ChatBot and Activity Monitoring in Patients Undergoing Chemoradiotherapy

March 6, 2024 updated by: Abramson Cancer Center at Penn Medicine

Use of Natural Language Processing ChatBot and Automated Continuous Activity Monitoring Via Mobile Phones for Early Detection and Management of Symptoms in Patients Undergoing Cancer Treatment

Evaluate the feasibility of using a chatbot combined with continuous activity monitoring to proactively identify, appropriately triage and help manage patients' symptoms during cancer treatment Determine whether such an early outpatient clinic-based intervention can decrease rates of excess triage visits

Correlate changes in activity and early symptom management to emergency department visits, unplanned inpatient hospitalizations and treatment breaks

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults (age >18 years) with a diagnosis of a head and neck, lung, gastrointestinal cancer, that are receiving concurrent chemotherapy and radiation treatment.
  • Possession of a mobile device that can receive SMS texts and can deliver FitBit data wirelessly
  • Ability read and respond in English
  • Ability to provide informed consent to participate in the study

Exclusion Criteria:

  • Patients who are bed bound at baseline (ECOG 4)
  • Patients who rely on a wheelchair for ambulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Activity Monitoring and ChatBot
Patients will receive standard of care chemotherapy and radiation therapy regimens, activity monitoring and utilize a ChatBot
Device: ChatBot
The automated chatbot will check in with the patient on two pre-specified days between scheduled outpatient visits. The chatbot will follow pre-specified symptom algorithms and classify symptoms as requiring high, intermediate and low risk follow ups. High risk symptoms will trigger a same day nursing/physician visit or telemedicine call/video. Intermediate risk symptoms will trigger a nursing triage visit or telemedicine call/video on the next day or treatment day. Low risk symptoms will notify the treating physician to address the symptoms at the next scheduled on treatment visit (OTV). If adjustments are needed in the chat bot triage algorithms, they will be updated in real time to decrease risk for adverse patient events.
No Intervention: Activity Monitoring without ChatBot
Patients will receive standard of care chemotherapy and radiation therapy regimens, activity monitoring alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of triage visits
Time Frame: 13 weeks
Difference between Poisson event rates of triage visits between intervention and control arms
13 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Count of unplanned inpatient hospitalization
Time Frame: 13 weeks
13 weeks
Count of treatment breaks
Time Frame: 13 weeks
13 weeks
Count of emergency department visits
Time Frame: 13 weeks
13 weeks
Quality of Life scores
Time Frame: 13 weeks
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Investigators

  • Principal Investigator: Arun Goel, MD, University of Pennsylvania
  • Principal Investigator: Kristine Kim, MD, University of Pennsylvania
  • Principal Investigator: Nishant Shah, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

May 22, 2023

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

December 6, 2021

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 18921

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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