivor
The chatbot persona is a Black woman who is a breast cancer survivor.
Group 3
Primary care doctor with indirect messages
Other: Persona: Primary care doctor
The chatbot persona is a Black woman who is a primary care doctor.
Other: Communication Style: Indirect
The chatbot messages are characterized by subjunctive modal verb forms (''would like'') and cooperative addresses (''we", "let's").
Group 4
Breast cancer survivor persona with indirect messages
Other: Persona: Breast cancer survivor
The chatbot persona is a Black woman who is a breast cancer survivor.
Other: Communication Style: Indirect
The chatbot messages are characterized by subjunctive modal verb forms (''would like'') and cooperative addresses (''we", "let's").
Group 5
Control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Trust
Time Frame: Day 1
The human-computer trust scale assesses user trust, which is based on similar constructs of trust (benevolence, competence, reciprocity, perceived risk). 7 of the 12 items were selected which use a 5-point Likert scale from 'Strongly disagree' to 'Strongly agree'.
Day 1
Intention to Use
Time Frame: Day 1
This measure assesses likelihood to use this system to schedule a mammogram in the future, and is scored on a 5-point Likert scale from 'Very unlikely' to 'Very likely'.
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Engagement
Time Frame: Day 1
This measure consists of 4 semantic differential scales assessing traits (important, interesting, relevant, warm) on a 7-point scale.
Day 1
Directness
Time Frame: Day 1
This measure consists of 7 semantic differential scales assessing traits (direct, friendly, caring, straightforward, demanding, respectful, polite) on a 7-point scale.
Day 1
Expertness and Homophily
Time Frame: Day 1
These 4 items measure the perceived expertise and attitude of the system on a 5-point Likert scale from 'Strongly disagree' to 'Strongly agree'.
Day 1
Self-brand connection
Time Frame: Day 1
This measure consists of 3 items to assess self-brand connection on a 5-point Likert scale from 'Strongly disagree' to 'Strongly agree'.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leah Marcotte, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00011606
  • 5P50CA244432 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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