- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02565017
Examining Patient Preferences About the IBM Watson Oncology Clinical Decision Support System
June 23, 2020 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to learn what cancer patients think about IBM Watson Oncology.
IBM Watson Oncology is a computer program designed to help inform oncologists about the best chemotherapy choices for their patients.
The investigators will conduct focus groups with cancer patients who have received chemotherapy treatment at MSK in order to understand cancer patients' thoughts about IBM Watson Oncology.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
MSKCC clinics
Description
Inclusion Criteria:
- MSKCC patient 18 years or older
Breast, lung, or colorectal cancer MSK patient as per EMR or clinician judgment having either:
- Chemotherapeutic adjuvant or neoadjuvant treatment with the first chemo visit occurring within the past 8 months and primary treatment (i.e., surgery), occurring within the past 6 months)at MSK
- OR chemotherapeutic treatment for metastatic disease with the first chemo visit occurring within the past 8 months at MSK
- OR chemotherapeutic treatment through an on-going MSK clinical trial as per clinician
- Residing in New York metro-area
Exclusion Criteria:
- Non-English speakers because we do not have the resources to conduct and translate the focus groups into other languages
- Patients who are not or will not receive their cancer care at MSKCC.
- Patient unwilling or unable to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Breast Cancer
and treatment type (chemotherapeutic adjuvant (i.e., chemotherapy delivered after primary therapy/surgery) or neoadjuvant (i.e., chemotherapy delivered prior to primary therapy/surgery) treatment, chemotherapeutic treatment for metastatic disease, or chemotherapeutic treatment through a clinical trial).
|
After the presentation of the of IBM Watson Oncology at the opening of the focus group, participants will be asked to fill out a de-identified brief 15-item questionnaire to assess participants' first impressions of IBM Watson Oncology.
The questionnaire will be self administered, and will take approximately 5 minutes to complete.
Completed questionnaires will be collected by a member of the study staff, and the focus group will proceed with introductions.
The focus group will be audio recorded from the completion of the introductions and notes will be taken.
The focus group guide will address the study aims.
At the end of the focus group, participants will complete a 7-item questionnaire to capture simple demographic information including education, income, and health literacy.
This questionnaire will take 3-5 minutes to complete.
|
|
Lung Cancer
and treatment type (chemotherapeutic adjuvant (i.e., chemotherapy delivered after primary therapy/surgery) or neoadjuvant (i.e., chemotherapy delivered prior to primary therapy/surgery) treatment, chemotherapeutic treatment for metastatic disease, or chemotherapeutic treatment through a clinical trial).
|
After the presentation of the of IBM Watson Oncology at the opening of the focus group, participants will be asked to fill out a de-identified brief 15-item questionnaire to assess participants' first impressions of IBM Watson Oncology.
The questionnaire will be self administered, and will take approximately 5 minutes to complete.
Completed questionnaires will be collected by a member of the study staff, and the focus group will proceed with introductions.
The focus group will be audio recorded from the completion of the introductions and notes will be taken.
The focus group guide will address the study aims.
At the end of the focus group, participants will complete a 7-item questionnaire to capture simple demographic information including education, income, and health literacy.
This questionnaire will take 3-5 minutes to complete.
|
|
Colorectal Cancer
and treatment type (chemotherapeutic adjuvant (i.e., chemotherapy delivered after primary therapy/surgery) or neoadjuvant (i.e., chemotherapy delivered prior to primary therapy/surgery) treatment, chemotherapeutic treatment for metastatic disease, or chemotherapeutic treatment through a clinical trial).
|
After the presentation of the of IBM Watson Oncology at the opening of the focus group, participants will be asked to fill out a de-identified brief 15-item questionnaire to assess participants' first impressions of IBM Watson Oncology.
The questionnaire will be self administered, and will take approximately 5 minutes to complete.
Completed questionnaires will be collected by a member of the study staff, and the focus group will proceed with introductions.
The focus group will be audio recorded from the completion of the introductions and notes will be taken.
The focus group guide will address the study aims.
At the end of the focus group, participants will complete a 7-item questionnaire to capture simple demographic information including education, income, and health literacy.
This questionnaire will take 3-5 minutes to complete.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of IBM Watson Oncology
Time Frame: 1 year
|
Data collected through the brief questionnaires (e.g.,initial impressions of IBM Watson Oncology, sociodemographics) will be entered into an SPSS data file on the secure MSK server.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2015
Primary Completion (Actual)
June 22, 2020
Study Completion (Actual)
June 22, 2020
Study Registration Dates
First Submitted
September 30, 2015
First Submitted That Met QC Criteria
September 30, 2015
First Posted (Estimate)
October 1, 2015
Study Record Updates
Last Update Posted (Actual)
June 25, 2020
Last Update Submitted That Met QC Criteria
June 23, 2020
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-226
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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