- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06463977
Using Surveys to Examine the Association of Exposure to ML Mortality Risk Predictions With Medical Oncologists' Prognostic Accuracy and Decision-making
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Medical oncologists who treat lung cancer
Exclusion Criteria:
- Medical oncologists who do not see lung cancer patients
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1A 2B 3C
1. Intermediate; 1.A. Reference dependent; 2. Poor; 2.B.
Absolute prognosis; 3. Good; 3.C.
Both
|
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 2C 3B
1. Intermediate; 1.A. Reference dependent; 2. Poor; 2.C.
Both; 3. Good; 3.B.
Absolute prognosis
|
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.
|
1B 2A 3C
1. Intermediate; 1.B.
Absolute; 2. Poor; 2.A. Reference dependent; 3. Good; 3.C.
Both
|
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.
|
1B 2C 3A
1. Intermediate; 1.B.
Absolute; 2. Poor; 2.C.
Both; 3. Good; 3.A.
Reference dependent
|
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.
|
1C 2A 3B
1. Intermediate; 1.C.
Both; 2. Poor; 2.A. Reference dependent; 3. Good; 3.B.
Absolute
|
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.
|
1C 2B 3A
1. Intermediate; 1.C.
Both; 2. Poor; 2.B.
Absolute; 3. Good; 3.A.
Reference dependent
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prognostic accuracy as assessed via survey
Time Frame: Up to 3 months
|
Prognostic estimates were measured using two items administered after Parts 1 and 2 of each of the 3 vignettes:
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Advance care planning decisions as assessed via survey
Time Frame: Up to 3 months
|
ACP decision-making was assessed using the following item administered after Parts 1 and 2 of each of the 3 vignettes: 1) Would you have a discussion about advance care planning at this point in her disease course? Each question was operationalized as a Yes/No answer and was followed by a free response box asking, "Please share your reason for this decision." |
Up to 3 months
|
Palliative care referral as assessed via survey
Time Frame: Up to 3 months
|
Palliative care referral was assessed using the following item administered after Parts 1 and 2 of each of the 3 vignettes: 1) Would you refer him/her to a palliative care specialist at this point in her disease course? Each question was operationalized as a Yes/No answer and was followed by a free response box asking, "Please share your reason for this decision." |
Up to 3 months
|
Collaborators and Investigators
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
- UPCC 10524
- 850382 (Other Identifier: Penn IRB)
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
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