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

Not Applicable

Terminated

• Conditions: Cancer
• Interventions: Behavioral: Online Survey; Behavioral: Chatbot prototype; Behavioral: Open to Options (O2O) Program

• Registration Number: NCT04616651
• Lead Sponsor: University of Michigan Rogel Cancer Center

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".

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 Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-05
• Study Start: 2021-03-25
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-Chatbot survey arm	Online Survey	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.)
Pre-Chatbot survey arm	Online Survey	Participants will take the self-appraisal survey prior to interacting with the O2O program via the online Chatbot.
Pre-Chatbot survey arm	Open to Options (O2O) Program	Participants will take the self-appraisal survey prior to interacting with the O2O program via the online Chatbot.
Post-Chatbot survey arm	Open to Options (O2O) Program	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.)
Pre-Chatbot survey arm	Chatbot prototype	Participants will take the self-appraisal survey prior to interacting with the O2O program via the online Chatbot.
Post-Chatbot survey arm	Chatbot prototype	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.)

Primary Outcome Measures

Name	Time	Method
Feasibility of Integrating Chatbot in Clinic	At the time of scheduling an appointment with cancer physician; one day	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.
Acceptability - Reach	Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment	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.
Acceptability - Uptake	Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment	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.
Acceptability - Mean Satisfaction Scores	Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment	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.
Acceptability - Percent of Participants with High Satisfaction Scores	Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment	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.

Trial Locations

Locations (1)

University of Michigan Rogel Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States