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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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04616651
Enrollment
18
Registered
2020-11-05
Start date
2021-03-25
Completion date
2021-08-10
Last updated
2022-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Chatbot, Open to Options (O2O)

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.

Interventions

BEHAVIORALOnline Survey

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

BEHAVIORALChatbot 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).

BEHAVIORALOpen 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.

Sponsors

Cancer Support Community
CollaboratorUNKNOWN
University of Michigan Rogel Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Integrating Chatbot in ClinicAt the time of scheduling an appointment with cancer physician; one dayThe 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 - ReachBaseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointmentAssessed 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 - UptakeBaseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointmentAssessed 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 ScoresBaseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointmentPost-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 ScoresBaseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointmentPost-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.

Other

MeasureTime frameDescription
Mean Patient-reported Appraisal OutcomesBaseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointmentMean 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026