- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07526441
Use and Acceptance of Large Language Models for Cancer Shared Decision-Making
Use and Acceptance of Large Language Models in Oncological Shared Decision-Making Among Patients, the Public, and Healthcare Professionals
Study Overview
Status
Conditions
Detailed Description
Shared decision-making is a collaborative process in which clinicians support patients in reaching treatment decisions. Despite its importance in oncology, structured shared decision-making remains uncommon in routine clinical practice. Large language models offer a new way for patients to access and understand medical information, yet little is known about how key stakeholders perceive and use these tools for health decisions.
This observational study used a sequential mixed-methods design combining Delphi consensus methodology with cross-sectional survey deployment. A 44-expert panel across eight domains (clinical artificial intelligence, technical development, oncology, psychology, epidemiology, patient advocacy, ethics, and legal expertise) developed and validated the assessment instrument through two Delphi rounds, achieving consensus on 89 items. The final instrument contained 52 quantitative items and 8 qualitative prompts, distinguishing between general and healthcare-specific large language model use.
The study recruited three cohorts: 2,316 cancer patients with self-reported diagnosis within five years, 2,000 general population members from the United States and United Kingdom, and 2,835 licensed healthcare professionals. Quality control included attention checks, completion time monitoring, consistency validation, and verification procedures, resulting in exclusion of 694 responses (8.8%) from an initial 7,845.
Primary analyses included chi-squared testing and ANOVA with Bonferroni correction, multivariable logistic regression with hierarchical model building to identify adoption predictors, and user segmentation through cross-tabulation combined with k-means clustering. The study was approved by the institutional review board of the Technical University of Munich (TUM2024-89-S-SB).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bavaria
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Munich, Bavaria, Germany, 81675
- Technical University Munich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years or older
- English language proficiency
- Regular internet access
- Registered on the Prolific research platform
- For cancer patient cohort: self-reported cancer diagnosis within the past five years
- For healthcare professional cohort: licensed healthcare practitioner with active patient contact
- For general population cohort: resident of the United States or United Kingdom
Exclusion Criteria:
- Failure on embedded attention check questions (4 checks)
- Survey completion time less than 5 minutes or greater than 60 minutes
- Straight-line responding pattern detected by consistency validation algorithms
- Failure of cohort verification procedures
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cancer Patients
Adults aged 18 years or older with a self-reported cancer diagnosis within the past five years, recruited through the Prolific platform with verification through screening questions about diagnosis date, cancer type, and treatment status.
n=2,316.
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General Population
Adults aged 18 years or older from the United States and United Kingdom with no specific health condition requirement, recruited through the Prolific platform with stratified sampling quotas for age, gender, ethnicity, and education.
n=2,000.
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Healthcare Professionals
Licensed healthcare practitioners aged 18 years or older with active patient contact, including physicians and nursing staff, recruited through the Prolific platform from the United States, United Kingdom, and 28 additional countries.
n=2,835.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Healthcare-specific large language model usage rate
Time Frame: At time of survey completion (single assessment, March-May 2025)
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Proportion of participants reporting use of large language models specifically for health-related information, measured on a 5-point Likert frequency scale and dichotomised as use versus non-use.
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At time of survey completion (single assessment, March-May 2025)
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Future belief in large language model improvement of shared decision-making
Time Frame: At time of survey completion (single assessment, March-May 2025)
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Proportion of participants believing that large language models will improve the quality of shared decision-making in oncology, assessed via Likert-scale response.
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At time of survey completion (single assessment, March-May 2025)
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Barriers to large language model adoption
Time Frame: At time of survey completion (single assessment, March-May 2025)
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Prevalence of concerns regarding large language model use for health decisions, including reliability concerns, privacy concerns, and preference for human interaction, each assessed as binary (present or absent).
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At time of survey completion (single assessment, March-May 2025)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Independent predictors of large language model adoption
Time Frame: At time of survey completion (single assessment, March-May 2025)
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Odds ratios from hierarchical multivariable logistic regression identifying demographic and health-related predictors of healthcare-specific large language model acceptance, including age, sex, ethnicity, education, digital literacy, and confidence in understanding health information.
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At time of survey completion (single assessment, March-May 2025)
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User segmentation
Time Frame: At time of survey completion (single assessment, March-May 2025)
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Distribution of participants across data-driven user segments derived from cross-tabulation of current usage with perceived benefit, refined through k-means clustering: potential adopters, believing users, resistant non-users, and sceptical users.
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At time of survey completion (single assessment, March-May 2025)
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Healthcare professional recommendation patterns
Time Frame: At time of survey completion (single assessment, March-May 2025)
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Proportion of healthcare professionals who recommend large language models to patients for health information, compared with their personal use rate.
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At time of survey completion (single assessment, March-May 2025)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- LLM-SDM-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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