Phone-based virtual helper versus human caller for starting home remote monitoring.

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

This tests whether a phone-based virtual agent or a human caller is easier and more helpful for onboarding adults with lung cancer to home devices that measure weight and vital signs.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Duke University (other)
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT06682013 on ClinicalTrials.gov

What this trial studies

Adults with lung cancer who meet eligibility are randomized to receive telephone onboarding from either a virtual agent or a human agent. Both agents will instruct patients on how to use remote patient monitoring devices to measure weight, blood pressure, heart rate, temperature, and oxygen saturation. Participants will have medical and oncologic history, body measurements, and vital signs recorded during clinic visits and will complete questionnaires about their onboarding experience and overall well-being. The study is focused on feasibility and patient experience comparing the two onboarding methods.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with lung cancer treated at Duke, ECOG performance status 0–2, native or native-level spoken English, able to return to clinic for three consecutive days (or willing to do so), and who meet device limits for weight, vitals, and arm circumference.

Not a fit: Patients who are not fluent in spoken English, have ECOG >2, have vitals or arm measurements outside the device limits, or cannot attend the required Duke clinic visits are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, a virtual phone agent could make it easier and faster for patients to start home monitoring while reducing staff time and clinic burden.

How similar studies have performed: Remote patient monitoring programs and automated agents have shown promise for adherence and patient satisfaction in chronic and oncologic care, but head-to-head comparisons of virtual agents versus human callers are still limited.

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

Where this trial is running

Durham, North Carolina

• Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Laura Alder, MD — Duke University
• Study coordinator: Laura Alder, MD

Conditions: Lung Cancer