- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07772596
An Artificial Intelligence-Powered Supportive Care Chatbot to Address the Supportive Care Needs of Young Adult Cancer Survivors
August 13, 2026 updated by: University of Michigan Rogel Cancer Center
Feasibility, Usability, and Acceptability of an AI-Powered MASCC Supportive Care Platform Among Young Adults With Cancer
This clinical trial studies whether an artificial intelligence (AI)-powered supportive care chatbot is helpful for addressing the supportive care needs of young adult cancer survivors.
Young adult cancer survivors often experience ongoing and distressing symptoms following treatment, including extreme tiredness and lack of energy, anxiety, and difficulty sleeping.
Young adult cancer survivors report a variety of strategies to self-manage these symptoms; however, there remains a gap in targeted interventions focused on the needs in young adult survivors.
The AI-powered supportive care chatbot is designed to provide evidence-based information on supportive care for young adult cancer survivors.
Users interact with the chatbot by entering free-text questions or selecting from predefined topics to receive tailored educational responses related to supportive care across the cancer continuum, including treatment effects, symptom management, care transitions, and life after cancer.
The AI-powered supportive care chatbot may be an effective way to help address the supportive care needs of young adult cancer survivors.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Robert Knoerl
- Phone Number: 734-764-8617
- Email: rjknoerl@med.umich.edu
Study Locations
-
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Rogel Cancer Center
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Contact:
- Robert Knoerl
- Phone Number: 734-764-8617
- Email: rjknoerl@med.umich.edu
-
Principal Investigator:
- Robert Knoerl
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18 - 39 years old
- Able to speak/read English
- Completed primary cancer treatment (e.g., surgery, radiation, chemotherapy, immunotherapy) at least one month prior to the time of consent. Although, participants will be eligible if they are receiving maintenance treatments
- Report at least one moderate to severe symptom, side effect, or supportive care concern from cancer or its treatment
- Able to access Wi-Fi/internet
- Willing to complete surveys electronically
Exclusion Criteria:
- Completed cancer treatment more than three years ago
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supportive care (AI-powered supportive care chatbot)
Patients interact with AI-powered supportive care chatbot in a self-directed manner for 4 weeks.
Following the initial 4-week use period, patients choose to either continue to use the chatbot for an additional 8 weeks or conclude study participation.
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Ancillary studies
Ancillary studies
Interact with AI-powered supportive care chatbot
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of AI-powered supportive care chatbot
Time Frame: At end of intervention, assessed up to 12 weeks
|
Acceptability will be supported if mean scores on the Acceptability E-Scale are ≥ 4 (on a 5-point scale).
Will be described (i.e., means, medians, standard deviations, and ranges) at the post-intervention time point.
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At end of intervention, assessed up to 12 weeks
|
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Demand of AI-powered supportive care chatbot
Time Frame: Up to 12 months
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Demand will be demonstrated by successful recruitment of the target sample (N=30) within 12 months.
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Up to 12 months
|
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Implementation of AI-powered supportive care chatbot
Time Frame: During intervention use, assessed up to 12 weeks
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Implementation will be assessed by engagement with the chatbot, defined as ≥ 70% of participants reporting at least one use per week during the initial 4-week period, rather than a fixed duration of use, given the self-directed nature of the intervention.
Will be described (i.e., means, medians, standard deviations, and ranges) weekly.
Given the pilot nature of the study, no hypothesis testing or formal comparisons will be conducted.
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During intervention use, assessed up to 12 weeks
|
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Retention
Time Frame: Up to 12 weeks
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Retention will be considered feasible if ≥ 80% of participants complete 4-week assessments, and ≥ 50% elect to continue to the optional extended use period.
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Up to 12 weeks
|
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Usability of AI-powered supportive care chatbot
Time Frame: At end of intervention, assessed up to 12 weeks
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Usability will be supported if mean System Usability Scale scores are ≥ 70, indicating acceptable usability.
Will be described (i.e., means, medians, standard deviations, and ranges) at the post-intervention time point.
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At end of intervention, assessed up to 12 weeks
|
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Patient Reported Outcomes Measurement Information System measure
Time Frame: At baseline, 4 weeks, and/or 12 weeks
|
Will be summarized using descriptive statistics (e.g., means, medians, standard deviations, and ranges) at each time point.
Changes over time (baseline, post-intervention, as applicable) will be examined descriptively.
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At baseline, 4 weeks, and/or 12 weeks
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Digital Health Literacy Scale
Time Frame: At baseline
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Will be summarized using descriptive statistics (e.g., means, medians, standard deviations, and ranges) at the baseline time point.
The Digital Health Literacy Scale is a 0 to 12 point score (based on 3 items), with higher scores indicating greater digital health care literacy.
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At baseline
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Interview themes and subthemes
Time Frame: At end of intervention, assessed up to 12 weeks
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The audio-recorded interviews will be transcribed verbatim by a professional transcription company and verified for accuracy by another study team member.
The finalized transcripts will be imported into NVivo 12 (QSR International Pty Ltd).
Inductive content analysis will be used to analyze the interview transcripts.
Two study team members will review the transcripts and the interview guide to create an initial list of codes.
Three transcripts will be independently coded using the initial codebook.
After three interviews are coded, two study team members will meet to resolve any coding discrepancies and to revise the codebook further.
The same process will be repeated after three more interviews are coded.
After the codebook is finalized, one study team member will code the remaining interviews.
Subsequently, the study team will meet as a group to review the transcripts in their entirety, making sense of the data and generating potential major themes and subthemes.
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At end of intervention, assessed up to 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robert Knoerl, University of Michigan Rogel Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
October 1, 2028
Study Registration Dates
First Submitted
July 30, 2026
First Submitted That Met QC Criteria
August 13, 2026
First Posted (Actual)
August 19, 2026
Study Record Updates
Last Update Posted (Actual)
August 19, 2026
Last Update Submitted That Met QC Criteria
August 13, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMCC 2026.025
- NCI-2026-05454 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- HUM00288074 (Other Identifier: University of Michigan Rogel Cancer Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified participant data will be shared with other researchers upon reasonable request and execution of a data transfer agreement.
IPD Sharing Time Frame
After publication of results and within 7 years after study completion.
IPD Sharing Access Criteria
De-identified participant data will be shared with other researchers upon reasonable request and execution of a data transfer agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.