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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Behavioral: Focus groups
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).
Behavioral: Focus groups
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).
Behavioral: Focus groups
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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