NCT04616651

Brief Summary

This study is designed to study the feasibility and acceptability of the Open to Options (O2O) Chatbot prototype. The O2O program is an existing patient support program with content currently delivered via in-person counseling with a trained mental health professional or via an existing web-based program (Let's Talk Treatment Options).The Chatbot is an automated, menu-based agent being developed in this study to extend the reach and accessibility of the O2O program via the Chatbot's "virtual coaching".

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

March 25, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

October 6, 2020

Last Update Submit

August 10, 2022

Conditions

Cancer

Keywords

ChatbotOpen to Options (O2O)

Outcome Measures

Primary Outcomes (5)

  • Feasibility of Integrating Chatbot in Clinic

    The feasibility of integrating an Open to Options (O2O) Chatbot into the clinical workflow, assessed by the number of patients who accept the invitation to receive more information about the study, among all those invited.

    At the time of scheduling an appointment with cancer physician; one day

  • Acceptability - Reach

    Assessed by the number of patients who log-in to the O2O Chatbot program and create an account, among all those who accepted the invitation to receive information.

    Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment

  • Acceptability - Uptake

    Assessed by the number of patients who proceed to view the full Chatbot prototype and generate a summary, among all those who created an account.

    Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment

  • Acceptability - Mean Satisfaction Scores

    Post-Intervention Survey Group only: In addition to the survey given to all participants, the post-intervention survey group will answer 6 questions about their perception of the Chatbot prototype. Each of the 6 questions will be scored on a scale from 1 (strongly disagree) to 5 (strongly agree). Investigators will calculate the mean value (and Standard Deviation) on a 1-5 scale for each question.

    Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment

  • Acceptability - Percent of Participants with High Satisfaction Scores

    Post-Intervention Survey Group only: In addition to the survey given to all participants, the post-intervention survey group will answer 6 questions about their perception of the Chatbot prototype. Each of the 6 questions will be scored on a scale from 1 (strongly disagree) to 5 (strongly agree). For each of the six questions, investigators will calculate the percentage of participants who strongly agree.

    Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment

Other Outcomes (1)

  • Mean Patient-reported Appraisal Outcomes

    Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment

Study Arms (2)

Pre-Chatbot survey arm

ACTIVE COMPARATOR

Participants will take the self-appraisal survey prior to interacting with the O2O program via the online Chatbot.

Behavioral: Online SurveyBehavioral: Chatbot prototypeBehavioral: Open to Options (O2O) Program

Post-Chatbot survey arm

EXPERIMENTAL

Participants will take the self-appraisal survey after interacting with the O2O program via the online Chatbot. (This arm will also answer additional questions regarding participants' satisfaction with the O2O Chatbot.)

Behavioral: Online SurveyBehavioral: Chatbot prototypeBehavioral: Open to Options (O2O) Program

Interventions

Online SurveyBEHAVIORAL

Participants respond to online survey questions either before or after using the Chatbot O2O intervention.

Also known as: Qualtrix Survey
Post-Chatbot survey armPre-Chatbot survey arm
Chatbot prototypeBEHAVIORAL

An online, automated, menu-based agent in which all responses are pre-programmed to be consistent with the existing O2O program. The chat-like responses help guide the participant through a process with the goal of developing a list of questions for their upcoming appointment with a cancer clinician. The session is meant to be completed in one sitting and estimated to take about 45 minutes to complete (including the pre- or post-intervention survey); however, if a participant stops in the middle, they may go back and complete the Chatbot session (or survey).

Post-Chatbot survey armPre-Chatbot survey arm
Open to Options (O2O) ProgramBEHAVIORAL

Evidence-based program developed by Cancer Support Community that helps patients actively engage in their treatment decision process by preparing them for their upcoming appointments.

Post-Chatbot survey armPre-Chatbot survey arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a cancer diagnosis
  • Able to speak and read English, and willing to electronically consent
  • Appointment with a Rogel Cancer Center cancer clinician within the next 3 weeks
  • Patient must have a way to access the internet (includes mobile phone)

You may not qualify if:

  • Age \<18 years
  • Inability to speak or read English
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Sarah Hawley, PhD, MPH

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2020

First Posted

November 5, 2020

Study Start

March 25, 2021

Primary Completion

August 10, 2021

Study Completion

August 10, 2021

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)