Virtual Agent Feasibility in Oncology Patients (NTT Data)

Duke University

Status: Enrolling

Conditions: Lung Cancer

Treatments: Device: Virtual agent; Other: Human agent

Study type: Interventional

Funder types: Other

Identifiers

NCT06682013

Pro00116186

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Virtual agent

Experimental group

Treatment:

Device: Virtual agent

Human agent

Active Comparator group

Treatment:

Other: Human agent