NCT06463977

Brief Summary

Nearly half of cancer patients in the US will receive care that is inconsistent with their wishes prior to death. Early advanced care planning (ACP) and palliative care improve goal-concordant care and symptoms and reduce unnecessary utilization. A promising strategy to increase ACP and palliative care is to identify patients at risk of mortality earlier in the disease course in order to target these services. Machine learning (ML) algorithms have been used in various industries, including medicine, to accurately predict risk of adverse outcomes and direct earlier resources. "Human-machine collaborations" - systems that leverage both ML and human intuition - have been shown to improve predictions and decision-making in various situations, but it is not known whether human-machine collaborations can improve prognostic accuracy and lead to greater and earlier ACP and palliative care. In this study, we contacted a national sample of medical oncologists and invited them complete a vignette-based survey. Our goal was to examine the association of exposure to ML mortality risk predictions with clinicians' prognostic accuracy and decision-making. We presented a series of six vignettes describing three clinical scenarios specific to a patient with advanced non-small cell lung cancer (aNSCLC) that differ by age, gender, performance status, smoking history, extent of disease, symptoms and molecular status. We will use these vignette-based surveys to examine the association of exposure to ML mortality risk predictions with medical oncologists' prognostic accuracy and decision-making.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 13, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

April 30, 2024

Last Update Submit

November 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prognostic accuracy as assessed via survey

    Prognostic estimates were measured using two items administered after Parts 1 and 2 of each of the 3 vignettes: 1. What is your anticipated life expectancy for this patient, in months? 2. What do you think is the likelihood that she will die within 12 months? Please provide a percentage on a scale of 0% to 100%. Accurate prognoses were defined as whether the reported life expectancy estimate was within 33% of the LCPI estimate, as modified after the focus groups. Participants answered the first question in months and the second question as a percentage between 0-100%.

    Up to 3 months

Secondary Outcomes (2)

  • Advance care planning decisions as assessed via survey

    Up to 3 months

  • Palliative care referral as assessed via survey

    Up to 3 months

Study Arms (6)

1A 2B 3C

1\. Intermediate; 1.A. Reference dependent; 2. Poor; 2.B. Absolute prognosis; 3. Good; 3.C. Both

Other: Survey

1A 2C 3B

1\. Intermediate; 1.A. Reference dependent; 2. Poor; 2.C. Both; 3. Good; 3.B. Absolute prognosis

Other: Survey

1B 2A 3C

1\. Intermediate; 1.B. Absolute; 2. Poor; 2.A. Reference dependent; 3. Good; 3.C. Both

Other: Survey

1B 2C 3A

1\. Intermediate; 1.B. Absolute; 2. Poor; 2.C. Both; 3. Good; 3.A. Reference dependent

Other: Survey

1C 2A 3B

1\. Intermediate; 1.C. Both; 2. Poor; 2.A. Reference dependent; 3. Good; 3.B. Absolute

Other: Survey

1C 2B 3A

1\. Intermediate; 1.C. Both; 2. Poor; 2.B. Absolute; 3. Good; 3.A. Reference dependent

Other: Survey

Interventions

SurveyOTHER

The study consisted of a 3 × 3 online factorial experiment employing a survey instrument hosted via Qualtrics presenting describing three patient vignettes. The three patient vignettes varied by various clinical characteristics including age, gender, performance status, smoking history, extent of disease, symptoms and molecular status. Each patient had advanced non-small cell lung cancer (aNSCLC). Each vignette had two parts: Part 1 described the case history for one of the three patients, after which prognostic estimates and medical decision-making was assessed (i.e. 1, 2, 3). Part 2 immediately followed and described the same vignette from the same patient with added information from a hypothetical ML predictive algorithm (i.e. A, B, C). The order of the vignettes in each survey was randomized with regard to presentation strategies for the ML risk predictions, so that there were 6 versions of the survey to which each participant was randomized.

1A 2B 3C1A 2C 3B1B 2A 3C1B 2C 3A1C 2A 3B1C 2B 3A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of a convenience sample of practicing medical oncologists who treated lung cancer in the US. We recruited medical oncologists through direct emails to the Principal Investigator's personal contacts (n=29); direct messages via Doximity, an online networking service for medical professionals (n=17), using a "thoracic oncology" ; and direct messages via X (formerly Twitter) (n=4). Efforts were taken to sample equally from 4 US geographic regions (Northeast, South, Midwest, West).

You may qualify if:

  • Medical oncologists who treat lung cancer

You may not qualify if:

  • Medical oncologists who do not see lung cancer patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2024

First Posted

June 18, 2024

Study Start

March 13, 2023

Primary Completion

July 31, 2023

Study Completion

December 31, 2023

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations