NCT07772596

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
24mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

August 19, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 30, 2026

Last Update Submit

August 13, 2026

Conditions

Outcome Measures

Primary Outcomes (8)

  • Acceptability of AI-powered supportive care chatbot

    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.

    At end of intervention, assessed up to 12 weeks

  • Demand of AI-powered supportive care chatbot

    Demand will be demonstrated by successful recruitment of the target sample (N=30) within 12 months.

    Up to 12 months

  • Implementation of AI-powered supportive care chatbot

    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.

    During intervention use, assessed up to 12 weeks

  • Retention

    Retention will be considered feasible if ≥ 80% of participants complete 4-week assessments, and ≥ 50% elect to continue to the optional extended use period.

    Up to 12 weeks

  • Usability of AI-powered supportive care chatbot

    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.

    At end of intervention, assessed up to 12 weeks

  • Patient Reported Outcomes Measurement Information System measure

    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.

    At baseline, 4 weeks, and/or 12 weeks

  • Digital Health Literacy Scale

    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.

    At baseline

  • Interview themes and subthemes

    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.

    At end of intervention, assessed up to 12 weeks

Study Arms (1)

Supportive care (AI-powered supportive care chatbot)

EXPERIMENTAL

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.

Other: Artificial Intelligence-based InterventionOther: InterviewOther: Survey Administration

Interventions

Interact with AI-powered supportive care chatbot

Also known as: AI Intervention, AI-based Intervention
Supportive care (AI-powered supportive care chatbot)

Ancillary studies

Supportive care (AI-powered supportive care chatbot)

Ancillary studies

Supportive care (AI-powered supportive care chatbot)

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Completed cancer treatment more than three years ago

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Robert Knoerl

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 19, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

August 19, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

De-identified participant data will be shared with other researchers upon reasonable request and execution of a data transfer agreement.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After publication of results and within 7 years after study completion.
Access Criteria
De-identified participant data will be shared with other researchers upon reasonable request and execution of a data transfer agreement.

Locations