Virtual Agent Feasibility in Oncology Patients (NTT Data)

NCT ID: NCT06682013

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-08-31

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Virtual agent

Group Type: EXPERIMENTAL

Virtual agent

Intervention Type: DEVICE

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 agent

Group Type: ACTIVE_COMPARATOR

Human agent

Intervention Type: OTHER

The human agent will onboard the patient on use of the RPM devices.

Interventions

Virtual agent

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.

Intervention Type: DEVICE

Human agent

The human agent will onboard the patient on use of the RPM devices.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.

2. Age ≥18

3. Cancer (solid tumor)

4. 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.

5. Eastern Cooperative Oncology Group (ECOG) score of 0-2

6. Native fluency of spoken English as determined by the investigator

• Non-native English speakers are permitted to enroll if they have achieved native fluency.

7. 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

8. Arm circumference of 22-42 cm

Exclusion Criteria

1. 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.

2. 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.

3. Is pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Alder, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Laura Alder, MD

Role: CONTACT

laura.alder@duke.edu

919-862-5400

Facility Contacts

Julia Hurrelbrink, BA, BSN, RN

Role: primary

Other Identifiers

Pro00116186

Identifier Type: -

Identifier Source: org_study_id