Lung CancerNCT06682013
Virtual Agent Feasibility in Oncology Patients (NTT Data)
A study testing Virtual agent and Human agent in people with Lung Cancer, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to compare the use of a virtual agent vs. a human agent when onboarding oncology patients over the telephone to Remote Patient Monitoring (RPM) devices. RPM devices are instruments that a patient can use to measure their own weight and vital signs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Virtual agent and Human agent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to May 2026
- 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
- Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.
- Age ≥18
- Cancer (solid tumor)
- Planning to return to Duke Cancer Center clinic for three days in a row
- Patients whose treatment does not require that they return to clinic for three days in a row, but who are willing to voluntarily return to participate in this study are permitted to enroll.
- Eastern Cooperative Oncology Group (ECOG) score of 0-2
Show all 15Show fewer
- Native fluency of spoken English as determined by the investigator
- Non-native English speakers are permitted to enroll if they have achieved native fluency.
- Vitals as collected by the clinic using Duke maintained equipment must be within the ranges specified by the remote patient monitoring devices.
- Weight ≤ 180 kg
- Systolic blood pressure ≤ 300 mmHg
- Pulse rate of 40-200 bpm
- SpO2 of 70-100%
- Temperature 34.0-42.2°C
- Arm circumference of 22-42 cm
Who cannot join
- 1. Vision, speech, auditory, physical, cognitive or other impairment that has the potential to interfere with the use of the remote patient monitoring device or agent, in the opinion of the investigator or study coordinator.
- Has an implanted pacemaker, arterio-venus (A-V) shunt, a history of mastectomy or lymph node clearance, history of severe blood flow problems or blood disorders, or a history of severe circulatory deficit in the arm.
- Is pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Randomized Pilot Study Comparing the Feasibility of Using a Virtual Agent vs. an Off-site Human Agent to Onboard Oncology Patients to a Remote Monitoring Device
The purpose of this study is to compare the use of a virtual agent vs. a human agent when onboarding oncology patients over the telephone to Remote Patient Monitoring (RPM) devices. RPM devices are instruments that a patient can use to measure their own weight and vital signs. Both the virtual and human agents will be available by telephone to instruct the patient on how to use the RPM devices to measure weight, blood pressure, heart rate, temperature, and oxygen saturation. Patients will be randomized to either the virtual or human agent, have assessments of their medical and oncological history, overall well-being, body measurements, and vital signs, and will complete questionnaires about their experience.
- Conditions
- Lung Cancer
- Being tested
- Virtual agent, Human agent
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual agentDevice
The virtual agent is an interactive audio agent that is similar to voice agents that interact with callers in many industries today. They create a very human-like interaction in contrast to more traditional virtual call agents that can only respond to menu options (e.g. "choose "1" for appointments, choose "2" for questions about your bill", etc.). The virtual agent is engineered to accomplish the very specific task of onboarding the patient on use of the RPM devices. It is trained to understand normal human English speech, detects emotional tone and frustration of callers, and is trained to deescalate when appropriate.
Human agentOther
The human agent will onboard the patient on use of the RPM devices.
| Study group | Role | What they receive |
|---|---|---|
| Virtual agent | Experimental | Not described Receives: Device: Virtual agent |
| Human agent | Active comparator | Not described Receives: Other: Human agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of virtual agent vs. human agent for onboarding patients to RPM devices as assessed by the System Usability Scale (SUS)
The SUS is a questionnaire that assesses perceived usability. It includes 10 five-point items with alternating positive and negative tone. The final score is a number 0-100 with a higher score indicating better usability.
Measured: Day 1, Day 2, Day 3
Secondary outcomes (2)
Description of the patient experience when using a virtual agent in the context of teaching a patient as assessed by the patient experience survey.
The patient experience survey includes 3 open-ended questions about experience with the training process, input on using monitoring devices at home, and any other important information for the researchers to know. Descriptive analysis will be conducted within each arm.
Measured: Day 3
Identification of opportunities to improve the use of a virtual agent in the context of teaching a patient as assessed by the patient experience survey.
The patient experience survey includes 3 open-ended questions about experience with the training process, input on using monitoring devices at home, and any other important information for the researchers to know. Descriptive analysis will be conducted within each arm.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study startMay 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Alder, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682013
- Sponsor's protocol ID
- Pro00116186
- Status last verified
- May 2026
- First submitted
- 7 Nov 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study Comparing the Feasibility of Using a Virtual Agent vs. an Off-site Human Agent to Onboard Oncology Patients to a Remote Monitoring Device
- ClinicalTrials.gov ID
- NCT06682013
- Acronym / sponsor ID
- Pro00116186
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 12 Nov 2024 (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.
The purpose of this study is to compare the use of a virtual agent vs. a human agent when onboarding oncology patients over the telephone to Remote Patient Monitoring (RPM) devices. RPM devices are instruments that a patient can use to measure their own weight and vital signs. Both the virtual and human agents will be available by telephone to instruct the patient on how to use the RPM devices to measure weight, blood pressure, heart rate, temperature, and oxygen saturation. Patients will be randomized to either the virtual or human agent, have assessments of their medical and oncological history, overall well-being, body measurements, and vital signs, and will complete questionnaires about their experience.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual agent | Experimental | Device: Virtual agent |
| Human agent | Active comparator | Other: Human agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.
- Age ≥18
- Cancer (solid tumor)
- Planning to return to Duke Cancer Center clinic for three days in a row
- Eastern Cooperative Oncology Group (ECOG) score of 0-2
Key exclusion criteria (3 listed)
- 1. Vision, speech, auditory, physical, cognitive or other impairment that has the potential to interfere with the use of the remote patient monitoring device or agent, in the opinion of the investigator or study coordinator.
- Has an implanted pacemaker, arterio-venus (A-V) shunt, a history of mastectomy or lymph node clearance, history of severe blood flow problems or blood disorders, or a history of severe circulatory deficit in the arm.
- Is pregnant
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 |
|---|---|---|
| Virtual agentThe virtual agent is an interactive audio agent that is similar to voice agents that interact with callers in many industries today. They create a very human-like interaction in contrast to more traditional virtual call agents that can only respond to menu options (e.g. "choose "1" for appointments, choose "2" for questions about your bill", etc.). The virtual agent is engineered to accomplish the very specific task of onboarding the patient on use of the RPM devices. It is trained to understand normal human English speech, detects emotional tone and frustration of callers, and is trained to deescalate when appropriate. | Device | Virtual agent |
| Human agentThe human agent will onboard the patient on use of the RPM devices. | Other | Human agent |
Primary outcome
Usability of virtual agent vs. human agent for onboarding patients to RPM devices as assessed by the System Usability Scale (SUS)
Time frame: Day 1, Day 2, Day 3
The SUS is a questionnaire that assesses perceived usability. It includes 10 five-point items with alternating positive and negative tone. The final score is a number 0-100 with a higher score indicating better usability.
2 secondary outcomes
Description of the patient experience when using a virtual agent in the context of teaching a patient as assessed by the patient experience survey.
Time frame: Day 3
Identification of opportunities to improve the use of a virtual agent in the context of teaching a patient as assessed by the patient experience survey.
Time frame: Day 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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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.
Laura Alder, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual agent and Human agent in people with Lung Cancer, run by Duke University 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 15 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: withdrawn, as of the sponsor's last update on 29 May 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Usability of virtual agent vs. human agent for onboarding patients to RPM devices as assessed by the System Usability Scale (SUS) (time frame: Day 1, Day 2, Day 3). 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 29 May 2026.