- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07226934
An AI-Generated, Personalized Question Prompt List Intervention for Patients With Hematologic Cancers
Feasibility and Preliminary Efficacy of GPT-QPL: An AI-Generated, Personalized Question Prompt List Intervention for Patients With Hematologic Cancers
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jessica Hahne, MA, MPH
- Phone Number: 314-935-6173
- Email: hahne.j@wustl.edu
Study Locations
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Missouri
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St Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
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Contact:
- Jessica Hahne, MA, MPH
- Phone Number: 314-935-6173
- Email: hahne.j@wustl.edu
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Principal Investigator:
- Jessica Hahne, MA, MPH
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Sub-Investigator:
- Brian D Carpenter, Ph.D.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Eligibility Criteria as determined by Electronic Health Record (EHR) Screening:
- Documented diagnosis of lymphoma, as defined by ICD-10 codes C81-C88 or multiple myeloma, as defined by ICD codes C90.0-C90.02
Has a scheduled follow-up appointment at a participating outpatient oncology clinic within the next month. Participating clinics include:
- Dr. David Russler-Germain: Outpatient Lymphoma Clinic
- Dr. Michael Slade: Outpatient Multiple Myeloma Clinic
- Dr. Dilan Patel: Outpatient Lymphoma Clinic
Undergoing infusion or injection-based systemic therapy intended to cure or manage the disease, as opposed to regimens delivered solely for palliative purposes, at a frequency of once every 1-4 weeks.
- For eligible patients with lymphoma, this includes, but is not limited to, commonly prescribed treatment combinations such as R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin/Hydroxydaunorubicin, Vincristine, and Prednisone) for Non-Hodgkin Lymphoma, or ABVD (Adriamycin/Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine) for Hodgkin Lymphoma-both regimens that are frequently administered every three weeks
- For patients with multiple myeloma, eligibility will include patients in the "induction" phase of chemotherapy treatment, which frequently requires patients to come in for outpatient appointments once every four weeks as well as patients in a maintenance phase of treatment that otherwise requires them to attend outpatient appointments at a frequency of every one to four weeks
- Between the ages of 18-99 at enrollment (Patients older than 99 will be excluded so that the study team is able to elicit questions from WashU ChatGPT using a standardized prompt that describes the patient's age only as specifically as a 10-year decade range (i.e., "I am a patient in my 20's, 30's, 40's, etc. Patients who are 18 or 19 years old will be described in the following manner: "I am a young adult patient in my late teens").
- Able to consent to medical care independently (does not have a legally authorized representative or documented diagnosis of cognitive impairment)
Eligibility Criteria as determined by subsequent recruitment phone call or In-person approach after a clinic appointment:
- Does not have visual impairments or English literacy limitations that would interfere with ability to engage in an intervention that requires being able to read material on an electronic device and on paper and communicate aloud during appointments with health care providers, based on patient self-report
- Able to use email (consent form will be distributed electronically through DocuSign and associated emails), based on successful completion of electronic informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: GPT-QPL: An AI-Generated, Personalized Question Prompt List
Participants will complete surveys at appointment 1 (pre-intervention) and after being provided the AI-Generated, Personalized Question Prompt List at appointment 2 (post-intervention).
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A research team member will generate a QPL that is personalized to the patient's demographics (from EHR screening and Baseline Demographic Survey) and concerns (from Distress Thermometer Problem Checklist and Interview).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in communicative self-efficacy
Time Frame: Appointment 1 (pre-intervention) and appointment 2 (post-intervention) (estimated to be 12 weeks)
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Appointment 1 (pre-intervention) and appointment 2 (post-intervention) (estimated to be 12 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in perceived amount of cancer information received as measured by an abbreviated version the EORTC QLQ - INFO25
Time Frame: Appointment 1 (pre-intervention) and appointment 2 (post-intervention) (estimated to be 12 weeks)
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Appointment 1 (pre-intervention) and appointment 2 (post-intervention) (estimated to be 12 weeks)
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Changes in satisfaction with cancer information received as measured by the EORTC QLQ - INFO25
Time Frame: Appointment 1 (pre-intervention) and appointment 2 (post-intervention) (estimated to be 12 weeks)
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Appointment 1 (pre-intervention) and appointment 2 (post-intervention) (estimated to be 12 weeks)
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Changes in the number of questions asked during appointments
Time Frame: Appointment 1 (pre-intervention) and appointment 2 (post-intervention) (estimated to be 12 weeks)
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Appointment 1 (pre-intervention) and appointment 2 (post-intervention) (estimated to be 12 weeks)
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Changes in self-reported degree of intention to use AI chatbots for healthcare tasks
Time Frame: Appointment 1 (pre-intervention) and appointment 2 (post-intervention) (estimated to be 12 weeks)
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Appointment 1 (pre-intervention) and appointment 2 (post-intervention) (estimated to be 12 weeks)
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Collaborators and Investigators
Investigators
- Principal Investigator: Jessica Hahne, MA, MPH, Washington University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Behavior
- Hemic and Lymphatic Diseases
- Neoplasms
- Lymphoma
- Multiple Myeloma
- Communication
Other Study ID Numbers
- 202509134
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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