ChatBot and Activity Monitoring in Patients Undergoing Chemoradiotherapy

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05318027
Collaborator
(none)
70
2
6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: ChatBot
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
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
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of triage visits [13 weeks]

    Difference between Poisson event rates of triage visits between intervention and control arms

Secondary Outcome Measures

  1. Count of unplanned inpatient hospitalization [13 weeks]

  2. Count of treatment breaks [13 weeks]

  3. Count of emergency department visits [13 weeks]

  4. Quality of Life scores [13 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Abramson Cancer Center of the University of Pennsylvania

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05318027
Other Study ID Numbers:
  • UPCC 18921
First Posted:
Apr 8, 2022
Last Update Posted:
Jun 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 6, 2022