Advanced Malignant Female Reproductive System NeoplasmNCT06182332
An Artificial Intelligence Algorithm for Identifying Gynecologic Cancer Patients in Need of Outpatient Palliative Care
A study testing Electronic Health Record Review and Internet-Based Intervention in people with Advanced Malignant Female Reproductive System Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial tests an artificial intelligence (AI) algorithm for its ability to identify patients who may benefit from a palliative care consult for gynecologic cancer that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Female Reproductive System Neoplasm
- What is being tested?
- Electronic Health Record Review and Internet-Based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2023to 26 Jul 2024
- Phase
- Interventional
- 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
Who may be able to join
- Adult patient in Enhanced, Electronic health record (EHR)-facilitated Cancer Symptom Control (E2C2) with a diagnosis of advanced gynecologic malignancy (International Classification of Diseases [ICD] codes C51 through C58)
- Weekly the reviewers will select patients by looking at patients in sorted order starting with the highest score and proceeding down the list and evaluating each patient for exclusion criteria
Who cannot join
- Patients that have been seen by palliative care will be excluded for 75 days
- Patients under the age of 18 years
- Patients currently enrolled with hospice
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Piloting an Artificial Intelligence Algorithm Used to Identify Patients in Need of Outpatient (or Ambulatory) Palliative Care in an Oncology Population
This clinical trial tests an artificial intelligence (AI) algorithm for its ability to identify patients who may benefit from a palliative care consult for gynecologic cancer that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A significant delay in referral to palliative care often occurs among patients with cancer. This delay can lead to poorer symptom management, decreased quality of life, and care that does not align with patient goals or values. AI algorithms are computer programs that use step-by-step procedures to solve a problem. In this trial, an AI algorithm is applied to patients' medical records in order to identify patients with a high burden of disease. Information gathered from this study may help researchers learn whether this AI algorithm is useful for identifying patients who could benefit from outpatient palliative care consultation.
Read the detailed description
PRIMARY OBJECTIVE:
- To pilot an oncology risk prediction model to identify patients who may benefit from outpatient palliative care consultation to improve symptom management and goal-concordant care in this population.
OUTLINE:
Patients' medical records are reviewed for consideration of palliative care consult using AI algorithm once a week (QW) for 6 months.
- Being tested
- Electronic Health Record Review, Internet-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Undergo medical record review
Internet-Based InterventionOther
Use AI algorithm
| Study group | Role | What they receive |
|---|---|---|
| Screening (AI algorithm) | Experimental | Patients' medical records are reviewed for consideration of palliative care consult using AI algorithm QW for 6 months. Receives: Other: Electronic Health Record Review; Other: Internet-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timely identification for need of palliative care
Will be measured as time to the electronic record of consult by the palliative care team in the outpatient setting.
Measured: Up to 6 months
Secondary outcomes (5)
Number of palliative care consultations
Number of palliative care consultations will be assessed as the number of participants who receive palliative care consultations.
Measured: Up to 6 months
Number of advanced care planning notes documented in the electronic health record
Participant electronic health records will be reviewed for the number of advanced care planning notes listed.
Measured: Up to 6 months
Number of billing codes International Classification of Diseases, 10th Revision for palliative care
Participant electronic health records will be reviewed for the number of International Classification of Diseases, 10th Revision (ICD-10) billing codes for palliative care.
Measured: Up to 6 months
Positive predictive value of screened patients
Will be assessed as the number of patients identified by Artificial Intelligence algorithm who actually received palliative care consultation.
Measured: Up to 6 months
Performance metrics on reviewer/oncologist handoff
Will be assessed by agreement statistics and descriptive statistics on time between oncology contact and oncology response.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start11 Dec 2023
- Primary completion26 Jun 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Female Reproductive System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel D. Havyer, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182332
- Sponsor's protocol ID
- 23-008371
- Other IDs
- NCI-2023-09943, 23-008371
- Status last verified
- Apr 2025
- First submitted
- 8 Dec 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting an Artificial Intelligence Algorithm Used to Identify Patients in Need of Outpatient (or Ambulatory) Palliative Care in an Oncology Population
- ClinicalTrials.gov ID
- NCT06182332
- Acronym / sponsor ID
- 23-008371
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 26 Dec 2023 (actual)
- 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.
This clinical trial tests an artificial intelligence (AI) algorithm for its ability to identify patients who may benefit from a palliative care consult for gynecologic cancer that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A significant delay in referral to palliative care often occurs among patients with cancer. This delay can lead to poorer symptom management, decreased quality of life, and care that does not align with patient goals or values. AI algorithms are computer programs that use step-by-step procedures to solve a problem. In this trial, an AI algorithm is applied to patients' medical records in order to identify patients with a high burden of disease. Information gathered from this study may help researchers learn whether this AI algorithm is useful for identifying patients who could benefit from outpatient palliative care consultation.
Detailed description
PRIMARY OBJECTIVE:
- To pilot an oncology risk prediction model to identify patients who may benefit from outpatient palliative care consultation to improve symptom management and goal-concordant care in this population.
OUTLINE:
Patients' medical records are reviewed for consideration of palliative care consult using AI algorithm once a week (QW) for 6 months.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (AI algorithm) | Experimental | Other: Electronic Health Record Review, Other: Internet-Based InterventionPatients' medical records are reviewed for consideration of palliative care consult using AI algorithm QW for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient in Enhanced, Electronic health record (EHR)-facilitated Cancer Symptom Control (E2C2) with a diagnosis of advanced gynecologic malignancy (International Classification of Diseases [ICD] codes C51 through C58)
- Weekly the reviewers will select patients by looking at patients in sorted order starting with the highest score and proceeding down the list and evaluating each patient for exclusion criteria
Key exclusion criteria (3 listed)
- Patients that have been seen by palliative care will be excluded for 75 days
- Patients under the age of 18 years
- Patients currently enrolled with hospice
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 |
|---|---|---|
| Electronic Health Record ReviewUndergo medical record review | Other | Screening (AI algorithm) |
| Internet-Based InterventionUse AI algorithm | Other | Screening (AI algorithm) |
Primary outcome
Timely identification for need of palliative care
Time frame: Up to 6 months
Will be measured as time to the electronic record of consult by the palliative care team in the outpatient setting.
5 secondary outcomes
Number of palliative care consultations
Time frame: Up to 6 months
Number of advanced care planning notes documented in the electronic health record
Time frame: Up to 6 months
Number of billing codes International Classification of Diseases, 10th Revision for palliative care
Time frame: Up to 6 months
Positive predictive value of screened patients
Time frame: Up to 6 months
Performance metrics on reviewer/oncologist handoff
Time frame: Up to 6 months
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 4 Apr 2025.
- Mayo Clinic Clinical TrialsLink 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.
Rachel D. Havyer, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Health Record Review and Internet-Based Intervention in people with Advanced Malignant Female Reproductive System Neoplasm, run by Mayo Clinic 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 2 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 4 Apr 2025. 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?
Timely identification for need of palliative care (time frame: Up to 6 months). 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 4 Apr 2025; AzTrials last refreshed its copy on 30 Oct 2026.