Virtual Agent Feasibility in Oncology Patients (NTT Data)

NCT06682013 | Recruiting FDA Device

• 1 other identifier: Pro00116186
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  Day 3

Study Arms (2)

Virtual agent

EXPERIMENTAL

Device: Virtual agent

Human agent

ACTIVE COMPARATOR

Other: Human agent

Interventions

Virtual agent 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.

Virtual agent

Human agent OTHER

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

Human agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

reducing agent and tunicamycin-responsive protein, human

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Laura Alder, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Alder, MD

CONTACT

919-862-5400; laura.alder@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)