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Search / Trial NCT06682013

Virtual Agent Feasibility in Oncology Patients (NTT Data)

Launched by DUKE UNIVERSITY · Nov 7, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring whether a virtual assistant or a human agent is better at helping patients with lung cancer learn how to use Remote Patient Monitoring (RPM) devices over the phone. RPM devices allow patients to measure important health information like weight, blood pressure, heart rate, temperature, and oxygen levels from home. Patients participating in the study will be randomly assigned to either the virtual or human agent and will receive guidance on using the devices. They will also have their medical history assessed and answer questions about their experience.

To be eligible for this trial, participants must be at least 18 years old, have a diagnosis of lung cancer, and be willing to return to the Duke Cancer Center for three consecutive days. They should also be able to communicate in English and meet certain health criteria, such as having specific vital sign measurements. It's important to note that the trial is not yet recruiting participants, but once it begins, those who join can expect to receive support in managing their health through these devices while contributing to research that may improve patient onboarding in the future.

Gender

ALL

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. Lung cancer
  • 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. Vision, speech or auditory impairment that has the potential to interfere with the use of the remote patient monitoring device or agent, in the opinion of the investigator.
  • 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
  • 4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the investigator.

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Patients applied

0 patients applied

Trial Officials

Laura Alder, MD

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported