RECRUITING

Virtual Agent Feasibility in Oncology Patients (NTT Data)

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06682013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Laura Alder, MD

CONTACT

919-862-5400

laura.alder@duke.edu

Principal Investigator

Laura Alder, MD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Duke University

Laura Alder, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09

Study Completion Date2026-08

Study Record Updates

Study Start Date2025-09

Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

Lung Cancer