- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07772596
An Artificial Intelligence-Powered Supportive Care Chatbot to Address the Supportive Care Needs of Young Adult Cancer Survivors
13 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Robert Knoerl
- Telefonnummer: 734-764-8617
- E-post: rjknoerl@med.umich.edu
Studieorter
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- University of Michigan Rogel Cancer Center
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Kontakt:
- Robert Knoerl
- Telefonnummer: 734-764-8617
- E-post: rjknoerl@med.umich.edu
-
Huvudutredare:
- Robert Knoerl
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Sidostudier
Sidostudier
Interact with AI-powered supportive care chatbot
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Acceptability of AI-powered supportive care chatbot
Tidsram: At end of intervention, assessed up to 12 weeks
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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
Tidsram: 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
Tidsram: During intervention use, assessed up to 12 weeks
|
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
Tidsram: 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
Tidsram: 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
Tidsram: At baseline, 4 weeks, and/or 12 weeks
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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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Robert Knoerl, University of Michigan Rogel Cancer Center
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 oktober 2026
Primärt slutförande (Beräknad)
1 oktober 2028
Avslutad studie (Beräknad)
1 oktober 2028
Studieregistreringsdatum
Först inskickad
30 juli 2026
Först inskickad som uppfyllde QC-kriterierna
13 augusti 2026
Första postat (Faktisk)
19 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 augusti 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UMCC 2026.025
- NCI-2026-05454 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- HUM00288074 (Annan identifierare: University of Michigan Rogel Cancer Center)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
De-identified participant data will be shared with other researchers upon reasonable request and execution of a data transfer agreement.
Tidsram för IPD-delning
After publication of results and within 7 years after study completion.
Kriterier för IPD Sharing Access
De-identified participant data will be shared with other researchers upon reasonable request and execution of a data transfer agreement.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
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