Breast CancerNCT02565017
Examining Patient Preferences About the IBM Watson Oncology Clinical Decision Support System
An observational study of Breast Cancer and Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Colorectal Cancer
- What is being tested?
- Focus groups
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2015to 22 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MSKCC clinics
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
- Conditions
- Breast Cancer, Lung Cancer, Colorectal Cancer
- Being tested
- Focus groups
- Keywords
- IBM Watson, Clinical Decision Support System, Patient Preferences, 15-226
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Focus groups | |
| 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). Receives: Behavioral: Focus groups | |
| 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). Receives: Behavioral: Focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of IBM Watson Oncology
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study start15 Sep 2015
- Primary completion22 Jun 2020
- Study completion22 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jada Hamilton, PhD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565017
- Sponsor's protocol ID
- 15-226
- Status last verified
- Aug 2019
- First submitted
- 30 Sep 2015
- Last updated
- 25 Jun 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Patient Preferences About the IBM Watson Oncology Clinical Decision Support System
- ClinicalTrials.gov ID
- NCT02565017
- Acronym / sponsor ID
- 15-226
- Conditions
- Breast Cancer, Lung Cancer, Colorectal Cancer
- Keywords
- IBM Watson, Clinical Decision Support System, Patient Preferences, 15-226
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 22 Jun 2020 (actual)
- Study completion
- 22 Jun 2020 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | – | Behavioral: Focus groupsand 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). |
| Lung Cancer | – | Behavioral: Focus groupsand 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). |
| Colorectal Cancer | – | Behavioral: Focus groupsand 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSKCC clinics
Key inclusion criteria (6 listed)
- MSKCC patient 18 years or older
- Breast, lung, or colorectal cancer MSK patient as per EMR or clinician judgment having either:
- Residing in New York metro-area
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus groupsAfter 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. | Behavioural | Breast Cancer, Colorectal Cancer, Lung Cancer |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jada Hamilton, PhD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of IBM Watson Oncology (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.