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Recruiting NCT07226934

An AI-Generated, Personalized Question Prompt List Intervention for Patients With Hematologic Cancers

No phase Interventional Lymphoma Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GPT-QPL.
Who it may be relevant to
Registry conditions: Lymphoma, Multiple Myeloma. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Feasibility and Preliminary Efficacy of GPT-QPL: An AI-Generated, Personalized Question Prompt List Intervention for Patients With Hematologic Cancers

Overview

The goal of this study is to evaluate the feasibility and preliminary efficacy of an artificial intelligence (AI)-generated personalized question prompt list (a list of suggested questions to ask during outpatient appointments) for patients with hematologic cancers. The intervention will involve tailoring a standardized prompt to patients' individual characteristics and concerns. This prompt will then be used to ask Washington University's (WashU) HIPAA compliant ChatGPT to generate personalized question lists for outpatient appointments. Analyses will assess the impact of personalized QPLs on patients' question-asking behavior; communicative self-efficacy; and self-reported amount and satisfaction with information obtained about their disease and its treatment. Sub-analyses will explore patterns in questions generated by WashU ChatGPT. Patients will also provide feedback pertaining to the perceived helpfulness and ease-of-use of WashU-ChatGPT-generated question lists, as well as their attitudes and intentions regarding use of AI chatbots and whether they would engage in pre-appointment AI-assisted question brainstorming independently in the future.

Interventions

  • Other GPT-QPL
    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).

Primary outcome measures

  • Changes in communicative self-efficacy [Time frame: Appointment 1 (pre-intervention) and appointment 2 (post-intervention) (estimated to be 12 weeks)]
Secondary outcome measures (4)
  • 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)]
  • 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)]
  • 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)]
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Identifiers

NCT: NCT07226934 · 202509134

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗