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ChatBot and Activity Monitoring in Patients Undergoing Chemoradiotherapy

Primary Purpose

Lung Cancer, Gastrointestinal Cancer, Head and Neck Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ChatBot

About this trial

This is an interventional other trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Abramson Cancer Center of the University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Activity Monitoring and ChatBot

Activity Monitoring without ChatBot

Arm Description

Patients will receive standard of care chemotherapy and radiation therapy regimens, activity monitoring and utilize a ChatBot

Patients will receive standard of care chemotherapy and radiation therapy regimens, activity monitoring alone

Outcomes

Primary Outcome Measures

Number of triage visits

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

Secondary Outcome Measures

Count of unplanned inpatient hospitalization

Count of treatment breaks

Count of emergency department visits

Quality of Life scores

Full Information

NCT ID

NCT05318027

First Posted

December 6, 2021

Last Updated

July 19, 2023

Sponsor

Abramson Cancer Center at Penn Medicine

1. Study Identification

Unique Protocol Identification Number

NCT05318027

Brief Title

ChatBot and Activity Monitoring in Patients Undergoing Chemoradiotherapy

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 22, 2023 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Gastrointestinal Cancer, Head and Neck Cancer

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Activity Monitoring and ChatBot

Arm Type

Experimental

Arm Description

Patients will receive standard of care chemotherapy and radiation therapy regimens, activity monitoring and utilize a ChatBot

Arm Title

Activity Monitoring without ChatBot

Arm Type

No Intervention

Arm Description

Patients will receive standard of care chemotherapy and radiation therapy regimens, activity monitoring alone

Intervention Type

Device

Intervention Name(s)

ChatBot

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of triage visits

Description

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

Time Frame

13 weeks

Secondary Outcome Measure Information:

Title

Count of unplanned inpatient hospitalization

Time Frame

13 weeks

Title

Count of treatment breaks

Time Frame

13 weeks

Title

Count of emergency department visits

Time Frame

13 weeks

Title

Quality of Life scores

Time Frame

13 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michell Kim

Phone

215-760-2487

Michell.Kim@pennmedicine.upenn.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arun Goel, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kristine Kim, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nishant Shah, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abramson Cancer Center of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arun Goel, MD

Phone

215-662-6059

Arun.Goel@pennmedicine.upenn.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27413701

Citation

Uyterlinde W. Overcoming toxicity-challenges in chemoradiation for non-small cell lung cancer. Transl Lung Cancer Res. 2016 Jun;5(3):239-43. doi: 10.21037/tlcr.2016.05.03.

Results Reference

background

PubMed Identifier

26514533

Citation

Ghosh S, Rao PB, Kumar PR, Manam S. Concurrent Chemoradiation with Weekly Cisplatin for the Treatment of Head and Neck Cancers: an Institutional Study on Acute Toxicity and Response to Treatment. Asian Pac J Cancer Prev. 2015;16(16):7331-5. doi: 10.7314/apjcp.2015.16.16.7331.

Results Reference

background

PubMed Identifier

24485047

Citation

Haj Mohammad N, Hulshof MC, Bergman JJ, Geijsen D, Wilmink JW, van Berge Henegouwen MI, van Laarhoven HW. Acute toxicity of definitive chemoradiation in patients with inoperable or irresectable esophageal carcinoma. BMC Cancer. 2014 Jan 31;14:56. doi: 10.1186/1471-2407-14-56.

Results Reference

background

PubMed Identifier

25413398

Citation

Waddle MR, Chen RC, Arastu NH, Green RL, Jackson M, Qaqish BF, Camporeale J, Collichio FA, Marks LB. Unanticipated hospital admissions during or soon after radiation therapy: Incidence and predictive factors. Pract Radiat Oncol. 2015 May-Jun;5(3):e245-e253. doi: 10.1016/j.prro.2014.08.004. Epub 2014 Sep 17.

Results Reference

background

PubMed Identifier

20351327

Citation

Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.

Results Reference

background

PubMed Identifier

19528407

Citation

Lang K, Sussman M, Friedman M, Su J, Kan HJ, Mauro D, Tafesse E, Menzin J. Incidence and costs of treatment-related complications among patients with advanced squamous cell carcinoma of the head and neck. Arch Otolaryngol Head Neck Surg. 2009 Jun;135(6):582-8. doi: 10.1001/archoto.2009.46.

Results Reference

background

PubMed Identifier

28387544

Citation

Beg MS, Gupta A, Stewart T, Rethorst CD. Promise of Wearable Physical Activity Monitors in Oncology Practice. J Oncol Pract. 2017 Feb;13(2):82-89. doi: 10.1200/JOP.2016.016857.

Results Reference

background

PubMed Identifier

16818906

Citation

McNeely ML, Campbell KL, Rowe BH, Klassen TP, Mackey JR, Courneya KS. Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. CMAJ. 2006 Jul 4;175(1):34-41. doi: 10.1503/cmaj.051073.

Results Reference

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ChatBot and Activity Monitoring in Patients Undergoing Chemoradiotherapy

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