CancerNCT04616651
Patient-centered Development of the Cancer Support Community's Open to Options ®Chatbot Program
A study testing Online Survey, Chatbot prototype and Open to Options (O2O) Program in people with Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Online Survey, Chatbot prototype and Open to Options (O2O) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2021to 10 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Age <18 years
- Inability to speak or read English
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: 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".
Read the 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.
- Conditions
- Cancer
- Being tested
- Online Survey, Chatbot prototype, Open to Options (O2O) Program
- Keywords
- Chatbot, Open to Options (O2O)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online SurveyBehavioural
Also called Qualtrix Survey
Participants respond to online survey questions either before or after using the Chatbot O2O intervention.
Chatbot prototypeBehavioural
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).
Open to Options (O2O) ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Chatbot survey arm | Active comparator | Participants will take the self-appraisal survey prior to interacting with the O2O program via the online Chatbot. Receives: Behavioral: Online Survey; Behavioral: Chatbot prototype; Behavioral: 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.) Receives: Behavioral: Online Survey; Behavioral: Chatbot prototype; Behavioral: Open to Options (O2O) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start25 Mar 2021
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Support Community
- Responsible party
- Sponsor
- Investigators
- Sarah Hawley, PhD, MPH, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616651
- Sponsor's protocol ID
- UMCC 2020.083
- Other IDs
- HUM00179538
- Status last verified
- Aug 2022
- First submitted
- 6 Oct 2020
- Last updated
- 11 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centered Development of the Cancer Support Community's Open to Options ®Chatbot Program Cancer Treatment Support in Partnership With the Cancer Support Community
- ClinicalTrials.gov ID
- NCT04616651
- Acronym / sponsor ID
- UMCC 2020.083
- Conditions
- Cancer
- Keywords
- Chatbot, Open to Options (O2O)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Cancer Support Community
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Chatbot survey arm | Active comparator | Behavioral: Online Survey, Behavioral: Chatbot prototype, Behavioral: Open to Options (O2O) ProgramParticipants will take the self-appraisal survey prior to interacting with the O2O program via the online Chatbot. |
| Post-Chatbot survey arm | Experimental | Behavioral: Online Survey, Behavioral: Chatbot prototype, Behavioral: Open to Options (O2O) ProgramParticipants 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.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Age <18 years
- Inability to speak or read English
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online SurveyAlso: Qualtrix SurveyParticipants respond to online survey questions either before or after using the Chatbot O2O intervention. | Behavioural | Post-Chatbot survey arm, Pre-Chatbot survey arm |
| Chatbot prototypeAn 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). | Behavioural | Post-Chatbot survey arm, Pre-Chatbot survey arm |
| Open to Options (O2O) ProgramEvidence-based program developed by Cancer Support Community that helps patients actively engage in their treatment decision process by preparing them for their upcoming appointments. | Behavioural | Post-Chatbot survey arm, Pre-Chatbot survey arm |
Primary outcome
Feasibility of Integrating Chatbot in Clinic
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Hawley, PhD, MPH principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Survey, Chatbot prototype and Open to Options (O2O) Program in people with Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Integrating Chatbot in Clinic (time frame: At the time of scheduling an appointment with cancer physician; one day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.