Patient-centered Development of the Cancer Support Community's Open to Options ®Chatbot Program

Patient-centered Development of the Cancer Support Community's Open to Options ®Chatbot Program Cancer Treatment Support in Partnership With the Cancer Support Community

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".

Study Overview

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Online Survey; Behavioral: Chatbot prototype; Behavioral: Open to Options (O2O) Program

Detailed Description

This is a pilot study to assess feasibility and acceptability, and to gather preliminary data on how patients with a diagnosis of cancer appraise being prepared for their upcoming visit with a cancer specialist. Participants will be randomized to take a survey either before or after their Chatbot interaction. The surveys collect participants' self-appraisal regarding preparedness for their upcoming appointment with a cancer physician, cancer distress and cancer anxiety. The study will examine whether patients who take the survey after viewing the Chatbot feel more prepared for their upcoming appointment than those who take the survey before the Chatbot interaction.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Pre-Chatbot survey arm; Participants will take the self-appraisal survey prior to interacting with the O2O program via the online Chatbot.	Behavioral: Online Survey; Participants respond to online survey questions either before or after using the Chatbot O2O intervention.; Other Names: Qualtrix Survey; Behavioral: Chatbot prototype; 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).; Behavioral: Open to Options (O2O) Program; 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.
EXPERIMENTAL: Post-Chatbot survey arm; 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 Survey; Participants respond to online survey questions either before or after using the Chatbot O2O intervention.; Other Names: Qualtrix Survey; Behavioral: Chatbot prototype; 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).; Behavioral: Open to Options (O2O) Program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Patient-reported Appraisal Outcomes	Mean values of the following 5 self-appraisals: Cancer related distress [scale from 0 (none) to 10 (extreme)]; Cancer diagnosis anxiety [scale from 0 (none) to 10 (extreme)]; Self-efficacy for question asking [scale from 0 (not at all confident) to 10 (extremely confident)]; Decision preparedness [scale from 1 (not at all) to 5 (a great deal)]; Decision self-efficacy [scale from 0 (not at all confident) to 4 (very confident)] The mean values will be compared by group (pre- vs. post-intervention survey group) using t-tests.	Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: Cancer Support Community
• Investigators: Principal Investigator: Sarah Hawley, PhD, MPH, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 25, 2021
• Primary Completion (ACTUAL): August 10, 2021
• Study Completion (ACTUAL): August 10, 2021

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (ACTUAL): November 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Chatbot; Open to Options (O2O)
• Other Study ID Numbers: UMCC 2020.083; HUM00179538 (OTHER: University of Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No